Lorlatinib is a novel third-generation small-molecule ALK/ROS1 dual-target inhibitor developed by Pfizer Inc.
Side effects requiring immediate medical attention for Lorlatinib
If any of the following side effects occur while taking Lorlatinib, seek immediate medical attention:
Common side effects
(1) Loss of control, aggression, restlessness, anxiety, black tarry stools, bleeding gums, blood in urine or stool, blurred vision or other vision changes, body aches or pains, burning sensations, crawling sensations, itching, numbness, tingling, "pinching," stinging or pain;
(2) Behavioral changes, chills, cough, deficits in intelligence, short-term memory, learning ability and attention, difficulty or straining to breathe, discouragement, dizziness, dry mouth, ear fullness, false or abnormal comfort, sadness or emptiness, fever;
(3) Skin (3) Red, dry skin; fruity breath; headache; hoarseness; increased appetite; increased thirst; increased urination; irritability; loss of appetite; loss of interest or pleasure; aphonia; lower back or side pain; nausea; anxiety;
(4) Painful or difficult urination; pale skin; pinpoint red spots on the skin; tinnitus; runny or congested nose; visual, auditory, or tactile hallucinations; rash; slow or fast heartbeat; sneezing; sore throat; stomach pain; sweating; swelling;
(5) Hyperactivity in speech, mood, and behavior; suicidal thoughts; chest tightness; difficulty concentrating; insomnia; difficulty breathing; unexplained weight loss; unsteady gait or clumsy movements; abnormal bleeding or bruising; unusual fatigue or weakness; vomiting; weakness in the arms, hands, legs, or feet.
Mild Side Effects of Lorlatinib
If any of the following side effects persist or are bothersome while taking Lorlatinib, or if you have any questions about these side effects, please consult a healthcare professional:
Common Side Effects
Unusual dreams, back pain, constipation, difficulty moving, difficulty speaking, drowsiness, joint pain, muscle aches, cramps, pain or stiffness, pain in the arms or legs, sleep talking, joint swelling.
Side Effects of Lorlatinib for Healthcare Professionals' Reference
1. Very Common Adverse Reactions (Incidence 10% or More)
(1) Musculoskeletal Issues
Joint pain, myalgia/musculoskeletal pain, back pain, limb pain.
(2) Ocular Issues
Visual disturbances (e.g., diplopia, photophobia, flashes of light, blurred vision, decreased vision, visual impairment, vitreous opacity).
(3) Metabolic Aspects
Hypercholesterolemia, hypertriglyceridemia, edema (peripheral edema, eyelid edema, facial edema, generalized edema, localized edema, periorbital edema, peripheral swelling, swelling), hyperglycemia, hypoalbuminemia, weight gain, elevated lipase, elevated alkaline phosphatase, elevated amylase, hypophosphatemia, hyperkalemia, hypomagnesemia, grade 3 or 4 elevated total cholesterol, grade 3 or 4 elevated triglycerides.
(4) Mental Aspects
Cognitive effects (e.g., amnesia, cognitive impairment, dementia, attention deficit, memory impairment, mental impairment, attention deficit/hyperactivity disorder, confusion, delirium, disorientation, dyslexia), mood changes, sleep changes (e.g., abnormal dreams, insomnia, nightmares, sleep disorders, sleep talking, sleepwalking).
(5) Liver Aspects
When used in combination with a potent CYP4503A inducer, grade 4 alanine aminotransferase/aspartate aminotransferase levels increase; when used in combination with a potent CYP4503A inducer, grade 3 alanine aminotransferase/aspartate aminotransferase levels increase.
(6) Respiratory System Aspects
Dyspnea, cough, upper respiratory tract infections (e.g., fungal upper respiratory tract infections, viral upper respiratory tract infections).
(7) Hematological Aspects
Anemia, thrombocytopenia, lymphopenia.
(8) Nervous System Aspects
Peripheral neuropathy (e.g., burning sensation, carpal tunnel syndrome, paresthesia, tingling sensation, gait disturbance, hypoesthesia, muscle weakness, neuralgia, peripheral neuropathy, neurotoxicity, paresthesia, peripheral sensory neuropathy, sensory disturbance), speech disorders (e.g., aphasia, dysarthria, bradysphagia).
(9) Skin Aspects
Rash (e.g., acne-like dermatitis, maculopapular rash, pruritic rash, rashes).
(10) Other Aspects
Weakness/fatigue, fever.
2. Common Adverse Reactions (Incidence 1%-10%)
(1) Mental Aspects
Hallucinations, altered mental status.
(2) Liver Aspects
When used in combination with potent CYP4503A inducers, grade 2 alanine aminotransferase/aspartate aminotransferase levels increase.
(3) Respiratory Aspects
Interstitial lung disease (ILD), pneumonia.
(4) Nervous System Aspects
Seizures.
(5) Cardiovascular Aspects
Atrioventricular block, hypertension.
