Lorlatinib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 19, 2024.

Applies to lorlatinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills. Female patients should use effective birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

Do not use this medicine together with rifampin (Rifadin®). Using these medicines together may increase risk for serious liver problems.

Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause brain or nerve problems. Check with your doctor right away if you have changes in your behavior, discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, seizures, thoughts of killing oneself, tiredness, trouble concentrating, or trouble sleeping.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. Symptoms of high blood pressure are blurred vision, severe headache, a slow or fast heartbeat, lightheadedness, or dizziness.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of lorlatinib

Along with its needed effects, lorlatinib 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 lorlatinib:

Other side effects of lorlatinib

Some side effects of lorlatinib 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:

For healthcare professionals

Applies to lorlatinib: oral tablet.

General adverse events

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]

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%)

Hematologic

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

See also:

Frequently asked questions

• What type of drug is Lorbrena?

Further information

Lorlatinib 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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