Talzenna (Talazoparib Tosylate)

What is Talzenna and how to use it?

Talzenna is a prescription medicine in use to treat the symptoms of Breast Cancer, it may also be in use alone or with other medications.

Talzenna belongs to a class of drugs called Antineoplastics, PARP Inhibitors.

What are the possible side effects of Talzenna?

Talzenna may also cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • blood in your urine or stools,
  • easy bruising,
  • unusual bleeding,
  • purple or red spots under your skin,
  • weight loss,
  • pale skin,
  • weakness,
  • tiredness,
  • shortness of breath,
  • cold hands and feet,
  • fever,
  • mouth sores,
  • skin sores,
  • sore throat,
  • cough, and also, trouble breathing

Get medical help right away, if you have any of the symptoms listed above, additionally, tell the doctor if you have any side effect that bothers you or that does not go away, these are not all the possible side effects of Talzenna, for more information, ask your doctor or pharmacist.DESCRIPTION

Talazoparib is additionally an inhibitor of mammalian polyadenosine 5′-diphosphoribose polymerase (PARP) enzyme and the chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1), chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons, the chemical structure of talazoparib tosylate is below:

TALZENNA™ (talazoparib) Structural Formula Illustration

Talazoparib tosylate is a white to yellow solid, additionally, TALZENNA capsules for oral use are available as a 0.25 mg hard hypromellose (HPMC) capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base or as a 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 white/ivory and also white/light red opaque capsule shells contain 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.

INDICATIONS

Additionally, TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy also based on an FDA-approved companion diagnostic for TALZENNA.

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients for the treatment of advanced breast cancer with TALZENNA based on the presence of germline BRCA mutations, information on the FDA-approved test for the detection of BRCA mutations is also available at http://www.fda.gov/companiondiagnostics.

The dose in recommendation for TALZENNA is 1 mg orally once daily, with or without food.

The 0.25 mg capsule is also available for dose reduction.

Patients should be treated until disease progression or unacceptable toxicity occurs.

The hard capsules should be swallowed whole and must not be opened or dissolved, additionally, if the patient vomits or misses a dose, an additional dose should not be taken, the next prescribed dose should be taken at the usual time.

Dose Modifications For Adverse Reactions

To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation, treatment with TALZENNA should be discontinued if more than three dose reductions are required.