Regranex (Becaplermin) - Complete Drug Information

Becaplermin is a recombinant human platelet-derived growth factor (rhPDGF) that is used as a topical gel for the treatment of diabetic ulcers, particularly those that are slow to heal. Diabetic ulcers can be particularly challenging to treat due to impaired wound healing associated with diabetes. Becaplermin works by stimulating the growth of new tissue and blood vessels, which can help speed up the healing process. It's often used in conjunction with standard wound care practices, such as debridement and infection control.

It encourages the production of met haemoglobin, which is in competition with the cyanide ions. Cyano-methemoglobin is produced when cyanide and methemoglobin are combined.

  • When diabetic neuropathic ulcers in the lower limbs have a sufficient blood supply and spread into the subcutaneous tissue or beyond, it is utilised as an additional therapy.
  • Limitations of use:
    • It has not been studied in the following patient groups:
      • patients who have neuropathic, superficial diabetic ulcers
      • not through the dermis into the subcutaneous tissue-extending ulcers (Stage I or II, International Association of Enterostomal Therapy [IAET] staging classification)
      • diabetic ischemic ulcers.
    • Its efficacy has not been determined for venous or pressure ulcers.

Treatment response is best when good glycemic control is achieved preferably with insulin. Symptomatic treatment like pregabalin, duloxetine or gabapentin may be required.

Regranex (Becaplermin) Dose in Adult

Regranex (Becaplermin) use in the treatment of lower extremity of diabetic ulcers:

Becaplermin is a gel used to treat diabetic ulcers on the lower extremities, like feet and legs.

  • Application: Use a cotton swab or similar tool to apply the gel once a day directly onto the ulcer. The amount of gel you need depends on the size of the ulcer.
  • Monitoring: If the ulcer doesn't get smaller by about 30% after 10 weeks, or if it hasn't healed completely in 20 weeks, talk to your doctor about whether to keep using the gel.
  • Estimating Gel Amount: To know how much gel you need, measure the length and width of the ulcer. Then calculate:
    • In centimeters: Divide the product of length and width by 4.
    • In inches: Multiply the product of length and width by 0.6.
  • Adjustments: Keep checking the ulcer's size and adjust the amount of gel needed every 1 to 2 weeks, depending on how fast the ulcer changes.

Regranex (Becaplermin) Dose in Children

Becaplermin Use in the therapy of lower extremity of Diabetic ulcers:

  • Adolescents ≥16 years:
    • Refer to adult dosing.

Regranex (Becaplermin) pregnancy Risk factor: Undefined

  • No studies have been done on how this medicine affects animals when they're having babies.

Becaplermin use during breastfeeding:

  • We're not sure if Becaplermin passes into breast milk.
  • The decision to breastfeed while using this medication should consider factors like the potential risk to the baby, the benefits of breastfeeding for the baby, and how important the treatment is for the mother.

Becaplermin dose in kidney disease:

  • The instructions from the manufacturer don't mention any changes in dosage for people with kidney problems.
  • This is because the medication is unlikely to be absorbed much into the bloodstream, so adjustments probably aren't necessary.

Becaplermin dose in liver disease:

  • The manufacturer's instructions don't include any specific changes in dosage for individuals with liver issues.
  • This is because the medication is not expected to be absorbed into the bloodstream much, so adjustments in dosage are unlikely to be needed.

Common Side Effects of Regranex (Becaplermin) Include:

  • Dermatologic:
    • Erythematous rash

Contraindications to Regranex (Becaplermin) Include:

  • This means there's a known tumor or tumors at the area where you apply the medication.

Cautions and alerts

Malignancy:

  • There have been reports of different types of cancers occurring, but they were all in areas away from where the becaplermin was applied.
  • If you have a known cancer, be careful when using this medication.
  • It should only be used if the benefits are likely to be greater than the risks.

Application site reactions:

  • Sometimes, when you use this medication, you might notice reactions on the skin where it's applied.
  • This could be irritation or sensitivity.
  • It might happen because of certain ingredients like parabens or m-cresol.
  • If this occurs, you might need to stop using the medication and get further evaluation, like patch testing, to figure out the cause.

Monitor:

Monitoring Your Ulcer:

  • Ulcer Volume (Pressure Ulcers): Keep an eye on how deep the ulcer is and if it's getting smaller over time.
  • Wound Area: Measure the size of the wound regularly to see if it's shrinking.
  • Evidence of Closure: Look for signs that the wound is starting to heal, like new skin forming over it.
  • Drainage (Diabetic Ulcers): Pay attention to any fluid or discharge coming from the ulcer, as it could indicate an infection.

Watching for Side Effects:

  • Signs/Symptoms of Toxicity: Keep an eye out for redness or local infections around the area where you apply the medication. If you notice these, it could mean the medication is causing irritation or an allergic reaction.

How to administer Regranex (Becaplermin)?

  • For Topical Use Only: This medication is meant to be used on the skin only, not taken by mouth, put in the eyes, or used inside the vagina.
  • Application Process:
    • Squeeze out the right amount of gel onto a clean surface like wax paper.
    • Spread the gel thinly and evenly over the entire area of the ulcer, aiming for a layer about the thickness of a half-inch.
    • Cover the treated area with a dressing moistened with saline solution and leave it on for about 12 hours.
  • After 12 Hours:
    • Remove the dressing and rinse the area with saline solution or water to get rid of any remaining gel.
    • Cover the ulcer with a fresh dressing moistened with saline (without any gel) for the rest of the day.
  • Continued Use:
    • Repeat this process once daily until the ulcer is completely healed.

Mechanism of action of Regranex (Becaplermin):

  • This medication is a type of protein called recombinant B-isoform homodimer of human platelet-derived growth factor (rPDGF-BB). What it does is it helps the body make new tissue called granulation tissue, which is important for healing wounds.
  • It also helps cells called fibroblasts grow and change in a way that speeds up wound healing. Plus, it helps new blood vessels grow, which is called angiogenesis. All of these actions together promote the healing of wounds.

International Brands of Becaplermin:

  • Becaplex
  • Regranex

Regranex (Becaplermin) Brands in Pakistan:

No brands available in Pakistan

Becaplermin is a recombinant human platelet-derived growth factor (rhPDGF) that is used as a topical gel for the treatment of diabetic ulcers, particularly those that are slow to heal. Diabetic ulcers can be particularly challenging to treat due to impaired wound healing associated with diabetes. Becaplermin works by stimulating the growth of new tissue and blood vessels, which can help speed up the healing process. It's often used in conjunction with standard wound care practices, such as debridement and infection control.

It encourages the production of met haemoglobin, which is in competition with the cyanide ions. Cyano-methemoglobin is produced when cyanide and methemoglobin are combined.

  • When diabetic neuropathic ulcers in the lower limbs have a sufficient blood supply and spread into the subcutaneous tissue or beyond, it is utilised as an additional therapy.
  • Limitations of use:
    • It has not been studied in the following patient groups:
      • patients who have neuropathic, superficial diabetic ulcers
      • not through the dermis into the subcutaneous tissue-extending ulcers (Stage I or II, International Association of Enterostomal Therapy [IAET] staging classification)
      • diabetic ischemic ulcers.
    • Its efficacy has not been determined for venous or pressure ulcers.

Treatment response is best when good glycemic control is achieved preferably with insulin. Symptomatic treatment like pregabalin, duloxetine or gabapentin may be required.

Regranex (Becaplermin) Dose in Adult

Regranex (Becaplermin) use in the treatment of lower extremity of diabetic ulcers:

Becaplermin is a gel used to treat diabetic ulcers on the lower extremities, like feet and legs.

  • Application: Use a cotton swab or similar tool to apply the gel once a day directly onto the ulcer. The amount of gel you need depends on the size of the ulcer.
  • Monitoring: If the ulcer doesn't get smaller by about 30% after 10 weeks, or if it hasn't healed completely in 20 weeks, talk to your doctor about whether to keep using the gel.
  • Estimating Gel Amount: To know how much gel you need, measure the length and width of the ulcer. Then calculate:
    • In centimeters: Divide the product of length and width by 4.
    • In inches: Multiply the product of length and width by 0.6.
  • Adjustments: Keep checking the ulcer's size and adjust the amount of gel needed every 1 to 2 weeks, depending on how fast the ulcer changes.

Regranex (Becaplermin) Dose in Children

Becaplermin Use in the therapy of lower extremity of Diabetic ulcers:

  • Adolescents ≥16 years:
    • Refer to adult dosing.

Regranex (Becaplermin) pregnancy Risk factor: Undefined

  • No studies have been done on how this medicine affects animals when they're having babies.

Becaplermin use during breastfeeding:

  • We're not sure if Becaplermin passes into breast milk.
  • The decision to breastfeed while using this medication should consider factors like the potential risk to the baby, the benefits of breastfeeding for the baby, and how important the treatment is for the mother.

Becaplermin dose in kidney disease:

  • The instructions from the manufacturer don't mention any changes in dosage for people with kidney problems.
  • This is because the medication is unlikely to be absorbed much into the bloodstream, so adjustments probably aren't necessary.

Becaplermin dose in liver disease:

  • The manufacturer's instructions don't include any specific changes in dosage for individuals with liver issues.
  • This is because the medication is not expected to be absorbed into the bloodstream much, so adjustments in dosage are unlikely to be needed.

Common Side Effects of Regranex (Becaplermin) Include:

  • Dermatologic:
    • Erythematous rash

Contraindications to Regranex (Becaplermin) Include:

  • This means there's a known tumor or tumors at the area where you apply the medication.

Cautions and alerts

Malignancy:

  • There have been reports of different types of cancers occurring, but they were all in areas away from where the becaplermin was applied.
  • If you have a known cancer, be careful when using this medication.
  • It should only be used if the benefits are likely to be greater than the risks.

Application site reactions:

  • Sometimes, when you use this medication, you might notice reactions on the skin where it's applied.
  • This could be irritation or sensitivity.
  • It might happen because of certain ingredients like parabens or m-cresol.
  • If this occurs, you might need to stop using the medication and get further evaluation, like patch testing, to figure out the cause.

Monitor:

Monitoring Your Ulcer:

  • Ulcer Volume (Pressure Ulcers): Keep an eye on how deep the ulcer is and if it's getting smaller over time.
  • Wound Area: Measure the size of the wound regularly to see if it's shrinking.
  • Evidence of Closure: Look for signs that the wound is starting to heal, like new skin forming over it.
  • Drainage (Diabetic Ulcers): Pay attention to any fluid or discharge coming from the ulcer, as it could indicate an infection.

Watching for Side Effects:

  • Signs/Symptoms of Toxicity: Keep an eye out for redness or local infections around the area where you apply the medication. If you notice these, it could mean the medication is causing irritation or an allergic reaction.

How to administer Regranex (Becaplermin)?

  • For Topical Use Only: This medication is meant to be used on the skin only, not taken by mouth, put in the eyes, or used inside the vagina.
  • Application Process:
    • Squeeze out the right amount of gel onto a clean surface like wax paper.
    • Spread the gel thinly and evenly over the entire area of the ulcer, aiming for a layer about the thickness of a half-inch.
    • Cover the treated area with a dressing moistened with saline solution and leave it on for about 12 hours.
  • After 12 Hours:
    • Remove the dressing and rinse the area with saline solution or water to get rid of any remaining gel.
    • Cover the ulcer with a fresh dressing moistened with saline (without any gel) for the rest of the day.
  • Continued Use:
    • Repeat this process once daily until the ulcer is completely healed.

Mechanism of action of Regranex (Becaplermin):

  • This medication is a type of protein called recombinant B-isoform homodimer of human platelet-derived growth factor (rPDGF-BB). What it does is it helps the body make new tissue called granulation tissue, which is important for healing wounds.
  • It also helps cells called fibroblasts grow and change in a way that speeds up wound healing. Plus, it helps new blood vessels grow, which is called angiogenesis. All of these actions together promote the healing of wounds.

International Brands of Becaplermin:

  • Becaplex
  • Regranex

Regranex (Becaplermin) Brands in Pakistan:

No brands available in Pakistan