Adverse Reactions

Adverse reactions reported in ≥ 20% of patients with ovarian cancer treated with Rubraca (rucaparib) 600 mg twice daily

All Ovarian Cancer Patients (N=377), %
Adverse Reaction Grades* 1-4 Grades 3-4
Gastrointestinal Disorders
Nausea 77 5
Vomiting 46 4
Constipation 40 2
Diarrhea 34 2
Abdominal Pain 32 3
General Disorders
Asthenia/Fatigue 77 11
Blood and Lymphatic System Disorders
Anemia 44 25
Thrombocytopenia 21 5
Nervous System Disorders
Dysgeusia 39 0.3
Metabolism and Nutrition Disorders
Decreased appetite 39 3
Respiratory, Thoracic, and Mediastinal Disorders
Dyspnea  21 0.5
  • To manage adverse reactions, consider interruption of treatment or dose reduction
  • The following adverse reactions have been identified in < 20% of the 377 patients treated with Rubraca 600 mg twice daily: dizziness (17%), neutropenia (15%), rash (includes rash, rash erythematous, rash maculopapular and dermatitis) (13%), pyrexia (11%), photosensitivity reaction (10%), pruritus (includes pruritus and pruritus generalized) (9%), Palmar-plantar erythrodysaesthesia syndrome (2%), and febrile neutropenia (1%).
  • Adverse reactions led to dose reduction or interruption in 62% of patients, most frequently from anemia (27%), and fatigue/asthenia (22%). Adverse reactions led to dose discontinuation in 10% of patients, most frequently from fatigue/asthenia (2%)

*Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).

Rubraca [prescribing information]. Boulder, CO: Clovis Oncology; 2016.
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SELECT IMPORTANT SAFETY INFORMATION
SELECT IMPORTANT SAFETY INFORMATION

There are no contraindications with Rubraca.

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) was reported in 2 of 377 (0.5%) patients with ovarian cancer treated with Rubraca. The duration of Rubraca treatment prior to the diagnosis of MDS/AML was 57 days and 539 days. Both patients received prior treatment with platinum and other DNA damaging agents.

AML was reported in 2 (< 1%) patients with ovarian cancer enrolled in a blinded, randomized trial evaluating Rubraca versus placebo. One case of AML was fatal. The duration of treatment prior to the diagnosis of AML was 107 days and 427 days. Both patients had received prior treatment with platinum and other DNA damaging agents.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood count testing at baseline and monthly thereafter. For prolonged hematological toxicities, interrupt Rubraca and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%).

Most common laboratory abnormalities (≥ 35%; Grade 1-4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%), and decrease in absolute neutrophil count (35%).

Because of the potential for serious adverse reactions in breast-fed infants from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the final dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.

Please see full Prescribing Information for additional Important Safety Information.