Becaplermin

Name: Becaplermin

What brand names are available for becaplermin?

Regranex

Is becaplermin safe to take if I'm pregnant or breastfeeding?

Becaplermin has not been well studied in pregnant women. It may be used during pregnancy if the physician feels the benefits of using the drug outweigh the unknown risks to the developing fetus.

It is not known if becaplermin is secreted in breast milk. For this reason, it should be used with caution in a mother who is breastfeeding.

Side Effects of Becaplermin

Serious side effects have been reported with becaplermin. See the "Drug Precautions" section.

Common side effects of becaplermin include skin rashes.

This is not a complete list of becaplermin side effects. Ask your doctor or pharmacist for more information.

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

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

Becaplermin Interactions

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you apply other medicines to diabetic ulcers of your legs or feet. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Inform MD

Before using becaplermin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • Have cancer
  • Have poor blood flow to your legs and feet
  • Have allergies to any of the ingredients in becaplermin gel
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Advice to Patients

Patient Counseling Information

Counsel patients to review and discuss any questions or concerns with their healthcare provider before starting becaplermin and at regular intervals while receiving becaplermin.1

Patients should be advised that they should read the medication guide. 1

Hands should be washed thoroughly before applying becaplermin gel.1

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. 1

A cotton swab, tongue depressor, or other application aid should be used to apply becaplermin gel.1

Becaplermin gel should only be applied once a day in a carefully measured quantity. 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 becaplermin gel to be applied daily should be recalculated at weekly or biweekly intervals by the physician or wound care giver.1

Step-by-Step Instructions for Application of Becaplermin Gel

Squeeze the calculated length of gel onto a clean, firm, nonabsorbable surface (e.g., wax paper).1

With a clean cotton swab, tongue depressor, or similar application aid, spread the measured becaplermin gel over the ulcer surface to obtain an even layer.1

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 becaplermin gel). It is important to use becaplermin gel together with a good ulcer care program, including a strict non-weight-bearing program. Excess application of becaplermin gel has not been shown to be beneficial. Becaplermin gel should be stored in the refrigerator. Do not freeze becaplermin gel. Becaplermin gel should not be used after the expiration date on the bottom, crimped end of the tube.1

Use Labeled Indications

Diabetic ulcers: Adjunctive treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

Limitations of use: Efficacy has not been established for pressure and venous stasis ulcers; has not been evaluated for diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (stage I or II, International Association of Enterostomal Therapy [IAET] staging classification) or ischemic diabetic ulcers.

Drug Interactions

There are no known significant interactions.

ALERT U.S. Boxed Warning

Malignancy:

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of becaplermin in a postmarketing retrospective cohort study. Becaplermin should only be used when the benefits can be expected to outweigh the risks. Becaplermin should be used with caution in patients with known malignancy.

Monitoring Parameters

Ulcer volume (pressure ulcers); wound area; evidence of closure; drainage (diabetic ulcers); signs/symptoms of toxicity (erythema, local infections)

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Warnings

Contraindications

Hypersensitivity

Neoplasm at application site

Cautions

Malignancies distant from the site of application have occurred in patients using becaplermin gel a clinical study and in postmarketing use contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis; evaluate benefits and risks before prescribing in patients with known malignancy

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 (eg, patch testing) according to clinical circumstances

Pharmacology

Mechanism of Action

Recombinant human platelet-derived growth factor; promotes chemotactic recruitment and proliferation of cells involved in wound repair and enhances granulation tissue formation

Pharmacokinetics

Onset of action: Within 8 weeks (15% completely healed); within 10 weeks (25% completely healed)

Distribution: Binds to normal skin and granulation tissue

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