ALECENSA- alectinib hydrochloride capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

ALECTINIB HYDROCHLORIDE (UNII: P9YY73LO6J) (ALECTINIB - UNII:LIJ4CT1Z3Y)

Доступна з:

Genentech, Inc.

ІПН (Міжнародна Ім'я):

ALECTINIB HYDROCHLORIDE

Склад:

ALECTINIB 150 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

ALECENSA is 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. None. Risk Summary Based on animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on ALECENSA use in pregnant women. Administration of alectinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7 times those observed in humans treated with alectinib at 600 mg twice daily (see Data) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a preliminary rabbit embryo-fetal study, adm

Огляд продуктів:

Hard capsules, white 150 mg capsules with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body, available in: Storage and stability: Do not store above 30°C (86°F). Store in the original container to protect from light and moisture.

Статус Авторизація:

New Drug Application

Характеристики продукта

ALECENSA- ALECTINIB HYDROCHLORIDE CAPSULE
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALECENSA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALECENSA.
ALECENSA (ALECTINIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
1/2021
Warnings and Precautions (5.6)
9/2021
INDICATIONS AND 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. (1)
DOSAGE AND ADMINISTRATION
600 mg orally twice daily. Administer ALECENSA with food. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 150 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Monitor liver laboratory 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. In case of severe ALT, AST, or
bilirubin elevations, withhold, then
reduce dose, or permanently discontinue ALECENSA. (2.3, 5.1)
Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold
ALECENSA in patients diagnosed with
ILD/pneumonitis and permanently discontinue if no other potential
causes of ILD/pneumonitis have
been identified. (2.3, 5.2)
Renal Impairment: Withhold ALECENSA for severe renal impairment, then
resume ALECENSA at
reduced dose upon recovery or permanently discontinue (2.3, 5.3).
Bradycardia: Monitor heart rate and blood pressure regularly. If
symptomatic, withhold ALECENSA then
reduce dose, or permanently discontinue. (2.3, 5.4)
Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Assess CPK
every 2 weeks during the first
month of treatment and in patients reporting unexplained muscle pain,
tenderness, or weakness. In
case of severe CPK elevations, withhold, then resume or reduce dose.
(2.3, 5.5)
Hemolytic Anemia: If hemol