Brand Name
Rubraca
Generic Name
Rucaparib
View Brand Information FDA approval date: December 19, 2016
Classification: Poly(ADP-Ribose) Polymerase Inhibitor
Form: Tablet
What is Rubraca (Rucaparib)?
RUBRACA is a poly polymerase inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation - associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Approved To Treat
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Brand Information
Rubraca (rucaparib)
1DOSAGE FORMS AND STRENGTHS
- Tablets (200 mg): blue, round, immediate-release, film-coated, debossed with “C2”.
- Tablets (250 mg): white, diamond, immediate-release, film-coated, debossed with “C25”.
- Tablets (300 mg): yellow, oval, immediate-release, film-coated, debossed with “C3”.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Myelodysplastic Syndrome/Acute Myeloid Leukemia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population for patients with ovarian cancer in the WARNINGS AND PRECAUTIONS section reflect exposure to Rubraca at 600 mg orally twice daily in 1594 patients treated on clinical trials including ARIEL3. In this group, 57% of patients were exposed for 6 months or longer and 33% were exposed for greater than one year.
In the pooled safety population for patients with ovarian cancer, the most common adverse reactions in ≥ 10% of patients were nausea (68%), asthenia/fatigue (65%), anemia/hemoglobin decreased (45%), AST/ALT increased (39%), vomiting (36%), diarrhea (29%), decreased appetite (27%), thrombocytopenia/platelet count decreased (25%), dysgeusia (24%), neutropenia/neutrophil count decreased (21%), blood creatinine increased (17%), dyspnea (16%), dizziness (14%), dyspepsia (11%), photosensitivity reaction (10%), and leukopenia/white blood cell count decreased (10%).
4DESCRIPTION
Rucaparib is an inhibitor of the mammalian polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme. The chemical name is 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one ((1S,4R)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl)methanesulfonic acid salt. The chemical formula of rucaparib camsylate is C
The chemical structure of rucaparib camsylate is shown below:
Rucaparib camsylate is a white to pale yellow powder; formulated into a tablet for oral use. Rucaparib shows pH-independent low solubility of approximately 1 mg/mL across the physiological pH range.
Rubraca (rucaparib) tablets contain rucaparib camsylate as the active ingredient. Each 200 mg tablet contains 344 mg rucaparib camsylate equivalent to 200 mg rucaparib free base. Each 250 mg tablet contains 430 mg rucaparib camsylate equivalent to 250 mg rucaparib free base. Each 300 mg tablet contains 516 mg rucaparib camsylate equivalent to 300 mg rucaparib free base.
The inactive ingredients in Rubraca tablets include: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. The cosmetic blue film coating for 200 mg tablets, cosmetic white film coating for 250 mg tablets, and cosmetic yellow film coating for 300 mg tablets is Opadry II containing polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, and talc. The coating is colorized as blue using brilliant blue aluminum lake and indigo carmine aluminum lake, or yellow using yellow iron oxide.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (