Note: This document contains side effect information about palifermin. Some dosage forms listed on this page may not apply to the brand name Kepivance.

Summary

Common side effects of Kepivance include: arthralgia, dysesthesia, edema, hyperesthesia, hypoesthesia, increased serum amylase, paresthesia, pruritus, skin rash, tongue edema, dysgeusia, erythema of skin, mouth discoloration, and tongue discoloration. Continue reading for a comprehensive list of adverse effects.

Applies to palifermin: intravenous powder for solution.

Serious side effects of Kepivance

Along with its needed effects, palifermin (the active ingredient contained in Kepivance) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking palifermin:

More common

• Fever

Rare

• Skin rash (severe)

Other side effects of Kepivance

Some side effects of palifermin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bad, unusual, or unpleasant (after) taste
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• difficulty with moving
• discoloration of the tongue
• dizziness
• flushing or redness of the skin
• headache
• increased sensitivity to pain
• increased sensitivity to touch
• itching skin
• muscle pain or stiffness
• nervousness
• pain
• pain in the joints
• pounding in the ears
• rash (mild)
• slow or fast heartbeat
• swelling
• thickening of the tongue
• tingling in the hands and feet
• unusually warm skin

Incidence not known

• redness or swelling of the vagina
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• ulceration of the skin

For Healthcare Professionals

Applies to palifermin: intravenous powder for injection.

General

The most commonly reported side effects included all grades of elevated serum amylase, rash, treatment-emergent infections, and fever.^[Ref]

Gastrointestinal

Peak amylase and lipase increases occurred during cytotoxic therapy, and usually returned to baseline by the day of hematopoietic stem cell infusion.

Most taste and tongue disorders were reversible and mild to moderate in severity, usually occurred within the first 6 days of treatment, and typically lasted 5 days.^[Ref]

Very common (10% or more): All grades of elevated serum amylase (up to 62%), grades 3 and 4 elevated serum amylase (up to 38%), all grades of elevated serum lipase (up to 28%), mouth/tongue thickness/discoloration (up to 17%), grades 3 and 4 elevated serum lipase (up to 11%)

Common (1% to 10%): Oral fungal infection, oral paresthesia

Frequency not reported: taste disorder, tongue disorder

Postmarketing reports: mouth edema, tongue bumps, tongue edema, tongue redness^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 62%), pruritus (up to 35%), erythema (up to 32%)

Common (1% to 10%): grade 3 skin rashes

Postmarketing reports: face edema, hand-foot syndrome, palmar-plantar erythrodysesthesia syndrome, skin hyperpigmentation^[Ref]

Immunologic

Very common (10% or more): Treatment-emergent infections (up to 50%), sepsis/septic shock (up to 12%)

Common (1% to 10%): Herpes virus infection, immunogenicity/antibody positivity^[Ref]

Approximately 50% of patients reported treatment-emergent infections when this drug was given 3 days prior to and 3 days after treatment with melphalan; 47% of patients given this drug 3 days prior to treatment with melphalan reported infections, and 25% of patients given placebo with melphalan reported infection.^[Ref]

Other

Very common (10% or more): Fever (up to 39%), pain (up to 16%)^[Ref]

Nervous system

Very common (10% or more): Taste altered (up to 16%), dysesthesia (up to 12%), hyperesthesia (up to 12%), hypoesthesia (up to 12%), paresthesia (up to 12%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 10%)^[Ref]

Cardiovascular

Very common (10% or more): Edema (up to 28%)

Postmarketing reports: Edema on the soles, palmar edema^[Ref]

Genitourinary

Postmarketing reports: Vaginal edema, vaginal erythema^[Ref]

Ocular

Postmarketing reports: Cataracts^[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions, anaphylactic reactions^[Ref]