Applies to futibatinib: oral tablet.
Serious side effects of Futibatinib
Along with its needed effects, futibatinib 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 futibatinib:
More common
- Bladder pain
- bloody or cloudy urine
- bone or joint pain
- confusion
- constipation
- cracked lips
- diarrhea
- difficult, burning, or painful urination
- difficulty in breathing
- difficulty in swallowing
- dry eyes
- dry mouth
- fever
- frequent urge to urinate
- irregular heartbeats
- loss of appetite
- lower back or side pain
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- nausea
- numbness and tingling around the mouth, fingertips, or feet
- painful irritation of the clear front part of the eye
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach cramps, tenderness, or pain
- swelling, irritation, soreness, or inflammation of the mouth
- tingling of the hands and feet
- ulceration of the skin
- vomiting
- vomiting of blood or material that looks like coffee grounds
- watering of the eyes
- watery or bloody diarrhea
- weakness
Less common
- Black, tarry stools
- bloody stools
- pale skin
- unusual bleeding or bruising
- unusual tiredness or weakness
Other side effects of Futibatinib
Some side effects of futibatinib 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
- Bluish-brownish hands
- change in taste
- difficulty in moving
- lack or loss of strength
- loss of taste
- muscle aches, cramps, pains, or stiffness
- redness or soreness around the fingernails or loosening of the fingernails
For Healthcare Professionals
Applies to futibatinib: oral tablet.
Dermatologic
Very common (10% or more): Alopecia (34%), dry skin (29%), nail toxicity (47%), palmar-plantar erythrodysesthesia syndrome (21%)[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (30%), constipation (39%), diarrhea (39%), dry mouth (35%), nausea (24%), stomatitis (30%), vomiting (20%)[Ref]
General
-The most common adverse reactions (20% or greater) were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.
-Serious adverse reactions were reported in 39% of patients. Serious adverse reactions that occurred in 2% or more patients were pyrexia (3.9%), gastrointestinal hemorrhage (3.9%), ascites (2.9%), musculoskeletal pain (2.9%), and bile duct obstruction (2.9%).
-Permanent discontinuation due to an adverse reaction was reported in 4.9% of patients. Adverse reactions leading to discontinuation included esophagitis, oral dysesthesia, bile duct obstruction, dizziness, and anemia.
-The most common laboratory abnormalities (20% or greater) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocyte, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.[Ref]
Metabolic
Very common (10% or more): Decreased appetite (23%)[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (25%), musculoskeletal pain (43%)[Ref]
Ocular
Very common (10% or more): Dry eye (25%)
Common (1% to 10%): Retinal pigment epithelial detachment (RPED)[Ref]
Other
Very common (10% or more): Fatigue (37%), decreased weight (18%)[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection (23%)[Ref]
Nervous system
Very common (10% or more): Dysgeusia (25%)[Ref]
