Talazoparib

Talazoparib is used alone to treat certain types of breast cancer that has spread within the breast or to other areas of the body. Talazoparib is also used with enzalutamide (Xtandi) to treat certain types of prostate cancer that has spread to other parts of the body in men and who have not been helped by certain medical and surgical treatments that decrease testosterone levels. Talazoparib is in a class of medications called poly (ADP-ribose) polymerase (PARP) inhibitors. It works by stopping or slowing the growth of cancer cells.

Talazoparib comes as a capsule to take by mouth. It is usually taken with or without food once a day. Take talazoparib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take talazoparib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not dissolve or open them.

If you vomit after taking talazoparib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose of talazoparib, or permanently or temporarily stop your treatment, if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with talazoparib. Continue to take talazoparib even if you feel well. Do not stop taking talazoparib without talking to your doctor.

If you are taking talazoparib with enzalutamide (Xtandi) to treat prostate cancer and your doctor has prescribed another medication such as degarelix (Firmagon), goserelin (Zoladex), histrelin (Supprelin LA, Vantas), leuprolide (Eligard, Lupron, in Lupaneta Pack), or triptorelin (Trelstar, Triptodur) to treat your prostate cancer, you will need to continue receiving this medication during your treatment with talazoparib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking talazoparib,

• tell your doctor and pharmacist if you are allergic to talazoparib, any other medications, or any of the ingredients in talazoparib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had low blood levels of sodium, potassium, phosphate, or magnesium; low blood cell counts (leukopenia, lymphopenia, neutropenia, anemia); or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are taking talazoparib. If you are female, your doctor may perform a pregnancy test before you start treatment, and you should use birth control to prevent pregnancy during your treatment with talazoparib and for 7 months after your final dose. If you are male, you and your partner should use birth control to prevent pregnancy during your treatment with talazoparib and for 4 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. Talazoparib may decrease fertility in men. However, you should not assume that you or your partner cannot become pregnant. If you or your partner become pregnant while taking talazoparib, call your doctor. Talazoparib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking talazoparib and for 1 month after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking talazoparib.

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

If you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Talazoparib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• loss of appetite
• diarrhea
• vomiting
• stomach pain
• change in sense of taste
• heartburn
• mouth pain or sores
• hair loss
• fatigue

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• weakness
• feeling tired
• weight loss
• fever, chills, cough, or other signs of infection
• shortness of breath
• fast heartbeat
• headache, dizziness, confusion, or pale skin
• blood in urine or stool
• unusual bleeding or bruising
• broken bones or fractures

Some people who received talazoparib developed other forms of cancer such as leukemia (cancer that begins in the white blood cells) or myelodysplastic syndrome (condition in which blood cells do not develop normally) after they received the medication. Talk to your doctor about the risks of receiving this medication.

Talazoparib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

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