Talazoparib

Talazoparib is used in adults to treat a specific type of breast cancer that has spread to other areas of the body.

Talazoparib is also used in adults along with other medications to treat prostate cancer that has spread to other areas of the body, especially when surgery or other treatments to lower testosterone levels have not been effective.

Your doctor will confirm that you have the right type of tumor to be treated with talazoparib.

Talazoparib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take talazoparib with or without food.

Swallow the capsule whole and do not open or dissolve it.

If you vomit shortly after taking talazoparib, do not take another dose. Take your next dose as scheduled.

Talazoparib is usually given until your body no longer responds to the medication.

You may get infections or bleed more easily. Your blood will be tested before and during treatment and your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Do not change your dose or stop using this medicine without your doctor's advice.

Using talazoparib may raise your risk of bone marrow problems or leukemia.

Talazoparib can reduce your blood cell counts, which may lead to a higher chance of infections or easier bleeding. Contact your doctor if you notice unusual bruising or bleeding, blood in your urine or stools, weight loss, fever, weakness, tiredness, or difficulty breathing.

Your blood will be tested before and during treatment, and your cancer treatments may be postponed based on the results.

Tell your doctor if you have or have ever had:

• kidney disease.

Using talazoparib may increase your risk of developing bone marrow problems or leukemia. Ask your doctor about your individual risk.

Talazoparib can harm an unborn baby if the mother or the father is using talazoparib.

• If you are a woman, you may need a pregnancy test to ensure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.
• If you are a man, use birth control if your sex partner can get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Talazoparib may cause serious side effects. Call your doctor right away if you have:

• blood in your urine or stools;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• weight loss;
• frequent infections;
• low red blood cells (anemia)--pale skin, weakness, tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or stopped permanently if you have certain side effects.

Common side effects of talazoparib may include:

• low blood cell counts;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• bone injuries, low levels of calcium in your blood (hypocalcemia);
• high levels of bilirubin in the blood;
• high blood sugar;
• changes in your sense of taste;
• nausea, vomiting, diarrhea, loss of appetite;
• hair loss;
• dizziness, headache; or
• feeling weak or tired.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Breast Cancer:

1 mg orally once a day until disease progression or unacceptable toxicityComment:-Select patients based on the presence of germline BRCA mutations as determined by a US FDA-approved companion diagnostic for this drug.Use: For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer

Usual Adult Dose for Prostate Cancer:

0.5 mg orally once a day in combination with enzalutamide-Duration of therapy: Until disease progression or unacceptable toxicityComments:-Refer to the manufacturer product information for recommended enzalutamide dosing information.-Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.-Select patients based on the presence of alterations in genes directly or indirectly involved in homologous recombination repair (HRR), including ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C.-A US FDA-approved test for detection of HRR gene mutations for use with this drug is not currently available.Use: In combination with enzalutamide, for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Tell your doctor about all your other medicines, especially:

• amiodarone;
• carvedilol;
• clarithromycin;
• itraconazole; or
• verapamil.

This list is not complete. Other drugs may affect talazoparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.