Alectinib Side Effects
Applies to alectinib: oral capsule.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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. Use effective birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 3 months after the last dose. If you think a pregnancy has occurred with this medicine, tell your doctor right away.
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 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 those for lung cancer. Check with your doctor right away if you have a new or worsening cough, fever, or trouble breathing.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Bradycardia (slow heartbeat) may occur while you are using this medicine. Tell your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, or a slow or uneven heartbeat.
Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness after taking this medicine. These may be symptoms of a serious muscle problem.
This medicine may cause hemolytic anemia. Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors. Avoid sunlamps and tanning beds during treatment with this medicine and for at least 7 days after the last dose.
Serious side effects of alectinib
Along with its needed effects, alectinib 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 alectinib:
More common side effects
- bloody urine
- chest pain or discomfort
- cough
- decreased frequency or amount of urine
- difficulty with moving
- increased blood pressure
- increased thirst
- joint pain or swelling
- loss of appetite
- lower back or side pain
- lightheadedness, dizziness, or fainting
- muscle aching or cramping
- muscle pains or stiffness
- nausea
- slow or irregular heartbeat
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting
- weight gain
Less common side effects
- clay-colored stools
- dark urine
- decreased appetite
- fever
- headache
- itching or skin rash
- stomach pain or tenderness
- yellow eyes or skin
Rare side effects
- difficulty breathing
Incidence not known
- back, leg, or stomach pains
- bleeding gums
- chills
- general body swelling
- nosebleeds
- pale skin
- sore throat
Other side effects of alectinib
Some side effects of alectinib 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:
More common side effects
- back pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- difficulty having a bowel movement
- double vision
- lack or loss of strength
- rapid weight gain
- rash with flat lesions or small raised lesions on the skin
- seeing double
- seeing floating dark spots or material before the eyes
- swelling around the eyes
- tingling of the hands or feet
- unusual weight gain or loss
- vision changes
Less common side effects
- change in taste
- loss of taste
For healthcare professionals
Applies to alectinib: oral capsule.
Hematologic adverse events
- Very common (10% or more): Anemia (62%), lymphopenia (14%), neutropenia (14%)
- Postmarketing reports: Hemolytic anemia[Ref]
Hepatic
- Very common (10% or more): Increased AST (51%), increased alkaline phosphatase (47%), hyperbilirubinemia (39%), increased ALT (34%)[Ref]
Musculoskeletal
- Very common (10% or more): Increased CPK (43%), myalgia/musculoskeletal pain (29%), back pain (12%), back pain (12%)[Ref]
Other
- Very common (10% or more): Fatigue/asthenia (26%), edema (e.g., peripheral edema, edema, eyelid edema, localized edema, face edema) (22%)[Ref]
Metabolic
- Very common (10% or more): Hyperglycemia (36%), hypocalcemia (32%), hypokalemia (29%), hypophosphatemia (21%), hyponatremia (20%), increased weight (11%)[Ref]
Gastrointestinal
- Very common (10% or more): Constipation (34%), nausea (18%), diarrhea (16%), vomiting (12%)[Ref]
Renal
- Very common (10% or more): Increased creatinine (e.g., increased blood creatinine, creatinine renal clearance decreased, glomerular filtration rate decreased, acute kidney injury) (28%)[Ref]
Dermatologic
- Very common (10% or more): Rash (e.g., acneiform dermatitis, erythema, and different types of rash [macular, papular, maculopapular, generalized, and pruritic]) (15%)
- Common (1% to 10%): Photosensitivity[Ref]
Nervous system
- Very common (10% or more): Headache (17%)
- Common (1% to 10%): Dysgeusia/hypogeusia[Ref]
Respiratory
- Very common (10% or more): Cough (19%), dyspnea (16%)
- Uncommon (0.1% to 1%): Interstitial lung disease[Ref]
Ocular
- Very common (10% or more): Vision disorder (e.g., blurred vision, vitreous floaters, visual impairment, reduced visual acuity, asthenopia, diplopia) (10%)[Ref]
Cardiovascular
- Very common (10% or more): Bradycardia (11%)[Ref]
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References
1. (2015) "Product Information. Alecensa (alectinib)." Genentech
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Further information
Alectinib 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.