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Alectinib Side Effects

In Summary

Commonly reported side effects of alectinib include: cough, dyspnea, increased creatine phosphokinase, increased serum aspartate aminotransferase, musculoskeletal pain, and myalgia. Other side effects include: bradycardia, and increased serum bilirubin. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to alectinib: oral capsule

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

  • 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
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Less Common

  • Clay-colored stools
  • dark urine
  • decreased appetite
  • fever
  • headache
  • itching or skin rash
  • stomach pain or tenderness
  • yellow eyes or skin

Rare

  • Difficulty breathing

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

  • 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

  • Change in taste
  • loss of taste

For Healthcare Professionals

Applies to alectinib: oral capsule

Hematologic

Very common (10% or more): Anemia (56%), lymphopenia (22%)[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%)[Ref]

Other

Very common (10% or more): Fatigue/asthenia (41%), edema (30%)[Ref]

The following types of edema were reported: peripheral, generalized, eyelid, and periorbital.[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 (28%)[Ref]

Dermatologic

Very common (10% or more): Rash (18%)

Common (1% to 10%): Photosensitivity[Ref]

Reported cases of rash included acneiform dermatitis, erythema, and different types of rash (macular, papular, maculopapular, generalized, and pruritic).[Ref]

Nervous system

Very common (10% or more): Headache (17%)[Ref]

Respiratory

Very common (10% or more): Cough (19%), dyspnea (16%)

Uncommon (0.1% to 1%): Interstitial lung disease[Ref]

Ocular

Reported cases of vision disorder included blurred vision, vitreous floaters, visual impairment, reduced visual acuity, asthenopia, and diplopia.[Ref]

Very common (10% or more): Vision disorder (10%)[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia[Ref]

General

In 253 patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who received this drug (600 mg orally twice a day) for a median duration of 9.3 months, serious (19%) and fatal (2.8%) adverse reactions occurred.[Ref]

References

1. "Product Information. Alecensa (alectinib)." Genentech, South San Francisco, CA.

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.

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