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BOSULIF® (bosutinib) How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 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):

Table 11: Tablet Presentations
BOSULIF Tablets
Package ConfigurationTablet Strength
(mg)
NDCTablet Description
Abbreviation: NDC=National drug code.
120 tablets per bottle100 mg0069-0135-01Yellow, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "100" on the other.
30 tablets per bottle400 mg0069-0193-01Orange, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "400" on the other.
30 tablets per bottle500 mg0069-0136-01Red, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "500" on the other.

16.2 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].

16.3 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.

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