"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Kepivance Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Kepivance (palifermin) for Injection is a human keratinocyte growth factor (KGF) produced by recombinant DNA technology used to reduce the chance of developing sores and ulcers in the mouth and to shorten the time with sores or ulcers in patients with blood cancers who receive high doses of chemotherapy and radiation therapy before bone marrow transplants. Common side effects include swelling, pain, joint pain, increases in blood pancreas enzymes, increased blood pressure, or protein in the urine.
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. Kepivance may interact with heparin. Tell your doctor all medications and supplements you use. It is unknown if Kepivance will be harmful to a fetus. Tell your doctor if you are pregnant or become pregnant during treatment. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Kepivance (palifermin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Kepivance in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects from palifermin, seek emergency medical attention or contact your doctor immediately:
- breathing problems;
- skin and mucus membrane side effects such as rash, redness, swelling, itching, unusual sensations in the mouth, tongue color change, tongue thickening and changes in taste.
Other common side effects include:
- joint pain;
- increases in blood pancreas enzymes;
- increased blood pressure; or
- protein in the urine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kepivance (Palifermin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kepivance FDA Prescribing Information: Side Effects
The most common adverse reactions attributed to Kepivance were skin toxicities (rash, erythema, edema, pruritus), oral toxicities (dysesthesia, tongue discoloration, tongue thickening, alteration of taste), pain, arthralgias, and dysesthesia. The median time to onset of cutaneous toxicity was 6 days following the first of 3 consecutive daily doses of Kepivance, with a median duration of 5 days. In patients receiving Kepivance, dysesthesia (including hyperesthesia, hypoesthesia, and paresthesia) was usually localized to the perioral region, whereas in patients receiving placebo dysesthesias were more likely to occur in extremities.
Clinical Trial 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 clinical practice.
The data described in Table 1 and the discussion below reflect exposure to Kepivance in 409 patients with hematologic malignancies who were enrolled in 3 randomized, placebo-controlled clinical trials and a pharmacokinetic study. Patients received Kepivance either before, or before and after, regimens of myelotoxic chemotherapy, with or without total body irradiation (TBI), followed by hematopoietic stem cell support. Kepivance was administered in daily doses ranging from 5 to 80 mcg/kg/day. The total dose of Kepivance ranged from 15 to 480 mcg/kg with a median of 360 mcg/kg. The population had a median age of 48 years (range: 41 to
60 years), 62% were male and 83% were White with 7.4 % Black and 6.2 % Hispanic. Non Hodgkin's lymphoma (NHL) was the most common malignancy followed by Hodgkin's disease, multiple myeloma, and leukemia.
The most common serious adverse reaction attributed to Kepivance was skin rash, reported in less than 1% (3/409) of patients treated. Grade 3 skin rashes occurred in 3% of patients (9/409) receiving Kepivance and 2% (5/241) receiving placebo.
Table 1: Incidence of Adverse Reactions Occurring with
a Between-Group Difference of ≥ 5%
(n = 409) %
(n = 241) %
|BODY AS A WHOLE|
|Mouth/Tongue Thickness or Discoloration||17||8|
|SKIN AND APPENDAGES|
|CENTRAL NERVOUS SYSTEM / PERIPHERAL NERVOUS SYSTEM|
|Dysesthesia - Hyperesthesia / hypoesthesia/ paresthesia||12||7|
|Elevated serum lipase|
|Grade 3 and 4||11||5|
|Elevated serum amylase|
|Grade 3 and 4||38||31|
Cataracts: In a postmarketing safety study, the incidence of cataracts was numerically higher among patients receiving Kepivance than in the control population. (See Clinical Studies).
Laboratory Test Findings: Reversible elevations in serum lipase and amylase, which did not require treatment, were reported in 28% and 62% of patients receiving Kepivance and 23% and 54%of patients receiving placebo. In general, peak increases were observed during the period of cytotoxic therapy and returned to baseline by the day of hematopoietic stem cell infusion. Amylase was mainly salivary in origin.
As with all therapeutic proteins, there is a potential for immunogenicity. The clinical significance of antibodies to Kepivance is unknown but may include decreased activity and/or cross reactivity with other members of the FGF family of growth factors. In clinical trials, serum samples from patients treated with Kepivance were tested for antibodies to Kepivance using an electrochemiluminescence-based binding assay. Twelve of 645 patients (2%) tested positive; none had evidence of neutralizing activity in a cell-based assay.
The incidence of antibody positivity is highly dependent on the specific assay and its sensitivity. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to Kepivance with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified during postapproval use of Kepivance in the stem cell transplant setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Vaginal edema and erythema;
- Palmar-plantar Erythrodysaesthesia Syndrome (also known as “hand-foot syndrome”)
Read the entire FDA prescribing information for Kepivance (Palifermin)
Additional Kepivance Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.