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

Applies to lorlatinib: oral tablets.

Side effects include:

Adverse effects (≥20%): Edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, cough.

Laboratory abnormalities (≥20%): Hypercholesterolemia, hypertriglyceridemia, hyperglycemia, increased AST or ALT concentrations, hypoalbuminemia, anemia, thrombocytopenia, lymphopenia, increased lipase or amylase concentrations, increased alkaline phosphatase concentrations, hypophosphatemia, hyperkalemia, hypomagnesemia.

For Healthcare Professionals

Applies to lorlatinib: oral tablet.

Hematologic

Very common (10% or more): Anemia (52%), thrombocytopenia (23%), lymphopenia (22%)^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (23%), myalgia/musculoskeletal pain (17%), back pain (13%), pain in extremity (13%)^[Ref]

Ocular

Very common (10% or more): Vision disorder (e.g., diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters) (15%)^[Ref]

Metabolic

Very common (10% or more): Hypercholesterolemia (96%), hypertriglyceridemia (90%), edema (edema peripheral, eyelid edema, face edema, generalized edema, localized edema, periorbital edema, peripheral swelling, swelling) (57%), hyperglycemia (52%), hypoalbuminemia (33%), weight gain (24%), increased lipase (24%), increased alkaline phosphatase (24%), increased amylase (22%), hypophosphatemia (21%), hyperkalemia (21%), hypomagnesemia (21%), Grade 3 or 4 elevations in total cholesterol 17%), Grade 3 or 4 elevations in triglycerides (17%)^[Ref]

Psychiatric

Very common (10% or more): Cognitive effects (e.g., amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment, attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder) (29%), changes in mood (24%), changes in sleep (e.g., abnormal dreams, insomnia, nightmare, sleep disorder, sleep talking, somnambulism) (10%)

Common (1% to 10%): Hallucinations, mental status changes, (10%)^[Ref]

Hepatic

Very common (10% or more): Grade 4 ALT/AST elevation when taken concomitantly with a strong CYP450 3A inducer (50%), Grade 3 ALT/AST elevation when taken concomitantly with a strong CYP450 3A inducer (33%)

Common (1% to 10%): Grade 2 ALT/AST elevation when taken concomitantly with a strong CYP450 3A inducer^[Ref]

Respiratory

Very common (10% or more): Dyspnea (27%), cough (18%), upper respiratory tract infection (e.g., fungal upper respiratory infection, viral upper respiratory infection) (12%)

Common (1% to 10%): Interstitial lung disease (ILD), pneumonitis^[Ref]

Other

Very common (10% or more): Asthenia/fatigue (26%), pyrexia (12%)

General

The most common (20% or more) adverse reactions are edema, peripheral neuropathy, cognitive effects, dyspnea, cough, fatigue, weight gain, arthralgia, mood effects, and diarrhea. The most common (20% or more) laboratory abnormalities are hypercholesterolemia, hypertriglyceridemia, anemia, hyperglycemia, increased AST, hypoalbuminemia, increased ALT, increased lipase, and increased alkaline phosphatase.^[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (e.g., burning sensation, carpal tunnel syndrome, dysesthesia, formication, gait disturbance, hypoesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paresthesia, peripheral sensory neuropathy, sensory disturbance) (47%), speech disorder (e.g., aphasia, dysarthria, slow speech) (14%)

Common (1% to 10%): Seizures^[Ref]

Cardiovascular

Common (1% to 10%): AV block, hypertension^[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., dermatitis acneiform, maculopapular rash, pruritic rash, rash) (14%)^[Ref]