TALZENNA Description

(talazoparib)

11 DESCRIPTION

Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below:

Chemical Structure

Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as:

0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or
0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or
0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or
0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or
0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or
1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.

Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide; and the printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.

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Description

11 DESCRIPTION

Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below:

Chemical Structure

Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as:

0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or
0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or
0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or
0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or
0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or
1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.

Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide; and the printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.

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