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 solution

Along with its needed effects, palifermin 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)

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

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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