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.
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. © 2022 Genentech USA, Inc. All rights reserved.
M-US-00011976(v3.0)
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.