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Regranex is a brand name for Becaplermin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
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 each application, the ulcer should be gently rinsed with saline or water to remove residual gel.
- The tube should be closed tightly after each use. 2Medicinal product no longer authorised REGRANEX should not be used for more than 20 weeks. 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 18 years have not been established.
The safety of REGRANEX Gel was evaluated in 1883 adult patients who participated in 17 clinical trials of REGRANEX and placebo and/or standard therapy (saline dressing). These 1883 patients had at least one topical administration of REGRANEX and provided safety data.
2). Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of REGRANEX from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available clinical trial data).
Adverse Drug Reactions Reported in Clinical Trials and Postmarketing Experience System Organ Class Adverse Drug Reactions Frequency Category Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Infections and Infestations Infected skin ulcer,Cellulitis Osteomyelitis Nervous System Disorders Burning sensation1 Skin and Subcutaneous Tissue Disorders Rash, Erythema2 Dermatitis bullous, Excessive granulation tissue General Disorders and Administration Site Conditions Pain Oedema 1.
The bundled term burning sensation consists of the preferred terms burning sensation, skin burning sensation, and application site irritation, all of which referred specifically to burning at the application site. 2. Refers to erythema at the application site.
4. 1. 3. PHARMACEUTICAL FORM Gel. REGRANEX is a clear colourless to straw-coloured gel. 4. 1 Therapeutic 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.
2 Posology and method of administration 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 each application, the ulcer should be gently rinsed with saline or water to remove residual gel.
- The tube should be closed tightly after each use. 2Medicinal product no longer authorised REGRANEX should not be used for more than 20 weeks. 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.
Hypersensitivity to the active substance or to any of the excipients. 4). - In patients with clinically infected ulcers. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Becaplermin in European Union.
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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 18 years have not been established.
3 Contraindications - Hypersensitivity to the active substance or to any of the excipients. 4). - In patients with clinically infected ulcers. 4). 4 Special warnings and precautions for use 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 any 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 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. 1 Pharmacodynamic properties). 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).