ALECENSA® (alectinib) sponsored by Genentech USA, Inc. 



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Indications & Usage

ALECENSA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.


Please see Important Safety Information in full Prescribing Information.

Dosage & Administration

Administer ALECENSA® (alectinib) until disease progression or unacceptable toxicity.

            •           The recommended dose of ALECENSA is 600 mg orally twice daily with food

                            ◦  The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily with food

            •           Do not open or dissolve the contents of the capsule

            •           If a dose of ALECENSA is missed or vomiting occurs after taking a dose of ALECENSA, take the next dose at the scheduled time

 

For more information on ALECENSA dosing and dose modifications for adverse reactions, see full Prescribing Information.

Dosage Forms and Strengths

Capsules: 150 mg 

Please see Important Safety Information in full Prescribing Information.

ALECENSA® and its logo are registered trademarks of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan. © 2021 Genentech USA, Inc. All rights reserved.

M-US-00011976(v2.0)

Please see Important Safety Information below and in full Prescribing Information.


Indication and Important Safety Information


Indication

ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (mNSCLC) as detected by an FDA-approved test

Important Safety Information

Hepatotoxicity: Monitor liver function tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.

Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis occurred in 0.7% of patients. Immediately withhold ALECENSA in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified.

Renal Impairment: Renal impairment occurred in 8% of patients. Incidence of Grade ≥3 was 1.7%, of which 0.5% were fatal events. Based on the severity of the adverse reaction, withhold then dose reduce, or permanently discontinue ALECENSA.

Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then dose reduce or permanently discontinue.

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold, then resume or dose reduce ALECENSA.

Hemolytic Anemia: If hemolytic anemia is suspected, withhold ALECENSA. If hemolytic anemia is confirmed, consider resuming at a reduced dose upon resolution or permanently discontinue.

Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose.

Most Common Adverse Reactions: The most common adverse reactions (incidence ≥20%) were constipation (34%), fatigue (26%), myalgia (23%), edema (22%), and anemia (20%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888- 835-2555.

Please see additional Important Safety Information in full Prescribing Information.