Augtyro Side Effects

Generic name: repotrectinib

Medically reviewed by Drugs.com. Last updated on Dec 1, 2024.

Note: This document provides detailed information about Augtyro.

Applies to repotrectinib: oral capsules Side Effects associated with repotrectinib. Some dosage forms listed on this page may not apply specifically to the brand name Augtyro.

Applies to repotrectinib: oral capsules.

Side effects include:

Common adverse effects (incidence ≥20%); dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, nausea.

For healthcare professionals

Applies to repotrectinib: oral capsule.

General adverse events

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.

Psychiatric

• Common (1% to 10%): Confusional state, mood disorders, insomnia, anxiety, irritability, depression

Respiratory

• Very common (10% or more): Dyspnea (up to 30%), cough (up to 14%)
• Common (1% to 10%): Pneumonia, pleural effusion, hypoxia, pneumonitis
• Uncommon (0.1% to 1%): Interstitial lung disease
• Frequency not reported: Aspiration pneumonia, respiratory failure

Dyspnea included dyspnea and exertional dyspnea.

Cough included productive cough, cough, and upper-airway cough syndrome.

Further information

Augtyro 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.

Some side effects may not be reported. You may report them to the FDA.

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