Tablets – 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 with a child-resistant (CR) closure (Table 17) Bottles contain a desiccant.
Table 17: Tablet PresentationsBOSULIF Tablets |
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Package Configuration | Tablet Strength (mg) | NDC | Tablet Description |
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Abbreviation: NDC=National drug code. |
120 tablets per bottle | 100 mg | 0069-0135-01 | Yellow, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "100" on the other. |
30 tablets per bottle | 400 mg | 0069-0193-01 | Orange, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "400" on the other. |
30 tablets per bottle | 500 mg | 0069-0136-01 | Red, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "500" on the other. |
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.
Capsules - How Supplied
BOSULIF (bosutinib) capsules are supplied for oral administration in 2 strengths:
50 mg capsule: size 2 capsule, white body/orange cap with “BOS 50” printed on the body and “Pfizer” printed on the cap in black ink. 100 mg capsule: size 0 capsule, white body/brownish-red cap with “BOS 100” printed on the body and “Pfizer” printed on the cap in black ink. BOSULIF (bosutinib) capsules are available in the following packaging configurations with a CR closure. (Table 18).
Table 18: Capsule PresentationsAbbreviation: NDC=National drug code. |
BOSULIF Capsules |
Package Configuration Count | Capsule Strength (mg) | NDC | Capsule Description |
30 capsules per bottle | 50 | 0069-0504-30 | Size 2 capsule, white body/orange cap with “BOS 50” printed on the body and “Pfizer” printed on the cap in black ink. |
150 capsules per bottle | 100 | 0069-1014-15 | Size 0 capsule, white body/brownish-red cap with “BOS 100” printed on the body and “Pfizer” printed on the cap in black ink. |
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] and Store and Dispense in Original Container.
Handling and Disposal
Procedures for proper disposal of anticancer drugs should be considered. Patients and/or caregivers must wear gloves while handling the drug product, and wash their hands once finished. Any unused product or waste material should be disposed of in accordance with local requirements.