Regranex (Becaplermin) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Regranex

Diabetes (Type 1 and Type 2) »

Diabetes facts

Diabetes is a chronic condition associated with abnormally high levels of sugar (glucose) in the blood.
Insulin produced by the pancreas lowers blood glucose.
Absence or insufficient production of insulin causes diabetes.
The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent).
Symptoms of diabetes include increased urine output, thirst and hunger as well as fatigue.
Diabetes is diagnosed by blood sugar (glucose) testing.
The major complications of diabetes are both acute and chronic.
- Acutely: dangerously elevated blood sugar, abnormally low blood sugar due to diabetes medications may occur.
- Chronically: disease of the blood vessels (both small and large) which can damage the eye, kidneys, nerves, and heart may occur
Diabetes treatment depends...

Read the Diabetes (Type 1 and Type 2) article »

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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.

DRUG 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.

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