Drugs Details

Drugs Info of Implanon, Nexplanon
Drugs Details
  • Drugs Type  : Multum
  • Date : 17th Feb 2015 01:00 am
  • Brand Name : Implanon, Nexplanon
  • Generic Name : etonogestrel (implant) (Pronunciation: e toe noe JES trel)
Descriptions

IMPLANON (etonogestrel implant) is a progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 22). Each implant consists of an ethylene vinylacetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel, surrounded by an EVA copolymer skin. Once inserted subdermally, the release rate is 60 to 70 mcg/day in Week 5 to 6 and decreases to approximately 35 to 45 mcg/day at the end of the first year, to approximately 30 to 40 mcg/day at the end of the second year, and then to approximately 25 to 30 mcg/day at the end of the third year. IMPLANON is a progestin-only contraceptive and does not contain estrogen. IMPLANON does not contain latex and is not radio-opaque.

Figure 22 (Not to scale)

The implant - Illustration

 

Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one], structurally derived from 19­nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula (Figure 23).

Figure 23

IMPLANON® (etonogestrel) Structural Formula Illustration

 

 

What are the possible side effects of etonogestrel implant (Implanon, Nexplanon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • warmth, redness, swelling, or oozing where the implant was inserted;
  • sudden numbness or weakness, especially on one side of the body;
  • severe pain or cramping in your pelvic area (may be only on one side);
  • sudden severe headache, confusion, pain behind the eyes, problems with vision, speech, or...

Read All Potential Side Effects and See Pictures of Implanon »

What are the precautions when taking etonogestrel implant (Implanon)?

Before having the rod placed, tell your doctor or pharmacist if you are allergic to etonogestrel; or to other progestins; or to any anesthetics or antiseptics that might be used in the procedure; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abnormal breast exam, blood clots (e.g., in the legs, eyes, lungs), breast cancer, depression, high blood pressure, low levels of "good" cholesterol (HDL), diabetes, gall bladder disease, heart disease (e.g., chest pain, heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth...

Read All Potential Precautions of Implanon »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

IMPLANON® is indicated for use by women to prevent pregnancy.

Dosage Administration

The efficacy of IMPLANON does not depend on daily, weekly or monthly administration.

All healthcare providers should receive instruction and training prior to performing insertion and/or removal of IMPLANON.

A single IMPLANON implant is inserted subdermally in the upper arm. To reduce the risk of neural or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medialepicondyle of the humerus. The implant should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissues in the sulcus between the triceps and biceps muscles. IMPLANON must be inserted by the expiration date stated on the packaging. IMPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

Initiating Contraception With IMPLANON

IMPORTANT: Rule out pregnancy before inserting the implant.

Timing of insertion depends on the woman's recent contraceptive history, as follows:

  • No preceding hormonal contraceptive use in the past month

IMPLANON should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

  • Switching contraceptive method to IMPLANON
Combination Hormonal Contraceptives

IMPLANON should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of the removal of the vaginal ring or transdermal patch. At the latest, IMPLANON should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

Progestin-only Contraceptives

There are several types of progestin-only methods. IMPLANON should be inserted as follows:

  • Injectable Contraceptives: Insert IMPLANON on the day the next injection is due.
  • Minipill: A woman may switch to IMPLANON on any day of the month. IMPLANON should be inserted within 24 hours after taking the last tablet.
  • Contraceptive implant or intrauterine system (IUS): Insert IMPLANON on the same day as the previous contraceptive implant or IUS is removed.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

  • Following abortion or miscarriage
    • First Trimester: IMPLANON should be inserted within 5 days following a first trimester abortion or miscarriage.
    • Second Trimester: Insert IMPLANON between 21 to 28 days following second trimester abortion or miscarriage.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

  • Postpartum
    • Not Breastfeeding: IMPLANON should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
    • Breastfeeding: IMPLANON should be inserted after the fourth postpartum week [see Use In Specific Populations]. The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

Insertion Of IMPLANON

The basis for successful use and subsequent removal of IMPLANON is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Both the healthcare provider and the woman should be able to feel the implant under the skin after placement.

All healthcare providers performing insertions and/or removals of IMPLANON should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of IMPLANON will be sent upon request free of charge [1-877-IMPLANON (1-877-467-5266)].

Preparation

Prior to inserting IMPLANON carefully read the instructions for insertion as well as the full prescribing information.

Before insertion of IMPLANON, the healthcare provider should confirm that:

  • The woman is not pregnant nor has any other contraindication for the use of IMPLANON [see CONTRAINDICATIONS].
  • The woman has had a medical history and physical examination, including a gynecologic examination, performed.
  • The woman understands the benefits and risks of IMPLANON.
  • The woman has received a copy of the Patient Labeling included in packaging.
  • The woman has reviewed and completed a consent form to be maintained with the woman's chart.
  • The woman does not have allergies to the antiseptic and anesthetic to be used during insertion.

Insert IMPLANON under aseptic conditions.

The following equipment is needed for the implant insertion:

  • An examination table for the woman to lie on
  • Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional)
  • Local anesthetic, needles, and syringe
  • Sterile gauze, adhesive bandage, pressure bandage

An applicator and its parts are shown below (Figures 1a and 1b).

Figure 1a (Not to scale)

View Enlarged Table

 

Figure 1b

Grooved tip of obturator - Illustration

Grooved tip of obturator (enlarged)

 

The procedure used for IMPLANON insertion is opposite from that of an injection. The obturator keeps IMPLANON in place while the cannula is retracted. The obturator must remain fixed in place while the cannula with needle is retracted from the arm. Do not push the obturator.

Insertion Procedure

Step 1. Have the woman lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head (Figure 2).

Figure 2

Positioning the woman - Illustration

 

Step 2. Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus (Figure 3). The implant should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissue in the sulcus between the triceps and biceps muscles[see WARNINGS AND PRECAUTIONS].

Step 3. Make two marks with a sterile marker: first, mark the spot where the etonogestrel implant will be inserted, and second, mark a spot a few centimetersproximal to the first mark (Figure 3). This second mark will later serve as a direction guide during insertion.

Figure 3

Identify the insertion site - Illustration

 

Step 4. Clean the insertion site with an antiseptic solution.

Step 5. Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 mL of 1% lidocaine just under the skin along the planned insertion tunnel).

Step 6. Remove the sterile pre-loaded disposable IMPLANON applicator carrying the implant from its blister. Keep the IMPLANON needle and rod sterile. The applicator should not be used if sterility is in question. If contamination occurs, use a new package of IMPLANON with a new sterile applicator.

Step 7. Keep the shield on the needle and look for the IMPLANON rod, seen as a white cylinder inside the needle tip.

Step 8. If you don't see the IMPLANON rod, tap the top of the needle shield against a firm surface to bring the implant into the needle tip.

Step 9. Following visual confirmation, lower the IMPLANON rod back into the needle by tapping it back into the needle tip. Then remove the needle shield, while holding the applicator upright.

Step 10. Note that IMPLANON can fall out of the needle. Therefore, after you remove the needle shield, keep the applicator in the upright position until the moment of insertion

Step 11. With your free hand, stretch the skin around the insertion site with thumb and index finger (Figure 4).

Step 12. At a slight angle (not greater than 20°), insert only the tip of the needle with the beveled side up into the insertion site (Figure 5).

Figure 4

Stretch the skin around the insertion site - Illustration

 

Step 13. Lower the applicator to a horizontal position. Lift the skin up with the tip of the needle, but keep the needle in the subdermal connective tissue (Figure 6).

Figure 5

Insert only the tip of the needle - Illustration

 

Step 13. Lower the applicator to a horizontal position. Lift the skin up with the tip of the needle, but keep the needle in the subdermal connective tissue (Figure 6).

Figure 6

Lift the skin up with the tip of the needle - Illustration

 

Step 14. While “tenting” (lifting) the skin, gently insert the needle to its full length. Keep the needle parallel to the surface of the skin during insertion (Figure 7).

Figure 7

Insert the needle to its full length - Illustration

 

Step 15. If IMPLANON is placed too deeply, the removal process can be difficult or impossible. If the needle is not inserted to its full length, the implant may protrude from the insertion site and fall out.

Step 16. Break the seal of the applicator by pressing the obturator support (Figure 8).

Figure 8

Break the seal of the applicator - Illustration

 

Step 17. Turn the obturator 90° in either direction with respect to the needle (Figure 9).

Figure 9

Turn the obturator to either side - Illustration

 

Step 18. While holding the obturator fixed in place on the arm, fully retract thecannula (Figure 10). Note: This procedure is opposite from an injection. Do not push the obturator. By holding the obturator fixed in place on the arm and fully retracting the cannula, the implant will be left in its correct subdermal position. Do not simultaneously retract the obturator and cannula from the patient's arm.

Figure 10

Fully retract the cannula - Illustration

 

In this figure, the right hand is holding the obturator in place while the left hand is retracting the cannula.

Step 19. Confirm that the implant has been inserted by checking the tip of the needle for the absence of the implant. After insertion of the implant, the grooved tip of the obturator will be visible inside the needle (Figure 11).

Figure 11

Confirm that the implant has been inserted - Illustration

 

Step 20. Always verify the presence of the implant in the woman's arm immediately after insertion by palpation. By palpating both ends of the implant, you should be able to confirm the presence of the 4-cm rod (Figure 12).

Figure 12

Verify the presence of the implant - Illustration

 

If you cannot feel the implant or are in doubt of its presence,

  • Check the tip of the needle for the absence of the implant. After insertion of the implant, the grooved tip of the obturator will be visible inside the needle.
  • Use other methods to confirm the presence of the implant. Suitable methods to locate are: ultrasound (US) with a high-frequency linear array transducer(10 MHz or greater) or magnetic resonance imaging (MRI). Please note that the IMPLANON rod is not radiopaque and cannot be seen by X-ray or CT scan. If ultrasound and MRI fail, call 1-877­IMPLANON (1-877-467-5266) for information on the procedure for measuring etonogestrel blood levels.

Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method, such as condoms.

Step 21. Place a small adhesive bandage over the insertion site. Request that the woman palpate the implant.

Step 22. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage over the insertion site in 3 to 5 days.

Step 23. Complete the USER CARD and give it to the woman to keep. Also, complete the PATIENT CHART LABEL and affix it to the woman's medical record.

Step 24. The applicator is for single use only and should be disposed in accordance with the Center for Disease Control and Prevention guidelines for handling of hazardous waste.

Removal Of IMPLANON

Preparation

Before initiating the removal procedure, the healthcare provider should carefully read the instructions for removal and consult the USER CARD and/or the PATIENT CHART LABEL for the location of the implant. The exact location of the implant in the arm should be verified by palpation. If the implant is not palpable, ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging can be performed to verify its presence.

A non-palpable implant should always be first located prior to removal. Suitable methods for localization include ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging. If these imaging methods fail to locate the implant, etonogestrel blood level determination can be used for verification of the presence of the implant. For details on etonogestrel blood level determination, call 1-877-IMPLANON (1-877-467-5266) for further instructions.

After localization of a non-palpable implant, consider conducting removal with ultrasound guidance.

There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position. This may complicate localization of the implant by palpation, ultrasound or magnetic resonance imaging, and removal may require a larger incision and more time.

Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with theanatomy of the arm.

Before removal of the implant, the healthcare provider should confirm that:

  • The woman does not have allergies to the antiseptic or anesthetic to be used.

Remove the implant under aseptic conditions.

The following equipment is needed for removal of the implant:

  • An examination table for the woman to lie on
  • Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional)
  • Local anesthetic, needles, and syringe
  • Sterile scalpel, forceps (straight and curved mosquito)

Skin closure, sterile gauze, adhesive bandage and pressure bandages

Removal Procedure

Step 1. Clean the site where the incision will be made and apply an antiseptic. Locate the implant by palpation and mark the distal end (end closest to the elbow), for example, with a sterile marker (Figure 13).

Figure 13

Locate the implant by palpation - Illustration

 

Step 2. Anesthetize the arm, for example, with 0.5 to 1 mL 1% lidocaine at the marked site where the incision will be made (Figure 14). Be sure to inject the local anesthetic under the implant to keep it close to the skin surface.

Figure 14

Anesthetize the arm - Illustration

 

Step 3. Push down the proximal end of the implant (Figure 15) to stabilize it; a bulge may appear indicating the distal end of the implant. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow.

Figure 15

Push down the proximal end of the implant - Illustration

 

Step 4. Gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and gently remove the implant (Figure 16).

Figure 16

Gently push the implant towards the incision - Illustration

 

Step 5. If the implant is encapsulated, make an incision into the tissue sheath and then remove the implant with the forceps (Figures 17 and 18).

Figure 17

Remove the implant with the forceps - Illustration

 

Figure 18

Remove the implant with the forceps - Illustration

 

Step 6. If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision (Figure 19). Flip the forceps over into your other hand (Figure 20).

Figure 19

Gently insert a forceps into the incision - Illustration

 

Figure 20

Flip the forceps over into your other hand - Illustration

 

Step 7. With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant (Figure 21). The implant can then be removed.

Figure 21

Carefully dissect the tissue - Illustration

 

Step 8. Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions. [See Removal of IMPLANON] If the woman would like to continue using IMPLANON, a new implant may be inserted immediately after the old implant is removed using the same incision [see Replacing IMPLANON].

Step 9. After removing the implant, close the incision with a steri-strip and apply an adhesive bandage.

Step 10. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage in 3 to 5 days.

Replacing IMPLANON

Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 2.2 Insertion of IMPLANON.

The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. If the same incision is being used to insert a new implant, anesthetize the insertion site [for example, 2 mL lidocaine (1%)] applying it just under the skin along the 'insertion canal.'

Follow the subsequent steps in the insertion instructions [see Insertion of IMPLANON].

How Supplied

Dosage Forms And Strengths

Single, off-white, soft, flexible, ethylene vinylacetate (EVA) implant, 4 cm in length and 2 mm in diameter containing 68 mg etonogestrel.

One IMPLANON package consists of a single implant containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter, which is pre-loaded in the needle of a disposable applicator. The sterile applicator containing the implant is packed in a blister pack.

NDC 0052-0272-01

Storage And Handling

Store IMPLANON (etonogestrel implant) at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light. Avoid storing IMPLANON in direct sunlight or at temperatures above 30°C (86°F).

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA For patent information: www.merck.com/product/patent/home.html Revised: 07/2014

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling:

  • Changes in Menstrual Bleeding Patterns [see WARNINGS ANDPRECAUTIONS]
  • Ectopic Pregnancies [see WARNINGS AND PRECAUTIONS]
  • Thrombotic and Other Vascular Events [see WARNINGS ANDPRECAUTIONS]
  • Liver Disease [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials including 942 women who were evaluated for safety, change in menstrual bleeding patterns (irregular menses) was the most common adverse reaction causing discontinuation of use of IMPLANON (11.1% of women).

Adverse reactions that resulted in a rate of discontinuation of ≥ 1% are shown in Table 3.

Table 3: Adverse Reactions Leading to Discontinuation of Treatment in 1% or More of Subjects in Clinical Trials of IMPLANON

ADVERSE REACTIONS ALL STUDIES 
N = 942
Bleeding Irregularities* 11.1%
Emotional Lability† 2.3%
Weight Increase 2.3%
Headache 1.6%
Acne 1.3%
Depression‡ 1.0%
* Includes “frequent”, “heavy”, “prolonged”, “spotting”, and other patterns of bleeding irregularity. 
† Among US subjects (N=330), 6.1% experienced emotional lability that led to discontinuation. 
‡ Among US subjects (N=330), 2.4% experienced depression that led to discontinuation.

 

Other adverse reactions that were reported by at least 5% of subjects in clinical trials of IMPLANON are listed in Table 4.

Table 4: Common Adverse Reactions Reported by ≥ 5% of Subjects in Clinical Trials with IMPLANON

ADVERSE REACTION ALL STUDIES 
N=942
Headache 24.9%
Vaginitis 14.5%
Weight increase 13.7%
Acne 13.5%
Breast pain 12.8%
Abdominal pain 10.9%
Pharyngitis 10.5%
Leukorrhea 9.6%
Influenza-like symptoms 7.6%
Dizziness 7.2%
Dysmenorrhea 7.2%
Back pain 6.8%
Emotional lability 6.5%
Nausea 6.4%
Pain 5.6%
Nervousness 5.6%
Depression 5.5%
Hypersensitivity 5.4%
Insertion site pain 5.2%

 

Implant site complications were reported by 3.6% of subjects during any of the assessments in clinical trials. Pain was the most frequent implant site complication, reported during and/or after insertion, occurring in 2.9% of subjects. Additionally, hematoma, redness, and swelling were reported by 0.1%, 0.3%, and 0.3% of patients, respectively [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of IMPLANON. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: constipation, diarrhea, flatulence, vomiting.

General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia.

Immune system disorders: anaphylactic reactions

Infections and infestations: rhinitis, urinary tract infection.

Investigations: clinically relevant rise in blood pressure, weight decreased.

Metabolism and nutrition disorders: increased appetite.

Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, myalgia.

Nervous system disorders: convulsions, migraine, somnolence.

Pregnancy, puerperium and perinatal conditions: ectopic pregnancy.

Psychiatric disorders: anxiety, insomnia, libido decreased.

Renal and urinary disorders: dysuria.

Reproductive system and breast disorders: breast discharge, breast enlargement, ovarian cyst, pruritus genital, vulvovaginal discomfort.

Skin and subcutaneous tissue disorders: angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema, alopecia, chloasma, hypertrichosis, pruritus, rash, seborrhea, urticaria.

Vascular disorders: hot flush.

Complications related to insertion or removal of the implant reported include: bruising, slight local irritation, pain or itching, fibrosis at the implant site,paresthesia or paresthesia-like events, scarring and abscess.

Read the Implanon (etonogestrel implant) Side Effects Center for a complete guide to possible side effects

Learn More »
 

DRUG INTERACTIONS

Changes In Contraceptive Effectiveness Associated With Coadministration Of Other Products

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of IMPLANON. In women on long-term treatment with hepatic enzyme inducing drugs, it is recommended to remove the implant and to advise a contraceptive method that is unaffected by the interacting drug.

Some of these drugs or herbal products that induce enzymes, including CYP3A4, include:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • Topiramate
HIV Antiretrovirals

Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co­administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Increase In Plasma Concentrations Of Etonogestrel Associated With Coadministered Drugs

CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma concentrations of etonogestrel.

Changes In Plasma Concentrations Of Coadministered Drugs

Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporin) or decrease (for example, lamotrigine). Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

This monograph has been modified to include the generic and brand name in many instances.

Interactions

Changes In Contraceptive Effectiveness Associated With Coadministration Of Other Products

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of IMPLANON. In women on long-term treatment with hepatic enzyme inducing drugs, it is recommended to remove the implant and to advise a contraceptive method that is unaffected by the interacting drug.

Some of these drugs or herbal products that induce enzymes, including CYP3A4, include:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • Topiramate
HIV Antiretrovirals

Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co­administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Increase In Plasma Concentrations Of Etonogestrel Associated With Coadministered Drugs

CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma concentrations of etonogestrel.

Changes In Plasma Concentrations Of Coadministered Drugs

Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporin) or decrease (for example, lamotrigine). Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

The following information is based on experience with either IMPLANON, other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives.

Complications Of Insertion And Removal

IMPLANON should be inserted subdermally so that it will be palpable after insertion, and this should be confirmed by palpation immediately after insertion. Failure to insert IMPLANON properly may go unnoticed unless it is palpated immediately after insertion. Undetected failure to insert the implant may lead to an unintended pregnancy. Complications related to insertion and removal procedures, such as pain, paresthesias, bleeding, hematoma, scarring or infection, may occur. Occasionally in post-marketing use, implant insertions have failed because the implant fell out of the needle or remained in the needle during insertion.

If IMPLANON is inserted too deeply (intramuscular or in the fascia), neural orvascular injury may occur. To reduce the risk of neural or vascular injury, IMPLANON should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. IMPLANON should be inserted subdermally just under the skin to avoid the large blood vessels and nerves that lie deeper in the subcutaneous tissues in the sulcusbetween the triceps and biceps muscles. Deep insertions of IMPLANON have been associated with paraesthesia (due to neural injury) and migration of the implant (due to intramuscular or fascial insertion), and in a very few cases with intravascular insertion. If infection develops at the insertion site, start suitable treatment. If the infection persists, the implant should be removed. Incomplete insertions or infections may lead to expulsion. In postmarketing use there have been cases of failure to localize and remove the implant, probably due to deep insertion. There has been 1 case of an intravascular insertion reported post-marketing which led to inability to remove the implant.

Implant removal may be difficult or impossible if the implant is not inserted correctly, is inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. Deep insertions may lead to difficult localization of the implant and may also result in the need for a surgical procedure in an operating room in order to remove the implant. Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with theanatomy of the arm. Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

Changes In Menstrual Bleeding Patterns

After starting IMPLANON, women are likely to have a change from their normal menstrual bleeding pattern. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration. In clinical trials, bleeding patterns ranged from amenorrhea (1 in 5 women) to frequent and/or prolonged bleeding (1 in 5 women). The bleeding pattern experienced during the first three months of IMPLANON use is broadly predictive of the future bleeding pattern for many women. Women should be counseled regarding the bleeding pattern changes they may experience so that they know what to expect. Abnormal bleeding should be evaluated as needed to exclude pathologic conditions or pregnancy.

In clinical studies of IMPLANON, reports of changes in bleeding pattern were the most common reason for stopping treatment (11.1%). Irregular bleeding (10.8%) was the single most common reason women stopped treatment, while amenorrhea (0.3%) was cited less frequently. In these studies, women had an average of 17.7 days of bleeding or spotting every 90 days (based on 3,315 intervals of 90 days recorded by 780 patients). The percentages of patients having 0, 1-7, 8-21, or > 21 days of spotting or bleeding over a 90-day interval while using the IMPLANON implant are shown in Table 1.

Table 1: Percentages of Patients with 0, 1 - 7, 8 - 21, or > 21 Days of Spotting or Bleeding Over a 90-Day Interval While Using IMPLANON

TOTAL DAYS OF SPOTTING OR BLEEDING PERCENTAGE OF PATIENTS
TREATMENT DAYS 91-180 
(N = 745)
TREATMENT DAYS 271-360
(N = 657)
TREATMENT DAYS 631-720
(N = 547)
0 Days 19% 24% 17%
1-7 Days 15% 13% 12%
8-21 Days 30% 30% 37%
> 21 Days 35% 33% 35%

 

Bleeding patterns observed with use of IMPLANON for up to 2 years, and the proportion of 90-day intervals with these bleeding patterns, are summarized in Table 2.

Table 2: Bleeding Patterns Using IMPLANON during the First 2 Years of Use*

BLEEDING PATTERNS DEFINITIONS %†
Infrequent Less than three bleeding and/or spotting episodes in 90 days (excluding amenorrhea) 33.6
Amenorrhea No bleeding and/or spotting in 90 days 22.2
Prolonged Any bleeding and/or spotting episode lasting more than 14 days in 90 days 17.7
Frequent More than 5 bleeding and/or spotting episodes in 90 days 6.7
Based on 3,315 recording periods of 90 day's duration in 780 women, excluding the first 90 days after implant insertion 
† % = Percentage of 90-day intervals with this pattern

 

In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy.

Ectopic Pregnancies

As with all progestin-only contraceptive products, be alert to the possibility of anectopic pregnancy among women using IMPLANON who become pregnant or complain of lower abdominal pain. Although ectopic pregnancies are uncommon among women using IMPLANON, a pregnancy that occurs in a woman using IMPLANON may be more likely to be ectopic than a pregnancy occurring in a woman using no contraception.

Thrombotic And Other Vascular Events

The use of combination hormonal contraceptives (progestin plus estrogen) increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venousthromboembolism, deep venous thrombosis, retinal vein thrombosis, andpulmonary embolism). IMPLANON is a progestin-only contraceptive. It is unknown whether this increased risk is applicable to etonogestrel alone. It is recommended, however, that women with risk factors known to increase the risk of venous and arterial thromboembolism be carefully assessed.

There have been postmarketing reports of serious arterial and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using IMPLANON. IMPLANON should be removed in the event of a thrombosis.

Due to the risk of thromboembolism associated with pregnancy and immediately following delivery, IMPLANON should not be used prior to 21 days postpartum. Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence.

Evaluate for retinal vein thrombosis immediately if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

Consider removal of the IMPLANON implant in case of long-term immobilization due to surgery or illness.

Ovarian Cysts

If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally, these enlarged follicles disappear spontaneously. On rare occasion, surgery may be required.

Carcinoma Of The Breast And Reproductive Organs

Women who currently have or have had breast cancer should not use hormonal contraception because breast cancer may be hormonally sensitive [seeCONTRAINDICATIONS]. Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer; however, other studies have not confirmed such findings.

Some studies suggest that the use of combination hormonal contraceptives is associated with an increase in the risk of cervical cancer or intraepithelialneoplasia. However, there is controversy about the extent to which such findings are due to differences in sexual behavior and other factors.

Women with a family history of breast cancer or who develop breast nodules should be carefully monitored.

Liver Disease

Disturbances of liver function may necessitate the discontinuation of hormonal contraceptive use until markers of liver function return to normal. Remove IMPLANON if jaundice develops.

Hepatic adenomas are associated with combination hormonal contraceptives use. An estimate of the attributable risk is 3.3 cases per 100,000 for combination hormonal contraceptives users. It is not known whether a similar risk exists with progestin-only methods like IMPLANON.

The progestin in IMPLANON may be poorly metabolized in women with liver impairment. Use of IMPLANON in women with active liver disease or liver cancer is contraindicated [see CONTRAINDICATIONS].

Weight Gain

In clinical studies, mean weight gain in US IMPLANON users was 2.8 pounds after 1 year and 3.7 pounds after 2 years. How much of the weight gain was related to the implant is unknown. In studies, 2.3% of the users reported weight gain as the reason for having the implant removed.

Elevated Blood Pressure

Women with a history of hypertension-related diseases or renal disease should be discouraged from using hormonal contraception. For women with well-controlled hypertension, use of IMPLANON can be considered. Women with hypertension using IMPLANON should be closely monitored. lf sustained hypertension develops during the use of IMPLANON, or if a significant increase in blood pressure does not respond adequately to antihypertensive therapy, IMPLANON should be removed.

Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among combination hormonal contraceptive users. It is not known whether a similar risk exists with progestin-only methods like IMPLANON.

Carbohydrate And Lipid Metabolic Effects

Use of IMPLANON may induce mild insulin resistance and small changes in glucose concentrations of unknown clinical significance. Carefully monitor prediabetic and diabetic women using IMPLANON.

Women who are being treated for hyperlipidemia should be followed closely if they elect to use IMPLANON. Some progestins may elevate LDL levels and may render the control of hyperlipidemia more difficult.

Depressed Mood

Women with a history of depressed mood should be carefully observed. Consideration should be given to removing IMPLANON in patients who become significantly depressed.

Return To Ovulation

In clinical trials with IMPLANON, the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

Fluid Retention

Hormonal contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention. It is unknown if IMPLANON causes fluid retention.

Contact Lenses

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

Monitoring

A woman who is using IMPLANON should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated health care.

Drug-Laboratory Test Interactions

Sex hormone-binding globulin concentrations may be decreased for the first 6 months after IMPLANON insertion followed by a gradual recovery. Thyroxineconcentrations may initially be slightly decreased followed by gradual recovery to baseline.

Patient Counseling Information

“See FDA-Approved Patient Labeling (PATIENT INFORMATION)”

  • Counsel women about the insertion and removal procedure of the IMPLANON implant. Provide the woman with a copy of the Patient Labelingand ensure that she understands the information in the Patient Labelingbefore insertion and removal. A USER CARD and consent form are included in the packaging. Have the woman complete a consent form and retain it in your records. The USER CARD should be filled out and given to the patient after insertion of the IMPLANON implant so that she will have a record of the location of the implant in the upper arm and when it should be removed.
  • Counsel women that IMPLANON does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
  • Counsel women that the use of IMPLANON may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect.

FDA-Approved Patient Labeling

See the full PATIENT INFORMATION for IMPLANON.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg etonogestrel per day (equal to approximately 1.8-3.6 times the systemic steady state exposure in women using IMPLANON), no drug-relatedcarcinogenic potential was observed. Etonogestrel was not genotoxic in the in vitroAmes/Salmonella reverse mutation assay, the chromosomal aberration assay in Chinese hamster ovary cells or in the in vivo mouse micronucleus test. Fertility returned after withdrawal from treatment.

Use In Specific Populations

Pregnancy

IMPLANON is not indicated for use during pregnancy [seeCONTRAINDICATIONS].

Teratology studies have been performed in rats and rabbits using oral administration up to 390 and 790 times the human IMPLANON dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure.

Studies have revealed no increased risk of birth defects in women who have used combination oral contraceptives before pregnancy or during early pregnancy. There is no evidence that the risk associated with IMPLANON is different from that of combination oral contraceptives.

IMPLANON should be removed if maintaining a pregnancy.

Nursing Mothers

Based on limited clinical data, IMPLANON may be used during breastfeeding after the fourth postpartum week. Use of IMPLANON before the fourth postpartum week has not been studied. Small amounts of etonogestrel are excreted in breast milk. During the first months after insertion of IMPLANON, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Based on daily milk ingestion of 150 mL/kg, the mean daily infant etonogestrel dose one month after insertion of IMPLANON is about 2.2% of the weight-adjusted maternal daily dose, or about 0.2% of the estimated absolute maternal daily dose. The health of breast-fed infants whose mothers began using IMPLANON during the fourth to eighth week postpartum (n=38) was evaluated in a comparative study with infants of mothers using a non-hormonal IUD (n=33). They were breast-fed for a mean duration of 14 months and followed up to 36 months of age. No significant effects and no differences between the groups were observed on the physical and psychomotor development of these infants. No differences between groups in the production or quality of breast milk were detected.

Healthcare providers should discuss both hormonal and non-hormonal contraceptive options, as steroids may not be the initial choice for these patients.

Pediatric Use

Safety and efficacy of IMPLANON have been established in women of reproductive age. Safety and efficacy of IMPLANON are expected to be the same for postpubertal adolescents. However, no clinical studies have been conducted in women less than 18 years of age. Use of this product before menarche is not indicated.

Geriatric Use

This product has not been studied in women over 65 years of age and is not indicated in this population.

Hepatic Impairment

No studies were conducted to evaluate the effect of hepatic disease on the disposition of IMPLANON. The use of IMPLANON in women with active liver disease is contraindicated [see CONTRAINDICATIONS].

Renal Impairment

No studies were conducted to evaluate the effect of renal disease on the disposition of IMPLANON.

Overweight Women

The effectiveness of IMPLANON in women who weighed more than 130% of their ideal body weight has not been defined because such women were not studied in clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. It is therefore possible that IMPLANON may be less effective in overweight women, especially in the presence of other factors that decrease serum etonogestrel concentrations such as concomitant use of hepatic enzyme inducers.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Overdosage may result if more than 1 implant is inserted. In case of suspected overdose, the implant should be removed.

ContrainDications

IMPLANON should not be used in women who have

  • Known or suspected pregnancy
  • Current or past history of thrombosis or thromboembolic disorders
  • Liver tumors, benign or malignant, or active liver disease
  • Undiagnosed abnormal genital bleeding
  • Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past
  • Allergic reaction to any of the components of IMPLANON [see ADVERSE REACTIONS]

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

The contraceptive effect of IMPLANON is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

Pharmacodynamics

Exposure-response relationships of IMPLANON are unknown.

Pharmacokinetics

Absorption

After subdermal insertion of the etonogestrel implant, etonogestrel is released into the circulation and is approximately 100% bioavailable.

The mean peak serum concentrations in 3 pharmacokinetic studies ranged between 781 and 894 pg/mL and were reached within the first few weeks after insertion. The mean serum etonogestrel concentration decreases gradually over time declining to 192 to 261 pg/mL at 12 months (n=41), 154 to 194 pg/mL at 24 months (n=35), and 156 to 177 pg/mL at 36 months (n=17).

The pharmacokinetic profile of IMPLANON from 1 of 3 pharmacokinetic studies is shown in Figure 24.

Figure 24 : Mean Serum Concentration-time Profile of Etonogestrel During 2 Years of IMPLANON Use and After Removal in 20 Healthy Women

View Enlarged Table

 

Distribution

The apparent volume of distribution averages about 201 L. Etonogestrel is approximately 32% bound to sex hormone binding globulin (SHBG) and 66% bound to albumin in blood.

Metabolism

In vitro data shows that etonogestrel is metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. The biological activity of etonogestrel metabolites is unknown.

Excretion

The elimination half-life of etonogestrel is approximately 25 hours. Excretion of etonogestrel and its metabolites, either as free steroid or as conjugates, is mainly in urine and to a lesser extent in feces. After removal of the implant, etonogestrel concentrations decreased below sensitivity of the assay by 1 week.

Clinical Studies

Pregnancy

In clinical trials of up to 3 years duration that involved 923 subjects, 18 - 40 years of age at entry, and 1,756 women-years of IMPLANON use, the total exposures expressed as 28-day cycle equivalents by study year were:

Year 1: 10,866 cycles

Year 2: 8,581 cycles

Year 3: 3,442 cycles

The clinical trials excluded women who:

  • Weighed more than 130% of their ideal body weight
  • Were chronically taking medications that induce liver enzymes

In the subgroup of women 18 to 35 years of age at entry, 6 pregnancies during 20,648 cycles of use were reported. Two pregnancies occurred in each of Years 1, 2 and 3. Each conception was likely to have occurred shortly before or within 2 weeks after IMPLANON removal. With these 6 pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.

Return To Ovulation

In clinical trials with IMPLANON, the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

IMPLANON®
(etonogestrel implant) for Subdermal Use

IMPLANON® does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases. Read this Patient Information leaflet carefully before you decide if IMPLANON is right for you. This information does not take the place of talking with your healthcare provider. If you have any questions about IMPLANON, ask your healthcare provider.

What is IMPLANON?

IMPLANON is a hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years. The implant is a flexible plastic rod about the size of a matchstick that contains a progestin hormone called etonogestrel. Your healthcare provider will insert the implant just under the skin of the inner side of your upper arm. You can use a single IMPLANON implant for up to 3 years. IMPLANON does not contain estrogen.

 

The implant - Illustration

 

What if I need birth control for more than 3 years?

The IMPLANON implant must be removed after 3 years. Your healthcare provider can insert a new implant under your skin after taking out the old one if you choose to continue using IMPLANON for birth control.

What if I change my mind about birth control and want to stop using IMPLANON before 3 years?

Your healthcare provider can remove the implant at any time. You may become pregnant as early as the first week after removal of the implant. If you do not want to get pregnant after your healthcare provider removes the IMPLANON implant, you should start another birth control method right away.

How does IMPLANON work?

IMPLANON prevents pregnancy in several ways. The most important way is by stopping the release of an egg from your ovary. IMPLANON also thickens the mucus in your cervix and this change may keep sperm from reaching the egg. IMPLANON also changes the lining of your uterus.

How well does IMPLANON work?

When the IMPLANON implant is placed correctly, your chance of getting pregnant is very low (less than 1 pregnancy per 100 women who use IMPLANON for 1 year). It is not known if IMPLANON is as effective in very overweight women because studies did not include many overweight women.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

 

View Enlarged Table

 

Who should not use IMPLANON?

Do not use IMPLANON if you

  • Are pregnant or think you may be pregnant
  • Have, or have had serious blood clots, such as blood clots in your legs (deep venous thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke)
  • Have liver disease or a liver tumor
  • Have unexplained vaginal bleeding
  • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
  • Are allergic to anything in IMPLANON

Tell your healthcare provider if you have or have had any of the conditions listed above. Your healthcare provider can suggest a different method of birth control.

In addition, talk to your healthcare provider about using IMPLANON if you:

  • Have diabetes
  • Have high cholesterol or triglycerides
  • Have headaches
  • Have gallbladder or kidney problems
  • Have a history of depressed mood
  • Have high blood pressure
  • Have an allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implant is placed into or removed from your arm.

Interaction with Other Medicines

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Certain medicines may make IMPLANON less effective, including:

  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John's wort
  • topiramate
  • HIV medicines

Ask your healthcare provider if you are not sure if your medicine is one listed above.

If there are medicines that you have been taking for a long time, that make IMPLANON less effective, tell your healthcare provider. Your healthcare provider may remove the IMPLANON implant and recommend a birth control method that can be used effectively with these medicines.

When you are using IMPLANON, tell all of your healthcare providers that you have IMPLANON in place in your arm.

How is the IMPLANON implant placed and removed?

Your healthcare provider will place and remove the IMPLANON implant in a minor surgical procedure in his or her office. The implant is placed just under the skin on the inner side of your upper arm.

The timing of insertion is important. Your healthcare provider may:

  • Perform a pregnancy test before inserting IMPLANON
  • Schedule the insertion at a specific time of your menstrual cycle (for example, within the first days of your regular menstrual bleeding)

Immediately after the IMPLANON implant has been placed, you and your healthcare provider should check that the implant is in your arm by feeling for it.

If you and your healthcare provider cannot feel the IMPLANON implant, use a non-hormonal birth control method (such as condoms) until your healthcare provider confirms that the implant is in place. You may need special tests to check that the implant is in place or to help find the implant when it is time to take it out.

Your healthcare provider will cover the site where IMPLANON was placed with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage clean, dry, and in place for 3 to 5 days.

You will be asked to review and sign a consent form prior to inserting the IMPLANON implant. You will also get a USER CARD to keep at home with your health records. Your healthcare provider will fill out the USER CARD with the date the implant was inserted and the date the implant is to be removed. Keep track of the date the implant is to be removed. Schedule an appointment with your healthcare provider to remove the implant on or before the removal date.

Be sure to have checkups as advised by your healthcare provider.

What are the most common side effects I can expect while using IMPLANON?

  • Changes in Menstrual Bleeding Patterns (menstrual periods) 
    The most common side effect of IMPLANON is a change in your normal menstrual bleeding pattern. In studies, about one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern. You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and in between periods you may also have spotting.

Talk with your healthcare provider right away if:

  • You think you may be pregnant
  • Your menstrual bleeding is heavy and prolonged

Besides changes in menstrual bleeding patterns, other frequent side effects that caused women to stop using the implant include:

  • Mood swings
  • Weight gain
  • Headache
  • Acne
  • Depressed mood

Other common side effects include:

  • Headache
  • Vaginitis (inflammation of the vagina)
  • Weight gain
  • Acne
  • Breast pain
  • Viral infections such as sore throats or flu-like symptoms
  • Stomach pain
  • Painful periods
  • Mood swings, nervousness, or depressed mood
  • Back pain
  • Nausea
  • Dizziness
  • Pain
  • Pain at the site of insertion

This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

What are the possible risks of using IMPLANON?

  • Problems with Insertion and Removal

The implant may not be placed in your arm at all due to a failed insertion or if the implant has fallen out of the needle. If this happens, you may become pregnant. Immediately after insertion, and with help from your healthcare provider, you should be able to feel the implant under your skin. If you can't feel the implant, tell your healthcare provider.

Removal of the implant may be very difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of IMPLANON will continue for a longer period of time.

Other problems related to insertion and removal are:

    • Pain, irritation, swelling, or bruising at the insertion site
    • Scarring, including a thick scar called a keloid around the insertion site
    • Infection
    • Scar tissue may form around the implant making it difficult to remove
    • The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back up birth control method and call your healthcare provider right away if the implant comes out.
    • The need for surgery in the hospital to remove the implant
    • Injury to nerves or blood vessels in your arm
    • The implant breaks making removal difficult
  • Ectopic Pregnancy 
    If you become pregnant while using IMPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.
  • Ovarian Cysts 
    Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.
  • Breast Cancer 
    It is not known whether IMPLANON use changes a woman's risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use IMPLANON because some breast cancers are sensitive to hormones.
  • Serious Blood Clots 
    IMPLANON may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.

Some examples of serious blood clots are blood clots in the:

  • Legs (deep vein thrombosis)
  • Lung (pulmonary embolism)
  • Brain (stroke)
  • Heart (heart attack)
  • Eyes (total or partial blindness)

The risk of serious blood clots is increased in women who smoke. If you smoke and want to use IMPLANON, you should quit. Your healthcare provider may be able to help.

Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.

  • Other Risks 
    A few women who use birth control that contains hormones may get:
    • High blood pressure
    • Gallbladder problems
    • Rare cancerous or noncancerous liver tumors

When should I call my healthcare provider?

Call your healthcare provider right away if you have:

  • Pain in your lower leg that does not go away
  • Severe chest pain or heaviness in the chest
  • Sudden shortness of breath, sharp chest pain, or coughing blood
  • Symptoms of a severe allergic reaction, such as swollen face, tongue or throat; trouble breathing or swallowing
  • Sudden severe headache unlike your usual headaches
  • Weakness or numbness in your arm, leg, or trouble speaking
  • Sudden partial or complete blindness
  • Yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of appetite, dark colored urine, or light colored bowel movements
  • Severe pain, swelling, or tenderness in the lower stomach (abdomen)
  • Lump in your breast
  • Problems sleeping, lack of energy, tiredness, or you feel very sad
  • Heavy menstrual bleeding

What if I become pregnant while using IMPLANON?

You should see your healthcare provider right away if you think that you may be pregnant. It is important to remove the implant and make sure that the pregnancy is not ectopic (occurring outside the womb). Based on experience with other hormonal contraceptives, IMPLANON is not likely to cause birth defects.

Can I use IMPLANON when I am breastfeeding?

If you are breastfeeding your child, you may use IMPLANON if 4 weeks have passed since you had your baby. A small amount of the hormone contained in IMPLANON passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breastfeeding and want to use IMPLANON, talk with your healthcare provider for more information.

Additional Information

This Patient Information leaflet contains important information about IMPLANON. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about IMPLANON that is written for healthcare professionals. You may also call 1-877-IMPLANON (1-877-467-5266) or visit www.IMPLANON-USA.com

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

ETONOGESTREL - IMPLANT

 

(et-oh-no-GES-trel)

 

COMMON BRAND NAME(S): Implanon

 

USES: This medication is used to prevent pregnancy. It is a thin plastic rod about the size of a matchstick that is inserted under the skin by a health care professional. The rod slowly releases etonogestrel into the body over a 3-year period. The rod must be removed after 3 years and can be replaced if continued birth control is desired. The rod can be removed at any time by a trained health care professional if birth control is no longer desired or there are side effects. It does not contain any estrogen. Etonogestrel (a form of progestin) is a hormone that prevents pregnancy by preventing the release of an egg (ovulation) and by changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or for the fertilized egg to attach to the wall of the womb (implantation).

This medication may not work as well in women who are very overweight or those taking certain drugs. (See also Drug Interactions section.) Discuss your birth control options with your doctor.

Using this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist or health care provider before the rod is placed. Read and sign the Informed Consent provided by your doctor. You will also be given a User Card with the date and the place on your body where the rod was inserted. Keep the card and use it to remind yourself when to schedule an appointment to have the rod removed. If you have any questions, ask your doctor or pharmacist.

Ask your doctor about the best time to schedule your appointment to have the rod placed. Your doctor may want you to have a pregnancy test first. The medication usually starts working right away when the rod is inserted on days 1 through 5 after the start of your regular menstrual bleeding. If your appointment is at another time in your menstrual cycle, you may need to use a non-hormonal form of birth control (e.g., condoms, diaphragm, spermicide) for the first 7 days after the rod is placed. Ask your doctor about whether you need back-up birth control.

The rod will be inserted into the skin in your upper arm. Usually it will be placed in the arm opposite the side you write with. Be sure you can feel the rod underneath your skin after it has been placed.

There will be 2 bandages covering the area where the rod is placed. Leave the top bandage on for 24 hours. Keep the smaller bandage on for 3-5 days or as directed by your doctor. Keep the bandage clean and dry.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, stomach cramping/bloating, dizziness, headache, breast tenderness, acne, hair loss, weight gain, and vaginal irritation/discharge may occur. Pain, bruising, numbness, infection, and scarring may occur at the site where the rod is placed. If any of these effects persist or worsen, notify your doctor promptly.

Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. If bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor. If you miss 2 periods in a row, contact your doctor for a pregnancy test.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The rod must be removed after 3 years. This is usually a simple procedure done in your doctor's office. Rarely (e.g., if the rod has been placed too deeply or can't be felt), the rod may require surgery to remove.

Tell your doctor immediately if any of these unlikely but serious side effects occur: depression, unwanted facial/body hair.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal/pelvic pain, lumps in the breast, unusual tiredness, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Implanon (etonogestrel implant) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before having the rod placed, tell your doctor or pharmacist if you are allergic to etonogestrel; or to other progestins; or to any anesthetics or antiseptics that might be used in the procedure; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abnormal breast exam, blood clots (e.g., in the legs, eyes, lungs), breast cancer, depression, high blood pressure, low levels of "good" cholesterol (HDL), diabetes, gall bladder disease, heart disease (e.g., chest pain, heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, liver problems (e.g., liver tumor, active liver disease), migraine headaches, seizures, stroke, long periods of sitting or lying down (e.g., immobility such as being bedridden), unexplained vaginal bleeding.

Smoking cigarettes/using tobacco while using hormonal birth control (implant/pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).

Notify your doctor at least 4 weeks beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to have this medication removed temporarily or take special precautions at these times while you are using this drug.

The drug in this implant may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur.

This product should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. A certain serious pregnancy problem (ectopic pregnancy) may be more likely if you become pregnant while using this product.

This medication passes into breast milk in small amounts. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: azole antifungals (e.g., fluconazole, itraconazole), sodium tetradecyl sulfate.

Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication can affect the results of certain lab tests (e.g., sex-hormone-binding globulin, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.

 

OVERDOSE: This medication may be harmful if swallowed. Overdose may occur if more than 1 rod is placed or the old rod is not removed when a new rod is placed. If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.

 

MISSED DOSE: The rod must be removed or replaced after 3 years.

 

STORAGE: Store at room temperature away from light and moisture until insertion. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Implanon, Nexplanon

Generic Name: etonogestrel (implant) (Pronunciation: e toe noe JES trel)

  • What is etonogestrel implant (Implanon)?
  • What are the possible side effects of etonogestrel implant (Implanon)?
  • What is the most important information I should know about etonogestrel implant (Implanon)?
  • What should I discuss with my healthcare provider before receiving the etonogestrel implant (Implanon)?
  • How is the etonogestrel implant used (Implanon)?
  • What happens if I miss a dose (Implanon)?
  • What happens if I overdose (Implanon)?
  • What should I avoid while taking etonogestrel implant (Implanon)?
  • What other drugs will affect etonogestrel implant (Implanon)?
  • Where can I get more information?

What is etonogestrel implant (Implanon)?

 

Etonogestrel implant contains a hormone that prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Etonogestrel implant is used as contraception to prevent pregnancy. The medicine is contained in a small plastic rod that is implanted into the skin of your upper arm. The medicine is released slowly into the body. The rod can remain in place and provide continuous contraception for up to 3 years.

Etonogestrel implant may also be used for purposes not listed in this medication guide.

What are the possible side effects of etonogestrel implant (Implanon)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • warmth, redness, swelling, or oozing where the implant was inserted;
  • sudden numbness or weakness, especially on one side of the body;
  • severe pain or cramping in your pelvic area (may be only on one side);
  • sudden severe headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a breast lump;
  • swelling in your hands, ankles, or feet;
  • jaundice (yellowing of the skin or eyes);
  • symptoms of depression (sleep problems, weakness, tired feeling, mood changes); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • pain, numbness, or tingling where the implant was inserted;
  • minor bleeding or scarring where the implant was inserted;
  • menstrual cramps, changes in your menstrual periods;
  • mild headache, dizziness, mood changes;
  • vaginal itching or discharge;
  • breast pain;
  • acne;
  • problems with contact lenses;
  • nausea, mild stomach pain;
  • back pain;
  • feeling nervous or depressed;
  • sore throat, flu symptoms; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Implanon (etonogestrel implant) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about etonogestrel implant (Implanon)?

 

Do not use an etonogestrel implant if you are pregnant. If you have recently had a baby, wait at least 3 weeks (4 weeks if breast-feeding) before receiving an etonogestrel implant.

You should not use this implant if you are allergic to etonogestrel, or if you have any of the following conditions: unusual vaginal bleeding, liver disease or liver cancer, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.

Before receiving the etonogestrel implant, tell your doctor if you have diabetes, high blood pressure, high cholesterol, gallbladder disease, kidney disease, an ovarian cyst, headaches, a history of depression, if you are overweight, or if you are allergic to numbing medicines.

Etonogestrel implant is inserted through a needle into the skin of your upper arm. The medicine is released slowly into the body from the implant. The implant can remain in place to provide continuous contraception for up to 3 years.

You will most likely have irregular and unpredictable periods while using the etonogestrel implant. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

If you need surgery or medical tests or if you will be on bed rest, you may need to have your etonogestrel implant removed for a short time. Any doctor or surgeon who treats you should know that you have an etonogestrel implant.

The etonogestrel implant must be removed by the end of the third year after it was inserted and may be replaced at that time with a new implant. If you choose not to replace the implant, your ability to get pregnant will return quickly. Start using another form of birth control right away if you wish to avoid an unintended pregnancy.

Side Effects Centers
  • Implanon

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving the etonogestrel implant (Implanon)?

 

Do not use an etonogestrel implant if you are pregnant. If you have recently had a baby, wait at least 3 weeks (4 weeks if breast-feeding) before receiving an etonogestrel implant.

You should not use this implant if you are allergic to etonogestrel, or if you have:

  • a history of heart attack, stroke, or blood clot;
  • a history of hormone-related cancer such as breast or uterine cancer;
  • unusual vaginal bleeding that has not been checked by a doctor; or
  • liver disease or liver cancer.

To make sure you can safely use the etonogestrel implant, tell your doctor if you have any of these other conditions:

  • diabetes;
  • high cholesterol or triglycerides, or if you are overweight;
  • high blood pressure;
  • headaches;
  • gallbladder disease;
  • kidney disease;
  • an ovarian cyst;
  • a history of depression; or
  • if you are allergic to numbing medicines.

The etonogestrel implant should not be used in girls younger than 18 years old.

Do not use the implant if you are breast-feeding a baby younger than 4 weeks old.

How is the etonogestrel implant used (Implanon)?

 

Etonogestrel implant is inserted through a needle into the skin of your upper arm, just inside and above the elbow. The implant will be placed in your arm under local anesthetic in your doctor's office or other clinic setting.

Before receiving this implant, you may need a pregnancy test to make sure you are not pregnant.

The timing of when you will receive this implant depends on whether or not you were using birth control before, and what type it was. Follow your doctor's instructions.

This implant must be inserted only by a physician or other healthcare provider who has been specially trained in the insertion of the etonogestrel implant. Incorrect placement of the rod too deeply can make it difficult or impossible to remove later on. If the rod is incorrectly inserted and falls out, you will not be protected from unintended pregnancy.

Once the implant is inserted, you should be able to feel it under your skin. Tell your doctor if you cannot feel the implant under the skin at any time while it is in place.

Etonogestrel is released slowly into the body from the implant. The implant can remain in place to provide continuous contraception for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control. Follow your doctor's instructions.

After the implant is inserted, your doctor will cover your arm with two bandages. You may remove the top bandage after 24 hours, but leave the smaller bandage on your arm for 3 to 5 days. Keep the area clean and dry while wearing the bandage.

You will most likely have irregular and unpredictable periods while using the etonogestrel implant. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

Your doctor will need to see you on a regular basis while you are using this medication. You may also need to have routine mammograms. Do not miss any appointments.

If you need surgery or medical tests or if you will be on bed rest, you may need to have your etonogestrel implant removed for a short time. Any doctor or surgeon who treats you should know that you have an etonogestrel implant.

The etonogestrel implant must be removed by the end of the third year after it was inserted and may be replaced at that time with a new implant. If you choose not to replace the implant, your ability to get pregnant will return quickly. Some women have become pregnant within the first week after removal of an etonogestrel implant. Start using another form of birth control right away if you wish to avoid an unintended pregnancy.

Do not use etonogestrel implants for longer than recommended by your doctor.

Side Effects Centers
  • Implanon

Patient Detailed Avoid Taking

What happens if I miss a dose (Implanon)?

 

Since etonogestrel is given as an implant by a healthcare professional, you will not be on a frequent dosing schedule. Be sure to see your doctor for removal of the implant by the end of the third year.

What happens if I overdose (Implanon)?

 

If the implant is correctly inserted, an overdose of etonogestrel is highly unlikely. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking etonogestrel implant (Implanon)?

 

Do not smoke while using etonogestrel implant, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by etonogestrel implant.

Etonogestrel implant will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What other drugs will affect etonogestrel implant (Implanon)?

 

Some drugs can make etonogestrel less effective, which may result in pregnancy. Before receiving this implant, tell your doctor if you are using any of the following drugs:

  • bosentan (Tracleer);
  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
  • griseofulvin (Fulvicin, Grifulvin);
  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
  • antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);
  • drugs to treat hepatitis C, HIV, or AIDS;
  • medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil);
  • St. John's wort; or
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with etonogestrel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your doctor or pharmacist can provide more information about etonogestrel implant.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.02. Revision date: 6/27/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Implanon

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI