Written By: Jon Suyko Pharm.D., BCPS, UC Health Highlands Ranch
Description: The purpose of this PQI is to discuss the various indications for rucaparib (Rubraca).
Background: Rucaparib is an oral tricyclic indole and inhibitor of poly(ADP-ribose) polymerases (PARPs) PARP 1, PARP 2 and PARP 3, with antineoplastic activity.1 PARPs are a group of enzymes activated by single-strand DNA breaks. PARP inhibitors block the ability of PARP to repair DNA that has been damaged including the recruitment of other DNA repair proteins.2 Rucaparib selectively binds to PARP 1, 2 and 3 and inhibits PARP mediated DNA repair. The enhanced accumulation of DNA strand breaks ultimately promotes genomic instability and leads to cell arrest and apoptosis. This activity may also increase the cytotoxicity of DNA-damaging agents possibly reversing resistance to chemotherapy and radiation therapy.
Rucaparib is indicated as maintenance treatment in adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rucaparib is also indicated in adult patients with a deleterious BRCA mutation- associated metastatic castration resistant prostate cancer who have been previously treated with androgen receptor-directed therapy and taxane-based chemotherapy. Along with rucaparib approval, the FDA has approved next-generation sequencing (NGS)-based companion diagnostic to identify patients with advanced ovarian cancer eligible for treatment with rucaparib. The test detects alterations in BRCA1 and BRCA2 genes in the tumor tissue of ovarian cancer patients.
- Rucaparib initial dose for any indication is 600 mg (2 x 300 mg tabs) taken twice daily
- No initial dose adjustment required for renal or hepatic impairment
- May be taken with or without food
- Treatment should be continued until disease progression or toxicity
- If the patient is receiving rucaparib for metastatic castration-resistant prostate cancer (mCRPC) they should also be receiving a gonadotropin-releasing hormone (GnRH) analog
- If the mCRPC patient is not receiving a GnRH they should have had a bilateral orchiectomy
- Most common ADR’s requiring dose adjustment in ovarian cancer based on ARIEL 3 study3,4
- Most common ADR’s requiring dose adjustment in mCRPC based on Triton2 study3,4
Table 1. Recommended Dose Modification Schedule for Adverse Reactions3
|Starting Dose||600 mg twice daily (2 x 300 mg tablets)|
|First Dose Reduction||500 mg twice daily ( 2 x 250 mg tablets)|
|Second Dose Reduction||400 mg twice daily ( 2 x 200 mg tablets)|
|Third Dose Reduction||300 mg twice daily ( 1 x 300 mg tablet)|
Available Tablet Strengths:
- 200 mg tablet – blue, round, film coated, “C2” imprint
- 250 mg tablet – white, diamond, film coated “C25” imprint
- 300 mg tablet – yellow, oval, immediate release, film coated “C3” imprint
Patient Centered Activities:
- Patient Education
- Provide Oral Chemotherapy Education (OCE) Sheet
- Patients may have their dose adjusted several times during their course of treatment
- If the patient misses a dose they should skip the missed dose and resume their regular dosing schedule5
- Rucaparib should be stored at room temperature, away from heat, moisture and light
- Myelodysplastic syndrome/ acute myeloid leukemia have occurred, Grades 3 or 4 (8%) in patients taking rucaparib3
- Monitor for hematologic toxicity at baseline and monthly
- Monitor for symptoms of fatigue, anemia and AST/ALT elevation
- $0 Co-pay program for patients with commercial insurance
- Patients may receive support up to $30,000 per calendar year
- For patients with no health insurance or insurance that does not cover Rubraca®
- Based on household income and diagnosis
Clovis4YOU™8 Daily patient support via text messaging
- Medication and refill reminders
- Nutrition tips and more
- National Center for Biotechnology Information. “PubChem Compound Summary for CID 9931954, Rucaparib” PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/Rucaparib. Accessed 25 June, 2021.
- NCI, S., May 20, 2021, & April 22, 2021. (2020, June 11). FDA Approves Olaparib, Rucaparib to Treat Prostate Cancer. National Cancer Institute. https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-olaparib-rucaparib-prostate-cancer.
- Rubraca (rucaparib) Package Insert Revised: 10/2020
- Rubraca (rucaparib) dosing, indications, interactions, adverse effects, and more. (2020, October 9). https://reference.medscape.com/drug/rubraca-rucaparib-1000121.
- In: IBM Micromedex® CareNotes® [database on the Internet]. Greenwood Village (CO): IBM Corporation; publication year . Retrieved June 21, 2021 from: www.micromedexsolutions.com. Subscription required to view.
- “Rubraca Connections” Co-Pay Program https://www.rubraca.com/ovarian-cancer/patient-support-resources/patient-savings-support-programs
- “Rubraca Connections.” Patient assitance Program https://www.rubracaconnections.com/.
- Clovis4You™ Patient Support Program https://www.rubraca.com/ovarian-cancer/clovis4you-support-program.