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What is Rubraca, and how does it work?
Rubraca is a prescription medicine used for:
- the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy.
- the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer.
Your healthcare provider will perform a test to make sure Rubraca is right for you.
It is not known if Rubraca is safe and effective in children.
What are the side effects of Rubraca?
Rubraca may cause serious side effects.
The most common side effects of Rubraca include:
- tiredness or weakness
- decrease in hemoglobin (anemia)
- changes in how food tastes
- decreased appetite
- low blood cell counts
- mouth sores
- upper respiratory tract infection
- shortness of breath
- changes in liver or kidney function blood tests
- stomach (abdomen) pain
- increased cholesterol levels
These are not all of the possible side effects of Rubraca. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Rubraca?
Treatment Of BRCA-Mutated Ovarian Cancer After 2 Or More Chemotherapies
Select patients for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic). Information on the FDA-approved test for the detection of a tumor BRCA mutation in patients with ovarian cancer is available at: http://www.fda.gov/CompanionDiagnostics.
Treatment Of BRCA-Mutated mCRPC After Androgen Receptor-Directed Therapy And Chemotherapy
Select patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic). An FDA-approved test for the detection of BRCA1/BRCA2 mutations in patients with mCRPC is not currently available.
- The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken orally twice daily with or without food, for a total daily dose of 1,200 mg.
- Continue treatment until disease progression or unacceptable toxicity.
- If a patient misses a dose of Rubraca, the patient should wait to take the next dose at its scheduled time. Vomited doses should not be replaced.
- Patients receiving Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Dose Modifications For Adverse Reactions
To manage adverse reactions, consider interruption of treatment or dose reduction. Recommended Rubraca dose modifications for adverse reactions are indicated in Table 1.
Table 1. Recommended Dose Modifications for Adverse Reactions
|Starting Dose||600 mg twice daily (two 300 mg tablets)|
|First Dose Reduction||500 mg twice daily (two 250 mg tablets)|
|Second Dose Reduction||400 mg twice daily (two 200 mg tablets)|
|Third Dose Reduction||300 mg twice daily (one 300 mg tablet)|
What drugs interact with Rubraca?
Effect Of Rucaparib On Cytochrome P450 (CYP) Substrates
Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs.
Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.
Is Rubraca safe to use while pregnant or breastfeeding?
- Based on findings from animal studies and its mechanism of action, Rubraca can cause fetal harm when administered to pregnant women.
- There are no available data in pregnant women to inform the drug-associated risk.
- There is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child.
- Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks following the last dose.
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Related Disease Conditions
There are many types of ovarian cancer, epithelial carcinoma is the most common. Women with a family history of ovarian cancer have an increased risk of developing the disease. Some ovarian cancer symptoms include abdominal pain, nausea, diarrhea, constipation, and abnormal vaginal bleeding, however, they usually do not present until the disease has progressed. Early diagnosis is important for successful treatment.
What Are the Symptoms of Stage 1 Ovarian Cancer?
At stage 1 of ovarian cancer, the cancer is present only in the ovaries i.e. it has not spread in any other organs. Signs and symptoms at this stage may include a mass felt in the abdomen, distension or swelling of abdomen, abnormal vaginal bleeding (between menstrual periods or after menopause) and other signs. Stage 1 ovarian cancer has no symptoms in many women, however; often they may not experience symptoms until the cancer has spread significantly.
How Would I Know if I Have Ovarian Cancer?
Ovarian cancer is cancer of the ovaries that produce eggs. Signs and symptoms of ovarian cancer may include abnormal vaginal bleeding or discharge, abdominal pain, reduced appetite, bloating, pelvic pain, constipation and an increased urge to urinate.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.