Drugs Details

Drugs Info of Menopur, Repronex
Drugs Details
  • Drugs Type  : Multum
  • Date : 27th Feb 2015 10:52 pm
  • Brand Name : Menopur, Repronex
  • Generic Name : menotropins (injectable) (Pronunciation: MEN oh troe pins)
Descriptions

MENOPUR® is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR® is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR® contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid).

The biological activity of MENOPUR® is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicleweight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the W orld Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water soluble. Human ChorionicGonadotropin (hCG) is detected in MENOPUR® .

MENOPUR® has been mixed in vitro with Bravelle® with no evidence of aggregation.

Therapeutic class: Infertility

 

What are the possible side effects of menotropins (Menopur, Repronex)?

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if...

Read All Potential Side Effects and See Pictures of Menopur »

What are the precautions when taking menotropins injection (Menopur)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle stimulating hormone or luteinizing hormone; 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: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts/enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian...

Read All Potential Precautions of Menopur »

 

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

Indications

Development of Multiple Follicles and Pregnancy in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle Prior to initiation of treatment with MENOPUR®:

  • Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
  • Exclude the possibility of pregnancy
  • Evaluate the fertility status of the male partner
  • Exclude a diagnosis of primary ovarian failure

Dosage Administration

General Dosing Information

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Administer MENOPUR® subcutaneously in the abdomen as described in Instructions for Use.
  • MENOPUR® may be administered together with BRAVELLE® (urofollitropin for injection, purified).

Recommended Dosing For Assisted Reproductive Technology

The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of MENOPUR® for women who have received a GnRH agonist for pituitary suppression is 225 International Units. MENOPUR® may be administered together with BRAVELLE® (urofollitropin for injection, purified) and the total initial dose when the products are combined should not exceed 225 International Units (150 International Units of MENOPUR® and 75 International Units of BRAVELLE® or 75 International Units of MENOPUR® and 150 International Units of BRAVELLE®).

  • Beginning on cycle day 2 or 3, a starting dose of 225 International Units of MENOPUR® is administered subcutaneously daily. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.
  • Do not make additional dosage adjustments more frequently than every 2 days or by more than 150 International Units at each adjustment.
  • Continue treatment until adequate follicular development is evident, and then administer hCG. Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of MENOPUR® therapy [see WARNINGS ANDPRECAUTIONS].
  • Do not administer daily doses of MENOPUR® or MENOPUR® in combination with BRAVELLE® that exceed 450 International Units.
  • Therapy should not exceed 20 days.

How Supplied

Dosage Forms And Strengths

Lyophilized powder for Injection containing 75 International Units FSH and 75 International Units of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q•Cap® vial adapters.

MENOPUR® (menotropins for injection) is supplied in sterile vials as a lyophilized, white to off-white powder or pellet.

Each vial of MENOPUR® is accompanied by a vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride for Injection, USP:

75 International Units FSH and 75 International Units of LH activity, supplied as

NDC 55566-7501-1: Box of 5 vials + 5 vials diluent.
NDC 55566-7501-2: Box of 5 vials + 5 vials diluent + 5 Q•Cap® vial adapters

Storage And Handling

Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F) until dispensed. Protect from light. Use immediately after reconstitution. Discard unused material.

Manufactured For: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054. Rev 02/2014

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

Side Effects

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Abnormal Ovarian Enlargement [see WARNINGS AND PRECAUTIONS]
  • Ovarian Hyperstimulation Syndrome [see WARNINGS ANDPRECAUTIONS]
  • Atelectasis, acute respiratory distress syndrome and exacerbation ofasthma [see WARNINGS AND PRECAUTIONS]
  • Thromboembolic events [see WARNINGS AND PRECAUTIONS]
  • Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
  • Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
  • Congenital Malformations [see WARNINGS AND PRECAUTIONS]
  • Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
  • Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
  • Ovarian Neoplasms [see WARNINGS AND PRECAUTIONS]

Clinical Trial 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 trial of another drug and may not reflect the rates observed in practice.

In two single cycle, open label, multinational, multicenter, comparative trials, a total of 434 normal ovulatory infertile women were randomized and received subcutaneously administered MENOPUR® as part of an in vitrofertilization (IVF) cycle (both trials) or intracytoplasmic sperm injection (ICSI)] cycle (one of the two trials). All women received pituitary down-regulationwith gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring at an incidence of ≥ 2% in women receiving MENOPUR® are shown in Table 1.

Table 1: MENOPUR® Administered subcutaneously in Women Undergoing IVF and ICSI. Adverse Reactions with Incidence of 2% or Greater Occurring on or After GnRH Administration.

BODY SYSTEM/ PREFERRED TERM   IVF
N=434
N %
Body as a whole Abdominal cramps 13 3
  Abdomen enlarged 10 2.3
  Abdominal pain 29 6.7
  Headache 27 6.2
  Injection site pain + reaction 17 3.9
  Injection site inflammation 10 2.3
Urogenital OHSS 27 6.2

 

In addition, thrombophlebitis was reported in less than 1% of subjects.

In a second open label, multinational, multicenter, comparative IVF and ICSI trial, MENOPUR® and BRAVELLE® were administered in the same syringe to 60 normal ovulatory infertile women. OHSS, post retrieval cramping and nausea and spontaneous abortion were the most common adverse reactions occurring at an incidence of ≥ 5% in women receiving the combination of MENOPUR® and BRAVELLE® .

In a third open label, US multicenter, comparative trial for ovulation induction in anovulatory or oligovulatory infertile women, 76 subjects received subcutaneous or intramuscular injections of MENOPUR® . The most common adverse reactions occurring at an incidence of ≥ 5% in women receiving MENOPUR® were: headache; OHSS; injection site reaction, abdominal cramps, fullness and pain; and nausea.

Postmarketing Experience

The following adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to MENOPUR® cannot be reliably determined.

Gastrointestinal disorders: abdominal pain, abdominal pain lower, abdominal distension, nausea, vomiting, abdominal discomfort

General disorders and administration site conditions: injection site reactions (most frequently reported injection site reaction was injection site pain), fatigue

Nervous system disorders: headache, dizziness

Reproductive system disorders: OHSS [see WARNINGS ANDPRECAUTIONS], pelvic pain, ovarian cyst, breast complaints (includingbreast pain, breast tenderness, breast discomfort and breast swelling)

Skin and subcutaneous tissue disorders: acne, rash

Vascular disorders: hot flush

Read the Menopur (menotropins injection) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

No drug/drug interaction studies in humans have been conducted for MENOPUR® .

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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

MENOPUR® should only be used by physicians who are experienced ininfertility treatment. MENOPUR® contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications and multiple births.Gonadotropin therapy requires the availability of appropriate monitoring facilities. Use the lowest effective dose.

Abnormal Ovarian Enlargement

In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with MENOPUR® therapy, treatment should be individualized and the lowest effective dose should be used [see DOSAGE AND ADMINISTRATION]. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of ovarian stimulation.

If the ovaries are abnormally enlarged on the last day of MENOPUR® therapy, hCG should not be administered in order to reduce the chance of developing Ovarian Hyperstimulation Syndrome (OHSS). Prohibit intercourse in women with significant ovarian enlargement because of the danger of hemoperitoneum resulting from rupture of ovarian cysts.

Ovarian Hyperstimulation Syndrome (OHSS)

OHSS is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may revealhypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusion, hydrothorax, acute pulmonary distress, and thromboembolic reactions. Transient liver function test abnormalities suggestive of hepatic dysfunction, with or without morphologic changes on liver biopsy, have been reported in association with OHSS.

OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration, the hCG must be withheld.

Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least two weeks after hCG administration.

If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consideration should be given as to whether the woman needs to be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed). Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows:

  • Acute Phase: 
    Management should be directed at preventing hemoconcentration due to loss of intravascular volume to the third space and minimizing the risk of thromboembolic phenomena and kidney damage. Fluid intake and output, weight, hematocrit, serum and urinary electrolytes, urine specific gravity, BUN and creatinine, total proteins with albumin: globulin ratio,coagulation studies, electrocardiogram to monitor for hyperkalemia, and abdominal girth should be thoroughly assessed daily or more often based on the clinical need. Treatment, consisting of limited intravenous fluids, electrolytes, human serum albumin, is intended to normalize electrolytes while maintaining an acceptable but somewhat reduced intravascular volume. Full correction of the intravascular volume deficit may lead to an unacceptable increase in the amount of third space fluid accumulation.
  • Chronic Phase: 
    After the acute phase is successfully managed as above, excessive fluid accumulation in the third space should be limited by instituting severepotassium, sodium, and fluid restriction.
  • Resolution Phase: 
    As third space fluid returns to the intravascular compartment, a fall in hematocrit and increasing urinary output are observed in the absence of any increase in intake. Peripheral and/or pulmonary edema may result if the kidneys are unable to excrete third space fluid as rapidly as it is mobilized. Diuretics may be indicated during the resolution phase, if necessary, to combat pulmonary edema.

Do not remove ascitic, pleural, and pericardial fluid unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade.

OHSS increases the risk of injury to the ovary. Pelvic examination or intercourse may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should be avoided.

If bleeding occurs and requires surgical intervention, the clinical objective should be to control the bleeding and retain as much ovarian tissue as possible. A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances, should be consulted.

In the IVF clinical trial for MENOPUR®, OHSS occurred in 7.2% of the 373 MENOPUR® treated women.

Pulmonary And Vascular Complications

Serious pulmonary conditions (e.g. atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins. In addition, thromboembolic events both in association with, and separate from the Ovarian Hyperstimulation Syndrome (OHSS) have been reported in women treated with gonadotropins. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Women with generally recognized risk factors for thrombosis, such as personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonaryinfarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarctions. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of ovulationinduction and assisted reproductive technology need to be weighed against the risks. Pregnancy also carries an increased risk of thrombosis.

Ovarian Torsion

Ovarian torsion has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.

Multi-fetal Gestation And Birth

Multi-fetal gestation and births have been reported with all gonadotropin therapy including therapy with MENOPUR® .

In the IVF clinical trial of MENOPUR®, multiple pregnancy as diagnosed by ultrasound occurred in 35.3% (n=30) of 85 total pregnancies.

Before beginning treatment with MENOPUR®, advise the woman and her partner of the potential risk of multi-fetal gestation and birth.

Congenital Malformations

The incidence of congenital malformations after some ART [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.

Ectopic Pregnancy

Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased. Early confirmation ofintrauterine pregnancy should be determined by β-hCG testing andtransvaginal ultrasound.

Spontaneous Abortion

The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility.

Ovarian Neoplasms

There have been infrequent reports of ovarian neoplasms, both benign andmalignant, in women who have had multiple drug therapy for controlled ovarian stimulation; however, a causal relationship has not been established.

Laboratory Tests

In most instances, treatment of women with MENOPUR® will result only in follicular growth and maturation. In the absence of an endogenous LH surge, hCG is given when monitoring of the woman indicates that sufficient follicular development has occurred. This may be estimated by ultrasound alone or in combination with measurement of serum estradiol levels. The combination of both ultrasound and serum estradiol measurement are useful for monitoring follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement and minimizing the risk of the OHSS and multiple gestation.

The clinical confirmation of ovulation is obtained by direct or indirect indices of progesterone production as well as sonographic evidence of ovulation.

Direct or indirect indices of progesterone production:

  • Urinary or serum luteinizing hormone (LH) rise
  • A rise in basal body temperature
  • Increase in serum progesterone
  • Menstruation following the shift in basal body temperature

Sonographic evidence of ovulation:

  • Collapsed follicle
  • Fluid in the cul-de-sac
  • Features consistent with corpus luteum formation
  • Secretory endometrium

Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Dosing And Use

Instruct women on the correct usage and dosing of MENOPUR® [seeDOSAGE AND ADMINISTRATION]. Caution women not to change the dosage or the schedule of administration unless she is told to do so by her healthcare provider.

Duration And Monitoring Required

Prior to beginning therapy with MENOPUR®, inform women about the time commitment and monitoring procedures necessary for treatment [seeDOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Instructions Regarding A Missed Dose

Inform the woman that if she misses or forgets to take a dose of MENOPUR®, the next dose should not be doubled and she should call her healthcare provider for further dosing instructions.

Ovarian Hyperstimulation Syndrome

Inform women regarding the risks of OHSS [see WARNINGS AND PRECAUTIONS] and OHSS-associated symptoms including lung and blood vessel problems [see WARNINGS AND PRECAUTIONS] and ovarian torsion [see WARNINGS AND PRECAUTIONS] with the use of MENOPUR® .

Multi-fetal Gestation And Birth

Inform women regarding the risk of multi-fetal gestation and birth with the use of MENOPUR® [see WARNINGS AND PRECAUTIONS]

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic potential of menotropins.

Use In Specific Populations

Pregnancy

Teratogenic effects

Pregnancy Category X [see CONTRAINDICATIONS].

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Menopur®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Renal And Hepatic Insufficiency

Safety, efficacy, and pharmacokinetics of MENOPUR® in women with renal or hepatic insufficiency have not been established.

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

 
 

OverDose

Aside from possible OHSS [see WARNINGS AND PRECAUTIONS] and multiple gestations [see WARNINGS AND PRECAUTIONS], there is no additional information on the consequences of acute overdosage with MENOPUR® .

ContrainDications

MENOPUR® is contraindicated in women who exhibit:

  • Prior hypersensitivity to MENOPUR® or menotropins products or one of their excipients
  • High levels of FSH indicating primary ovarian failure [see INDICATIONS AND USAGE]
  • Pregnancy 
    MENOPUR® may cause fetal harm when administered to a pregnant woman [see Use In Specific Populations]. MENOPUR® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.
  • Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see INDICATIONS AND USAGE]
  • Sex hormone dependent tumors of the reproductive tract and accessoryorgans
  • Tumors of pituitary gland or hypothalamus
  • Abnormal uterine bleeding of undetermined origin
  • Ovarian cyst or enlargement of undetermined origin, not due topolycystic ovary syndrome

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

Clinical Pharamacology

Mechanism Of Action

MENOPUR®, administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. Treatment with MENOPUR® in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Pharmacokinetics

Two open-label, randomized, controlled trials were conducted to assess the pharmacokinetics of MENOPUR®. Study 2003-02 compared single doses of subcutaneous administration of the US and European (EU) formulations of MENOPUR® in 57 healthy, pre-menopausal females who had undergonepituitary suppression. The study established that the two formulations are bioequivalent. Study 2000-03 assessed single and multiple doses of MENOPUR® administered subcutaneously and intramuscularly in a 3 phase cross-over design in 33 healthy, pre-menopausal females who had undergone pituitary suppression. The primary pharmacokinetic endpoints were FSH AUC and C max values. The results are summarized in Table 2.

Table 2: FSH Pharmacokinetic Parameters [Mean (SD)] Following MENOPUR® Administration (Study 2000-03)

View Enlarged Table

 

Absorption

The subcutaneous route of administration trends toward greater bioavailability than the intramuscular route for single and multiple doses of MENOPUR® .

Distribution

Human tissue or organ distribution of FSH and LH has not been studied for MENOPUR® .

Metabolism

Metabolism of FSH and LH has not been studied for MENOPUR® in humans.

Excretion

The elimination half-lives for FSH in the multiple-dose phase were similar (11-13 hours) for subcutaneously administered MENOPUR® and intramuscularly administered MENOPUR® .

Clinical Studies

The efficacy of MENOPUR® was established in one randomized, open-label, multicenter, multinational (in Europe and Israel), comparative clinical trial of women undergoing in vitro fertilization (IVF) or IVF plus intracytoplasmic injection (ICSI) to achieve pregnancy.

All women began ovarian stimulation as part of an IVF cycle following pituitary suppression with a GnRH agonist. A total of 373 patients were randomized to the MENOPUR® arm. Randomization was stratified byinsemination technique [conventional IVF vs. ICSI]. Efficacy was assessed based on the primary efficacy parameter of continuing pregnancy. The initial daily dose of MENOPUR ® was 225 International Units administered subcutaneously for five days. Thereafter, the dose was individualized according to each patient's response, up to a maximum of 450 IU/day for a total maximum duration of stimulation of 20 days. Treatment outcomes are summarized in Table 3.

Table 3: Efficacy Outcome in IVF Study (one cycle of treatment)

PARAMETER SUBCUTANEOUSLY ADMINISTERED MENOPUR® 
N=373
Continuing Pregnancy (%)a 87 (23)b
Clinical Pregnancy (%) 98 (26)c
aContinuing pregnancy was defined as ultrasound visualization of gestational sac with fetal heartbeat at ≥ 10 weeks after ET
b Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis c Secondary efficacy parameter. Study was not powered to demonstrate differences in this parameter

 

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

 

Patient Information

MENOPUR®
(Men-oh-pyoor)
(menotropins) for Injection for Subcutaneous Use

Read this Patient Information before you start using MENOPUR® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is MENOPUR®?

MENOPUR® is a prescription medicine that contains follicle stimulating hormone (FSH) and luteinizing hormone (LH). MENOPUR® causes your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) cycle.

Who should not use MENOPUR®?

Do not use MENOPUR® if you:

  • are allergic to menotropins or any of the ingredients in MENOPUR®. See the end of this leaflet for a complete list of ingredients in MENOPUR® .
  • have ovaries that no longer make eggs (primary ovarian failure)
  • are pregnant or think you may be pregnant. If MENOPUR® is taken while you are pregnant, it may harm your baby.
  • have problems with your thyroid gland, adrenal gland or pituitary glandthat are not controlled by taking medicine.
  • have a tumor in your female organs, including your ovaries, breast, oruterus that may get worse with high levels of estrogen
  • have a tumor of your pituitary gland or hypothalamus
  • have abnormal bleeding from your uterus or vagina and the cause is not known
  • have ovarian cysts or enlarged ovaries, not due to a problem calledpolycystic ovary syndrome (PCOS)

What should I tell my healthcare provider before using MENOPUR®?

Before you use MENOPUR®, tell your healthcare provider if you:

  • have been told by a healthcare provider that you are at an increased risk for blood clots (thrombosis)
  • have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot
  • had twisting of your ovary (ovarian torsion)
  • had or have a cyst in your ovary
  • have any other medical conditions
  • are breast feeding or plan to breast feed. It is not known if MENOPUR® passes into your breast milk. You and your healthcare provider should decide if you will use MENOPUR® or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use MENOPUR®?

  • Read the Instructions for Use at the end of this Patient Information about the right way to use MENOPUR® or MENOPUR® mixed with BRAVELLE® .
  • Use MENOPUR® exactly as your healthcare provider tells you to use it.
  • Your healthcare provider will tell you how much MENOPUR® to use and when to use it.
  • Your healthcare provider may change your dose of MENOPUR® if needed.
  • If you miss a dose of MENOPUR®, call your healthcare provider right away. Do not double the amount of MENOPUR® you are using.
  • You may need more than 1 vial of MENOPUR® for your dose.
  • MENOPUR® may be mixed with BRAVELLE® in the same syringe.

What are possible side effects of MENOPUR®?

MENOPUR® may cause serious side effects, including:

  • ovaries that are too large. MENOPUR® may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area. If your ovaries become too large your healthcare provider may tell you that you should not have intercourse (sex) so you do not rupture an ovarian cyst.
  • ovarian hyperstimulation syndrome (OHSS). Using MENOPUR® may cause OHSS. OHSS is a serious medical condition that can happen when your ovaries produce too many eggs (overstimulated). OHSS can cause fluid to suddenly build up in the area of your stomach, chest, heart, and cause blood clots to form. OHSS may also happen after you stop using MENOPUR®. Stop using MENOPUR® and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of OHSS:
    • severe pelvic or stomach pain
    • swollen stomach
    • nausea
    • diarrhea
    • vomiting
    • trouble breathing
    • sudden weight gain
    • decreased or no urine
  • lung problems. MENOPUR® may cause serious lung problems that can sometimes lead to death including fluid in the lungs, trouble breathing, and worsening of asthma.
  • blood clots. MENOPUR® may increase your chance of having blood clots in your blood vessels. Blood clots can cause:
    • blood vessel problems (thrombophlebitis)
    • stroke
    • loss of your arm or leg
    • blood clot in your lung (pulmonary embolus)
  • twisted (torsion) of your ovary. MENOPUR® may increase the chance of your ovary twisting, if you already have certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.
  • pregnancy with and birth of multiple babies. MENOPUR® may increase your chance of having a pregnancy with more than 1 baby. Having a pregnancy and giving birth to more than 1 baby at a time increases the health risk for you and your babies. Your healthcare provider should talk to you about your chances of multiple births before you start using MENOPUR® .
  • birth defects. Babies born after ART may have an increased chance of birth defects. Your age, certain sperm problems, your genetic background and that of your partner, and a pregnancy with more than 1 baby at a time may increase the chance that your baby may have birth defects.
  • ectopic pregnancy (pregnancy outside your womb). MENOPUR® may increase your chance of having a pregnancy that is abnormally outside of your womb. Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.
  • miscarriage. Your chance of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.
  • tumors of the ovary. If you have used medicines like MENOPUR® more than 1 time to get pregnant, you may have an increased chance of having tumors in your ovaries, including cancer.

The most common side effects of MENOPUR® include:

  • stomach cramps, fullness or pain
  • headache
  • injection site swelling, heat, redness and pain

These are not all the possible side effects of MENOPUR®. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

How should I store MENOPUR®?

  • Before mixing, store MENOPUR® powder in the refrigerator at room temperature between 37°F to 77°F (3°C to 25°C).
  • Protect MENOPUR® from light.
  • MENOPUR® should be used right after mixing.
  • Throw away any unused MENOPUR® .

Keep MENOPUR® and all medicines out of the reach of children.

General Information about the safe and effective use of MENOPUR® .

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MENOPUR® for a condition for which it was not prescribed. Do not give MENOPUR® to other people, even if they have the same condition you have. It may harm them.

This Patient Information summarizes the most important information about MENOPUR®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about MENOPUR® that is written for health professionals.

For more information go to www.menopur.com, or call 1-888-FERRING (1-888-337-7464).

What are the ingredients in MENOPUR®?

Active ingredient: menotropins

Inactive ingredients: lactose monohydrate, polysorbate, sodium phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid)

Instructions for Use

MENOPUR® 
(Men-oh-pyoor)
(menotropins for injection) for subcutaneous use

Your healthcare provider should show you how to mix and injectMENOPUR® or MENOPUR® mixed with BRAVELLE® before you do it for the first time. Before using MENOPUR® or MENOPUR® mixed with BRAVELLE® for the first time, read this Instructions for Use carefully. Keep this leaflet in a safe place and read it when you have questions.

Supplies you will need to give your injection of MENOPUR® or MENOPUR® mixed with BRAVELLE®. See Figure A.

  • a clean, flat surface to work on, like a table
  • vials of MENOPUR® powder (and BRAVELLE® powder if you are going to mix the 2 medicines)
  • vials of 0.9% Sodium Chloride, USP used for mixing the medicine
  • alcohol pads
  • rubbing alcohol
  • gauze pads
  • a sterile syringe and needle. Your healthcare provider should tell you which syringe and needle to use.
  • the Q•Cap® that comes with your medicine
  • a sharps disposal container for throwing away your used needles and syringes. See “Disposing of your used needles and syringes” at the end of these instructions.

Figure A

Supplies needed -  Illustration

 

Step 1. Preparing your MENOPUR® or MENOPUR® mixed with BRAVELLE® .

  • Wash your hands well with soap and water. Dry your hands with a clean towel.
  • Place all the supplies you need on the clean surface you already prepared.
  • Open the Q•Cap® by peeling back the label. See Figure B.

Figure B

Open the Q•Cap - Illustration

 

  • Set aside the blister pouch with the Q•Cap®. Do not take the Q•Cap® out of the pouch at this time. Do not touch the ends of the Q•Cap® .
  • Remove the plastic caps from the vials of MENOPUR® (and BRAVELLE® if needed) and 0.9% Sodium Chloride, USP. See Figure C.

Figure C

Remove the plastic caps from the vials - Illustration

 

  • Check the vial of MENOPUR® (and BRAVELLE® if needed) to make sure there is powder or a pellet in the vial. Check the 0.9% Sodium Chloride, USP vial to make sure that there are no particles in the liquid and the liquid in the vial is clear. If you do not see powder or see particles or the liquid is discolored, do not use the vial and call your pharmacist or healthcare provider.
  • Wipe the tops of the vials with alcohol and allow them to dry. Do not touch the tops of the vials after you have wiped them. See Figure D.

Figure D

Wipe the tops of the vials - Illustration

 

  • Place the vial of 0.9% Sodium Chloride, USP on the table. Remove the Q•Cap® from the blister pouch by holding the sides with your fingers. See Figure E. Carefully twist the syringe onto the connector end (luer) of the Q•Cap® until it is tight. Do not touch the spike at the end of the Q•Cap® . See Figure E.

Figure E

Twist the syringe onto the connector - Illustration

 

  • Pull down on the syringe plunger until you have withdrawn the amount of 0.9% Sodium Chloride, USP from the vial that your healthcare provider told you to use.
    • The usual amount of 0.9% Sodium Chloride, USP used to mix your MENOPUR® is 1 mL, but you should use the amount that your healthcare provider tells you to use. See Figure F.

    Figure F

    Draw the required amount - Illustration

     

    Hold the syringe and place the spike end of the Q•Cap® over the top of the 0.9% Sodium Chloride, USP vial. Push the tip of the Q•Cap® into the rubber stopper of the vial until it stops. Be careful not to push down on the syringe plunger during this step. See Figure G.

    Figure G

    Push the tip of the Q•Cap® into the rubber stopper - Illustration

     

    • Slowly push down on the syringe plunger to push the air from the syringe into the vial. Keeping the syringe and Q•Cap® together, turn the vial upside down and pull down on the syringe plunger to withdraw the right amount of 0.9% Sodium Chloride, USP from the vial. Your healthcare provider should tell you the right amount of 0.9% Sodium Chloride, USP to use. See Figure H.

    Figure H

    Withdraw the right amount of 0.9% Sodium Chloride - Illustration

     

    • Place the 0.9% Sodium Chloride, USP vial on the table. Remove the Q•Cap® and syringe from the vial by pulling up on the syringe barrel. Throw away the 0.9% Sodium Chloride, USP vial in your household trash. See Figure I.

    Figure I

    Remove the Q•Cap® and syringe from the vial - Illustration

     

    • Hold the vial of MENOPUR® powder in 1 hand. Hold the sides of the syringe with your other hand and place the tip of the Q•Cap® over the top of the vial. Push the tip of the Q•Cap® into the rubber stopper of the vial until it stops. Be very careful not to push down on the syringe plunger during this step. See Figure J.

    Figure J

    Push the tip of the Q•Cap® into the rubber stopper - Illustration

     

    • Slowly push down on the syringe plunger to push the 0.9% Sodium Chloride, USP into the vial with the MENOPUR® powder in it. Gently swirl the vial until the MENOPUR® powder is completely dissolved. Do not shake the vial as this will cause bubbles. See Figure K.

    Figure K

    Gently swirl the vial - Illustration

     

    • As soon as the powdered medicine has completely dissolved, turn the vial upside down and pull down on the plunger to withdraw all of the MENOPUR® into the syringe. See Figure L.

    Figure L

    Pull down on the plunger - Illustration

     

    If your healthcare provider tells you to use more than 1 vial of MENOPUR® or tells you to mix your MENOPUR® with BRAVELLE® in the same syringe:

    • Mix your first vial of MENOPUR® powder or BRAVELLE® powder with 0.9% Sodium Chloride, USP. Do not inject your dose yet.
    • Use the liquid in the syringe you have just mixed to mix the next vial of MENOPUR® or BRAVELLE® . See Figure J through Figure L.
    • You can use the liquid in the syringe to mix up to 5 more vials of medicine.
    • Your healthcare provider will tell you how many vials of MENOPUR® and BRAVELLE® to use.

    Step 2. Removing the Q•Cap® and adding your needle for injection.

    • When you have finished mixing the last vial needed for your injection and have withdrawn all the medicine into the syringe, remove the syringe from the Q•Cap® .
    • Twist the syringe counter-clockwise while holding the Q•Cap® steady. Carefully remove the syringe from the Q•Cap® . See Figure M. Throw away the Q•Cap® with the attached medicine vial into your household trash. Carefully set the syringe with the medicine down on the table, being careful not to touch the tip of the syringe.

    Figure M

    Twist the syringe counter-clockwise - Illustration

     

    • You are now ready to attach the needle to the syringe for your injection. Your healthcare provider will tell you what needle you should use for your injection.
    • While holding the syringe with the syringe tip pointing up, place the needle on the top of the syringe. Gently push down on the needle and twist the needle onto the syringe in a clockwise direction until it is tight. See Figure N.

    Figure N

    Twist the needle onto the syringe - Illustration

     

    • Hold the syringe with the needle pointing straight up. Pull down slightly on the plunger and tap the barrel of the syringe so that any air bubbles rise to the top. Slowly press the plunger up until all the air is out of the syringe and a small drop of liquid is seen at the tip of the needle. See Figure O.

    Figure O

    A small drop of liquid is seen at the tip of the needle - Illustration

     

    • Tap the syringe to remove the small drop of liquid at the tip of the needle. See Figure P.

    Figure P

    Tap the syringe - Illustration

     

    • Carefully set the syringe with needle down on the table. Do not let the needle touch anything to keep it sterile. The medicine is now ready for you to inject. See Figure Q.

    Figure Q

    Carefully set the syringe with needle down on the table - Illustration

     

    Step 3. Injecting MENOPUR® or MENOPUR® mixed with BRAVELLE® .

    • Select a site to inject MENOPUR® or MENOPUR® mixed with BRAVELLE® on your stomach area (abdomen).
      • Pick a site a site on your lower abdomen, 1-2 inches below the navel, alternating between left and right sides.
      • Each day, inject in a different site to help reduce soreness and skin problems. For example, on day 1, inject yourself on the right side of your abdomen. The next day, inject yourself on the left side of your abdomen. Changing your injection sites every day will help reduce soreness and skin problems. See Figure R.

    Figure R

    Select a site to inject - Illustration

     

    • Clean your injection site with an alcohol pad. Let the alcohol dry.See Figure S.

    Figure S

    Clean your injection site - Illustration

     

    • Carefully remove the needle cap from the syringe. See Figure T.

    Figure T

    Carefully remove the needle cap - Illustration

     

    • Hold the syringe in 1 hand. Use your other hand to gently hold a fold of skin where you will insert your needle. Hold the skin between your thumb and index finger. See Figure U.

    Figure U

    Gently hold a fold of skin - Illustration

     

    • Hold your syringe at a right angle to your skin, like a dart. Quickly insert the needle all the way into your skin fold. See Figure V.

    Figure V

    Quickly insert the needle - Illustration

     

    • Push down the plunger of the syringe with a steady motion. Keep pushing until all the fluid is injected into your skin. See Figure W.

    Figure W

    Push down the plunger - Illustration

     

    • Let go of your skin fold and pull the needle straight out of your skin.See Figure X.

    Figure X

    Pull the needle straight out - Illustration

     

    Step 4. After your injection.

    • If there is any bleeding at your injection site, place a gauze pad over your injection site. Apply gentle pressure to stop the bleeding. Do not rub the site. See Figure Y.

    Figure Y

    Place a gauze pad over your injection site - Illustration

     

    • If your injection site becomes sore or red, you may put ice on your injection site for 1 minute and then take it off for 3 minutes. If needed, you may repeat this 3 or 4 times.

    Step 5. Disposing of your used needles and syringes.

    • Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
    • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
      • made of a heavy-duty plastic,
      • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
      • upright and stable during use,
      • leak-resistant, and
      • properly labeled to warn of hazardous waste inside the container.
    • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

    Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

    This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

    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.

 

MENOTROPINS - SUBCUTANEOUS INJECTION

 

(men-oh-TROW-pins)

 

COMMON BRAND NAME(S): Menopur

 

USES: This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help healthy ovaries to make eggs. This medication is usually used in combination with another hormone (human chorionic gonadotropin-hCG) to help you become pregnant by bringing about the growth and release of a mature egg (ovulation).

This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before starting this medication and each time you get a refill. You will be trained by a healthcare professional on how to properly use this medication. Learn and understand all preparation and usage instructions. If you have any questions, consult your doctor or pharmacist.

Use this medication exactly as directed by your doctor in order to get the most benefit from it. To help you remember, use it at the same time each day.

Inject this medication under the skin exactly as directed by your doctor. The dosage and length of treatment are based on your medical condition, response to therapy and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Be sure to keep all medical appointments so your doctor can closely monitor your response to determine the dosage that is right for you. The manufacturer recommends that your dose should not be more than 450 international units per day and that the medication should not be used for more than 20 days per treatment cycle. Do not change the dose or use this drug for a longer period than prescribed unless instructed by your doctor.

Follow all instructions for proper mixing with the correct fluid provided with this medication. Before using, check the solution visually for particles or discoloration. If either is present, do not use the liquid. Use the solution immediately after the medication is mixed. Discard any unused solution. If you have questions regarding the use of this medication, consult your pharmacist.

Wash hands with soap and water before using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid discomfort and problem areas under the skin.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: flu-like symptoms (e.g., fever, chills, joint pain, muscle ache, tiredness).

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, sudden vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, shortness of breath.

This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy or after treatment has been stopped. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain/swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Menopur (menotropins injection) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle stimulating hormone or luteinizing hormone; 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: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts/enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian torsion), personal/family history of blood clots, blood clotting disorders (such as thrombophilia), obesity, stroke, certain heart diseases (e.g., heart attack), lung problems (e.g., asthma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Multiple births may occur because of this treatment. Consult your doctor for more details.

Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. 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: gonadorelin.

 

OVERDOSE: 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: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol level, vaginal ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of your hCG dose.

Lifestyle changes that may help improve the effect of this medication include limiting alcohol and stopping smoking. Consult your doctor or pharmacist to discuss lifestyle changes that might benefit you.

 

MISSED DOSE: It is important to use this medication on a fixed schedule exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist immediately for instructions. Do not double the dose to catch up.

 

STORAGE: Store the medication refrigerated or at room temperature between 37-77 degrees F (3-25 degrees C). Protect from light. Do not freeze. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Menopur, Repronex

Generic Name: menotropins (injectable) (Pronunciation: MEN oh troe pins)

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

What are menotropins (Menopur)?

 

Menotropins are an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are important for the development of follicles (eggs) produced by the ovaries and for the development of sperm.

Menotropins are used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. Menotropins are also used to stimulate the development of multiple eggs for in vitro fertilization. Likewise, menotropins are used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient.

Menotropins may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of menotropins (Menopur)?

 

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Serious pulmonary (lung and breathing) conditions have been reported in patients using menotropins. Seek medical attention if you experience any sudden changes in your breathing.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
  • nausea, vomiting, or diarrhea;
  • shortness of breath;
  • pain, warmth, or tenderness centralized in an arm or leg;
  • fever or chills;
  • headache or drowsiness;
  • weakness or aching of muscles or joints;
  • breast enlargement or tenderness;
  • pain, swelling, or irritation at the injection site; or
  • rash.

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

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 Menopur (menotropins injection) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about menotropins (Menopur)?

 

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Side Effects Centers
  • Repronex
  • Menopur

Patient Detailed How Take

What should I discuss with my healthcare provider before using menotropins (Menopur)?

 

Menotropins will not induce ovulation or sperm production if your ovaries or testes are not functioning properly.

Do not use menotropins without first taking to your doctor if you

  • might be pregnant;
  • have a thyroid problem;
  • have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;
  • have undiagnosed vaginal bleeding;
  • have ovarian cysts or enlargement; or
  • have any other serious or chronic medical illness.

You may not be able to use menotropins, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Do not use menotropins if you are pregnant. Menotropins are in the FDA pregnancy category X. This means that they are known to cause birth defects.

It is not known whether menotropins pass into breast milk. Do not use menotropins without first talking to your doctor if you are breast-feeding a baby.

How should I use menotropins (Menopur)?

 

Use menotropins exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Formulations of menotropins intended for intramuscular injection (an injection into muscle) must not be administered subcutaneously (under the skin), and vice versa. If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give yourself the injection. Do not inject menotropins if you are not sure how.

Use the solution immediately after it is mixed. Throw away any medicine that is left over.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Store menotropins at room temperature or in the refrigerator, away from direct light, moisture, and heat.

Side Effects Centers
  • Repronex
  • Menopur

Patient Detailed Avoid Taking

What happens if I miss a dose (Menopur)?

 

Contact your doctor if you miss a dose of menotropins. Do not use a double dose of this medication without first talking to your doctor.

What happens if I overdose (Menopur)?

 

An overdose of menotropins is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice.

Symptoms of a menotropins overdose are not known. Ovarian hyperstimulation syndrome (OHSS) may result with an overdose of menotropins. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal.

What should I avoid while using menotropins (Menopur)?

 

There are no restrictions on food, beverages, or activity during therapy with menotropins unless your doctor directs otherwise.

What other drugs will affect menotropins (Menopur)?

 

It is not known whether other medications will interact with menotropins. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

Where can I get more information?

 

Your pharmacist can provide more information about menotropins.


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: 4.02. Revision date: 12/15/2010.

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
  • Repronex
  • Menopur

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