Becaplermin Topical
Becaplermin topical is a human platelet-derived growth factor gel used to help heal lower extremity diabetic neuropathic ulcers that extend into deep tissue.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Becaplermin Topical: Patient Information Guide
A plain-language walkthrough of Becaplermin Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Becaplermin topical is approved for a specific type of hard-to-heal diabetic wound. Here is what the evidence supports:
- Regranex Gel 0.01% is indicated for lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue (the layer beneath the skin) or deeper, and that have an adequate blood supply
- It must be used as an add-on to standard wound care — including sharp debridement (removal of dead tissue), pressure relief, and infection control — not as a replacement
- Regranex has not been shown to work for pressure ulcers or venous stasis ulcers
- It has not been evaluated for shallower diabetic ulcers (Stage I or II) that do not reach the subcutaneous layer, or for ischemic diabetic ulcers (those with poor blood supply)
- Regranex is not intended for wounds that close naturally on their own (primary intention healing)
- Its effects on exposed joints, tendons, ligaments, or bone have not been established in humans
⚙️How it works▾
Becaplermin is a lab-made (recombinant) version of a protein your body naturally produces called platelet-derived growth factor (PDGF). In a healthy healing wound, PDGF signals repair cells to travel to the site, multiply, and build new tissue. Diabetic ulcers often lack enough of this signal. Becaplermin helps fill that gap — drawing repair cells to the wound and encouraging the formation of granulation tissue (the new, healthy tissue that fills in a healing wound).
💊How it's taken▾
Regranex gel is applied topically to the ulcer once a day. The exact amount depends on the size of the wound — your doctor or wound care provider will calculate the correct length of gel to use based on the ulcer's length and width, and will recalculate it regularly as the wound changes. Apply it as a thin, even layer, cover with a moist gauze dressing for about 12 hours, then rinse and cover with a plain moist dressing for the rest of the day.
- Apply once daily until the ulcer is fully healed
- If the ulcer hasn't shrunk by about 30% after 10 weeks, or hasn't healed by 20 weeks, your doctor will reassess whether to continue
- Follow your prescriber's instructions and the detailed Instructions for Use — do not adjust the amount on your own
🤒Side effects — in detail▾
Most people using Regranex tolerate it well, but some side effects have been reported:
- Redness of the skin (erythematous rash) — seen in about 2% of patients in clinical trials
- Burning sensation at the application site
- Skin irritation or erythema (redness) at the wound area
More seriously, cancers at locations away from the wound site have been reported in Regranex users — including a higher rate of cancer-related deaths in patients who used 3 or more tubes. Tell your doctor immediately if you notice any new or unusual lumps, growths, or other symptoms that could suggest cancer.
⚠️Warnings & precautions▾
- Cancer risk: Because becaplermin promotes cell growth and the formation of new blood vessels (angiogenesis), it may potentially encourage tumor growth. Cancers distant from the wound site have been reported in clinical studies and postmarketing experience. One postmarketing study found a higher rate of death from systemic malignancies in patients who used 3 or more tubes. Anyone with a current or past cancer diagnosis should discuss the risks carefully with their doctor before using Regranex.
- Do not use on tumors: Regranex is contraindicated (must not be used) if there is a known tumor at or near the wound site.
- Skin reactions: Burning and redness at the application site have been reported. If a skin reaction occurs, your doctor may consider stopping treatment and testing for sensitivity to the preservatives (parabens or m-cresol) in the gel.
- Not a substitute for wound care: Regranex only works when used alongside proper ulcer management — it does not replace debridement, pressure relief, or infection control.
🔀What it interacts with▾
There is limited information on how Regranex interacts with other medications applied to the wound.
- Other topical wound products: It is not known whether Regranex interacts with other topical medicines used on the ulcer — this combination has not been studied. Check with your doctor or pharmacist before applying other topical treatments to the same wound.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Known tumor at the wound site: Do not use Regranex if you have a known cancer (neoplasm) at or near the site of application — this is a contraindication.
- History of cancer: Tell your doctor about any past or current cancer diagnosis. The potential cancer risk of Regranex must be carefully weighed before starting treatment.
- Pregnancy: There are no human data on Regranex use during pregnancy. Discuss with your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is unknown whether becaplermin passes into breast milk. Discuss the risks and benefits with your doctor if you are nursing.
- Children under 16: Safety and effectiveness have not been established in patients younger than 16 years old.
- Adults 65 and older: Clinical trial data did not show meaningful differences in safety or effectiveness in adults 65 and older compared to younger adults, though data in those 75 and older are very limited.
🚑If you take too much▾
There are no data available on what happens if too much Regranex is applied. If you think you or someone else has used more than directed, contact your doctor or a poison control center for guidance.
🔬Pharmacokinetics — how your body processes it▾
In a small study, 10 people with deep diabetic leg ulcers applied becaplermin gel 0.01% once daily for 14 days. Most participants showed little to no detectable increase in PDGF (platelet-derived growth factor) levels in their blood during the study — suggesting that very little of the active ingredient is absorbed into the bloodstream through the wound surface. Only two of the ten participants showed any intermittent increase above their starting levels.
📦How to store it▾
Store refrigerated at 2° - 8°C (36° - 46°F). Do not freeze.
📄 Written from Becaplermin Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Becaplermin Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Regranex supposed to do for my ulcer? ▾
How do I know how much gel to use each time? ▾
I heard there might be a cancer risk. Should I be worried? ▾
Can I put other wound creams or gels on the ulcer while using Regranex? ▾
How long will I need to use this? ▾
Is it safe to use Regranex if I'm pregnant or breastfeeding? ▾
Is Becaplermin Topical available over the counter? ▾
When was Becaplermin Topical first available? ▾
Who makes Becaplermin Topical? ▾
💬 Answers drafted from Becaplermin Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Becaplermin Topical comes
Becaplermin Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Regranex Gel 0.01% is used to treat lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or deeper and have an adequate blood supply
- Regranex is used alongside — not instead of — good wound care practices such as debridement, pressure relief, and infection control
- Regranex is not indicated for pressure ulcers, venous stasis ulcers, or wounds intended to close by primary intention
- Regranex gel is applied topically to the clean ulcer once daily — the amount is calculated based on the length and width of the ulcer
- Regranex should be spread in a thin, continuous layer (about 1/16 inch thick) over the entire wound, then covered with a saline-moistened gauze dressing for approximately 12 hours
- After 12 hours, remove the dressing, rinse the wound with saline or water to remove residual Regranex gel, then cover with a plain moist dressing for the rest of the day
- Regranex is for topical wound use only — it is not for oral, eye (ophthalmic), or vaginal use
📊 Becaplermin Topical across the U.S. market
How Becaplermin Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Becaplermin Topical products
A representative set of FDA-listed product records for Becaplermin Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 0.1 mg/g | Topical | LRM Therapeutics, LLC | BLA | View NDC → |
| 100 mcg/g | Topical | Smith & Nephew, Inc. × 2 listings | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Becaplermin Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Becaplermin Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Becaplermin Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Becaplermin Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 115238 1 dose form · 1 strength
-
Dose form (SCDF) Topical Gel RxCUI 385096In current FDA listingsClinical drug / strength (SCD) 0.0001 MG/MGRxCUI 308579
Look up RxCUI 115238 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Becaplermin Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Becaplermin Topical belongs to the Human Platelet-derived Growth Factor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. LRM Therapeutics, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.