to 50 mg/kg/day (with maternal systemic exposures approximately 0.04 times the
Doses should be taken approximately 12 hours apart. (3%) and nausea (3%).Adverse reactions occurring < 20% of patients treated
in two multicenter, single-arm, open-label clinical trials, Study 10
For more information, ask your healthcare provider or pharmacist.Call your healthcare provider for medical advice about
polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3), organic anion transporters 1
Select patients for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer with Rubraca based on the presence of a deleterious The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken orally twice daily with or without food, for a total daily dose of 1,200 mg.Continue treatment until disease progression or unacceptable toxicity.If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time.
down regulated CYP3A4 and CYP2B6.Rucaparib inhibited the P-glycoprotein (P-gp) efflux
mutagenic in a bacterial reverse mutation (Ames) test.Fertility studies with rucaparib have not been conducted. ULN) are unknown.Based on population pharmacokinetic analyses,
Specific
your blood cell counts:Your healthcare provider will perform a test to make sure
patients have not been established.In clinical studies 40% (297/749) of patients with
treatment or dose reduction. patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer
Rubraca was approved based on response rate and how long patients’ responses lasted.
MDS/cancer therapy-related AML; in all cases, patients had received previous
2 weeks after the last dose of Rubraca [see Instruct patients to take Rubraca orally twice daily with
should treat symptomatically.Rucaparib is an inhibitor of poly (ADP-ribose) polymerase
after two or more chemotherapies.No starting dose adjustment is recommended for patients
35 months) for patients who received Rubraca and 5.5 months for patients who
(NCT01968213), a double-blind, multicenter clinical trial in which 564 patients
chemotherapy [see Rubraca is indicated for the treatment of adult patients
Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca. with two or more chemotherapies. high genomic loss of heterozygosity) was confirmed by the FoundationFocus™ CDx BRCA
distributed to red blood cells with a blood-to-plasma concentration ratio of
(65/749) were 75 years or older. coefficient of variation [CV]) and AUC0-12h was 16900 h•ng/mL (54% CV) at the approved
These dose levels resulted in
early resorptions) was observed in all animals at doses greater than or equal
and/or laboratory findings of low blood cell counts, or a need for blood
rucaparib during the period of organogenesis. ovarian, fallopian tube, or primary peritoneal cancer who have been treated
bone marrow problem called ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid
anemia (17%), nausea (15%), and fatigue/asthenia (13%). reproductive potential prior to initiating Rubraca.Rubraca can cause fetal harm when administered to a
Rubraca International non-proprietary name: rucaparib Procedure No. (AML) occur uncommonly in patients treated with Rubraca, and are potentially
The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken orally twice daily with or without food, for a total daily dose of 1,200 mg. Continue treatment until disease progression or unacceptable toxicity. No recommendation for starting dose adjustment is
Prior
Do not store in the bathroom. The coating is colorized as blue using brilliant blue aluminum lake and indigo carmine aluminum lake, or yellow using yellow iron oxide.Rubraca is indicated for the maintenance treatment of
If a patient misses a dose of Rubraca, instruct the patient to take the next dose at its scheduled time. Rucaparib induced CYP1A2, and
with mild to moderate renal impairment (baseline creatinine clearance [CLcr]
ovarian cancer who had progressed after 2 or more prior chemotherapies. For
characterized.The effect of multiple doses of Rubraca on QTc interval was
patients received Rubraca 600 mg orally twice daily as monotherapy until
CYP3A4.Based on population pharmacokinetic analyses, age, race,
fallopian tube, or primary peritoneal cancer with Rubraca based on the presence
Rubraca 600 mg twice daily as compared to patients with normal hepatic function
30% (56/186) had a somatic BRCA mutation.ARIEL3 demonstrated a statistically significant
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. patients and 4% of placebo patients. The major efficacy outcome was investigator-assessed progression-free
be replaced.To manage adverse reactions, consider interruption of
Dosing and Administration (2.3) 04/2018 Warnings and Precautions (5.1) 04/2018-----INDICATIONS AND USAGE----- RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: • for … patients 65 years or older, the most common Grade 3-4 adverse reactions were
It is not known if Rubraca is safe and effective in children. CDxBRCA test, which is FDA approved for selection of patients for Rubraca
between 30 and 89 mL/min, as estimated by the Cockcroft-Gault method). received placebo.Dose interruptions due to an adverse reaction of any
Rucaparib has been shown to decrease tumor growth in mouse xenograft models of
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. and 32% higher steady-state AUC, respectively, compared to patients with normal
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