Abiraterone Acetate (a-bir-A-ter-one AS-e-tate), Niraparib (nye-RAP-a-rib)

Treats prostate cancer. This medicine is given with prednisone.

Brand Name(s):

Akeega

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine on an empty stomach. Do not eat food 2 hours before or 1 hour after taking this medicine.
• Swallow the tablet whole. Do not break, crush, or chew it.
• 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: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed 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 niraparib/abiraterone works. Tell your doctor if you are using dextromethorphan, pioglitazone, repaglinide, or rifampin.

Warnings While Using This Medicine:

• Women who are pregnant or may become pregnant should not touch this medicine without wearing gloves.
• This medicine may cause birth defects if a man is using it when his partner becomes pregnant. Use a condom plus another form of birth control during treatment with this medicine and for at least 4 months after the last dose. Tell your doctor right away if a pregnancy occurs while you are using this medicine.
• Tell your doctor if you have kidney disease, liver disease, heart or blood vessel disease, heart failure, high blood pressure, heart rhythm problems, a recent heart attack, diabetes, or a history of adrenal gland problems.
• This medicine may cause the following problems:
  • Bone marrow problems, including myelodysplastic syndrome or acute myeloid leukemia
  • High blood pressure
  • Fluid retention (swelling)
  • Heart rhythm problems, including QT prolongation and torsades de pointes
  • Liver problems
  • Adrenal problems
  • Hypoglycemia (low blood sugar), especially when used together with diabetes medicine
  • Increased risk of bone fractures and death, when used with a radiation treatment (radium Ra 223 dichloride)
  • Nervous system problem, including posterior reversible encephalopathy syndrome (PRES)
• Do not stop using this medicine, even for a short time, without first asking your doctor.
• 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.
• 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.
• 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 stool, trouble breathing, weight loss
• Bone pain, pain or swelling in the arms or legs without any injury
• Dark freckles, skin color changes, feeling of coldness, tiredness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Shaking, trembling, sweating, faintness or lightheadedness, hunger, confusion
• Unusual bleeding, bruising, or weakness

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

• Constipation
• Headache
• Trouble sleeping

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