BOSULIF (bosutinib) tablet Dosage Forms, Composition And Packaging

Medical Information
Canada
 

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BOSULIF (bosutinib) 100 mg tablets:
Each 100 mg BOSULIF tablet contains 103.40 mg of bosutinib monohydrate, equivalent to 100 mg of bosutinib.
Yellow, oval, biconvex, film-coated tablet debossed with “Pfizer” on one side and “100” on the other.

Non-medicinal ingredients:
Croscarmellose sodium, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc, and titanium dioxide.

BOSULIF (bosutinib) 400 mg tablets §:
Each 400 mg BOSULIF tablet contains 413.60 mg of bosutinib monohydrate, equivalent to 400 mg of bosutinib.
Orange, oval, biconvex, film-coated tablet debossed with “Pfizer” on one side and “400” on the other.

Non-medicinal ingredients:
Croscarmellose sodium, iron oxide yellow, iron oxide red, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc, and titanium dioxide.

BOSULIF (bosutinib) 500 mg tablets:
Each 500 mg BOSULIF tablet contains 516.98 mg of bosutinib monohydrate, equivalent to 500 mg of bosutinib.
Red, oval, biconvex, film-coated tablet debossed with “Pfizer” on one side and “500” on the other.

Non-medicinal ingredients:
Croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.

BOSULIF (bosutinib) tablets are available in the following packaging configurations (Table 12):

Table 12: Tablet Presentations
*
White opaque 3-ply Polyvinyl chloride (PVC)/ACLAR/PVC blisters sealed with push-through foil backing
§
Not commercially available in Canada

Tablet Strength (mg)

Package Configuration

Tablet Description

100 mg

120 tablets per bottle

Yellow, oval, biconvex, film-coated tablets, debossed “Pfizer” on one side and “100” on the other.

28 tablets

(2 blister packs* with 14 tablets each)

400 mg§

30 tablets per bottle

Orange, oval, biconvex, film-coated tablets, debossed “Pfizer” on one side and “400” on the other.

28 tablets

(2 blister packs* with 14 tablets each)

500 mg

30 tablets per bottle

Red, oval, biconvex, film-coated tablets, debossed “Pfizer” on one side and “500” on the other

28 tablets

(2 blister packs* with 14 tablets each)

 

Control #: 227624
09 August 2019