Talazoparib (tal-a-ZOE-pa-rib)

Treats breast and prostate cancer.

Brand Name(s):

Talzenna

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not open, crush, break, or dissolve it.
• For prostate cancer: You should also receive a gonadotropin-releasing hormone (GnRH) analog treatment or have had a surgery to lower testosterone in your body (surgical castration) during treatment with this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• If you vomit after taking a dose, do not take an extra dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how talazoparib works. Tell your doctor if you are using amiodarone, carvedilol, clarithromycin, itraconazole, or verapamil.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Tell your doctor if you have kidney disease, liver disease, or blood or bone marrow problems.
• This medicine may increase your risk for cancer, including myelodysplastic syndrome or acute myeloid leukemia.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine or stools
• Bone pain or fracture
• Fever, chills, cough, sore throat, body aches
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste, decreased appetite, stomach pain
• Hair loss, headache, dizziness
• Nausea, vomiting, diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088