Abiraterone / Niraparib Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 25, 2024.

Applies to abiraterone / niraparib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Pregnant women or women who may become pregnant should not handle or touch the tablets without protection (eg, 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 bone pain, blood in the urine or stools, fever or chills, cough, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a bone marrow problem called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

This medicine can temporarily lower the number of white blood cells in your blood, which may increase the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you or your child think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause hypokalemia. Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have decrease in amount of urine, swelling of the fingers, hands, feet, or lower legs, trouble breathing, or weight gain. These may be symptoms of fluid retention.

This medicine may cause heart rhythm problems (eg, QT prolongation and torsades de pointes). Check with your doctor right away if you have chest pain or discomfort, irregular or slow heart rate, fainting, or trouble breathing.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not interrupt or stop using this medicine together with prednisone without first asking your doctor. This medicine may cause adrenal gland problem. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause hypoglycemia (low blood sugar), especially if you have diabetes and take certain medicines for diabetes. Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.

Abiraterone and prednisone/prednisolone may increase your risk for bone fractures and death when used together with radium Ra 223 dichloride (radiation treatment). You should not receive treatment with radium Ra 223 dichloride for at least 5 days after your last dose of Akeega™ with prednisone. Tell your doctor if you are having any other treatment for your prostate cancer.

This medicine may increase your chance of having a brain condition, called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you start having chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are receiving this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

Along with its needed effects, abiraterone / niraparib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking abiraterone / niraparib:

Other side effects

Some side effects of abiraterone / niraparib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to abiraterone / niraparib: oral tablet.

General adverse events

The most common adverse reactions occurring in 10% or greater included musculoskeletal pain, fatigue, constipation, hypertension, nausea, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, weight decreased, arrhythmia, fall, and pyrexia.

The most common laboratory abnormalities that worsened from baseline in 10% or greater of patients included hemoglobin decreased, platelets decreased, neutrophils decreased, creatinine increased, potassium decreased, AST increased, ALT increased, and bilirubin increased.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (33%), hemorrhage (12%), arrhythmia (10%)
• Common (1% to 10%): Cerebrovascular accident, deep vein thrombosis
• Frequency not reported: Cardiopulmonary arrest, potential for increased pulse rate

Postmarketing reports with individual components in other clinical trials:

Abiraterone acetate: QT prolongation, Torsades de Pointes

Niraparib: Hypertensive crisis, hypertension

Dermatologic

• Common (1% to 10%): Rash

Endocrine

Adverse reactions reported with abiraterone acetate in other trials: Adrenal insufficiency

Gastrointestinal

• Very common (10% or more): Constipation (34%), nausea (33%), vomiting (15%), abdominal pain (12%)

Hematologic

• Very common (10% or more): Hemoglobin decreased (67%), lymphocyte decreased (55%), white blood cell count decreased (48%), platelets decreased (37%), neutrophils decreased (32%)
• Frequency not reported: Anemia

Adverse reactions reported with individual components of this drug in other trials: Febrile neutropenia

Hepatic

• Very common (10% or more): AST increased (up to 20%), ALT increased (up to 18%), bilirubin increased (12%)

Postmarketing reports with abiraterone acetate in other trials: Severe hepatic toxicity, including fulminant hepatitis, acute liver failure, and death

Hypersensitivity

Adverse reactions reported with individual components of this drug in other trials: Anaphylactic reaction

Metabolic

• Very common (10% or more): Alkaline phosphatase increased (34%), creatinine increased (30%), potassium increased (25%), potassium decreased (20%), edema (17%), decreased appetite (15%), weight decreased (10%)

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (44%)

Adverse reactions reported with individual components of this drug in other trials: Myopathy, rhabdomyolysis

Oncologic

Adverse reactions reported with niraparib in other clinical trials: Myelodysplastic syndrome/acute myeloid leukemia

Other

• Very common (10% or more): Fatigue (43%), COVID-19 (13%), fall (10%), pyrexia (10%)
• Frequency not reported: Septic shock, asthenia

Psychiatric

• Very common (10% or more): Insomnia (12%)

Renal

• Common (1% to 10%): Acute kidney injury

Respiratory

• Very common (10% or more): Dyspnea (15%), cough (12%)
• Common (1% to 10%): Pulmonary embolism
• Frequency not reported: Pneumonia

Adverse reactions reported with individual components of this drug in other trials: Allergic alveolitis

Nervous system

• Very common (10% or more): Dizziness (14%), headache (12%)

Adverse reactions reported with individual components of this drug in other trials:

Niraparib: Posterior reversible encephalopathy

Abiraterone acetate: Increased risk of fractures and death when used in combination with radium 223 dichloride

Genitourinary

• Very common (10% or more): Urinary tract infection (12%)
• Frequency not reported: Hematuria

See also:

Further information

Abiraterone/niraparib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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