Augtyro Side Effects

Generic name: repotrectinib

Medically reviewed by Drugs.com. Last updated on Nov 30, 2023.

Note: This document contains side effect information about repotrectinib. Some dosage forms listed on this page may not apply to the brand name Augtyro.

Applies to repotrectinib: oral capsule.

Warning

Call your doctor if you have nervous system problems such as weakness, vision or hearing problems, dizziness, mood changes, vertigo (spinning sensation), problems with balance or coordination, problems with thinking or memory, hallucinations, or sleep problems.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

nervous system problems--weakness, vision or hearing problems, dizziness, mood changes, vertigo (spinning sensation), problems with balance or coordination, problems with thinking or memory, hallucinations, sleep problems;
high levels of uric acid in blood--joint problems, stomach pain, little or no urination, nausea, vomiting, pink or brown urine;
lung problems--fever, wheezing, dry cough, chills, cough with mucus, chest pain, feeling short of breath;
muscle or bone problems--severe bone pain, severe joint or muscle pain, tenderness, weakness; or
liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be changed or permanently discontinued if you have certain side effects.

Common side effects may include:

dizziness, tiredness;
changes in your sense of taste, nausea;
constipation;
numbness or tingling, loss of balance or coordination;
shortness of breath; or
hallucinations, problems with thinking or memory.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to repotrectinib: oral capsule.

General

The most frequently reported side effects included ataxia, cognitive disorders, constipation, dizziness, dysgeusia, dyspnea, fatigue, nausea, and peripheral neuropathy.

The most frequently reported grade 3 or 4 laboratory abnormalities included decreased hemoglobin, decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased phosphate, decreased sodium, increased ALT, increased alkaline phosphatase, increased AST, increased creatine phosphokinase, increased GGT, increased glucose, increased magnesium, and increased urate.^[Ref]

Cardiovascular

Frequency not reported: Cardiac arrest, cardiac failure, sudden cardiac death, sudden death

Gastrointestinal

Very common (10% or more): Constipation (up to 37%), nausea (up to 20%), diarrhea (up to 13%), vomiting (10%)

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 73%), decreased lymphocytes (up to 43%), decreased leukocytes (up to 36%), decreased neutrophils (up to 34%), increased activated partial thromboplastin time (up to 25%), increased prothrombin INR (up to 20%)

Frequency not reported: Disseminated intravascular coagulation

Hepatic

Very common (10% or more): Increased GGT (up to 48%), increased AST (up to 40%), increased ALT (up to 35%)

Frequency not reported: Hepatotoxicity

Metabolic

Very common (10% or more): Increased glucose (up to 23%), increased urate (up to 21%)

Common (1% to 10%): Hyperuricemia

Musculoskeletal

Very common (10% or more): Increased creatine phosphokinase (up to 57%), muscular weakness (up to 21%), myalgia (up to 13%)

Common (1% to 10%): Skeletal fractures

Myalgia included myalgia, myositis, musculoskeletal discomfort, and musculoskeletal pain.

Nervous system

Very common (10% or more): Central nervous system (CNS) adverse reactions (up to 75%), dizziness (up to 64%), dysgeusia (up to 50%), peripheral neuropathy (up to 47%), ataxia (up to 29%), cognitive disorders (up to 23%), headache (up to 19%), memory impairment (13%), disturbance in attention (11%)

Common (1% to 10%): CNS toxicity, somnolence, hypersomnia

Frequency not reported: Tremor

Dizziness included dizziness, vertigo, postural dizziness, exertional dizziness, and positional vertigo.

Dysgeusia included dysgeusia, ageusia, anosmia, and hypogeusia.

Peripheral neuropathy included neuralgia, peripheral neuropathy, peripheral sensory neuropathy, dysesthesia, peripheral motor neuropathy, polyneuropathy, paresthesia, hypoesthesia, and hyperesthesia.

Ataxia included ataxia, gait disturbance, balance disorder, and cerebellar ataxia.

Cognitive disorders included memory impairment, disturbance in attention, cognitive disorder, confusional state, amnesia, attention deficit hyperactivity disorder, delirium, altered state of consciousness, aphasia, delusion, depressed level of consciousness, hallucination, mental status changes, and neurological decompensation.

Headache included headache, migraine, and tension headache.

Ocular

Very common (10% or more): Vision disorders (up to 11%)

Vision disorders included blurred vision, dry eye, visual impairment, visual field defect, cataract, conjunctivitis, eye pain, photophobia, photosensitivity reaction, reduced visual acuity, vitreous floaters, blepharospasm, color blindness, diplopia, eye hematoma, eye swelling, eyelid disorder, eyelid injury, eyelid pruritus, glaucoma, night blindness, and ophthalmic herpes zoster.

Other

Very common (10% or more): Fatigue (up to 29%), increased sodium (up to 29%), increased alkaline phosphatase (up to 26%), decreased glucose (up to 21%), increased weight (up to 14%), edema (up to 12%)

Common (1% to 10%): Decreased phosphate, decreased sodium, fall, increased magnesium, pyrexia

Frequency not reported: Death

Fatigue included fatigue and asthenia.

Edema included generalized edema, periorbital edema, localized edema, face edema, peripheral edema, edema, eye edema, and scrotal edema.