BOSULIF® How Supplied/Storage and Handling

(bosutinib)

16 HOW SUPPLIED/STORAGE AND HANDLING

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 Presentations
BOSULIF Tablets
Package ConfigurationTablet Strength (mg)NDCTablet Description
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.

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.

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 Presentations
Abbreviation: 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.

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

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 Presentations
BOSULIF Tablets
Package ConfigurationTablet Strength (mg)NDCTablet Description
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.

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.

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 Presentations
Abbreviation: 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.

Medication Guide

Health Professional Information

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