Akeega - Niraparib; Abiraterone Tablets

What is this medication?

NIRAPARIB; ABIRATERONE (nye RAP a rib; A bir A ter one) treats prostate cancer. It works by decreasing levels of the hormone testosterone in the body. It also blocks a protein that causes cancer cells to grow and multiply. This prevents prostate cancer cells from spreading or growing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AKEEGA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Addison disease
• Diabetes
• Heart attack
• Heart disease
• Heart failure
• High blood pressure
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low adrenal gland function
• Low blood cell levels (white cells, red cells, and platelets)
• Low levels of potassium in the blood
• An unusual or allergic reaction to abiraterone, niraparib, other medications, foods, dyes, or preservatives
• If your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Handling this medication may be harmful if you or your partner are pregnant. Wear gloves while touching the medication or bottle. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Check your blood pressure as directed. Know what your blood pressure should be and when to contact your care team.

You may need blood work while taking this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of therapy even though you feel ill unless your care team tells you to stop.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
• Swelling of the ankles, hands, or feet
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Fatigue
• Muscle pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.