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Niraparib/Abiraterone Acetate is available as an oral tablet that contains 50 mg niraparib/500 mg abiraterone acetate or 100 mg niraparib/500 mg abiraterone acetate.

• Niraparib/Abiraterone Acetate is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCAmutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC)

Niraparib/Abiraterone Acetate contains two active substances: niraparib and abiraterone acetate. Niraparib blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells. The blocking of the PARP enzymes prevents cancer cells from repairing damaged DNA, and, as a result, the cancer cells die.
The other active substance, abiraterone acetate, stops the body producing testosterone by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, abiraterone acetate helps slow the growth of the prostate cancer.

• Niraparib/Abiraterone Acetate is typically taken as 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity
• Patients receiving Niraparib/Abiraterone Acetate should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy
• Take Niraparib/Abiraterone Acetate on an empty stomach. Do not eat food two hours before and one hour after taking Niraparib/Abiraterone Acetate

Niraparib/Abiraterone Acetate is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Niraparib/Abiraterone Acetate:

• Decreased hemoglobin, lymphocytes, neutrophils, and white blood cells
• Musculoskeletal pain
• Fatigue
• Decreased platelets
• Constipation
• Hypertension
• Nausea
• Increased creatinine
• Increased potassium
• Edema
• Shortness of breath
• Decreased appetite
• Vomiting
• Dizziness
• Headache
• Abdominal pain
• Urinary tract infection
• Cough
• Insomnia

Serious side effects are rare with Niraparib/Abiraterone Acetate. Some examples include:

• High blood pressure (hypertension), low blood potassium levels (hypokalemia), fluid retention (edema), and irregular heartbeats.
• Adrenal problems
• Severe liver problems
• Liver problems
• Low blood sugarIncreased risk of bone fracture and deathPosterior Reversible Encephalopathy Syndrome (PRES)

The following medications may interact with Niraparib/Abiraterone Acetate:

• Strong CYP3A4 Inducers: Avoid coadministration
• CYP2D6 Substrates: Avoid coadministration of Niraparib/Abiraterone Acetate with CYP2D6 substrates for which minimal changes in concentration may lead to serious toxicities
• If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate

Various FDA-approved generic manufacturers

The safety and efficacy of Niraparib/Abiraterone Acetate have not been established in females. Based on findings from animal studies and the mechanism of action, Niraparib/Abiraterone Acetate can cause fetal harm and potential loss of pregnancy.

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