Abiraterone / Niraparib
Abiraterone and niraparib is a combination used to treat BRCA-mutated metastatic prostate cancer in adult men, either when the cancer is castration-sensitive or castration-resistant.
🧬 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 →
📖 Abiraterone / Niraparib: Patient Information Guide
A plain-language walkthrough of Abiraterone / Niraparib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Abiraterone/niraparib (AKEEGA) is a combination cancer medicine approved for adult men with metastatic prostate cancer that has a BRCA gene mutation, confirmed by an FDA-approved test.
- AKEEGA with prednisone treats BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC) — cancer that has spread to other parts of the body and still responds to testosterone-lowering treatment
- AKEEGA with prednisone treats BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) — cancer that has spread and is no longer controlled by testosterone-lowering treatment
- Patients must be selected for AKEEGA based on a confirmed BRCA gene alteration using an FDA-approved companion diagnostic test
⚙️How it works▾
AKEEGA pairs two cancer-fighting mechanisms. Niraparib is a PARP inhibitor — it blocks enzymes (PARP-1 and PARP-2) that cancer cells rely on to repair their DNA. When those repair tools are blocked, BRCA-mutated cancer cells accumulate damage and die. Abiraterone acetate is converted in the body to abiraterone, which blocks an enzyme called CYP17 found in the testes, adrenal glands, and prostate tumor tissue. CYP17 is essential for making androgens (male hormones, including testosterone) that feed prostate cancer growth. By blocking it, abiraterone cuts off that hormonal fuel supply throughout the body — not just in the testes. In lab models of prostate cancer, the combination was more effective than either drug used alone.
💊How it's taken▾
AKEEGA tablets are taken once daily by mouth, always on an empty stomach — at least one hour before eating or two hours after a meal. Eating with the tablets can dramatically increase abiraterone exposure in an unpredictable way. Swallow tablets whole with water; do not break, crush, or chew them.
- AKEEGA is always taken with prednisone (the dose differs depending on which type of prostate cancer is being treated)
- Unless you have had surgical removal of the testes, you will also receive a GnRH analog (a hormone-lowering injection) at the same time
- If you miss a dose, take it as soon as you remember on the same day, then return to your regular schedule the next day — do not double up
- Your doctor may adjust, pause, or reduce your dose if side effects occur; never change your dose without guidance
🤒Side effects — in detail▾
The most common side effects seen in clinical trials include:
- Decreased red blood cell count (anemia) — fatigue, weakness, shortness of breath
- Decreased white blood cell count (neutropenia) and platelet count (thrombocytopenia)
- High blood pressure (hypertension)
- Muscle and bone pain
- Constipation
- Nausea
- Fatigue
- Fluid retention or swelling (edema)
- Abnormal heart rhythm (arrhythmia)
- Low potassium levels
Serious reactions that need prompt medical attention include severe anemia requiring blood transfusions, dangerous drops in blood pressure control, signs of liver injury (yellowing skin or eyes), adrenal gland problems, severe low blood sugar in diabetic patients, and a rare brain condition called PRES (sudden severe headache, seizures, or vision changes).
⚠️Warnings & precautions▾
- Bone marrow suppression: Low blood counts are common and can be severe. A small number of patients developed MDS or AML (serious bone marrow cancers), including fatal cases. Blood counts are checked very frequently throughout treatment.
- High blood pressure and low potassium: AKEEGA can cause significant blood pressure rises and potassium drops, which can lead to dangerous heart rhythm problems including QT prolongation and Torsades de Pointes. Patients with existing heart problems need close monitoring.
- Liver toxicity: Severe liver injury, including acute liver failure and deaths, has been reported — primarily with the abiraterone component. Liver function tests are monitored regularly.
- Adrenal insufficiency: Because AKEEGA affects adrenal hormone production and is taken with prednisone, stopping prednisone suddenly or being under unusual physical stress can trigger adrenal crisis — extreme weakness, dizziness, low blood pressure.
- PRES (posterior reversible encephalopathy syndrome): A rare but serious brain complication — sudden headache, confusion, vision changes, or seizures. Stop the medicine and seek immediate care if these occur.
- Fetal harm: AKEEGA can cause serious harm to a developing fetus. Males with female partners who could become pregnant must use effective contraception during treatment and for 4 months after the last dose.
- Do not combine with radium Ra 223 dichloride outside of clinical trials — this combination has been linked to more fractures and deaths.
- Older patients (75+) had significantly higher rates of fatal side effects in clinical trials.
🔀What it interacts with▾
AKEEGA can interact with several other medications, either reducing its own effectiveness or increasing the risk of side effects from other drugs:
- Strong CYP3A4 inducers (e.g., rifampin, certain anticonvulsants) — these lower abiraterone levels and may make AKEEGA less effective; avoid combining them
- CYP2D6 substrates (e.g., some antidepressants, antipsychotics, certain heart medicines) — AKEEGA raises their blood levels, increasing the risk of toxicity; avoid or reduce the dose of the other drug
- CYP2C8 substrates — AKEEGA can increase their levels; monitor carefully for signs of toxicity from those medicines
- Diabetes medicines containing thiazolidinediones (e.g., pioglitazone) or repaglinide — severe low blood sugar has been reported; blood glucose must be monitored closely
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Liver disease: AKEEGA should be avoided in patients with moderate or severe liver impairment; the medicine's levels can become dangerously high
- Heart conditions: Patients with heart failure (NYHA Class II–IV), recent heart attack, or arrhythmias were excluded from clinical trials — the safety of AKEEGA in these patients has not been established
- High blood pressure or low potassium: These should be controlled before and during treatment
- Diabetes: Blood sugar must be monitored during and after treatment, especially if taking pioglitazone or repaglinide
- Severe kidney disease: Requires closer monitoring; very severe cases (very low kidney filtration) have not been fully studied
- Reproductive potential: Males with female partners who could become pregnant must use contraception during and for 4 months after treatment; AKEEGA may also impair male fertility
- Handling of tablets: Females who are or may be pregnant should handle AKEEGA tablets with gloves
- Children: Safety and effectiveness have not been established in pediatric patients
- Older adults (75+): Had a significantly higher rate of fatal adverse reactions in clinical trials — discuss risks carefully
🚑If you take too much▾
If too much AKEEGA is taken, the medicine should be stopped right away. There is no specific antidote for an overdose. Monitoring for heart rhythm problems (arrhythmia), heart failure, and liver function changes is recommended. Seek emergency medical care immediately if an overdose is suspected.
📡Pharmacodynamics — effects in the body▾
AKEEGA raises blood pressure and heart rate measurably — niraparib affects transporters that regulate dopamine, norepinephrine, and serotonin, which can increase pulse rate and both systolic and diastolic blood pressure. Abiraterone's blockade of CYP17 also increases the production of certain adrenal hormones called mineralocorticoids, which can cause fluid retention, high blood pressure, and low potassium. PSA (a prostate cancer marker) levels may change during treatment, but changes in PSA have not been shown to reliably predict whether treatment is working in individual patients.
🔬Pharmacokinetics — how your body processes it▾
After taking AKEEGA tablets, niraparib reaches peak blood levels in about 3 hours and abiraterone in about 1.5 hours. Eating food — especially a fatty meal — dramatically increases abiraterone absorption (up to 10–17 times higher than fasting), which is why AKEEGA must be taken on an empty stomach. Niraparib stays in the body for a long time, with a half-life (time for blood levels to drop by half) of about 62 hours; abiraterone's half-life is about 20 hours. Niraparib is mainly broken down by enzymes called carboxylesterases, while abiraterone is processed by CYP3A4 and SULT2A1 enzymes in the liver. Niraparib is excreted roughly equally in urine and stool; abiraterone is eliminated mainly in the stool.
📦How to store it▾
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 Abiraterone / Niraparib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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.
Why do I have to take AKEEGA on an empty stomach? Does it really matter? ▾
What side effects should I just push through, and which ones should make me call my doctor? ▾
My doctor ordered a lot of blood tests. Why do I need so many? ▾
I have a wife who could get pregnant. Do I need to worry about that while on this medicine? ▾
Can I take my other medications alongside AKEEGA? ▾
I'm 77. Is AKEEGA safe for someone my age? ▾
Is Abiraterone / Niraparib available over the counter? ▾
When was Abiraterone / Niraparib first available? ▾
Who makes Abiraterone / Niraparib? ▾
💬 Answers drafted from Abiraterone / Niraparib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Abiraterone / Niraparib 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.
Tablet
How this form is used
- AKEEGA tablets with prednisone are used to treat BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC) in adults
- AKEEGA tablets with prednisone are used to treat BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in adults
- AKEEGA is only for patients whose tumors have been confirmed to carry a BRCA gene alteration by an FDA-approved test
- AKEEGA tablets are taken by mouth once daily on an empty stomach — at least 1 hour before or 2 hours after food
- Swallow AKEEGA tablets whole with water; do not break, crush, or chew them
- AKEEGA is taken alongside prednisone and, unless you have had surgical testosterone removal, with a GnRH analog as well
- If you miss a dose, take it as soon as possible on the same day, then resume your normal schedule the following day
📊 Abiraterone / Niraparib across the U.S. market
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 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 → |
| 500; 50 mg/1; mg | Oral | Janssen Biotech, Inc. | NDA | View NDC → |
| 500; 100 mg/1; mg | Oral | Janssen Biotech, Inc. | NDA | View NDC → |
| NIRAPARIB TOSYLATE MONOHYDRATE 50 mg/1; ABIRATERONE ACETATE 500 mg | — | Patheon France S.A.S. | DRUG FOR FURTHER PROCESSING | View NDC → |
| ABIRATERONE ACETATE 500 mg/1; NIRAPARIB TOSYLATE MONOHYDRATE 100 mg | — | Patheon France S.A.S. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Abiraterone / Niraparib NDCs →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Abiraterone / Niraparib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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
-
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.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
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.
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.