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Lorbrena Side Effects

Generic name: lorlatinib

Medically reviewed by Drugs.com. Last updated on Sep 27, 2022.

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: Edema (including generalized and localized edema, swelling, and peripheral, eyelid, facial, or periorbital edema), peripheral neuropathy, cognitive effects (including memory impairment, cognitive disorder, and amnesia), dyspnea, fatigue/asthenia, weight gain, arthralgia, mood effects, diarrhea.

Laboratory abnormalities: 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]

Frequently asked questions

References

1. "Product Information. Lorbrena (lorlatinib)." Pfizer U.S. Pharmaceuticals Group (2018):

Further information

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.