Palifermin
Palifermin is a human growth factor used to reduce the severity and duration of severe oral mucositis (painful mouth sores) in people with blood cancers undergoing stem cell transplant.
🧬 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 →
📖 Palifermin: Patient Information Guide
A plain-language walkthrough of Palifermin — 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▾
Palifermin is used in the hospital or clinic setting to protect the lining of the mouth and throat during intensive cancer treatment. Its use is product- and setting-specific:
- Kepivance is approved to reduce the frequency and duration of severe oral mucositis (WHO Grade 3 or higher mouth sores) in patients with hematologic malignancies (blood cancers such as non-Hodgkin's lymphoma, Hodgkin's disease, multiple myeloma, and leukemia) who are receiving high-dose, myelotoxic therapy followed by autologous hematopoietic stem cell support (transplant using the patient's own stem cells).
- Kepivance is specifically indicated when the preparative chemotherapy or radiation regimen is predicted to cause severe mucositis in the majority of patients.
- Kepivance was not effective for reducing severe mucositis in the setting of allogeneic hematopoietic stem cell support (using a donor's cells).
- Kepivance is not recommended for use with a high-dose melphalan 200 mg/m² conditioning regimen.
- The safety and effectiveness of Kepivance have not been established in patients with non-hematologic malignancies (solid tumors or other non-blood cancers).
⚙️How it works▾
Palifermin is a synthetic version of a naturally occurring protein called keratinocyte growth factor (KGF). It binds to KGF receptors on the surface of epithelial cells — the thin layer of cells lining the mouth, throat, and digestive tract. When palifermin binds to these receptors, it signals the cells to proliferate (multiply), differentiate (mature), and migrate, which thickens and strengthens the mucosal lining. By reinforcing this protective barrier before and after the harsh effects of high-dose chemotherapy or radiation, it helps limit how severely the lining breaks down and how long the damage lasts.
Importantly, KGF receptors have not been found on blood-forming (hematopoietic) cells, which means palifermin's direct effects are on the mucosal lining rather than on the blood system itself. However, KGF receptors are present on many other tissues in the body, which is why there is a theoretical concern about tumor stimulation in non-blood cancers.
💊How it's taken▾
Kepivance is given exclusively as an intravenous (IV) bolus injection by a healthcare professional — it is not a pill or a self-administered injection. It is given once daily for 3 days before myelotoxic therapy begins and once daily for 3 days after therapy ends, for a total of 6 doses. Precise timing relative to chemotherapy is critical:
- The third pre-treatment dose should be given 24 to 48 hours before chemotherapy starts.
- The first post-treatment dose is given on the day of stem cell infusion, after the infusion is complete, and at least 7 days after the most recent Kepivance dose.
- Kepivance must never be given within 24 hours of chemotherapy administration.
🤒Side effects — in detail▾
The most common side effects of Kepivance include skin and mouth reactions that typically appear around 6 days after the first dose and last about 5 days:
- Skin rash (the most common, affecting about 62% of patients)
- Itching (pruritus)
- Skin redness (erythema)
- Swelling (edema)
- Fever
- Mouth or tongue thickening or discoloration
- Altered taste
- Tingling, numbness, or heightened skin sensitivity (dysesthesia), often around the mouth and lips
- Joint aches (arthralgias)
- Reversible elevations in blood levels of amylase and lipase (enzymes from the pancreas and salivary glands)
The most common serious adverse reaction was skin rash, which was severe (Grade 3) in about 3% of patients. A postmarketing study noted a higher rate of infections in patients who received Kepivance with high-dose melphalan, and a numerically higher incidence of cataracts was also reported. Tell your care team right away if you develop a severe rash, signs of infection, or any new eye changes.
⚠️Warnings & precautions▾
- Potential to stimulate tumor growth: Kepivance binds to receptors found on many types of epithelial cells. Lab studies have shown it can enhance the growth of certain epithelial tumor cell lines. It is approved only for blood cancer patients — its safety in people with solid tumors or other non-hematologic cancers is unknown.
- Increased infections with melphalan: In a postmarketing study using Kepivance with high-dose melphalan, infection rates were significantly higher in the Kepivance group (47–50%) compared to placebo (25%). Kepivance is not recommended with this specific conditioning regimen.
- Cataracts: A postmarketing safety study found a numerically higher rate of cataracts in patients treated with Kepivance compared to a control group.
- Fetal harm: Based on animal studies, Kepivance may harm a developing baby. Pregnancy should be avoided during treatment.
- Fertility effects: Animal studies suggest palifermin may impair fertility in both men and women; whether this is reversible is not yet known.
🔀What it interacts with▾
Kepivance has two key drug interactions to be aware of:
- Heparin (a blood thinner often used to keep IV lines open): When given together, heparin dramatically increases the amount of palifermin in the bloodstream — by as much as 5-fold in single doses. The IV line must always be flushed with saline before and after each Kepivance dose to prevent this interaction. There is no significant effect in the other direction — palifermin does not meaningfully change how heparin works.
- Myelotoxic chemotherapy: Kepivance must not be given within 24 hours before, during, or within 24 hours after myelotoxic chemotherapy. In a clinical trial, giving Kepivance too close to chemotherapy actually increased the severity and duration of oral mucositis rather than reducing it.
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▾
- Non-blood cancers (non-hematologic malignancies): Kepivance has not been studied in solid tumors or other non-blood cancers, and it may stimulate tumor cell growth — it should not be used in these patients.
- Allogeneic stem cell transplant: Kepivance was not effective in patients using a donor's stem cells — confirm with your team that your transplant type is autologous (your own cells).
- Pregnancy: Kepivance may cause fetal harm based on animal studies. Tell your doctor right away if you are pregnant or become pregnant during treatment.
- Breastfeeding: It is not known whether palifermin passes into breast milk. Breastfeeding should be stopped during treatment and for at least 2 weeks after the last dose.
- Fertility: Both men and women of reproductive potential should discuss fertility concerns with their doctor before treatment, as animal studies suggest possible effects on fertility.
- Older adults (65+): Older patients tend to clear palifermin more slowly, but no dose adjustment is currently recommended based on the available data.
- Kidney impairment: Studies show kidney impairment has little to no effect on how the body handles palifermin; no dose adjustment is required.
- Liver impairment: The effect of liver problems on palifermin levels has not been studied.
- Children (ages 1–16): Kepivance has been used in pediatric patients in a Phase 1 study, with a safety profile similar to adults. Age did not significantly affect how the drug is processed in the body over the studied dose range.
📡Pharmacodynamics — effects in the body▾
Palifermin's effect on epithelial cell growth has been directly measured in human studies. In healthy volunteers who received Kepivance by IV for three consecutive days, biopsies of the inner cheek (buccal mucosa) showed a three-fold or greater increase in cell proliferation markers in half of the subjects tested. In a separate group of healthy subjects given a single higher IV dose, cell proliferation in the cheek lining increased in a dose-dependent way — meaning higher doses produced more cell growth — measured 48 hours after dosing. This confirms that Kepivance actively stimulates the growth and thickening of the mucosal lining that lines the mouth.
🔬Pharmacokinetics — how your body processes it▾
After an IV dose of Kepivance, drug levels in the blood drop by more than 95% within the first 30 minutes, followed by a slight plateau between 1 and 4 hours, and then a gradual final decline. The average half-life (the time it takes for half the drug to leave the body) is about 4.5 hours in both healthy individuals and cancer patients. Cancer patients tend to clear palifermin 2 to 4 times faster than healthy subjects, so more drug is needed to achieve the same effect. The drug does not build up in the body with repeated daily doses. Kidney impairment does not meaningfully affect how palifermin is processed. In patients over 65, clearance is about 30% slower on average, but no dose adjustment is recommended. When heparin is given at the same time, it significantly slows palifermin clearance and greatly increases blood levels of the drug — making careful IV line management essential.
📦How to store it▾
Store Kepivance vials in the dispensing pack in its carton refrigerated at 2° to 8°C (36° to 46°F) until time of use. Protect from light.
📄 Written from Palifermin’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 →
Supplements & herbs that interact with Palifermin
17 supplements and herbal products have documented interactions with Palifermin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Palifermin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Kepivance for, and why am I getting it? ▾
How and when will I receive it? ▾
What side effects should I expect? ▾
Is there anything I need to know about other medications I'm on? ▾
Is it safe if I'm pregnant or want to have children in the future? ▾
Can Kepivance make my cancer grow faster? ▾
Is Palifermin available over the counter? ▾
When was Palifermin first available? ▾
💬 Answers drafted from Palifermin’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 Palifermin comes
Palifermin 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.
Injection
How this form is used
- Kepivance intravenous injection is used to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy before autologous hematopoietic stem cell transplant
- Kepivance is indicated as supportive care when the preparative regimen is expected to cause severe (WHO Grade 3 or higher) mucositis in most patients
- Kepivance is given as an intravenous bolus injection once daily for 3 consecutive days before myelotoxic therapy and once daily for 3 consecutive days after therapy is complete — 6 total doses
- Kepivance must not be given within 24 hours before, during, or within 24 hours after myelotoxic chemotherapy
- If heparin is used to keep the IV line open, the line must be flushed with saline before and after each Kepivance dose
- Kepivance is prepared fresh from a powder and should be used immediately after reconstitution; if not used right away, it can be refrigerated for up to 24 hours but must not be frozen or left at room temperature for more than 1 hour
📊 Palifermin across the U.S. market
How Palifermin 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.
🔍 Compare Palifermin products
A representative set of FDA-listed product records for Palifermin — 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 |
|---|---|---|---|---|
| 💊Injection | ||||
| 5.16 mg/1.2 mL | Intravenous | Swedish Orphan Biovitrum AB (publ) × 2 listings | BLA | View NDC → |
| 6.25 mg/1.2 mL | Intravenous | Swedish Orphan Biovitrum AB (publ) | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Palifermin 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 Palifermin — 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 Palifermin 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 Palifermin 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 196319 1 dose form · 2 strengths
-
Dose form (SCDF) Injection RxCUI 1737725In current FDA listings
Look up RxCUI 196319 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 Palifermin 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
Palifermin belongs to the Mucocutaneous Epithelial Cell 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.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Swedish Orphan Biovitrum AB (publ) 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.