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Pemigatinib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 29, 2023.

Applies to pemigatinib: oral tablet.

Serious side effects of Pemigatinib

Along with its needed effects, pemigatinib 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 immediately if any of the following side effects occur while taking pemigatinib:

More common

Less common

Other side effects of Pemigatinib

Some side effects of pemigatinib 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

For Healthcare Professionals

Applies to pemigatinib: oral tablet.

General

The most common adverse reactions were hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, dry skin, rash, anemia, epistaxis, serous retinal detachment, extremity pain, dyspepsia, blurred vision, peripheral edema, palmar-plantar erythrodysesthesia syndrome, and dizziness.

The most common laboratory abnormalities with a frequency of 20% or greater were increased phosphate, decreased lymphocytes, decreased leukocytes, increased alkaline phosphatase, decreased hemoglobin, increased ALT, increased AST, decreased neutrophils, increased creatinine, decreased phosphate, decreased sodium, increased glucose, decreased platelets, decreased calcium, increased calcium, decreased potassium, and increased bilirubin.[Ref]

Dermatologic

Very common (10% or more): Nail toxicity (up to 62%), alopecia (up to 59%), rash (up to 35%), dry skin (up to 24%), palmar-plantar erythrodysesthesia syndrome (up to 18%)

Common (1% to 10%): Abnormal hair growth

Uncommon(0.1% to 1%): Cutaneous calcification[Ref]

Nail toxicity included ingrowing nail, nail discoloration, nail pigmentation, nail bed inflammation, nail bed tenderness, nail dystrophy, nail hypertrophy, nail ridging, nail infection, abnormal nail growth, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.

Dry skin included xerosis.

Palmar-plantar erythrodysesthesia syndrome included palmar-erythema, palmer-plantar erythrodysesthesia, and plantar erythema.

Rash included dermatitis, dermatitis acneiform, lichen planus, rash, rash macular, and skin exfoliation.[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis (up to 53%), diarrhea (up to 50%), nausea (up to 40%), abdominal pain (up to 35%), constipation (up to 35%), dry mouth (up to 34%), vomiting (up to 27%), dyspepsia (up to 24%)[Ref]

Stomatitis included aphthous ulcer, cheilitis, lip ulceration, mouth ulceration, pharyngeal inflammation, and tongue ulceration.

Abdominal pain included lower abdominal pain, upper abdominal pain, and abdominal rigidity.[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 16%)[Ref]

Hematologic

Very common (10% or more): Decreased lymphocytes (up to 65%), increased leukocytes (up to 65%), decreased hemoglobin (up to 53%), decreased neutrophils (up to 45%), anemia (up to 35%), decreased platelets (up to 29%), decreased leukocytes (up to 18%), elevated prothrombin time/international normalized ratio (up to 16%)[Ref]

Hepatic

Very common (10% or more): Increased ALT (up to 50%), increased AST (up to 47%), increased bilirubin (up to 26%)[Ref]

Metabolic

Very common (10% or more): Hyperphosphatemia (up to 74%), increased glucose (up to 36%), decreased appetite (up to 33%), increased urate (up to 30%), hypophosphatemia (up to 23%), elevated uric acid (up to 18%), dehydration (up to 15%), decreased glucose (up to 11%)

Common (1% to 10%): Hyponatremia

Frequency not reported: Nonuremic calciphylaxis[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (up to 26%), arthralgia (up to 25%), back pain (up to 24%)

Common (1% to 10%): Fractures, pathologic fractures

Frequency not reported: Soft tissue mineralization[Ref]

Soft tissue mineralization, including cutaneous calcification, calcinosis, and nonuremic calciphylaxis associated with hyperphosphatemia were observed during the treatment with this drug.

Back pain included both back pain and spinal pain.

Pathologic fractures included patients with and without cholangiocarcinoma.[Ref]

Nervous system

Very common (10% or more): Dysgeusia (up to 40%), dizziness (up to 21%), headache (up to 16%)[Ref]

Ocular

Very common (10% or more): Dry eye (up to 50%), retinal pigment epithelial detachment (up to 26%), blurred vision (up to 21%), trichiasis (up to 18%)

Common (1% to 10%): Punctate keratitis[Ref]

Dry eye included keratitis, increased lacrimation, pinguecula, and punctate keratitis.

Retinal pigment epithelial detachment included detachment of retinal pigment epithelium, maculopathy, retinal detachment, retinal disorder, retinal thickening, serous retinal detachment, and subretinal fluid.[Ref]

Other

Very common (10% or more): Increased alkaline phosphatase (up to 62%), fatigue/asthenia (up to 44%), increased calcium (up to 43%), decreased sodium (up to 41%), decreased albumin (up to 34%), decreased calcium (up to 26%), decreased potassium (up to 26%), peripheral edema (up to 21%), pyrexia (up to 18%), weight loss (up to 16%), increased potassium (up to 12%)

Frequency not reported: Calcinosis[Ref]

Renal

Very common (10% or more): Increased blood creatinine (up to 44%)[Ref]

Respiratory

Very common (10% or more): Epistaxis (up to 29%)[Ref]

References

1. Product Information. Pemazyre (pemigatinib). Incyte Biosciences UK Ltd. 2023.

2. Product Information. Pemazyre (pemigatinib). Incyte Corporation. 2022;SUPPL-2.

3. Product Information. Pemazyre (pemigatinib). Specialised Therapeutics Alim Pty Ltd. 2023;20231019_PEM_AU_PI_S.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.