Applies to entrectinib: oral capsule.

Serious side effects of Entrectinib

Along with its needed effects, entrectinib 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 entrectinib:

More common

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in color vision
• clay colored stools
• confusion
• dark urine
• decreased appetite
• defects in intelligence, short-term memory, learning ability, and attention
• difficulty seeing at night
• dizziness
• fever
• headache
• increased sensitivity of the eyes to sunlight
• itching or skin rash
• joint pain, stiffness, or swelling
• loss of appetite
• lower back, side, or stomach pain
• nausea and vomiting
• problems with balance
• sleepiness or unusual drowsiness
• stomach pain or tenderness
• swelling of the feet or lower legs
• trouble sleeping
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Chest pain or tightness
• decreased urine output
• dilated neck veins
• double vision
• extreme fatigue
• fainting
• irregular breathing
• irregular heartbeat recurrent
• loss of memory
• problems with memory
• problems with speech or speaking
• seeing double
• seeing, hearing, or feeling things that are not there
• swelling of the face, fingers, feet, or lower legs
• trouble remembering
• trouble breathing
• weight gain

Other side effects of Entrectinib

Some side effects of entrectinib 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

• Change or loss of taste
• diarrhea
• difficulty having a bowel movement (stool)

For Healthcare Professionals

Applies to entrectinib: oral capsule.

Hematologic

Very common (10% or more): Anemia (67%), lymphopenia (40%), neutropenia (28%)^[Ref]

Immunologic

Common (1% to 10%): Pneumonia, sepsis^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (e.g., musculoskeletal pain, musculoskeletal chest pain, myalgia, neck pain) (28%), fractures in children (e.g., hip, femoral or tibial shaft, bilateral femoral neck) (23%), arthralgia (21%), muscular weakness (12%), back pain (12%), pain in extremity (11%)

Common (1% to 10%): Fractures in adults (e.g. hip, femoral or tibial shaft, bilateral femoral neck)

Very rare (less than 0.01%): Tumor lysis syndrome (TLS)^[Ref]

Ocular

Very common (10% or more): Vision disorders (e.g., blindness, cataract, cortical cataract, corneal erosion, diplopia, eye disorder, photophobia, photopsia, retinal hemorrhage, vision blurred, visual impairment, vitreous adhesions, vitreous detachment, vitreous floaters) (21%)^[Ref]

Metabolic

Very common (10% or more): Hyperuricemia (52%), hypernatremia (35%), hypocalcemia (34%), hypophosphatemia (30%), hypoalbuminemia (28%), weight gain (25%), hyperkalemia (25%), anorexia (13%), dehydration (10%)

Uncommon (0.1% to 1%): Tumor lysis syndrome (TLS)^[Ref]

Psychiatric

Very common (10% or more): Cognitive impairment (e.g., amnesia, aphasia, cognitive disorder, confusional state, delirium, disturbance in attention, hallucinations, visual hallucination, memory impairment, mental disorder, mental status changes (27%), sleep disorder (e.g., hypersomnia, insomnia, sleep disorder, somnolence) (14%), mood disorder (e.g., anxiety, affect lability, affective disorder, agitation, depressed mood, euphoric mood, mood altered, mood swings, irritability, depression, persistent depressive disorder, psychomotor retardation) (10%)^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (13%)^[Ref]

Hepatic

Very common (10% or more): Increased AST (44%), increased ALT (38%), increased alkaline phosphatase (25%)^[Ref]

Respiratory

Very common (10% or more): Dyspnea (30%), cough (24%), lung infection (e.g., lower respiratory tract infection, lung infection, pneumonia, respiratory tract infection) (10%)

Common (1% to 10%): Pleural effusion, pulmonary embolism, respiratory failure, hypoxia^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (48%), edema (e.g., face edema, fluid retention, generalized edema, localized edema, edema, edema peripheral, peripheral swelling) (40%), pyrexia (21%)^[Ref]

General

The most common adverse reactions (20% or greater) are fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, and vision disorders.^[Ref]

Nervous system

Very common (10% or more): Dysgeusia (44%), dizziness (e.g., dizziness, vertigo, dizziness postural) (38%), dysesthesia (e.g., paresthesia, hyperesthesia, hypoesthesia, dysesthesia, oral hypoesthesia, palmar-plantar erythrodysesthesia, oral paresthesia, genital hypoesthesia) (34%), headache (21%), paresthesia (20%), peripheral sensory neuropathy (e.g., neuralgia, neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy) (18%), ataxia (e.g., ataxia, balance disorder, gait disturbance) (18%), dysphagia (10%)

Common (1% to 10%): Aphasia, fall^[Ref]

Renal

Very common (10% or more): Increased creatinine (73%)^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (e.g., hypotension, orthostatic hypotension) (18%)

Common (1% to 10%): Congestive heart failure (CHF), QT interval prolongation, syncope^[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., rash, rash maculopapular, rash pruritic, rash erythematous, rash papular) (11%)^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (46%), diarrhea (35%), nausea (34%), increased lipase (28%), increased amylase (26%), vomiting (24%), abdominal pain (e.g., abdominal pain upper, abdominal pain, lower abdominal discomfort, abdominal tenderness) (16%)

Uncommon (0.1% to 1%): Large intestine perforation^[Ref]