SPL Set ID: da7b5dda-79ed-4c4a-88aa-52394fdc7c54

Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure: The molecular formula for lenalidomide dimethyl sulphoxide is C 13 H 13 N 3 O 3 .½ (C 2 H 6 OS), and the gram molecular weight is 298.33. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. 1