Abiraterone and niraparib

Generic name: abiraterone and niraparib [ A-bir-A-te-rone-and-nye-RAP-a-rib ]
Brand name: Akeega
Dosage form: oral tablet (500 mg-100 mg; 500 mg-50 mg)
Drug class: Antineoplastic combinations

Medically reviewed by Drugs.com on Nov 7, 2023. Written by Cerner Multum.

What is abiraterone and niraparib?

Abiraterone and niraparib is a combination medicine used together with prednisone in adults to treat prostate cancer that has spread to other parts of the body (metastatic) and cannot be treated with surgery.

Abiraterone and niraparib is used only if your cancer has a specific genetic marker (an abnormal "BRCA" gene) or other gene mutations. Your doctor will make sure you have the correct tumor type to be treated with abiraterone and niraparib.

Abiraterone and niraparib is not for use by women or children.

Abiraterone and niraparib may also be used for purposes not listed in this medication guide.

Abiraterone and niraparib side effects

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

Abiraterone and niraparib may cause serious side effects. Call your doctor at once if you have:

• swelling in your hands, ankles, legs or feet;

• pain in your legs;

• fast or irregular heartbeats;

• weight loss, dizziness, feeling tired or light-headed, like you might pass out;

• headache, confusion, thinking problems, weakness, vision loss, seizure;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• liver problems--stomach pain (upper right side), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes); or

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery.

Your abiraterone and niraparib treatments may change, be delayed, or permanently discontinued if you have certain side effects.

Common side effects of abiraterone and niraparib may include:

• muscle and bone pain, feeling very weak or tired;

• easy bruising or bleeding;

• loss of appetite, weight loss;

• irregular heartbeats, increased blood pressure;

• swelling in your legs or feet;

• pain and burning when you urinate, painful urination;

• abnormal liver function tests or other blood tests;

• trouble sleeping;

• shortness of breath, dizziness, falls, headache;

• stomach pain, nausea, vomiting, constipation; or

• COVID-19 or cold symptoms such as fever, stuffy nose, sneezing, cough, sore throat.

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.

Warnings

Using abiraterone and niraparib may increase your risk of developing cancer. Call your doctor at once if you have fever, frequent infections, weakness, tiredness, shortness of breath, weight loss, blood in your urine or stools, easy bruising or bleeding, or pale skin. These may be symptoms of bone marrow disorder and may lead to death.

Before taking this medicine

Abiraterone and niraparib may increase your risk of developing serious bone marrow problems or other types of cancer, such as leukemia. Ask your doctor about your individual risk.

Tell your doctor if you have or have ever had:

• diabetes;

• heart problems, high blood pressure;

• low levels of potassium in your blood;

• problems with your adrenal gland; or

• liver or kidney disease.

Abiraterone and niraparib can cause miscarriage and harm an unborn baby if a woman is exposed to abiraterone and niraparib during pregnancy. An abiraterone and niraparib tablet should be handled with protection (gloves) by a woman who is pregnant or may become pregnant.

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.

How should I take abiraterone and niraparib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Abiraterone and niraparib is usually taken once per day with prednisone. Follow your doctor's dosing instructions very carefully.

Take with a full glass of water.

Do not change your dose or stop using abiraterone and niraparib or prednisone without your doctor's advice.

You may also be treated with another medicine called a gonadotropin-releasing hormone, or GnRH. GnRH helps prevent the testicles from producing testosterone.

Your blood pressure and your blood sugar will need to be checked often, and you may need frequent blood tests.

Take abiraterone and niraparib on an empty stomach. Do not eat anything for at least 2 hours before or 1 hour after taking this medicine.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

Abiraterone and niraparib dosing information

Usual Adult Dose for Prostate Cancer:

Recommended dose: Niraparib 200 mg-abiraterone acetate 1000 mg orally once a day in combination with prednisone 10 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Patients receiving this drug should also receive concurrent treatment with a gonadotropin-releasing hormone analog or should have had bilateral orchiectomy.

Comments:
-Select patients for treatment based on the presence of a BRCA gene alteration.
-For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation.

Use: For the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
-Select patients for therapy based on an FDA-approved test for this drug.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses in one day.

What happens if I overdose?

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

What should I avoid while taking abiraterone and niraparib?

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

What other drugs will affect abiraterone and niraparib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect abiraterone and niraparib, especially:

• other prostate cancer medicines, especially radium Ra 223 (may increase your risk of fractures while you are taking abiraterone and niraparib); or

• pioglitazone or repaglinide to treat diabetes (may cause severe low blood sugar hypoglycemia while you are taking abiraterone and niraparib.

This list is not complete and many other drugs may affect abiraterone and niraparib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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