SPL Set ID: ed7a3099-ce31-4865-b212-358d9ff6261b

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(7-amino-3-oxo-1 H- isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(7-amino-3-oxo-1 H- isoindol-2-yl) piperidine-2,6-dione The molecular formula for lenalidomide is C 13 H 13 N 3 O 3 , and the gram molecular weight is 259.27. Lenalidomide is an off-white to pale brown color powder. It is soluble in N,N-Dimethyl acetamide and insoluble in water. Lenalidomide is chiral and possesses an asymmetric carbon and is a racemic mixture since it undergoes racemization under physiological conditions. Lenalidomide Capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The components of black ink are shellac, black iron oxide and potassium hydroxide. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). chemical-structure