Regranex Gel 0.01% .1 mg/g
Becaplermin gel 0.01% · GEL · LRM Therapeutics, LLC
Regranex Gel 0.01% is a gel containing becaplermin gel 0.01% at .1 mg/g, taken topical. Manufactured by LRM Therapeutics, LLC.
Key Facts
- Brand Name
- Regranex Gel 0.01%
- Generic Name
- Becaplermin gel 0.01%
- NDC Code (Product)
85822-734- Manufacturer
- LRM Therapeutics, LLC
- Strength
- .1 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- BLA103691
- Drug Class
- Human Platelet-derived Growth Factor [EPC]
- Marketing Start
- 06/13/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE REGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. Limitations of Use: The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers [ see Clinical Studies ( 14.2 ) ] and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue [Stage I or II, International Association of Enterostomal Therapy (IAET) staging classification] or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans [ see Nonclinical Toxicology ( 13.2 ) ]. REGRANEX is not intended to be used in wounds that close by primary intention. REGRANEX is a human platelet-derived growth factor indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION REGRANEX is for topical use; it is not for oral, ophthalmic or intravaginal use. The amount of REGRANEX to be applied depends upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2. Table 1: Formula to Calculate Length of Gel in Inches to Be Applied Daily Tube Size INCHES Formula 15 g tube length × width × 0.6 Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15 g tube. For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15 g tubes (1 x 2 x 0.6 = 1 1/4). Table 2: Formula to Calculate Length of Gel in Centimeters to Be Applied Daily Tube Size CENTIMETERS Formula 15 g tube length × width ÷ 4 Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centime…
Contraindications
4 CONTRAINDICATIONS REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application. Known neoplasm(s) at the site(s) of application ( 4 )
Drug Interactions
7 DRUG INTERACTIONS It is not known if REGRANEX interacts with other topical medications applied to the ulcer site. The use of REGRANEX with other topical drugs has not been studied.
Adverse Reactions
6 ADVERSE REACTIONS Erythematous rashes occurred in 2% of patients treated with REGRANEX. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Lynch Regenerative Medicine, LLC at 1-888-576-7343 6.1 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 clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care), and none in subjects receiving good ulcer care alone. Subjects treated with REGRANEX did not develop neutralizing antibodies against becaplermin. In a retrospective follow-up study of 491 of 651 subjects (75%) from two randomized, controlled trials of another formulation of becaplermin gel 0.01%, the subjects were followed for a median of approximately 20 months to evaluate safety and recurrence of healed diabetic lower extremity ulcers. Eight of 291 subjects (2.7%) from the becaplermin gel group and two of 20…
Frequently Asked Questions
What is Regranex Gel 0.01% used for?
Regranex Gel 0.01% contains Becaplermin gel 0.01%. It is a gel taken topical. Consult your doctor for specific uses.
Is Regranex Gel 0.01% a controlled substance?
Regranex Gel 0.01% is not classified as a controlled substance by the DEA.
What is the generic name for Regranex Gel 0.01%?
The generic name for Regranex Gel 0.01% is Becaplermin gel 0.01%. There are no other listed brand versions of Becaplermin gel 0.01%.
What is the NDC code for Regranex Gel 0.01% .1 mg/g?
The NDC (National Drug Code) for Regranex Gel 0.01% .1 mg/g is 85822-734, listed by LRM Therapeutics, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)