Dosage Forms, Composition And Packaging
SUTENT (sunitinib malate) is supplied as a hard gelatin capsule for daily oral administration.
12.5-mg capsules: Hard gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body.
25-mg capsules: Hard gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body.
37.5-mg capsules: Hard gelatin capsule with standard yellow cap and standard yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body.
50-mg capsules: Hard gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body.
SUTENT capsules are supplied as printed hard shell capsules containing sunitinib malate equivalent to 12.5, 25, 37.5, or 50 mg of sunitinib together with mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients.
The orange capsule shells contain gelatin, titanium dioxide, and red iron oxide. The caramel capsule shells also contain yellow iron oxide and black iron oxide. The imprinting ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide. The yellow capsule shells contain titanium dioxide, yellow iron oxide, and gelatin. The imprinting ink for the yellow shells contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.
Supplied as bottles of 28 or 30§ capsules and in blisters§ strips boxed as 28 capsules (combination of 4 strips of 7 capsules).
- not commercially available in Canada
Control #: 226908
11 July 2019