Drugs Details

Drugs Info of Regranex
Drugs Details
  • Drugs Type  : FDA
  • Date : 19th Mar 2015 03:06 am
  • Brand Name : Regranex
  • Generic Name : becaplermin topical (Pronunciation: be KAP ler min TOP ik al)
Descriptions

REGRANEX Gel contains becaplermin, a recombinant human platelet-derived growth factor for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae. Becaplermin has a molecular weight of approximately 25 KD and is a homodimer composed of two identical polypeptide chains that are bound together by disulfide bonds. REGRANEX Gel is a non-sterile, low bioburden, preserved, sodium carboxymethylcellulose-based (CMC) topical gel, containing the active ingredient becaplermin and the following inactive ingredients: carboxymethylcellulose sodium, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection. Each gram of REGRANEX Gel contains 100 mcg of becaplermin.

What are the possible side effects of becaplermin topical (Regranex)?

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.

Stop using becaplermin topical and call your doctor at once if you have severe itching, redness, blistering, peeling, or other skin irritation.

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...

Read All Potential Side Effects and See Pictures of Regranex »

What are the precautions when taking becaplermin (Regranex)?

See also Warning section.

Before using becaplermin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as parabens), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: cancer in the ulcer area.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your...

Read All Potential Precautions of Regranex »

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

Indications

Indication

REGRANEX (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Limitations of Use

The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers [see Clinical Studies] and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.

The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans, [see Nonclinical Toxicology]

REGRANEX Gel is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that dose by primary intention.

Dosage Administration

For topical use; not for oral, ophthalmic or intravaginal use.

The amount of REGRANEX Gel to be applied will vary depending upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2.

Table 1: Formula to Calculate Length of Gel in Inches to Be Applied Daily

  INCHES
Tube Size Formula
15 g tube length X width X 0.6
2 g tube (physician sample) length X width X 1 .3

Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15gtube, or approximately 1 1/3 inch length of the gel from a 2g tube (physician sample). For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15g tubes (1 X 2 X 0.6 = 1 1 /4) and 2 3/4 inch gel length should be used for a 2g tube (1 X 2 X 1.3 = 2 3/4).

Table 2: Formula to Calculate Length of Gel in Centimeters to Be Applied Daily

  CENTIMETERS
Tube Size Formula
15 g tube length X width ÷ 4
2 g tube (physician sample) length X width ÷ 2

Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15g tube, or approximately a 0.5 centimeter length of gel from a 2g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 centimeter length of gel should be used for a 15g tube [(4 X 2) ÷ 4 = 2] and a 4 centimeter length of gel should be used for a 2g tube [(4 X 2) ÷ 2 = 4].

The amount of REGRANEX Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area. The weight of REGRANEX Gel from 15g tubes is 0.65g per inch length and 0.25g per centimeter length.

To apply REGRANEX Gel, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper. The measured REGRANEX Gel is transferred from the clean measuring surface using an application aid and then spread over the entire ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The site(s) of application should then be covered by a saline moistened dressing and left in place for approximately 12 hours. The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a second moist dressing (without REGRANEX Gel) for the remainder of the day. REGRANEX Gel should be applied once daily to the ulcer until complete healing has occurred. If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX Gel should be reassessed. The step-by-step instructions for applying REGRANEX Gel for home administration are described under "Patient Counseling Information", [see PATIENT INFORMATION]

How Supplied

Dosage Forms and Strengths

Gel: 0.01 %; clear, colorless to straw-colored gel

REGRANEX Gel 0.01% is available in a multi-use tube in the following size:

15g tube..............NDC 0045-0810-15

REGRANEX Gel 0.01% is for external use only.

Store refrigerated at 2° - 8° C (36° - 46°F). Do not freeze. Do not use the gel after the expiration date shown at the bottom of the tube.

Manufactured by: OMJ Pharmaceuticals, Inc. San German, Puerto Rico 00683. Manufactured for: Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ 08869. Becaplermin Concentrate provided by: Novartis NPC, 2010 Cessna Dr.,Vacaville, CA 95688. Revised: 10/2011

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

Side Effects

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 a follow-up study from two randomized, controlled trials, an increased rate of cancer remote from the becaplermin treatment site was observed in subjects treated with REGRANEX Gel. [see WARNINGS AND PRECAUTIONS]

In clinical trials, erythematous rashes occurred in 2% of patients treated with REGRANEX Gel (and good ulcer care) or placebo (and good ulcer care), and none in patients receiving good ulcer care alone. Patients treated with REGRANEX Gel did not develop neutralizing antibodies against becaplermin.

Postmarketing Experience

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study, [see BOXED WARNING and WARNINGS AND PRECAUTIONS]

Burning sensation at the site of application and erythema have been reported during post-approval use of REGRANEX Gel. Because post approval adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.

Read the Regranex (becaplermin) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

It is not known if REGRANEX Gel interacts with other topical medications applied to the ulcer site. The use of REGRANEX Gel with other topical drugs has not been studied.

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

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Cancer and Cancer Mortality

REGRANEX Gel contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. [see CLINICAL PHARMACOLOGY] The benefits and risks of becaplermin treatment should be carefully evaluated before prescribing. Becaplermin should be used with caution in patients with a known malignancy.

Malignancies distant from the site of application have occurred in becaplermin users in both a clinical study and postmarketing use, and an increased rate of death from systemic malignancies was seen in patients who have received 3 or more tubes of REGRANEX Gel.

In a follow-up study, 491 (75%) of 651 subjects from two randomized, controlled trials of becaplermin gel 0.01% were followed for a median of approximately 20 months to identify malignancies diagnosed after the end of the trials. Eight of 291 subjects (3%) from the becaplermin group and two of 200 subjects (1%) from the vehicle/standard of care group were diagnosed with cancers during the follow-up period, a relative risk of 2.7 (95% confidence interval 0.6-12.8). The types of cancers varied and all were remote from the treatment site.

In a retrospective study of a medical claims database, cancer rates and overall cancer mortality were compared between 1,622 patients who used REGRANEX Gel and 2,809 matched comparators. Estimates of the incidence rates reported below may be under-reported due to limited follow-up for each individual.

  • The incidence rate for all cancers was 10.2 per 1,000 person years for patients treated with REGRANEX Gel and 9.1 per 1,000 person years for the comparators. Adjusted for several possible confounders, the rate ratio was 1.2 (95% confidence interval 0.7-1.9). Types of cancers varied and were remote from the site of treatment.
  • The incidence rate for mortality from all cancers was 1.6 per 1,000 person years for those who received REGRANEX Gel and 0.9 per 1,000 person years for the comparators. The adjusted rate ratio was 1.8 (95% confidence interval 0.7-4.9).
  • The incidence rate for mortality from all cancers among patients who received 3 or more tubes of REGRANEX Gel was 3.9 per 1,000 person years and 0.9 per 1,000 person years in the comparators. The adjusted rate ratio for cancer mortality among those who received 3 or more tubes relative to those who received none was 5.2 (95% confidence interval 1.6-17.6). [see BOXED WARNING]

Application Site Reactions

If application site reactions occur, the possibility of sensitization or irritation caused by parabens or m-cresol should be considered. Consider interruption or discontinuation and further evaluation (e.g. patch testing) as dictated by clinical circumstances.

Patient Counseling Information

[See FDA-approved patient labeling (Medication Guide]

Counsel patients to review and discuss any questions or concerns with their healthcare provider before starting REGRANEX and at regular intervals while receiving REGRANEX. Patients should be advised that:

  • they should read the medication guide;
  • hands should be washed thoroughly before applying REGRANEX Gel;
  • the tip of the tube should not come into contact with the ulcer or any other surface; the tube should be recapped tightly after each use;
  • a cotton swab, tongue depressor, or other application aid should be used to apply REGRANEX Gel;
  • REGRANEX Gel should only be applied once a day in a carefully measured quantity [see DOSAGE AND ADMINISTRATION]. The measured quantity of gel should be spread evenly over the ulcerated area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The measured length of the gel to be squeezed from the tube should be adjusted according to the size of the ulcer. The amount of REGRANEX Gel to be applied daily should be recalculated at weekly or biweekly intervals by the physician or wound care giver.

Step-by-step instructions for application of REGRANEX Gel are as follows:

  • Squeeze the calculated length of gel onto a clean, firm, nonabsorbable surface, e.g., wax paper.
  • With a clean cotton swab, tongue depressor, or similar application aid, spread the measured REGRANEX Gel over the ulcer surface to obtain an even layer.
  • Cover with a saline moistened gauze dressing.
    • after approximately 12 hours, the ulcer should be gently rinsed with saline or water to remove residual gel and covered with a saline-moistened gauze dressing (without REGRANEX Gel);
    • it is important to use REGRANEX Gel together with a good ulcer care program, including a strict non-weight-bearing program;
    • excess application of REGRANEX Gel has not been shown to be beneficial;
    • REGRANEX Gel should be stored in the refrigerator. Do not freeze REGRANEX Gel;
    • REGRANEX Gel should not be used after the expiration date on the bottom, crimped end of the tube.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Becaplermin was not genotoxic in a battery of in vitro assays (including those for bacterial and mammalian cell point mutation, chromosomal aberration, and DNA damage/repair). Becaplermin was also not mutagenic in an in vivo assay for the induction of micronudei in mouse bone marrow cells. Carcinogenesis and reproductive toxicity studies have not been conducted with REGRANEX Gel.

Use In Specific Populations

Pregnancy

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with REGRANEX Gel. REGRANEX Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with REGRANEX Gel.

Nursing Mothers

It is not known whether becaplermin is excreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REGRANEX Gel is administered to nursing women.

Pediatric Use

Safety and effectiveness of REGRANEX Gel in pediatric patients below the age of 16 years have not been established.

Geriatric Use

Among patients receiving any dose of REGRANEX Gel in clinical studies of diabetic lower extremity ulcers, 150 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients < 65 years of age and patients ≥ 65 years of age. The number of patients aged 75 and older were insufficient (n=34) to determine whether they respond differently from younger patients.

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

OverDose

There are no data on the effects of becaplermin overdose.

ContrainDications

REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.

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

Clinical Pharamacology

Mechanism of Action

REGRANEX Gel has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.

Pharmacodynamics

Clinical pharmacodynamic studies have not been conducted.

Pharmacokinetics

Ten patients with Stage III or IV (as defined in the International Association of Enterostomal Therapy (IAET) guide to chronic wound staging,1,2 lower extremity diabetic ulcers received topical applications of becaplermin gel 0.01% at a dose range of 0.32-2.95 µg/kg (µg/cm2) daily for 14 days. Six patients had non-quantifiable PDGF levels at baseline and throughout the study, two patients had PDGF levels at baseline which did not increase substantially, and two patients had PDGF levels that increased sporadically above their baseline values during the 14 day study period.

Animal Toxicology and/or Pharmacology

In nonclinical studies, rats injected at the metatarsals with 3 or 10 mcg/site (approximately 60 or 200 mcg/kg) of becaplermin every other day for 13 days displayed histological changes indicative of accelerated bone remodeling consisting of periosteal hyperplasia and subperiosteal bone resorption and exostosis. The soft tissue adjacent to the injection site had fibroplasia with accompanying mononuclear cell infiltration reflective of the ability of PDGF to stimulate connective tissue growth, [see INDICATIONS]

Clinical Studies

The effects of REGRANEX Gel on the incidence of and time to complete healing in lower extremity diabetic ulcers were assessed in four randomized controlled studies. Of 922 patients studied, 478 received either REGRANEX Gel 0.003% or 0.01%. All study participants had lower extremity diabetic neuropathic ulcers that extended into the subcutaneous tissue or beyond (Stages III and IV of the IAET guide to chronic wound staging). Ninety-three percent of the patients enrolled in these four trials had foot ulcers. The remaining 7% of the patients had ankle or leg ulcers. The diabetic ulcers were of at least 8 weeks duration and had an adequate blood supply (defined as Tcp02 > 30 mm Hg). In the four trials, ninety-five percent of the ulcers measured in area up to 10 cm2, and the median ulcer size at baseline ranged from 1.4 cm2 to 3.5 cm2. All treatment groups received a program of good ulcer care consisting of initial complete sharp debridement, a non-weight-bearing regimen, systemic treatment for wound-related infection if present, moist saline dressings changed twice a day, and additional debridement as necessary. REGRANEX Gel 0.003% or 0.01% or placebo gel was applied once a day and covered with a saline moistened dressing. After approximately 12 hours, the gel was gently rinsed off and a saline moistened dressing was then applied for the remainder of the day. Patients were treated until complete healing, or for a period of up to 20 weeks. Patients were considered a treatment failure if their ulcer did not show an approximately 30% reduction in initial ulcer area after eight to ten weeks of REGRANEX Gel therapy.

The primary endpoint, incidence of complete ulcer closure within 20 weeks, for all treatment arms is shown in Figure 1. In each study, REGRANEX Gel in conjunction with good ulcer care was compared to placebo gel plus good ulcer care or good ulcer care alone. In Study 1, a multicenter, double-blind, placebo controlled trial of 118 patients, the incidence of complete ulcer closure for REGRANEX Gel 0.003% (n=61) was 48% versus 25% for placebo gel (n=57; p=0.02, logistic regression analysis).

In Study 2, a multicenter, double-blind, placebo controlled trial of 382 patients, the incidence of complete ulcer closure for REGRANEX Gel 0.01% (n=123) was 50% versus 36% for

REGRANEX Gel 0.003% (n=132) and 35% for placebo gel (n=127). Only REGRANEX Gel 0.01% was significantly different from placebo gel (p=0.01, logistic regression analysis).

The primary goal of Study 3, a multicenter controlled trial of 172 patients, was to assess the safety of vehicle gel (placebo; n=70) compared to good ulcer care alone (n=68). The study included a small (n=34) REGRANEX Gel 0.01% arm. Incidences of complete ulcer closure were 44% for REGRANEX Gel, 36% for placebo gel and 22% for good ulcer care alone.

In Study 4, a multicenter, evaluator-blind, controlled trial of 250 patients, the incidences of complete ulcer closure in the REGRANEX Gel 0.01% arm (n=128) (36%) and good ulcer care alone (n=122) (32%) were not statistically different.

Figure 1. Incidence of Complete Healing

View Enlarged Table

In general, where REGRANEX Gel was associated with higher incidences of complete ulcer closure, differences in the incidence first became apparent after approximately 10 weeks and increased with continued treatment (Table 3).

Table 3: Life Table Estimates of the Incidence (%) of Complete Healing over Time for Study 2

  REGRANEX Gel 0.01%
(%)
Placebo Gel
(%)
Week 2 1 0
Week 4 6 2
Week 6 9 6
Weeks 16 14
Week 10 23 18
Week 12 34 25
Week 14 37 28
Week 16 43 33
Week 18 46 34
Week 20 50 37

In a 3-month follow-up period where no standardized regimen of preventative care was utilized, the incidence of ulcer recurrence was approximately 30% in all treatment groups, demonstrating that the durability of ulcer closure was comparable in all treatment groups. In a randomized, double-blind study of REGRANEX Gel (100 mcg/g once daily for 16 weeks) in patients with Stage III or IV pressure ulcers, the incidence of complete ulcer closure was 15% (28/189) in the becaplermin group and 12% (22/190) in the vehicle control group. This difference was not statistically significant.

In two small, randomized, double-blinded studies of REGRANEX Gel (100 mcg/g once daily for 16 weeks) in patients with venous stasis ulcers, the combined incidence of complete ulcer closure was 46% (30/65) in the becaplermin group and 39% (26/67) in the vehicle control group. This difference was not statistically significant.

REFERENCES

1. J. Enterostomal Ther 15:4,1988

2. Decubitis 2:24,1989

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

Patient Information

MEDICATION GUIDE

REGRANEX®
(RE'-GRAN-IX)
(becapleimin) Gel

Read this Medication Guide before you start using REGRANEX 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 the most important information I should know about REGRANEX?

People who use 3 or more tubes of REGRANEX may have an increased risk of death from cancer.

  • You should talk with your healthcare provider about the possible benefits and risks to you if you use more than 3 tubes of REGRANEX.
  • If you already have cancer, you and your healthcare provider should carefully consider whether you will use REGRANEX.

If you decide to use REGRANEX, your healthcare provider will tell you how to use REGRANEX. See the section "How should I use REGRANEX?" below.

What is REGRANEX?

REGRANEX is a man-made protein medicine that is used with other ulcer care practices (such as good wound care) to treat diabetic sores (ulcers) of your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs. It is not known if REGRANEX is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation).

It is not known if REGRANEX is safe and effective in children under 16 years of age.

Who should not use REGRANEX?

Do not use REGRANEX if you have a skin tumor at the area where you apply REGRANEX.

What should I tell my healthcare provider before using REGRANEX?

Before you use REGRANEX tell your healthcare provider if you:

  • have cancer
  • have poor blood flow to your lower legs and feet
  • have allergies to any of the ingredients in REGRANEX. See the end of this Medication Guide for a complete list of ingredients in REGRANEX.
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if REGRANEX will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if REGRANEX passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you apply other medicines to diabetic ulcers of your legs or feet.

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 REGRANEX?

  • Use REGRANEX together with good ulcer care, as prescribed byyour healthcare provider. This includes following your healthcare provider's instructions about not putting weight on the affected leg and foot (non-weight bearing).
  • Use REGRANEX exactly as your healthcare provider tells you to use it.
  • REGRANEX is for use on skin ulcers only. Do not use REGRANEX in your mouth, eyes, or vagina.
  • REGRANEX comes as a gel. Your healthcare provider should tell you how often to use REGRANEX and how much REGRANEX to use.
  • Your healthcare provider should check the size of your ulcer every 1 to 2 weeks.
  • Your healthcare provider may change the amount of REGRANEX to be applied to your ulcer as the size of your ulcer changes. So, the amount of REGRANEX to be squeezed from the tube may change as the size of your ulcer changes.
  • Close your REGRANEX tube tightly after each use.
  • Put the REGRANEX tube back in the refrigerator after each use.
  • Use a cotton swab, tongue depressor, or other application aid when you apply your REGRANEX. Do not let the tip of your REGRANEX tube touch the ulcer or any other surface.
  • Apply REGRANEX one time each day.

Apply REGRANEX as follows:

    • Wash your hands well before you apply REGRANEX.
    • Carefully measure the amount of REGRANEX that your healthcare provider tells you to use.
    • Squeeze the amount of REGRANEX needed for your ulcer on to a clean, firm, non-absorbable surface, such as wax paper.
    • Use a clean cotton swab, tongue depressor, or similar application aid, to spread the REGRANEX gel in a thin even layer over the surface of the ulcer on your foot or leg.
    • Cover the area with a saline-moistened gauze dressing.
    • After about 12 hours, gently rinse the ulcer with saline or water to remove the rest of the REGRANEX. Cover the ulcer with a new saline-moistened gauze dressing. Do not apply any more REGRANEX.

What are the possible side effects of REGRANEX?

REGRANEX may cause serious side effects.

  • See the section, "What is the most important information I should know about REGRANEX?"
  • Common side effects of REGRANEX include:
    • Red skin rash
    • Burning at the application site

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

These are not all the possible side effects of REGRANEX gel. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Ortho-McNeil at 1-888-734-7263.

How should I store REGRANEX?

  • Store REGRANEX in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze REGRANEX.
  • Do not use REGRANEX after the expiration date on the bottom (sealed end) of the tube.
  • Throw away your REGRANEX that is out of date or no longer needed for your treatment.

Keep REGRANEX and all medicines out of the reach of children.

General information about REGRANEX

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REGRANEX for a condition for which it was not prescribed. Do not give REGRANEX to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about REGRANEX. If you would like more information about REGRANEX, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about REGRANEX that is written for health professionals.

What are the ingredients in REGRANEX?

Active ingredient: becaplermin

Inactive ingredients: carboxymethylcellulose sodium, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection.

This Medication Guide 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.

 

BECAPLERMIN GEL - TOPICAL

 

(be-KAP-ler-min)

 

COMMON BRAND NAME(S): Regranex

 

WARNING: Discuss the risks and benefits of using this medication with your doctor. Before using this medication, tell your doctor if you have cancer or a history of cancer.

 

USES: This medication is used to treat certain foot/leg ulcers in people with diabetes. It is used along with good foot/leg care (e.g., keeping pressure off the wound) to help the ulcer heal completely. Becaplermin works by attracting certain natural substances to the ulcer that help wound healing.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using becaplermin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Wash hands thoroughly before applying this medicine. To avoid contaminating the container tip, do not touch it to the skin or any other surface. Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist.

The amount of the medication applied is based on the size of the ulcer. Your doctor or wound specialist should adjust your dose every 1 to 2 weeks.

Squeeze the prescribed amount of medication onto a clean, firm, and non-absorbent surface (e.g., waxed paper). Use a clean applicator (e.g., cotton swab, tongue depressor) to apply a thin layer of the medication evenly over the ulcer, usually once daily or as directed by your doctor.

Cover the ulcer with wound dressing as directed by your doctor. After 12 hours, remove the dressing, rinse the ulcer, and apply new dressing on the ulcer. Do not apply more medication at this time.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Use this medication until the ulcer heals completely.

Do not apply a thick layer of the medication or use more of the medication than directed. This will not increase the effects of the medication or help the wound heal faster and may increase the risk of side effects. Talk to your doctor for more details.

Tell your doctor if your condition worsens, does not improve after 10 weeks, or does not heal completely after 20 weeks.

Consumer Overview Side Effect

SIDE EFFECTS: 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.

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 Regranex (becaplermin) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before using becaplermin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as parabens), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: cancer in the ulcer area.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or 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.

This medication has been prescribed for your current wound only. Do not use it later for another wound unless told to do so by your doctor. A different medication may be necessary in that case.

Good foot care can help reduce the chances of foot ulcers. Wash your feet daily and check for cuts, sores, or blisters. Keep your toenails neat and trimmed. Choose shoes that are well-fitting, and always wear socks with your shoes.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store in the refrigerator at 36-46 degrees F (2-8 degrees C). Do not freeze. Keep tube tightly closed. 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 March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Regranex

Generic Name: becaplermin topical (Pronunciation: be KAP ler min TOP ik al)

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

What is becaplermin topical (Regranex)?

Becaplermin contains a human growth factor that helps your body heal. It works by promoting the growth of cells that aid in wound healing.

Becaplermin topical (for the skin) is used to treat diabetic foot ulcers.

Becaplermin topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of becaplermin topical (Regranex)?

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.

Stop using becaplermin topical and call your doctor at once if you have severe itching, redness, blistering, peeling, or other skin irritation.

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 Regranex (becaplermin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about becaplermin topical (Regranex)?

You should not use this medication if you are allergic to becaplermin or parabens, or if you have skin cancer affecting your feet. Do not apply becaplermin over any wound or surgical incision that has been closed with stitches, staples, or surgical tape.

A becaplermin dose is measured by the length of a ribbon of gel squeezed from the medicine tube. Ask your doctor, pharmacist, or wound care counselor if you have any questions about how to measure your becaplermin dose.

You will need to recalculate your dose about every week or two as the size of your ulcer changes. Follow your doctor's instructions.

Do not apply becaplermin gel more than once per day and never use more than your prescribed dose. Using more of the medication will not make it work faster and may cause unwanted side effects.

Use this medication for the full prescribed length of time. Call your doctor if your symptoms do not improve, or if they get worse while using becaplermin topical.

Becaplermin topical is only part of a complete ulcer care treatment program that may also include routine foot exams and avoiding weight on the affected foot. Follow your doctor's instructions very closely.

Some people who used 3 or more courses of treatment with becaplermin topical have developed cancer. However, it is not known whether this medication actually causes cancer. Talk with your doctor about your own specific cancer risk.

Side Effects Centers
  • Regranex

Patient Detailed How Take

What should I discuss with my healthcare provider before using becaplermin topical (Regranex)?

You should not use this medication if you are allergic to becaplermin or parabens, or if you have skin cancer affecting your feet. Do not apply becaplermin over any wound or surgical incision that has been closed with stitches, staples, or surgical tape.

FDA pregnancy category C. It is not known whether becaplermin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether becaplermin topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child younger than 16 years old.

Some people who used 3 or more courses of treatment with becaplermin topical have developed cancer. However, it is not known whether this medication actually causes cancer. Talk with your doctor about your own specific cancer risk.

How should I use becaplermin topical (Regranex)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Using more of this medication will not make it work faster and may cause unwanted side effects.

A becaplermin dose is measured by the length of a ribbon of gel squeezed from the medicine tube. To calculate the proper dose, measure the length and width of your ulcer and use one of the following formulas:

  • When using a 15-gram tube of becaplermin gel: multiply length x width x 0.6. For example, 2 inches x 1 inch x 0.6 = 1.25 inches of gel.
  • When using a 2-gram tube of becaplermin gel: multiply length x width x 1.3. For example, 2 inches x 1 inch x 1.3 = 2.75 inches of gel.
  • To measure the dose in centimeters: Multiply length x width and divide by 4 if using a 15-gram tube, or divide by 2 if using a 2-gram tube. For example, 4 centimeters x 2 centimeters / 4 = 2 centimeters of gel from the 15-gram tube; or 4 centimeters x 2 centimeters / 2 = 4 centimeters of gel from the 2-gram tube.
  • Ask your doctor, pharmacist, or wound care counselor if you have any questions about how to measure your becaplermin dose.

Make sure you are aware of which tube size you are using when calculating your becaplermin topical dose. Always check your refills to make sure you have received the correct tube size prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

You will need to recalculate your dose about every week or two as the size of your ulcer changes. Follow your doctor's instructions.

Wash your hands before and after using this medication.

To apply becaplermin topical gel:

  • Squeeze a ribbon of gel (in the correct length for your ulcer) onto a clean, firm surface that will not absorb the gel such as wax paper.
  • To keep the tip of the medicine tube from getting contaminated, do not allow the tip to touch any surface, including your fingers, the firm surface, or the ulcer you are treating.
  • Use a cotton swab, tongue depressor, or other disposable applicator to lift the gel from the firm surface
  • Spread the gel evenly in a thin layer (about 1/16 of an inch thick) over the ulcerated skin area.
  • Cover the treated skin area with a cotton gauze bandage that has been moistened with saline. Leave this gauze dressing on for the next 12 hours.
  • After 12 hours have passed, remove the gauze and rinse the ulcer with saline or water to remove the gel. Moisten a new gauze bandage with saline and cover the ulcer without applying any becaplermin gel.

Do not apply becaplermin gel more than once per day and never use more than your prescribed dose.

Use this medication for the full prescribed length of time. Call your doctor if your symptoms do not improve, or if they get worse while using becaplermin topical.

Becaplermin topical is only part of a complete ulcer care treatment program that may also include routine foot exams and avoiding weight on the affected foot. Follow your doctor's instructions very closely.

Store in the refrigerator, do not freeze. Keep the medicine tube tightly capped when not in use. Do not use becaplermin gel past the expiration date on the tube.

Side Effects Centers
  • Regranex

Patient Detailed Avoid Taking

What happens if I miss a dose (Regranex)?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Regranex)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using becaplermin topical (Regranex)?

Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with water.

Avoid using other medications on the areas you treat with becaplermin unless your doctor tells you to.

What other drugs will affect becaplermin topical (Regranex)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied becaplermin. But many drugs can interact with each other. 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 pharmacist can provide more information about becaplermin topical.


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: 2.02. Revision date: 5/7/2012.

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Side Effects Centers
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