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Drug Details

REGRANEX

• Drug Class Description
  Recombinant human platelet derived growth factor-BB (rhPDGF- BB) / leg ulcer treatments.
• Generic Name
  Becaplermin
• Presentation
  Gel REGRANEX is a clear colourless to straw-coloured preserved gel.
• Description
  Each gram of gel contains100 ?g of becaplermin*. *Recombinant human Platelet Derived Growth Factor-BB (rhPDGF-BB) produced in Saccharomyces cerevisiae by recombinant DNA technology. Excipients: Each gram contains E218 (methyl parahydroxybenzoate) 1.56mg and E216 (propyl parahydroxybenzoate) 0.17mg,
• Indications
  REGRANEX is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2
• Adult Dosage
  

  Treatment with REGRANEX should be initiated and monitored by physicians (specialists or non-specialists) who are experienced in the management of diabetic wounds.

  REGRANEX should always be used in conjunction with good wound care consisting of initial debridement (to remove all the necrotic and/or infected tissue), additional debridement as necessary and a non-weight-bearing regimen to alleviate pressure on the ulcer. REGRANEX should be applied as a continuous thin layer to the entire ulcerated area(s) once daily using a clean application aid. The site(s) of application should then be covered by a moist saline gauze dressing that maintains a moist wound-healing environment. REGRANEX should not be used in conjunction with occlusive dressings.

  - A tube of REGRANEX should be used on a single patient only

  - Care should be taken during use to avoid microbial contamination and spoilage

  - Hands should be washed thoroughly before applying REGRANEX

  - The tip of the tube should not come into contact with the wound or any other surface

  - The use of a clean application aid is recommended and contact with other parts of the body should be avoided

  - Before application, the ulcer should be gently rinsed with saline or water to remove residual gel.

  - The tube should be closed tightly after each use.

  REGRANEX should not be used for more than 20 weeks in any individual patient.

  If during treatment with REGRANEX no meaningful healing progress is evident after the first ten weeks of continuous therapy, treatment should be re- evaluated, and factors known to compromise healing (such as osteomyelitis, ischaemia, infection) should be re- assessed. Therapy should be continued to the maximum of 20 weeks as long as healing progress is seen on periodic evaluations.

  Special population

  Paediatric population

  Safety and effectiveness in children and adolescents below the age of 18years have not been established.

  REGRANEX has not been studied in children.

• Child Dosage
  Under 18 years, not recommended.
• Contra Indications
  

  - Known hypersensitivity to the active substance or to any of the excipients.

  - Any known malignancies.

  - In patients with clinically infected ulcers.

• Special Precautions
  

  Malignancies distant from the site of application have occurred in becaplermin users in both clinical trial and in post-marketing use. In view of these data, and since becaplermin is a growth factor, REGRANEX treatment is contraindicated in patients with known malignancies.

  Prior to the use of REGRANEX, related underlying conditions such as osteomyelitis and peripheral arteriopathy should be excluded or treated if present. Osteomyelitis should be assessed by X-ray examination. Peripheral arteriopathy should be excluded by the assessment of the pedal pulses or other techniques. Ulcers with a suspicious appearance should be biopsied to exclude malignancy.

  Wound infection should be treated prior to the use of REGRANEX. If a wound becomes infected during REGRANEX therapy, the product should be discontinued until the infection has cleared.

  REGRANEX should not be used in patients with ulcers that are not of primarily neuropathic origin, such as those due to arteriopathy or other factors.

  REGRANEX should not be used in ulcers of baseline surface area> 5 cm², or for more than 20 weeks in any individual. There are insufficient data to support safe use of the product for more than 20 weeks. Efficacy has not been demonstrated for ulcers of baseline surface area> 5 cm².

  REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate). These may cause allergic reactions (possibly delayed).

• Interactions
  

  No interaction studies have been performed. Consequently, it is recommended that REGRANEX should not be applied to the ulcer site in conjunction with other topical medications.

• Adverse Drug Reactions
  

  The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.

  Adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare ( <1/10,000); not known.

  Serious adverse reactions reported in clinical trials.

  System organ class	Very Common	Common	Rare
  Infections and infestations	Infections Cellulitis	Osteomyelitis
  Skin and subcutaneous tissue disorders	Skin ulceration	Skin disorder (including erythema)	Dermatitis bullous Excessive granulation tissue*
  General disorders and administration sites conditions		Pain	Oedema

  *Based on post marketing experience