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Rucaparib oral

Updated 2 Feb 2023 | Rucaparib


Oral formulations of rucaparib.

Drugs List

  • RUBRACA 200mg film coated tablets
  • RUBRACA 250mg film coated tablets
  • RUBRACA 300mg film coated tablets
  • Rucaparib 200mg film coated tablets
  • Rucaparib 250mg film coated tablets
  • Rucaparib 300mg film coated tablets
  • Therapeutic Indications


    Fallopian tube cancer
    Platinum sensitive high grade epithelial ovarian cancer
    Primary peritoneal cancer

    Monotherapy maintenance treatment of adult patients with platinum sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

    Monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    There is no requirement for BRCA testing prior to using rucaparib for maintenance treatment. BRCA testing must be performed and confirmation of BRCA 1/BRCA 2 gene before treatment for relapsed or progressive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.


    600mg twice daily, taken approximately 12 hours apart, continued until disease progression or unacceptable toxicity.

    Patients should not start rucaparib until they have recovered from haematological toxicities caused by previous chemotherapy.

    Maintenance treatment should start no later than 8 weeks after completion of the patient's final dose of the platinum containing regimen.

    Additional Dosage Information

    If the patient vomits

    If a patient vomits after taking rucaparib, the patient should not retake the dose and should take at the next scheduled dose.

    If a dose is missed

    If a dose is missed, the patient should take rucaparib at the next scheduled dose.

    Dose modifications
    First dose reduction: 500mg twice daily.
    Second dose reduction: 400mg twice daily.
    Third dose reduction: 300mg twice daily.

    Haematological toxicity
    Moderate to severe (Grade 3 or 4) haematological reactions, including neutropenia, anaemia and thrombocytopenia: Manage through a combination of dose interruptions and/or dose reductions with blood counts monitored weekly until recovery. If levels have not recovered after 4 weeks, the patient should be referred to a haematologist for further investigation.

    Liver enzyme elevations
    Grade 1 to 3 elevations in aspartate aminotransferase and/or alanine aminotransferase: Can be managed without dose interruption or dose reduction. With Grade 3 elevations without other signs of liver dysfunction, monitor LFTs weekly until resolution to Grade less than or equal to 2. Continue rucaparib as long as bilirubin is less than ULN and alkaline phosphatase is less than 3 times ULN. Interrupt treatment if aspartate aminotransferase and/or alanine aminotransferase levels do not decline within 2 weeks, resume rucaparib when values are Grade less than or equal to 2 at the same or reduced dose.
    Grade 4 elevations in aspartate aminotransferase and/or alanine aminotransferase: Manage through a combination of dose interruptions and/or dose reductions.With Grade 4 elevations, interrupt rucaparib until values are Grade less than or equal to 2. Resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks.

    Non-haematological toxicity
    Moderate to severe non-haematological reactions, including vomiting and nausea: Manage through a combination of dose interruptions, dose reductions and appropriate symptomatic management.


    Children under 18 years
    Moderate hepatic impairment
    Severe renal impairment

    Precautions and Warnings

    Patients over 65 years

    Advise ability to drive/operate machinery may be affected by side effects
    Confirm BRCA1 or BRCA2 mutation status prior to treatment
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Non-significant increase in QT interval at therapeutic doses
    Staff: Not to be handled by pregnant staff
    Exclude pregnancy prior to initiation of treatment
    Perform blood counts before and at monthly intervals during treatment
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Consider G-CSF in severe neutropenia / agranulocytosis
    Consider the use of anti-emetics before and during therapy
    Risk of myelodysplasia/myeloid leukaemia requires haematological follow-up
    Consider dose interruption & reduction in non-haematological toxicity
    Consider treatment interruption & dose reduction in haematological toxicity
    Discontinue if MDS or AML occurs requiring additional anticancer therapy
    Interrupt or reduce dose if significant gastrointestinal disturbances occur
    Advise patient not to take St John's wort concurrently
    Female: Contraception required during and for 6 months after treatment
    Breastfeeding: Do not breastfeed during & for 2 weeks after treatment
    Advise patient to use SPF 50+ sunscreen and lip balm during treatment
    Avoid direct exposure to sunlight

    Pregnancy and Lactation


    Rucaparib is contraindicated during pregnancy.

    Use of rucaparib during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited data on the use of rucaparib in human pregnancy. Animals studies have shown reproductive toxicity, including embryofoetal toxicity. The drug's mechanism of action indicates potential foetal harm when administered to a pregnant woman.


    Rucaparib is contraindicated during breastfeeding.

    The manufacturer states that breastfeeding is contraindicated during treatment with rucaparib and for 2 weeks after the final dose of rucaparib. At the time of writing it is unknown whether rucaparib or its metabolites is excreted in human breast milk. A risk to neonates and infants cannot be excluded.

    Side Effects

    Abdominal pain
    Acute myeloid leukaemia
    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Decreased appetite
    Febrile neutropenia
    Impaired memory
    Increase of liver transaminases
    Maculopapular rash
    Myelodysplastic syndrome
    Palmar-Plantar Erythrodysaesthesia syndrome
    Serum creatinine increased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2019

    Reference Sources

    Summary of Product Characteristics: Rubraca 200mg film-coated tablets. Clovis Oncology UK Ltd. Revised April 2019.

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