Rucaparib
Rucaparib is a PARP inhibitor used to treat certain BRCA mutation-associated recurrent ovarian cancer and metastatic castration-resistant prostate cancer.
🧬 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 →
📖 Rucaparib: Patient Information Guide
A plain-language walkthrough of Rucaparib — 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▾
Rucaparib is a PARP inhibitor approved for two specific BRCA mutation-driven cancers in adults. A BRCA mutation must be confirmed by appropriate testing before use.
- Rubraca is used as maintenance treatment for adults with a deleterious BRCA mutation (inherited or found in the tumor) who have recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and who are in a complete or partial response to platinum-based chemotherapy.
- Rubraca is used to treat adults with metastatic castration-resistant prostate cancer (mCRPC) associated with a deleterious BRCA mutation, who have already received androgen receptor-directed therapy. Patients must be selected using an FDA-approved companion diagnostic test.
⚙️How it works▾
Rucaparib works by blocking PARP enzymes (PARP-1, PARP-2, and PARP-3) — proteins that help cells repair damaged DNA. In cancer cells with BRCA gene mutations, DNA repair is already compromised. When rucaparib shuts down PARP as well, those cancer cells are overwhelmed by DNA damage and die through a process called apoptosis (programmed cell death). This is sometimes called "synthetic lethality" — targeting two weaknesses at once to selectively kill cancer cells while having less impact on healthy cells.
💊How it's taken▾
Rubraca tablets are taken by mouth twice a day, with or without food. Treatment continues until the disease progresses or side effects become unmanageable. If side effects are significant, your doctor can pause treatment or reduce the dose in a stepwise manner — do not adjust your dose on your own.
- Men receiving Rubraca for prostate cancer must also receive a GnRH analog (a hormone-suppressing medication) at the same time, unless they have already had surgical removal of the testicles.
- Your doctor will not start Rubraca until your blood counts have recovered from any previous chemotherapy.
🤒Side effects — in detail▾
Rucaparib causes side effects in most patients — many are manageable, but some require prompt medical attention.
- Nausea and vomiting
- Fatigue or weakness (asthenia)
- Anemia (low red blood cell count), which can cause tiredness and shortness of breath
- Elevated liver enzymes (ALT/AST) seen on blood tests
- Low platelet count (thrombocytopenia), which can cause bruising or bleeding
- Low white blood cell count (neutropenia/leukopenia), raising infection risk
- Decreased appetite
- Diarrhea, constipation, or stomach pain
- Altered taste (dysgeusia), dizziness, or rash
- Photosensitivity reaction (skin becomes more sensitive to sunlight)
Contact your doctor promptly if you notice unusual bruising, prolonged bleeding, severe fatigue, high fever, or shortness of breath — these may signal a serious drop in blood counts or, rarely, a dangerous blood disorder (MDS or AML).
⚠️Warnings & precautions▾
- Risk of serious blood disorders (MDS/AML): A small percentage of patients develop myelodysplastic syndrome or acute myeloid leukemia — serious, potentially fatal blood cancers. Blood counts must be checked before starting and every month during treatment. If counts stay dangerously low, the dose is paused or reduced. If MDS or AML is confirmed, Rubraca must be stopped permanently.
- Harm to unborn babies (embryo-fetal toxicity): Rucaparib can cause fetal death based on animal studies and its mechanism of action. Women should have a pregnancy test before starting, use effective contraception during treatment and for 6 months after the last dose, and must not breastfeed during treatment or for 2 weeks after the last dose. Men should use contraception during treatment and for 3 months after the last dose and should not donate sperm during this time.
- Effect on heart rhythm (QTc prolongation): Rucaparib can prolong the QTc interval — a measure of heart electrical activity — which may be relevant if you take other medications that affect heart rhythm.
🔀What it interacts with▾
Rucaparib affects liver enzymes that process many medications, which means it can raise the blood levels of certain other drugs you might be taking.
- Warfarin (blood thinner): Rubraca increases warfarin levels — more frequent INR (clotting) monitoring is recommended.
- CYP1A2 substrates (e.g., caffeine, certain antidepressants): Rubraca can significantly raise their levels, which may worsen their side effects.
- CYP3A substrates (e.g., midazolam, certain immunosuppressants): Levels can increase; dose adjustments of those drugs may be needed.
- CYP2C9 substrates: Rubraca raises their levels — including warfarin; monitor closely.
- CYP2C19 substrates (e.g., omeprazole, some antidepressants): Levels can increase; prescribers may need to adjust dosing.
- Hormonal contraceptives: Rubraca raises levels of ethinylestradiol and levonorgestrel; discuss contraception options with your doctor.
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▾
- Pregnancy: Rubraca can harm or kill an unborn baby. A pregnancy test is recommended before starting. Do not use if you are pregnant unless clearly discussed with your doctor.
- Breastfeeding: Do not breastfeed while taking Rubraca or for 2 weeks after the last dose — it is unknown if rucaparib passes into breast milk, but potential harm to the baby is serious.
- Women of childbearing potential: Use effective contraception during treatment and for 6 months after the last dose.
- Male patients: Use effective contraception during treatment and for 3 months after the last dose; do not donate sperm during this time.
- Children: The safety and effectiveness of Rubraca in patients under 18 have not been established.
- Older adults: Clinical trials included adults aged 65 and older, and no major safety differences were found compared to younger patients; standard monitoring still applies.
- Kidney problems: No dose change is needed for mild to moderate kidney impairment. Rubraca has not been studied in severe kidney impairment or dialysis patients.
- Liver problems: No dose change is needed for mild to moderate liver impairment. Rubraca has not been studied in severe liver impairment.
📡Pharmacodynamics — effects in the body▾
Rucaparib has been shown to prolong the QTc interval — a measure of the heart's electrical reset time between beats. At the standard twice-daily dose, the average QTc prolongation was about 15 milliseconds. This effect increases with higher drug levels, so your care team may monitor your heart rhythm, especially if you take other medications that also affect the QTc interval.
🔬Pharmacokinetics — how your body processes it▾
After taking a Rubraca tablet, peak blood levels are reached in about 2 hours, though eating a high-fat meal can delay this and modestly increase the total amount absorbed. The drug stays in the body for a meaningful time — its half-life (the time it takes blood levels to fall by half) is about 26 hours — so it builds up over repeated doses. Rucaparib is primarily broken down by the liver enzyme CYP2D6, with smaller contributions from CYP1A2 and CYP3A4, and is cleared mainly through the feces, with a smaller portion in urine.
📦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 Rucaparib’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 →
Supplements & herbs that interact with Rucaparib
105 supplements and herbal products have documented interactions with Rucaparib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 78
- Minor · 25
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Rucaparib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Rubraca for — why did my doctor prescribe it? ▾
Do I take this with food or on an empty stomach? ▾
What side effects should I actually expect, and which ones should make me call the doctor? ▾
Can I take my other medications at the same time as Rubraca? ▾
Is it safe to get pregnant or father a child while taking this? ▾
How long will I need to keep taking Rubraca? ▾
Is Rucaparib available over the counter? ▾
When was Rucaparib first available? ▾
Who makes Rucaparib? ▾
💬 Answers drafted from Rucaparib’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 Rucaparib comes
Rucaparib 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
- Rubraca tablets are used for maintenance treatment of BRCA mutation-associated recurrent ovarian, fallopian tube, or primary peritoneal cancer in adults who responded to platinum-based chemotherapy.
- Rubraca tablets are used to treat BRCA mutation-associated metastatic castration-resistant prostate cancer in adults previously treated with androgen receptor-directed therapy.
- Rubraca tablets are taken by mouth twice daily, with or without food.
- Rubraca treatment is continued until disease progression or unacceptable side effects occur — do not stop without talking to your doctor.
- If side effects are significant, your doctor may reduce your Rubraca dose in steps or pause treatment temporarily.
- Men taking Rubraca for prostate cancer should also receive concurrent GnRH analog therapy unless they have already had surgical removal of the testicles.
📊 Rucaparib across the U.S. market
How Rucaparib 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.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Rucaparib products
A representative set of FDA-listed product records for Rucaparib — 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 | ||||
| 200 mg | Oral | Clovis Oncology, Inc. × 2 listings | NDA | View NDC → |
| 250 mg | Oral | Clovis Oncology, Inc. × 2 listings | NDA | View NDC → |
| 300 mg | Oral | Clovis Oncology, Inc. × 2 listings | NDA | View NDC → |
| 200 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 250 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 300 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg | Oral | pharmaand GmbH × 2 listings | NDA | View NDC → |
| 250 mg | Oral | pharmaand GmbH × 2 listings | NDA | View NDC → |
| 300 mg | Oral | pharmaand GmbH × 2 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Lonza AG | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Rucaparib 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 Rucaparib — 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 Rucaparib 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 Rucaparib 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 ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1862579 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1862583In current FDA listings
Look up RxCUI 1862579 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 Rucaparib 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
Rucaparib belongs to the Poly(ADP-Ribose) Polymerase 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. pharmaand GmbH 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.