Palifermin
Palifermin (Kepivance) is a growth factor given by IV to help reduce severe mouth sores in people with blood cancers who are having intensive chemotherapy with their own stem cells given back.
🧬 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 (Kepivance) is a copy of keratinocyte growth factor, a natural protein that helps the mouth’s lining grow and repair. It is used to cut the chance and length of severe mouth sores (oral mucositis) in people with blood cancers getting intensive chemotherapy plus their own stem cells back, and it is a specialist hospital drug with no generic. It is usually well tolerated, though rash, redness and itching are common, and some notice a thickened or discolored tongue or altered taste. Report a severe or spreading rash, or any fever, to your team promptly, and know the timing is strict, since doses given within 24 hours of chemotherapy made mouth sores worse.
Clinical pearls
- If heparin keeps your IV line open, the nurse should flush it with saline before and after each palifermin dose.
- Mention any non-blood cancer, since lab studies suggest palifermin may fuel growth of some other tumors.
- Stop breastfeeding during treatment and for at least 2 weeks after the last dose.
- Mention any blurry or changing vision, since cataracts showed up more often with palifermin in a post-marketing study.
Patient information guide A plain-language walkthrough of Palifermin, written from its FDA label.
What Palifermin is used for
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Palifermin is used for one supportive-care purpose.
- Kepivance (intravenous) decreases the incidence and duration of severe oral mucositis (painful mouth sores) in people with blood cancers receiving myelotoxic therapy with autologous stem cell support.
- It is intended for treatment plans expected to cause WHO Grade 3 or worse mucositis in most patients.
- Safety and effectiveness are not established in non-blood cancers.
- It was not effective in reducing severe mucositis with allogeneic (donor) stem cell support.
How Palifermin works
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Palifermin is a form of KGF, a natural protein in the fibroblast growth factor family. It binds to KGF receptors on epithelial cells lining the mouth, gut, skin and other tissues. This prompts them to multiply, mature and migrate, which helps protect the lining from damage. The receptor is not present on blood-forming cells.
Palifermin dosage
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Palifermin (Kepivance) is given by a healthcare professional as a quick IV injection. Food does not apply.
- 3 days in a row before chemotherapy, then 3 days in a row after, for 6 doses.
- The third dose before chemotherapy is given 24 to 48 hours ahead of it.
- The first dose after is given on the day of stem cell infusion, once the infusion is finished, and at least 7 days after the last dose.
Your care team handles scheduling. Ask them what to do if a dose is delayed.
Dosing details from the FDA-approved label
From the Palifermin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Reduction of oral mucositis with myelotoxic therapy requiring hematopoietic stem cell support (before and after myelotoxic therapy)
- 60 mcg/kg/day as an intravenous bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of 6 doses
- Give the first 3 doses prior to myelotoxic therapy, with the third dose 24 to 48 hours prior to beginning myelotoxic therapy
- Give the last 3 doses after myelotoxic therapy is complete, with the first of these
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administer as an intravenous bolus injection at a dose of 60 mcg/kg/day for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses ( 2.1 ) Administer the first 3 doses prior to myelotoxic therapy with the third dose 24 to 48 hours before myelotoxic therapy ( 2.1 ) Administer the last 3 doses after myelotoxic therapy is complete with the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of Kepivance ( 2.1 ) 2.1 Recommended Dosage Regimen The recommended dose of Kepivance is 60 mcg/kg/day, administered as an intravenous bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of 6 doses. The recommended dose of Kepivance is 60 mcg/kg/day, administered as an intravenous bolus injection for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for a total of 6 doses. Administer the first 3 doses prior to myelotoxic therapy. Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy Administer the first 3 doses prior to myelotoxic therapy. Administer the third dose 24 to 48 hours prior to beginning myelotoxic therapy [see Drug Interactions ( 7 )]. Administer the last 3 doses after myelotoxic therapy is complete; administer the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of Kepivance [see Drug Interactions ( 7 )]. 2.2 Preparation and Administration Preparation Prepare the solution for infusion, using aseptic technique, as follows: Reconstitute Kepivance lyophilized powder with Sterile Water for Injection, USP (not supplied) by slowly injecting 1.2 mL of Sterile Water for Injection, USP to yield a final concentration of 5 mg/mL. Swirl the contents gently during dissolution. Do not shake or vigorously agitate the vial. Dissolution of Kepivance can take up to 3 minutes. Visually inspect the solution for discoloration and particulate matter before administration. The reconstituted solution should be clear and colorless. Do not administer Kepivance if discoloration or particulates are observed. Do not filter the reconstituted solution during preparation or administration.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Palifermin side effects
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Most side effects involve the skin, mouth and certain blood tests.
Common side effects
- Rash
- Fever
- Itching
- Redness of the skin
- Swelling (edema)
- Raised amylase blood test
- Mouth or tongue thickening or color change
- Altered taste
- Pain and joint pain
- Raised amylase and lipase blood levels, which were reversible and needed no treatment
When to get medical help
- Tell your care team about a severe or spreading skin rash.
- Report new numbness, tingling or unusual skin sensations, especially around the mouth.
- Report signs of infection, such as fever, promptly.
- Mention any vision changes, since cataracts were seen more often in a post-marketing safety study.
- Report hand and foot redness, pain or swelling, which has been reported after approval.
Skin rash was the most common serious reaction. Skin effects usually began about 6 days after the first of 3 daily doses and lasted about 5 days. Tell your team about severe rash or signs of infection.
Palifermin warnings and precautions
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The biggest concern is possible stimulation of tumor growth. Lab and animal studies showed growth of some epithelial tumor cells. Effects in people with non-blood tumors are unknown.
- Infections were reported more often than with placebo in a high-dose melphalan study.
- Cataracts were numerically more frequent in a post-marketing study.
- Antibodies to palifermin were found in 2% of patients tested, with unknown clinical significance.
Palifermin interactions
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Two interactions matter most.
- Heparin: it increases palifermin exposure in the body, so the IV line should be rinsed with saline before and after.
- Chemotherapy timing: palifermin should not be given within 24 hours before, during, or within 24 hours after, since it made mouth sores worse and longer in a trial.
Interactions listed in the FDA-approved label
From the Palifermin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Heparin (unfractionated and low molecular weight): Palifermin interacts with unfractionated and low molecular weight heparins with no noticeable effect on the pharmacodynamics of either drug; heparin increases systemic exposure. If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration.
- Myelotoxic chemotherapy: In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. Do not administer Kepivance within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy.
Read the label’s full interactions text
7 DRUG INTERACTIONS In vitro and in vivo data showed that palifermin interacts with unfractionated as well as low molecular weight heparins with no noticeable effect on the pharmacodynamics of either drug. If heparin is used to maintain an intravenous line, rinse the line with saline prior to and after Kepivance administration [see Clinical Pharmacology ( 12.3 )] . Do not administer Kepivance within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis. Heparin increases systemic exposure; flush intravenous line between heparin and Kepivance. ( 7 ) Do not administer within 24 hours of myelotoxic chemotherapy. ( 7 , 14 )
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Palifermin
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- No contraindications are listed.
- Pregnancy: animal data suggest it may harm the baby.
- Breastfeeding: stop during treatment and for at least 2 weeks after the last dose.
- Fertility: animal studies suggest possible impairment in women and men.
- Children 1 to 16 years: studied, but data are limited.
- Older adults: no dose adjustment recommended; few people 65+ were studied.
- Kidney problems: little or no effect on how the drug is processed.
- Liver problems: not studied.
What Palifermin does in the body
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In healthy volunteers, palifermin increased epithelial cell growth in the lining of the cheek. A 3-fold or greater increase in a growth marker (Ki67) was seen in 3 of 6 people after 3 daily IV doses. Higher single doses showed a dose-related increase in cell growth.
How your body processes Palifermin
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After an IV dose, palifermin levels fell more than 95% within 30 minutes. A small rise or plateau followed at about 1 to 4 hours, then a gradual decline. The average half-life was about 4.5 hours in both healthy people and cancer patients. It did not build up after 3 daily doses. Kidney problems had little effect, and heparin raised exposure.
How to store Palifermin
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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 the FDA-approved label with AI and reviewed by our pharmacy team. 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.
Palifermin: pharmacist answers to common questions
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 is palifermin for?
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How is it given and how often?
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What side effects should I expect?
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Does the timing around chemotherapy matter?
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Is there anything I should tell the team about my IV line?
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Is it safe in pregnancy or while breastfeeding?
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Is Palifermin available over the counter?
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When was Palifermin first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Palifermin on HelloPharmacist
Palifermin forms and strengths (how it 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Palifermin inactive ingredients by manufacturer.
Injection
How this form is used
- Kepivance is used to decrease the incidence and duration of severe oral mucositis in people with blood cancers receiving myelotoxic therapy with autologous stem cell support.
- Kepivance is given as an intravenous bolus injection.
- Kepivance is given for 3 consecutive days before and 3 consecutive days after myelotoxic therapy, for 6 doses total.
- If heparin is used to keep the IV line open, the line is rinsed with saline before and after Kepivance.
- Kepivance should not be given within 24 hours before, during, or after chemotherapy.
Palifermin on the U.S. market: products, makers and brands
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.
1 company lists 1 Palifermin product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2004. Brand names on the directory include Kepivance; the rest are generics.
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) | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Palifermin NDCs →
Palifermin side effects reported to the 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.
Palifermin FDA approval history
How Palifermin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Palifermin 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.
The FDA’s enforcement reports list no Palifermin recalls since July 2021.
✅No Palifermin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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
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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.
Palifermin supply and 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.
Palifermin brand names
Palifermin is sold under one brand name in the FDA directory — Kepivance. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Palifermin: manufacturers and labelers
One company lists Palifermin products with the FDA. By number of product records, the largest are Swedish Orphan Biovitrum AB (publ). Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Palifermin drug class (RxNorm)
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.
Sources for this Palifermin page
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 this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Swedish Orphan Biovitrum AB (publ) is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →