;
Decreased appetite 39 3
Respiratory, Thoracic, and Mediastinal Disorders
Dyspnea 21 0.5
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%).
Table 3. Laboratory Abnormalities Reported in ≥ 35% of Patients with Ovarian Cancer Treated with Rubraca 600 mg Twice Daily
a At least one worsening shift in CTCAE grade and by maximum shift from baseline.
b Increase in ALT/AST led to treatment discontinuation in 0.3% of patients (1/377).
Laboratory Parameter All Patients with Ovarian Cancer
(N = 377)
%
Grade 1-4 a Grade 3-4
Clinical Chemistry
Increase in creatinine 92 1
Increase in ALTb 74 13
Increase in ASTb 73 5
Increase in cholesterol 40 2
Hematologic
Decrease in hemoglobin 67 23
Decrease in lymphocytes 45 7
Decrease in platelets 39 6
Decrease in absolute neutrophil count 35 10 CLOSE
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
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. In an animal reproduction study, administration of rucaparib to pregnant rats during organogenesis resulted in embryo-fetal death at maternal exposure that were 0.04 times the AUC0-24h in patients receiving the recommended dose of 600 mg twice daily [see DATA]. Apprise pregnant women of the potential risk to a fetus.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
In a dose range-finding embryo-fetal development study, pregnant rats received oral doses of 50, 150, 500, or 1000 mg/kg/day of rucaparib during the period of organogenesis. Post-implantation loss (100% early resorptions) was observed in all animals at doses greater than or equal to 50 mg/kg/day (with maternal systemic exposures approximately 0.04 times the human exposure at the recommended dose based on AUC0-24h).
8.2 Lactation
Risk Summary
There is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed infant. 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.
8.3 Females and Males of Reproductive Potential
Pregnancy Testing
Pregnancy testing is recommended for females of reproductive potential prior to initiating Rubraca.
Contraception
Females
Rubraca can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to us |
