Abiraterone / Niraparib
Abiraterone / Niraparib is a once-daily combination of a PARP inhibitor and a hormone-blocking drug, taken with prednisone, for adults with certain BRCA-mutated metastatic prostate cancers.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Akeega pairs niraparib, a PARP inhibitor that stops cancer cells repairing damaged DNA, with abiraterone, which blocks the CYP17 enzyme the body needs to make the male hormones that feed prostate cancer. It is a specialist medicine, taken with prednisone, for metastatic prostate cancer with a BRCA gene change, and has been on the U.S. market since about 2023. Tiredness is what most people notice, largely from anemia (low red blood cells), along with muscle and bone pain, constipation and nausea. Watch above all for unusual bruising, bleeding or infections, since it lowers blood counts and rarely causes bone marrow cancers (MDS/AML), and expect regular blood count, blood pressure, potassium and liver checks.
Clinical pearls
- Take it on an empty stomach, at least one hour before or two hours after food, and swallow tablets whole.
- Never stop or skip the prednisone on your own, especially during illness or stress, because adrenal insufficiency can follow.
- If you have diabetes, tell your prescriber, since pioglitazone or repaglinide can cause severe low blood sugar with this medicine.
- Women who are or may be pregnant should wear gloves to handle the tablets, and men need contraception until four months after stopping.
Patient information guide A plain-language walkthrough of Abiraterone / Niraparib, written from its FDA label.
What Abiraterone / Niraparib is used for
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Abiraterone / Niraparib is used with prednisone for adults with certain prostate cancers.
- Akeega with prednisone treats BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
- Akeega with prednisone treats BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
- An FDA-approved test is used to select patients.
How Abiraterone / Niraparib works
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Niraparib blocks PARP enzymes that help cells repair DNA. This leads to DNA damage and cancer cell death. Abiraterone blocks CYP17, an enzyme needed to make androgens that fuel prostate cancer.
Hormone-lowering injections or surgery reduce androgens from the testes but not from the adrenal glands or the tumor. Abiraterone covers that gap.
Abiraterone / Niraparib dosage
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Akeega is a once-daily tablet taken with prednisone. Take it on an empty stomach, at least one hour before or two hours after food, and swallow it whole with water.
- Do not break, crush, or chew tablets.
- You should also be on a GnRH analog or have had both testicles removed.
- If you miss a dose, take it the same day as soon as possible, then resume normally the next day.
- Treatment continues until the disease progresses or side effects become unacceptable. Your doctor may pause or reduce the dose for side effects.
Dosing details from the FDA-approved label
From the Abiraterone / Niraparib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- BRCA2-mutated (BRCA2 m) Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
- 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 5 mg prednisone once daily until disease progression or unacceptable toxicity
- Take on an empty stomach at least one hour before or two hours after food; patients should also receive a GnRH analog concurrently or have had bilateral orchiectomy
- BRCA-mutated (BRCA m) Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone once daily until disease progression or unacceptable toxicity
- Take on an empty stomach at least one hour before or two hours after food; patients should also receive a GnRH analog concurrently or have had bilateral orchiectomy
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION BRCA2 m mCSPC: The recommended dosage of AKEEGA is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 5 mg prednisone daily until disease progression or unacceptable toxicity. ( 2.2 ) BRCA m mCRPC : The recommended dosage of AKEEGA is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity. ( 2.2 ) Patients receiving AKEEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ( 2.2 ) Take AKEEGA on an empty stomach at least one hour before or two hours after food. ( 2.2 ) For adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. ( 2.3 ) 2.1 Patient Selection Select patients for the treatment of mCSPC with AKEEGA based on the presence of a BRCA2 gene alteration [see Clinical Studies (14.1) ] . Select patients for the treatment of mCRPC with AKEEGA based on the presence of a BRCA gene alteration [see Clinical Studies (14.2) ] . Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage BRCA2- mutated ( BRCA2 m) Metastatic Castration-Sensitive Prostate Cancer (mCSPC) The recommended dosage of AKEEGA is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 5 mg prednisone once daily until disease progression or unacceptable toxicity. BRCA -mutated ( BRCA m) Metastatic Castration-Resistant Prostate Cancer (mCRPC) The recommended dosage of AKEEGA is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone once daily until disease progression or unacceptable toxicity. Patients receiving AKEEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Take AKEEGA on an empty stomach at least one hour before or two hours after food. Swallow tablets whole with water. Do not break, crush, or chew tablets. If a patient misses a dose, instruct patients to take the dose as soon as possible on the same day and resume their next dose at the normal schedule the following day. 2.3 Dosage Modification for Adverse Reactions The recommended dosage modifications for AKEEGA are provided in Table 1.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Abiraterone / Niraparib side effects
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Common side effects seen with Akeega include:
Common side effects
- Low red blood cell counts (anemia) and other low blood counts
- Muscle and bone pain
- Tiredness
- Constipation
- Nausea
- High blood pressure
- Swelling from fluid retention
- Respiratory tract infection
- Low red blood cells, white blood cells, and platelets
- Changes in potassium, creatinine, and liver tests
When to get medical help
- Call your doctor if you have unusual bleeding, bruising, constant tiredness, or signs of infection, which can signal low blood counts or a bone marrow problem such as MDS/AML.
- Call your doctor if you have very high blood pressure, swelling, muscle weakness, a racing or irregular heartbeat, or fainting. These can come from low potassium, fluid retention, or heart effects.
- Get help if you have yellowing of the skin or eyes, dark urine, or belly pain. These can be signs of severe liver problems.
- Tell your doctor if you feel very weak, dizzy, or ill, especially if you miss prednisone or are under stress or have an infection. This could be adrenal insufficiency.
- Get urgent help for sudden confusion, seizures, vision changes, or severe headache, which can be signs of PRES (a brain swelling condition).
- If you have diabetes, watch for low blood sugar, which can be severe with certain diabetes medicines.
Serious reactions include severe anemia needing transfusion, MDS/AML, severe liver problems, adrenal insufficiency, and PRES. Report these quickly.
Abiraterone / Niraparib warnings and precautions
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- Blood problems: low blood counts and rare MDS/AML. Counts are checked often.
- High blood pressure, low potassium, fluid retention: checked weekly for two months, then monthly.
- Liver injury: can be severe and fatal. Liver tests are checked regularly.
- Adrenal insufficiency: a risk if prednisone is stopped or during stress or infection.
- Low blood sugar: in people with diabetes on certain medicines.
- Radium Ra 223: not recommended together.
- PRES: a brain condition that requires stopping the drug.
- Fetal harm: it can harm a pregnancy.
Abiraterone / Niraparib interactions
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Several medicines can change how Akeega works or how other drugs behave.
- Strong CYP3A4 inducers: avoid, because they may lower abiraterone levels.
- CYP2D6 substrates: avoid or lower their dose, because abiraterone raises their levels.
- CYP2C8 substrates: monitor for toxicity, because abiraterone raises their levels.
- Pioglitazone or repaglinide: severe low blood sugar has been reported.
- Radium Ra 223 dichloride: more fractures and deaths seen.
Interactions listed in the FDA-approved label
From the Abiraterone / Niraparib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inducers: Abiraterone is a substrate of CYP3A4, and strong CYP3A4 inducers may decrease abiraterone concentrations, which may reduce the effectiveness of abiraterone. Avoid coadministration.
- CYP2D6 substrates: Abiraterone is a CYP2D6 moderate inhibitor, and AKEEGA increases the concentration of CYP2D6 substrates, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration unless otherwise recommended in the Prescribing Information for 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 drug.
- CYP2C8 substrates: Abiraterone is a CYP2C8 inhibitor, and AKEEGA increases the concentration of CYP2C8 substrates, which may increase the risk of adverse reactions related to these substrates. Monitor patients for signs of toxicity related to a CYP2C8 substrate for which a minimal change in plasma concentration may lead to serious or life-threatening adverse reactions.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Avoid coadministration. ( 7.1 ) CYP2D6 Substrates: Avoid coadministration of AKEEGA 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. ( 7.2 ) 7.1 Effect of Other Drugs on AKEEGA Effect of CYP3A4 Inducers Avoid coadministration with strong CYP3A4 inducers [see Clinical Pharmacology (12.3) ] . Abiraterone is a substrate of CYP3A4. Strong CYP3A4 inducers may decrease abiraterone concentrations [see Clinical Pharmacology (12.3) ], which may reduce the effectiveness of abiraterone. 7.2 Effects of AKEEGA on Other Drugs CYP2D6 Substrates Avoid coadministration unless otherwise recommended in the Prescribing Information for 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 drug. Abiraterone is a CYP2D6 moderate inhibitor. AKEEGA increases the concentration of CYP2D6 substrates [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions related to these substrates. CYP2C8 Substrates Monitor patients for signs of toxicity related to a CYP2C8 substrate for which a minimal change in plasma concentration may lead to serious or life-threatening adverse reactions. Abiraterone is a CYP2C8 inhibitor. AKEEGA increases the concentration of CYP2C8 substrates [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions related to these substrates.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Abiraterone / Niraparib
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- Tell your doctor about heart disease, heart failure, high blood pressure, low potassium, or irregular heartbeat.
- Avoid with moderate or severe liver impairment.
- Severe kidney impairment needs closer monitoring.
- Use effective contraception during treatment and for 4 months after the last dose if your partner could become pregnant.
- It may reduce male fertility.
- Not established in females or children.
- Adults 75 and older had more fatal side effects.
- No lactation information is available.
Abiraterone / Niraparib overdose
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If too much is taken, stop Akeega and seek medical care. Supportive care is given, including checks for irregular heartbeat, heart failure, and liver function. There is no specific antidote.
What Abiraterone / Niraparib does in the body
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Niraparib can raise pulse rate and blood pressure, possibly through effects on certain brain chemical transporters. No large QTc (heart rhythm) increases were found with niraparib or abiraterone acetate. Abiraterone lowers testosterone and other androgens, and blocking CYP17 can raise mineralocorticoid levels, leading to fluid retention and low potassium.
How your body processes Abiraterone / Niraparib
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Niraparib peaks about 3 hours after dosing and abiraterone about 1.5 hours. Food greatly increases abiraterone levels, which is why the tablets are taken on an empty stomach. Niraparib has a half-life of about 62 hours and abiraterone about 20 hours. Niraparib is broken down by carboxylesterases, and abiraterone by CYP3A4 and SULT2A1. Abiraterone is mostly cleared in feces, and niraparib in both urine and feces. Moderate to severe liver impairment raises abiraterone levels substantially.
How to store Abiraterone / Niraparib
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Abiraterone / Niraparib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Abiraterone / Niraparib — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How should I take it?
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What side effects should I expect?
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Can I stop prednisone if I feel fine?
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Do I need to worry about other medicines?
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Is it safe around pregnancy?
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Is Abiraterone / Niraparib available over the counter?
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When was Abiraterone / Niraparib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Abiraterone / Niraparib on HelloPharmacist
Abiraterone / Niraparib forms and strengths (how it comes)
Abiraterone / Niraparib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Abiraterone / Niraparib inactive ingredients by manufacturer.
Tablet
How this form is used
- Akeega with prednisone is used for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
- Akeega with prednisone is used for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
- Take Akeega once daily on an empty stomach, at least one hour before or two hours after food.
- Swallow Akeega tablets whole with water. Do not break, crush, or chew them.
- If you miss a dose of Akeega, take it as soon as possible the same day, then resume your normal schedule the next day.
Abiraterone / Niraparib on the U.S. market: products, makers and brands
How Abiraterone / Niraparib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Abiraterone / Niraparib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2023. Brand names on the directory include Akeega; the rest are generics.
Compare Abiraterone / Niraparib products
A representative set of FDA-listed product records for Abiraterone / Niraparib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| NIRAPARIB TOSYLATE MONOHYDRATE 50 mg/1; ABIRATERONE ACETATE 500 mg | Oral | Janssen Biotech, Inc. | NDA | View NDC → |
| NIRAPARIB TOSYLATE MONOHYDRATE 100 mg/1; ABIRATERONE ACETATE 500 mg | Oral | Janssen Biotech, Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Abiraterone / Niraparib NDCs →
Abiraterone / Niraparib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Abiraterone / Niraparib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Abiraterone / Niraparib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Abiraterone / Niraparib FDA approval history
How Abiraterone / Niraparib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Abiraterone / Niraparib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Abiraterone / Niraparib recalls since July 2021.
✅No Abiraterone / Niraparib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 2645240 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2645243In current FDA listingsClinical drug / strength (SCD) abiraterone acetate 500 MG / niraparib 100 MGRxCUI 2645251abiraterone acetate 500 MG / niraparib 50 MGRxCUI 2645244
Look up RxCUI 2645240 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Abiraterone / Niraparib supply and shortage status
Whether Abiraterone / Niraparib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Abiraterone / Niraparib brand names
Abiraterone / Niraparib is sold under one brand name in the FDA directory — Akeega. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Abiraterone / Niraparib: manufacturers and labelers
One company lists Abiraterone / Niraparib products with the FDA. By number of product records, the largest are Janssen Biotech, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Abiraterone / Niraparib drug class (RxNorm)
Abiraterone / Niraparib belongs to the Cytochrome P450 17A1 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Abiraterone / Niraparib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →