Alectinib | Alecensaro

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side effects
tests to perform
Dosing Guidelines
Additional resources

Timeline of Alectinib side effects:

A timeline of side effects showing onset times and incidence rates, including arthralgia, fatigue, pneumonia/ILD, renal impairment, bradycardia, myalgia, and hepatotoxicity.

Other Alectinib side effects:

A medical infographic showing the incidence rates of various side effects of alectinib, including constipation, edema, anemia, diarrhea, nausea, vision disorders, weight gain, dizziness, GI perforation, and photosensitivity, with associated icons.

Tests to perform before starting treatment:

Vial of blood and magnifying glass examining it.

    • Liver function test: ALT, AST, and total bilirubin.

    • Renal function test: creatine levels.

    • CPK test.

Pregnancy test showing a single pink line in the results window.

    • Effect on fertility is unknown.

    • May cause fetal harm- both men and women must use highly effective contraceptive methods during treatment and for 3 months following.

    • Avoid pregnancy and breast feeding while taking alectinib.

Blood pressure cuff used to measure blood pressure.

  • Monitor heart rate and blood pressure at the start of treatment. Exercise caution for low heart rate at baseline- less than 60bpm.

A medical monitoring timeline chart showing weekly blood tests and monitoring tasks over eight weeks, divided into two months, with specific tests and symptoms to watch for.

Tests to perform during treatment:

General dose guidelines:

Illustration of a prescription pill bottle labeled with 600mg, 2 times per day.

  • Recommended starting dose: 600mg orally 2x/day.

    Taken with food (avoid grapefruit, grapefruit juice, products containing grapefruit extract, star fruit, pomegranate, Seville oranges, and other similar fruits)

    Medication should be taken at the same time each day.

    Tablets should be swallowed whole, do not use if compromised (broken, cracked, etc.).

A prescription medication bottle labeled 450mg taken twice daily, with an arrow pointing down labeled "1st reduction".

  • First reduction: 450mg 2x/day

    Confirm condition does not fall under specific dose reductions.

A medication bottle labeled 300mg, taken twice daily, with a pink arrow indicating a second reduction.

  • Second reduction: 300mg 2x/day

    Confirm condition does not fall under specific dose reductions.

A red circle with a diagonal line through it, indicating a prohibition or 'no' symbol.

  • Discontinue if patient cannot tolerate 300mg 2x/day.

Specific dose guidelines:

Illustration of human lungs showing the trachea and bronchial tubes.

  • Pause treatment and if no other causes can be identified, permanently discontinue.

Illustration of a human liver in reddish-brown color on a white background.

  • For mild-moderate impairment: no dose adjustment required.

    For significant ALT/AST/bilirubin elevations: reduce dose to 450mg twice daily.

    For severe patterns: permanently discontinue.

Illustration of two kidneys with their ureters.

  • For mild-moderate impairment: no dose adjustment required.

    For grade 3: withhold until recovery then resume at reduced dose.

    For grade 4: permanently discontinue.

Illustration of the human digestive system showing the large and small intestines.

  • Permanently discontinue.

Pink heart with a red electrocardiogram line passing through the middle.

  • For grade 2 or 3: temporarily withhold until recovery to grade 1.

    • If concomitant medication is adjusted, resume at previous dose.

    • If no medication adjustment, resume at reduced dose.

    For grade 4: permanently discontinue.

    • If concomitant medication is identified, resume at reduced dose upon recovery to grade 1.

Illustration of a flexed arm showing muscle.

  • Over 5x ULN: temporarily withhold until recovery to baseline, then resume same dose.

    Over 10x ULN or second time elevation: withhold until recovery to baseline, then reduce dose.

Red droplet with a downward pointing arrow inside.

  • Withhold until resolution then resume at reduced dose or permanently discontinue.

Alectinib Monograph

Additional resources:

Know what to expect regarding alectinib side effects:

Overall, alectinib is well tolerated, and most side effects can be managed with dose modifications when necessary. Myalgia and peripheral edema are some of the more debilitating side effects for patients, while bradycardia and peripheral edema tend to be more difficult to manage for physicians.

Clinical experience and management of adverse events in patients with advanced ALK-positive non-small-cell lung cancer receiving alectinib

Alectinib has strong CNS/brain metastases activity

The risk of CNS progression is reduced with alectinib. 12% of patients taking alectinib had an event of CNS progression compared with 45% taking crizotinib.

Lorlatinib has a 2.8% cumulative incidence risk of CNS disease progression at 12 months, compared with alectinib with 9.4%.

Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer
Alectinib vs. Lorlatinib in the Front-Line Setting for ALK-Rearranged Non-Small-Cell Lung Cancer (NSCLC)
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