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

• Bladder pain
• bloody or cloudy urine
• bloody nose
• changes in the fingernails or toenails
• confusion
• decreased urination
• diarrhea
• difficult, burning, or painful urination
• difficulty in breathing
• dry eyes
• dry mouth
• eye redness, irritation, or pain
• frequent urge to urinate
• increase in heart rate
• irregular heartbeats
• lightheadedness, dizziness, fainting
• loosening of the fingernails
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth, fingertips, or feet
• pain in the bones
• pale skin
• rapid breathing
• redness or soreness around the fingernails
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain across part of your vision
• seizures
• stomach cramps
• sunken eyes
• swelling of the hands, ankles, feet, or lower legs
• thirst
• tremor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• wrinkled skin

Less common

• Pain or swelling in the arms or legs without any injury

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

• Acid or sour stomach
• belching
• bloating or swelling of the face, arms, hands, lower legs, or feet
• changes in taste
• constipation
• difficulty in moving
• dry skin
• hair loss
• heartburn
• indigestion
• loss of taste
• nausea
• pain in the joints
• rapid weight gain
• redness, swelling, pain of the skin
• scaling of the skin on the hands and feet
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• ulceration of the skin
• vomiting

For Healthcare Professionals

Applies to pemigatinib: oral tablet.

General

The most common adverse reactions with a frequency of 20% or greater 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, 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 alanine aminotransferase, increased aspartate aminotransferase, 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): Alopecia, nail toxicity (e.g., nail disorder, in growing nail, nail discoloration, nail pigmentation, nail bed inflammation, nail bed tenderness, nail dystrophy, nail hypertrophy, nail ridging, nail infection, nail growth abnormal, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, paronychia), dry skin (e.g., xerosis), palmar-plantar erythrodysesthesia syndrome (e.g., palmar-erythema, palmer-plantar erythrodysesthesia, and plantar erythema), rash (e.g., dermatitis, dermatitis acneiform, lichen planus, rash, rash macular, skin exfoliation)

Common (1% to 10%): Abnormal hair growth^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea, nausea, constipation, stomatitis (e.g., aphthous ulcer, cheilitis, lip ulceration, mouth ulceration, pharyngeal inflammation, tongue ulceration), dry mouth, vomiting, abdominal pain (e.g., lower abdominal pain, upper abdominal pain, abdominal rigidity), dyspepsia^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin, decreased lymphocytes, decreased platelets, increased leukocytes, decreased leukocytes, anemia, decreased neutrophils, increased blood creatinine^[Ref]

Metabolic

Very common (10% or more): Hyperphosphatemia, hypophosphatemia, increased alanine aminotransferase, increased aspartate aminotransferase, increased calcium, increased alkaline phosphatase, increased creatinine, increased sodium, increased glucose, decreased albumin, anorexia, increased urate, increased bilirubin, decreased potassium, decreased calcium, weight loss, dehydration, increased potassium, decreased glucose, hyponatremia^[Ref]

Musculoskeletal

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

-Back pain includes both back pain and spinal pain.^[Ref]

Very common (10% or more): Arthralgia, back pain, pain in extremity

Common (1% to 10%): Fractures, pathologic fractures (which include patients with and without cholangiocarcinoma)^[Ref]

Nervous system

Very common (10% or more): Dysgeusia, headache

Ocular

Very common (10% or more): Dry eye (e.g., dry eye, keratitis, increased lacrimation, pinguecula, punctate keratitis), blurred vision, trichiasis

Common (1% to 10%): Retinal pigment epithelial detachment (RPED) (e.g., 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): Fatigue (e.g., asthenia), edema peripheral, pyrexia, elevated uric acid, elevated prothrombin time/international normalized ratio^[Ref]

Respiratory

Very common (10% or more): Epistaxis