Pemazyre Side Effects

Generic name: pemigatinib

Medically reviewed by Drugs.com. Last updated on Jun 20, 2024.

Note: This document provides detailed information about Pemazyre.

Applies to pemigatinib: oral tablet Side Effects associated with pemigatinib. Some dosage forms listed on this page may not apply specifically to the brand name Pemazyre.

Applies to pemigatinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 1 week after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if eye pain, dryness, swelling, or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause hyperphosphatemia (high potassium levels in the blood). Check with your doctor right away it you have stomach cramps, confusion, seizures, difficulty in breathing, irregular heartbeat, mood or mental changes, muscle cramps in the hands, arms, feet, legs, or face, numbness and tingling around the mouth, fingertips, or feet, or tremor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Pemazyre

Along with its needed effects, pemigatinib (the active ingredient contained in Pemazyre) 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:

Other side effects of Pemazyre

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:

For healthcare professionals

Applies to pemigatinib: oral tablet.

General adverse events

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]

See also:

Further information

Pemazyre side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer