Regranex 0.01% Gel 15gm
It is used to treat skin ulcers.
Drug Class
Wound healing agent
Pharmacologic Class
Platelet-derived growth factor (PDGF) analog
Pregnancy Category
Category C
FDA Approved
Dec 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Regranex gel contains a protein that helps your body heal wounds, especially diabetic foot ulcers. It works by encouraging cells to grow and repair the damaged tissue.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication topically, directly to the affected skin area. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly. However, if the treated area is on your hand, do not wash that hand after application.
To avoid contamination, do not touch the container tip to your skin.
To apply the medication:
1. Squeeze the required amount of gel onto a piece of wax paper.
2. Use a clean cotton swab or tongue depressor to gently apply the gel to the ulcer.
3. Spread a thin, even layer of gel over the ulcer.
4. Cover the ulcer with a clean saline dressing for 12 hours.
5. After 12 hours, remove the dressing and rinse the area with saline or water.
6. Recover the ulcer with a clean saline dressing.
Replace the cap on the container after each use.
Storage and Disposal
Store this medication in the refrigerator at all times. Do not freeze.
Keep all medications in a safe, secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
* If you have questions about disposing of medications, consult your pharmacist. You may also have access to local drug take-back programs.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication topically, directly to the affected skin area. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause irritation or burning.
Before and after applying the medication, wash your hands thoroughly. However, if the treated area is on your hand, do not wash that hand after application.
To avoid contamination, do not touch the container tip to your skin.
To apply the medication:
1. Squeeze the required amount of gel onto a piece of wax paper.
2. Use a clean cotton swab or tongue depressor to gently apply the gel to the ulcer.
3. Spread a thin, even layer of gel over the ulcer.
4. Cover the ulcer with a clean saline dressing for 12 hours.
5. After 12 hours, remove the dressing and rinse the area with saline or water.
6. Recover the ulcer with a clean saline dressing.
Replace the cap on the container after each use.
Storage and Disposal
Store this medication in the refrigerator at all times. Do not freeze.
Keep all medications in a safe, secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
* If you have questions about disposing of medications, consult your pharmacist. You may also have access to local drug take-back programs.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Maintain good blood sugar control if you have diabetes, as this is crucial for wound healing.
- Follow all instructions for proper wound care, including cleaning the wound and changing dressings as directed by your healthcare provider.
- Avoid putting pressure on the ulcer (e.g., use special footwear or crutches).
- Do not pick at or disturb the healing wound.
- Keep the gel refrigerated and do not freeze it.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of gel (approximately 1/16 inch thickness) once daily to the ulcer surface. The amount of gel to be applied should be calculated based on the ulcer size.
Condition-Specific Dosing:
diabetic_neuropathic_ulcers:
Apply once daily to the ulcer surface, covered with a saline-moistened gauze dressing. Treatment should continue until complete healing or for up to 20 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No adjustment needed (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Becaplermin is a recombinant human platelet-derived growth factor-BB (rhPDGF-BB). It promotes the chemotactic recruitment and proliferation of cells involved in wound repair, including fibroblasts, macrophages, and neutrophils. It also stimulates angiogenesis and extracellular matrix formation, thereby facilitating the formation of granulation tissue and subsequent wound closure.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<3% of applied dose)
Tmax:
Not clinically relevant for systemic absorption; local effect is primary.
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not clinically relevant (localized action)
ProteinBinding:
Not clinically relevant (localized action)
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant systemically (localized action)
Clearance:
Not clinically relevant systemically
ExcretionRoute:
Not clinically relevant systemically
Unchanged:
Not clinically relevant systemically
Pharmacodynamics
OnsetOfAction:
Wound healing is a gradual process; not a single onset time.
PeakEffect:
Gradual improvement over weeks of treatment.
DurationOfAction:
Effect persists as long as treatment continues and wound care is maintained.
Safety & Warnings
BLACK BOX WARNING
Increased risk of cancer mortality in patients treated with Regranex. The risk of cancer mortality was higher in patients treated with three or more tubes of Regranex Gel in a single course of treatment. Regranex should be used with caution in patients with known malignancy.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience:
- Redness
or any other side effects that bother you or do not go away.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Irritation at the site where the medication was applied
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience:
- Redness
or any other side effects that bother you or do not go away.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of infection: increased redness, swelling, pain, warmth, pus, or fever.
- Allergic reaction: rash, itching, hives, swelling of the face/lips/tongue.
- Worsening of the ulcer or no improvement after several weeks of use.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a tumor in the area where this medication will be administered.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a tumor in the area where this medication will be administered.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks to experience the full effects of this drug.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. There have been reported cases of cancer in some individuals taking this medication. If you have concerns or questions, discuss them with your doctor, especially if you have a history of cancer.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. There have been reported cases of cancer in some individuals taking this medication. If you have concerns or questions, discuss them with your doctor, especially if you have a history of cancer.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with topical application is unlikely due to minimal systemic absorption. Local irritation might occur with excessive application.
What to Do:
If excessive amount is applied, gently wipe off excess. If swallowed, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Ulcer size and characteristics (depth, presence of infection, exudate)
Rationale: To establish baseline for assessing treatment efficacy and identifying potential complications.
Timing: Prior to initiation of therapy
Overall health status, including glycemic control for diabetic patients
Rationale: Systemic factors significantly impact wound healing.
Timing: Prior to initiation of therapy
Routine Monitoring
Ulcer size reduction
Frequency: Weekly or bi-weekly
Target: Progressive reduction in size
Action Threshold: Lack of progress or worsening after 4-6 weeks may indicate need for re-evaluation of treatment plan.
Signs of local infection (redness, swelling, pain, purulent discharge)
Frequency: Daily by patient, weekly by healthcare provider
Target: Absence of infection
Action Threshold: Presence of infection requires appropriate antimicrobial treatment and re-evaluation of becaplermin use.
Signs of local irritation or allergic reaction
Frequency: Daily by patient, weekly by healthcare provider
Target: Absence of irritation
Action Threshold: Discontinue use if severe irritation or allergic reaction occurs.
Symptom Monitoring
- Increased pain at the ulcer site
- Redness or warmth spreading from the ulcer
- Swelling around the ulcer
- Fever or chills
- New or worsening purulent discharge from the ulcer
- Unusual odor from the ulcer
- Rash or itching at the application site
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but animal studies have shown adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data, but systemic exposure is low.
Second Trimester:
Potential risk based on animal data, but systemic exposure is low.
Third Trimester:
Potential risk based on animal data, but systemic exposure is low.
Lactation
L3 (Moderately Safe). It is not known whether becaplermin is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be very low. Use with caution.
Infant Risk:
Low risk due to minimal systemic absorption by the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. Dosage adjustment is generally not required.
Clinical Information
Clinical Pearls
- Regranex must be used as an adjunct to, and not a substitute for, good ulcer care practices, including appropriate debridement, pressure relief, and infection control.
- The gel should be applied with a clean applicator (e.g., cotton swab, tongue depressor) and not directly from the tube to avoid contamination.
- Patients should be instructed on proper wound hygiene and dressing changes.
- Refrigeration is required (2°C to 8°C / 36°F to 46°F); do not freeze.
- Due to the black box warning regarding malignancy risk, careful consideration of patient history and risk factors is important, especially for prolonged use or multiple courses.
Alternative Therapies
- Advanced wound dressings (e.g., hydrocolloids, alginates, foams)
- Negative pressure wound therapy (NPWT)
- Skin substitutes (e.g., Apligraf, Dermagraft)
- Hyperbaric oxygen therapy
- Surgical debridement and revascularization procedures
Cost & Coverage
Average Cost:
$1000 - $2000+ per 15gm tube
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the incident, including the substance taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the incident, including the substance taken, the amount, and the time it occurred.