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  • RUBRACA 200 mg, 250 mg, 300 mg
    / Neopharm


    Active Ingredient
    Rucaparib 200mg, 250mg, 300mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    60

    full basket chart

    Dosage

    The recommended dose is 600 mg (two 300 mg tablets) taken orally twice daily with or without food.
    Continue treatment until disease progression or unacceptable toxicity.
    If a patient misses a dose, instruct the patient to take the next dose at its scheduled time. Vomited doses should not be replaced.
    To manage adverse reactions, consider interruption of treatment or dose reduction. Recommended dose reductions: Dose Reduction:
    Starting Dose:  600 mg twice daily (two 300 mg tablets).
    First Dose Reduction: 500 mg twice daily (two 250 mg tablets).
    Second Dose Reduction: 400 mg twice daily (two 200 mg tablets).
    Third Dose Reduction: 300 mg twice daily (one 300 mg tablet).
    Hepatic Impairment
    No starting dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] and AST greater than ULN, or total bilirubin between 1.0 to 1.5 times ULN and any AST). No recommendation for starting dose adjustment is available for patients with moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN) due to a lack of data.
    Renal Impairment
    No starting dose adjustment is recommended for patients with mild to moderate renal impairment (baseline creatinine clearance [CLcr] between 30 and 89 mL/min, as estimated by the Cockcroft-Gault method). There is no recommended starting dose for patients with  CrCl <30 mL/min or patients on dialysis due to a lack of data.


    Indications

    Indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
    Treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with rucaparib, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long term follow-up. Of these, 5 occurred during treatment or during the 28 day safety follow-up (0.5%). The duration of rucaparib treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.
    Do not start rucaparib until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt rucaparib or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue rucaparib.
    Embryo-Fetal Toxicity
    Rucaparib can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of rucaparib.
    See prescribing information for full details.


    Side Effects

    Nausea, Vomiting, Constipation, Diarrhea, Abdominal Pain, Asthenia/Fatigue Anemia, Thrombocytopenia, Nervous System Disorders, Dysgeusia, Decreased appetite, Dyspnea.
    See prescribing information for full details.


    Drug interactions

    Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs.
    Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.
    See prescribing information for full details. 


    Pregnancy and Lactation

    Pregnancy
    There are no available data in pregnant women to inform the drug-associated risk.
    Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose. See prescribing information for full details.
    Lactation
    There is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child. Because of the potential for serious adverse reactions in breast-fed children , advise lactating women not to breastfeed during treatment for 2 weeks following the last dose.


    Overdose

    There is no specific treatment in the event of overdose, and symptoms of overdose are not established. In the event of suspected overdose, physicians should follow general supportive measures and should treat symptomatically.


    Manufacturer
    Clovis Oncology, Inc
    Licence holder
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