BOSULIF- bosutinib tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

BOSUTINIB MONOHYDRATE (UNII: 844ZJE6I55) (BOSUTINIB - UNII:5018V4AEZ0)

Dostępny od:

U.S. Pharmaceuticals

INN (International Nazwa):

BOSUTINIB MONOHYDRATE

Skład:

BOSUTINIB MONOHYDRATE 100 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

BOSULIF is indicated for the treatment of adult patients with: - Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). - Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy. BOSULIF is contraindicated in patients with a history of hypersensitivity to BOSULIF. Reactions have included anaphylaxis [see Adverse Reactions (6.1)] . Risk Summary Based on findings from animal studies and its mechanism of action, BOSULIF can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies conducted in rats and rabbits, oral administration of bosutinib during organogenesis caused adverse developmental outcomes, including structural abnormalities, embryo-fetal mortality, and alterations to growth at maternal exposures (AUC) as low as 1.2 times the human exposure at t

Podsumowanie produktu:

How Supplied BOSULIF (bosutinib) tablets are supplied for oral administration in 3 strengths: a 100 mg yellow, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "100" on the other; a 400 mg orange, oval, biconvex, film coated tablet debossed with "Pfizer" on one side and "400" on the other; and a 500 mg red, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "500" on the other. BOSULIF (bosutinib) tablets are available in the following packaging configurations (Table 11): Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Handling and Disposal Procedures for proper disposal of anticancer drugs should be considered. Touching or handling crushed or broken tablets is to be avoided. Any unused product or waste material should be disposed of in accordance with local requirements, or drug take back programs.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

BOSULIF- BOSUTINIB TABLET, FILM COATED
U.S. PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BOSULIF SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BOSULIF.
BOSULIF (BOSUTINIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1)
5/2021
Warnings and Precautions, Gastrointestinal Toxicity (5.1)
5/2021
Warnings and Precautions, Hepatic Toxicity (5.3)
5/2021
Warnings and Precautions, Cardiovascular Toxicity (5.4)
5/2021
Warnings and Precautions, Fluid Retention (5.5)
5/2021
Warnings and Precautions, Renal Toxicity (5.6)
5/2021
INDICATIONS AND USAGE
BOSULIF is a kinase inhibitor indicated for the treatment of adult
patients with
Newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML).
(1)
Chronic, accelerated, or blast phase Ph+ CML with resistance or
intolerance to prior therapy. (1)
DOSAGE AND ADMINISTRATION
Newly-diagnosed chronic phase Ph+ CML: 400 mg orally once daily with
food. (2.1)
Chronic, accelerated, or blast phase Ph+ CML with resistance or
intolerance to prior therapy: 500 mg
orally once daily with food. (2.1)
Consider dose escalation by increments of 100 mg once daily to a
maximum of 600 mg daily in
patients who do not reach complete hematologic, cytogenetic, or
molecular response and do not have
Grade 3 or greater adverse reactions. (2.2)
Adjust dosage for toxicity and organ impairment (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 400 mg, and 500 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to BOSULIF. (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal Toxicity: Monitor and manage as necessary. Withhold,
dose reduce, or discontinue
BOSULIF. (2.3, 5.1)
Myelosuppression: Monitor blood counts and manage as necessary. (2.4,
5.2)
Hepatic Toxicity: Monitor liver enzymes at least monthly for the first
3 months and as needed. Withhold,
dose reduce, or discontinue BOSULIF. (2.3, 5.3)
Cardiovascular Toxicity: Monitor and manage as necessary. (5.4)
Fluid Retention: Mo