Rucaparib (Rubraca), a poly ADP-ribose polymerase inhibitor, has been approved by the Food and Drug Administration (FDA) as a new maintenance treatment for patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer that is completely or partially responding to platinum-based chemotherapy. The recommended dose of the drug is 600 mg (two 300-mg tablets) twice a day, with or without food. Rucaparib is thought to work by preventing damaged DNA from repairing. Previously, rucaparib was approved to treat harmful BRCA mutation (germline and/or somatic)-associated ovarian, fallopian tube, or primary peritoneal cancer that had already been treated with two or more chemotherapies.

FDA approval of the new indication was based on results of ARIEL3 (Assessment of Rucaparib in Ovarian Cancer: Phase 3 Trial), a randomized, double-blind, placebo-controlled trial, which showed that patients receiving rucaparib had a significant improvement in estimated median progression-free survival.

The most common adverse effects of rucaparib (occurring in 20% or more of patients) include fatigue, rash, gastrointestinal complaints (nausea, vomiting, abdominal pain/distension, altered taste, constipation, diarrhea, decreased appetite, dyspnea, stomatitis), hematologic issues (anemia, thrombocytopenia, neutropenia), and nasopharyngitis/upper respiratory infection. The adverse effects are similar when rucaparib is used to treat harmful BRCA mutation-associated ovarian, fallopian tube, or primary peritoneal cancer. The most common laboratory abnormalities (occurring in more than 25% of patients) were elevations in alanine transferase/aspartate transferase, increased alkaline phosphatase, decreased hemoglobin, increased cholesterol, decreased platelets, decreased leukocytes, decreased lymphocytes, and decreased neutrophils. Rucaparib carries a warning that it can cause myelodysplastic syndrome/acute myeloid leukemia and embryo-fetal toxicity.

Nurses caring for patients receiving rucaparib should monitor blood work for abnormalities. Patients should be advised that routine blood work will be needed to identify potentially serious blood cell counts. Patients should tell their health care provider if they experience symptoms that could be signs of low blood cell count or myelodysplastic syndrome/acute myeloid leukemia, such as weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, fatigue, and bruising or bleeding more easily. Patients should be told to take the two daily doses of rucaparib about 12 hours apart. Patients of childbearing age should be reminded to use effective birth control during rucaparib treatment.

For complete prescribing information for rucaparib see http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf.