Talazoparib is used in adults to treat certain type of breast cancer that has spread to other parts of the body.

Your doctor will make sure you have the correct tumor type to be treated with talazoparib.

Talazoparib may also be used for purposes not listed in this medication guide.

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

Talazoparib can lower your blood cell counts, and you may get infections or bleed more easily. Call your doctor if you have unusual bruising or bleeding, blood in your urine or stools, weight loss, fever, weakness, tiredness, or trouble breathing.

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

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.

Usual Adult Dose for Breast Cancer:

1 mg orally once a day until disease progression or unacceptable toxicity

Comments:
-Select patients based on the presence of germline BRCA mutations as determined by an FDA-approved test.

Use: For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer

Tell your doctor if you 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 make sure 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 is able to 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.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Talazoparib may cause serious side effects. Call your doctor at once 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 permanently discontinued if you have certain side effects.

Common side effects of talazoparib may include:

• low blood cell counts;

• nausea, vomiting, diarrhea, loss if appetite;

• hair loss;

• 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 FDA at 1-800-FDA-1088.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to talazoparib. Your doctor will also order a lab test before you begin your treatment to see whether your cancer can be treated with talazoparib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.