ZYKADIA- ceritinib tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

CERITINIB (UNII: K418KG2GET) (CERITINIB - UNII:K418KG2GET)

から入手可能:

Novartis Pharmaceuticals Corporation

INN（国際名）:

CERITINIB

構図:

CERITINIB 150 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

ZYKADIA® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)] . None. Risk Summary Based on animal studies and its mechanism of action [see Clinical Pharmacology (12.1)] , ZYKADIA can cause fetal harm when administered to a pregnant woman. The limited available data on the use of ZYKADIA in pregnant women are insufficient to inform a risk. Administration of ceritinib to rats and rabbits during the period of organogenesis at maternal plasma exposures below the recommended human dose caused increases in skeletal anomalies in rats and rabbits (see Data ). Advise a pregnant woman 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 are 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in which pregnant rats were administered daily doses of ceritinib during organogenesis, dose-related skeletal anomalies were observed at doses as low as 50 mg/kg (less than 0.5-fold the human exposure by AUC at the recommended dose). Findings included delayed ossifications and skeletal variations. In pregnant rabbits administered ceritinib daily during organogenesis, dose-related skeletal anomalies, including incomplete ossification, were observed at doses equal to or > 2 mg/kg/day (approximately 0.015-fold the human exposure by AUC at the recommended dose). A low incidence of visceral anomalies, including absent or malpositioned gallbladder and retroesophageal subclavian cardiac artery, was observed at doses equal to or > 10 mg/kg/day (approximately 0.13-fold the human exposure by AUC at the recommended dose). Maternal toxicity and abortion occurred in rabbits at doses of 35 mg/kg or greater. In addition, embryolethality was observed in rabbits at a dose of 50 mg/kg. Risk Summary There are no data regarding the presence of ceritinib or its metabolites in human milk, the effects of ceritinib on the breastfed child or its effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZYKADIA and for 2 weeks following completion of therapy. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating ZYKADIA [see Use in Specific Populations (8.1)] . Contraception ZYKADIA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Females Advise females of reproductive potential to use effective contraception during treatment with ZYKADIA and for 6 months following completion of therapy. Males Based on the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with ZYKADIA and for 3 months following completion of therapy [see Nonclinical Toxicology (13.1)] . The safety and effectiveness of ZYKADIA in pediatric patients have not been established. Of the 925 patients in clinical studies of ZYKADIA, 18% were 65 years or older, while 5% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. For patients with severe hepatic impairment (Child-Pugh C), reduce the dose of ZYKADIA [see Dosage and Administration (2.5)] . No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

製品概要:

ZYKADIA 150 mg capsules Hard gelatin capsule with opaque blue cap and opaque white body; opaque blue cap marked in black ink with “LDK 150MG”, opaque white body marked in black ink with “NVR”. Available in: Bottles of 70 capsules…………………………………………………………………………………….NDC 0078-0640-70 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. ZYKADIA 150 mg tablets Film-coated tablet, light blue, round, biconvex with beveled edges, without score, debossed with “NVR” on one side and “ZY1” on the other side. Available in: Bottles of 84 tablets…………………………………………………………………………………NDC 0078-0694-84 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

認証ステータス:

New Drug Application

製品の特徴

ZYKADIA- CERITINIB TABLET, FILM COATED
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZYKADIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZYKADIA.
ZYKADIA (CERITINIB) CAPSULES, FOR ORAL USE
ZYKADIA (CERITINIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Warnings and Precautions, Gastrointestinal Adverse Reactions (5.1)
8/2021
INDICATIONS AND USAGE
ZYKADIA is a kinase inhibitor indicated for the treatment of adults
with metastatic non-small cell lung
cancer (NSCLC) whose tumors are anaplastic lymphoma kinase
(ALK)-positive as detected by an FDA-
approved test. (1, 2.1)
DOSAGE AND ADMINISTRATION
Recommended Dosage: 450 mg orally once daily with food. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 150 mg (3)
Tablets: 150 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Adverse Reactions: ZYKADIA can cause gastrointestinal
adverse reactions. If severe or
intolerable, withhold if not responsive to antiemetics or
antidiarrheals; upon improvement, resume
ZYKADIA at a reduced dose. (2.3, 5.1)
Hepatotoxicity: ZYKADIA can cause hepatotoxicity. Monitor liver
laboratory tests at least monthly.
Withhold then dose reduce, or permanently discontinue ZYKADIA. (2.3,
5.2)
Interstitial Lung Disease/Pneumonitis: Occurred in 2.4% of patients.
Permanently discontinue ZYKADIA
in patients diagnosed with treatment-related interstitial lung disease
(ILD)/pneumonitis. (2.3, 5.3)
QT Interval Prolongation: ZYKADIA can cause QTc interval prolongation.
Monitor electrocardiograms and
electrolytes in patients with congestive heart failure,
bradyarrhythmias, electrolyte abnormalities, or
those who are taking medications that are known to prolong the QTc
interval. Withhold then dose
reduce, or permanently discontinue ZYKADIA. (2.3, 5.4)
Hyperglycemia: ZYKADIA can cause hyperglycemia. Monitor fasting
glucose prior to treatment and
periodically thereafter. Initiate or optimize an