Palifermin Side Effects

Some side effects of palifermin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to palifermin: intravenous powder for injection

If you experience any of the following serious side effects from palifermin, seek emergency medical attention or contact your doctor immediately:

• fever;

• 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:

• swelling;

• pain;

• 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.

For Healthcare Professionals

Applies to palifermin: intravenous powder for injection

Dermatologic

Dermatologic side effects for palifermin in relation to placebo therapy have included rash (62% vs. 50%), pruritus (35% vs. 24%), and erythema (32% vs. 22%).

Skin rash was the most common serious side effect reported.

Clinical studies (n=409) reported the occurrence of grade 3 skin rash in 14 patients (9 palifermin, 5 placebo) resulting in the discontinuation of treatment in 7 patients (5 palifermin, 2 placebo).

Following the first 3 consecutive days of administration, the median time to cutaneous side effects is 6 days with a median duration of 5 days.

Other

Following the first 3 consecutive days of administration, the median time to cutaneous side effects, including edema, is 6 days with a median duration of 5 days.

Other side effects for palifermin in relation to placebo therapy have included edema (28% vs. 21%), pain (16% vs. 11%), fever (39% vs. 34%) and perianal pain (12% vs. 5%). Other side effects of palifermin following a single 90 mcg/kg IV dose include fatigue (26%) and headache (23%).

Gastrointestinal

Gastrointestinal side effects for palifermin in relation to placebo therapy have included mouth/tongue thickness and/or discoloration (17% vs. 8%) and altered taste (16% vs. 8%). Oral/perioral dysesthesia and white film coating of the mouth or tongue has also been reported.

Musculoskeletal

Musculoskeletal side effects for palifermin in relation to placebo therapy have included arthralgia (10% vs 5%).

Nervous system

Dysthesias in palifermin treated patients have generally been reported as localized to the perioral region. In contrast, patients receiving placebo have generally reported dysthesias in extremities.

Nervous system side effects for palifermin in relation to placebo therapy have included dysthesias (12% vs. 7%). Types of dysthesias reported have included hyperesthesia, hypoesthesia, and paresthesia.

Oncologic

There are no available data on the effects of palifermin on stimulation of KGF receptor- expressing, non- hematopoietic tumors in patients.

At concentrations greater than 15 times the average therapeutic human concentration palifermin has been reported to enhance the growth of human epithelial tumor cell lines in vitro.

In nude mouse xenograft models, doses 25 and 67 times higher than the recommended human dose administered daily for 3 consecutive weeks and repeated weekly for 4 to 6 weeks may have resulted in a dose-dependent increase in the growth rate of 1 of 7 KGF receptor- expressing human tumor cell lines.

Oncologic side effects have included enhancement in the growth of human epithelial tumor cell lines in vitro and an increase in the rate of tumor cell line growth in a human carcinoma xenograft model.

Metabolic

Metabolic side effects for palifermin in relation to placebo therapy have included elevated serum lipase grade 3 (28% vs. 23%), elevated serum lipase grade 4 (11% vs. 5%), elevated serum amylase grade 3 (62% vs. 54%), and elevated serum amylase grade 4 (38% vs. 31%).

In clinical studies, the elevated serum lipase and amylase levels were reversible with peak increases recorded during the period of cytotoxic therapy. Levels returned to baseline by the day of PBPC infusion. There are no reports of required treatment intervention.

The increased amount of amylase is reported to be predominantly salivary in origin.

Cardiovascular

Hypertension was reported with doses of 60 mcg/kg and 80 mcg/kg in patients undergoing hematopoietic transplantation. This effect appeared to be transient. There are no reports of treatment discontinuation due to hypertension.

Cardiovascular side effects have included hypertension.

Genitourinary

There have been reports of 2+ or greater proteinuria in patients treated with palifermin; however, a causal relationship between palifermin and proteinuria has not been established.

Genitourinary side effects have included proteinuria.

General

In general, doses of 80 mcg/kg administered intravenously 3 doses prior to and 3 doses after myeloablative chemotherapy/TBI produced the same type of side effects seen with 60 mcg/kg doses; however, a higher level of severity was reported with the higher dose.

Respiratory

Respiratory side effects for palifermin in relation to placebo therapy have included cough (34% vs. 28%) and rhinitis (17% vs. 9%).

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