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Abiraterone / niraparib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 21, 2023.

Applies to abiraterone / niraparib: oral tablet.

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:

More common

Less common

Incidence not known

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:

More common

Less common

For Healthcare Professionals

Applies to abiraterone / niraparib: oral tablet.

General

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

References

1. Product Information. Akeega (abiraterone-niraparib). Janssen Biotech, Inc. 2023.

Further information

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

Some side effects may not be reported. You may report them to the FDA.