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Regranex

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Regranex

Regranex

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.

Last reviewed on RxList: 5/25/2012
This monograph has been modified to include the generic and brand name in many instances.

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