KISQALI- ribociclib tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

RIBOCICLIB SUCCINATE (UNII: BG7HLX2919) (RIBOCICLIB - UNII:TK8ERE8P56)

Tilgjengelig fra:

Novartis Pharmaceuticals Corporation

INN (International Name):

RIBOCICLIB

Sammensetning:

RIBOCICLIB 200 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

KISQALI is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: - an aromatase inhibitor as initial endocrine-based therapy; or - fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men. None. Risk Summary Based on findings from animal studies and the mechanism of action, KISQALI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available human data informing the drug-associated risk. In animal reproduction studies, administration of ribociclib to pregnant animals during organogenesis resulted in increased incidences of post implantation loss and reduced fetal weights in rats and increased incidences of fetal abnormalities in rabbits at exposures 0.6 or 1.5 times the exposure in humans, respectively, at the highest recommended dose

Produkt oppsummering:

KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base. Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in: Carton of 3 blister packs (63 tablets total) – each blister pack contains a 7-day supply of 21 tablets (200 mg per tablet) (600 mg daily dose). NDC 0078-0874-63 Carton of 3 blister packs (42 tablets total) – each blister pack contains a 7-day supply of 14 tablets (200 mg per tablet) (400 mg daily dose). NDC 0078-0867-42 Carton of 1 blister pack (21 tablets total) – each blister pack contains a 21-day supply of 21 tablets (200 mg per tablet) (200 mg daily dose). NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package.

Autorisasjon status:

New Drug Application

Preparatomtale

KISQALI- RIBOCICLIB 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
KISQALI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KISQALI.
KISQALI (RIBOCICLIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Warnings and Precautions (5)
10/2022
INDICATIONS AND USAGE
KISQALI is a kinase inhibitor indicated for the treatment of adult
patients with hormone receptor (HR)-
positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced or metastatic breast
cancer in combination with:
an aromatase inhibitor as initial endocrine-based therapy; or
fulvestrant as initial endocrine-based therapy or following disease
progression on endocrine therapy in
postmenopausal women or in men. (1)
DOSAGE AND ADMINISTRATION
KISQALI tablets are taken orally with or without food in combination
with an aromatase inhibitor or
fulvestrant. (2)
Recommended starting dose: 600 mg orally (three 200 mg tablets) taken
once daily with or without
food for 21 consecutive days followed by 7 days off treatment. (2.1)
Dose interruption, reduction, and/or discontinuation may be required
based on individual safety and
tolerability. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD)/Pneumonitis: Patients treated with CDK
4/6 inhibitors should be
monitored for pulmonary symptoms indicative of ILD/pneumonitis.
Interrupt and evaluate patients with
new or worsening respiratory symptoms suspected to be due to
ILD/pneumonitis. Permanently
discontinue KISQALI in patients with recurrent symptomatic or severe
ILD/pneumonitis. (2.2, 5.1)
Severe Cutaneous Adverse Reactions (SCARs): Stevens-Johnson syndrome
(SJS), toxic epidermal
necrolysis (TEN), and drug-reaction with eosinophilia and systemic
symptoms (DRESS) can occur with
KISQALI treatment. Permanently discontinue KISQALI in patients with
SCARs or other life-thre