Niraparib and Abiraterone

Niraparib and abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has already been treated with other medications and has spread to other parts of the body. Niraparib is in a class of medications called poly (ADP-ribose) polymerase (PARP) inhibitors. It works by killing cancer cells. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.

Niraparib and abiraterone comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day, at least 1 hour before or 2 hours after a meal for as long as your doctor recommends treatment. Take niraparib and abiraterone 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 niraparib and abiraterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with water; do not split, chew, or crush them.

Continue to take niraparib and abiraterone even if you feel well. Do not stop taking niraparib and abiraterone or prednisone without talking to your doctor.

Your doctor may need to stop or delay your treatment or decrease your dose if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.

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 niraparib and abiraterone,

• tell your doctor and pharmacist if you are allergic to niraparib, abiraterone, any other medications, or any of the ingredients in niraparib and abiraterone tablets. 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.
• The following nonprescription or herbal products may interact with niraparib and abiraterone: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking niraparib and abiraterone. Do not start this medication while taking niraparib and abiraterone without discussing with your healthcare provider.
• tell your doctor if you have an infection, a low level of potassium in your blood, are experiencing unusual stress, or have had a recent heart attack. Also, tell your doctor if you have or have ever had adrenal problems such as Cushing's syndrome, Addison's disease, or adrenal or pituitary tumors; diabetes; heart failure; an irregular heartbeat, including QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death); high blood pressure; or heart, kidney, or liver disease.
• you should know that niraparib and abiraterone is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breast feeding. If taken by pregnant women, niraparib and abiraterone may harm the fetus. Women who are, could become, or may be pregnant should not touch niraparib and abiraterone tablets without protective gloves. If a pregnant woman takes or touches niraparib and abiraterone tablets, she should call her doctor immediately.
• men taking abiraterone must use effective contraception during treatment and for 4 months weeks after the final dose before sexual activity with a female partner. Talk to your doctor about the types of birth control that are right for you.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking niraparib and abiraterone.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking niraparib and abiraterone.
• you should know that niraparib and abiraterone may cause an increase in blood glucose. If you have diabetes or high blood sugar, check your blood sugar as often as directed by your doctor. If your blood sugar is higher than usual, call your doctor. Tell your doctor immediately if you have any of the following symptoms while you are taking niraparib and abiraterone: headache, drowsiness, dizziness, feeling jittery, extreme hunger, irritability, fast heartbeat, sweating, confusion, or weakness. Your doctor may need to change your diet or medication to help control your blood sugar while you are taking niraparib and abiraterone.

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

Take the missed dose as soon as you remember it on the same day. However, if it is the next day, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• muscle or bone pain
• difficulty falling asleep or staying asleep
• nausea
• vomiting
• constipation
• loss of appetite
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• pale skin
• shortness of breath
• weakness
• tiredness
• weight loss
• bruising or bleeding easily
• blood in urine or stool
• burning feeling when you urinate
• frequent or urgent need to urinate
• fever, cough, runny nose, or other signs of infection
• dizziness
• feeling faint or lightheaded
• headache
• confusion
• fast or irregular heartbeats
• muscle weakness
• leg pain
• swelling of the hands, feet, ankles, or lower legs
• lack of energy
• nausea
• vomiting
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• bone fracture
• headache, vision changes, confusion, or seizure

Niraparib and abiraterone may increase the risk that you will develop other cancers. Talk to your doctor about this risk.

Niraparib and abiraterone 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.

Symptoms of overdose may include:

• fast or irregular heartbeats
• shortness of breath
• swelling of the hands, feet, ankles, or lower legs

Keep all appointments with your doctor and the laboratory. Your doctor will order a blood test to help decide if this medication is right for you. Your doctor will check your blood pressure regularly and order certain lab tests before and during your treatment to check your body's response to niraparib and abiraterone.

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.

• Akeega^®