Usual Adult Dose for Ovarian Cancer

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the maintenance treatment of patients with a deleterious BRCA (breast cancer gene) mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Fallopian Tube Cancer

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the maintenance treatment of patients with a deleterious BRCA (breast cancer gene) mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Peritoneal Cancer

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Uses: For the maintenance treatment of patients with a deleterious BRCA (breast cancer gene) mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Prostate Cancer

600 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• This indication was approved under accelerated approval based on objective response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trials.
• Selection of patients for treatment should be based on a US FDA-approved companion diagnostic for this drug.
• Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl between 30 and 89 mL/min): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Data not available

Comments:

• CrCl as estimated by the Cockcroft-Gault method

Liver Dose Adjustments

Mild to moderate liver dysfunction (total bilirubin up to 3 times the upper limit of normal [3 x ULN] or AST greater than ULN): No adjustment recommended
Severe liver dysfunction (total bilirubin greater than 3 x ULN and any AST): Data not available

Dose Adjustments

Interruption of therapy or dose reduction should be considered to manage adverse reactions.

Recommended Dose Reductions:

• Starting dose: 600 mg orally twice a day
• First dose reduction: 500 mg orally twice a day
• Second dose reduction: 400 mg orally twice a day
• Third dose reduction: 300 mg orally twice a day

• This drug should not be started until patients have recovered from hematological toxicity caused by previous chemotherapy (grade 1 or less).
• For prolonged hematological toxicities (greater than 4 weeks): This drug should be interrupted or the dose should be reduced as recommended above; blood counts should be monitored weekly until recovery.
• If levels have not recovered to grade 1 or less after 4 weeks of if myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) is suspected: Patients should be referred to a hematologist for further investigations (including bone marrow analysis and blood sample for cytogenetics).
• If MDS/AML is confirmed: This drug should be discontinued.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Select patients for maintenance treatment of recurrent ovarian cancer based on the presence of a deleterious BRCA mutation (germline and/or somatic).
• A US FDA-approved test for the detection of deleterious germline and/or somatic BRCA mutations is not currently available.
• Select patients for the treatment of mCRPC based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma specimens.
• A negative result from a plasma specimen does not mean that the patient's tumor is negative for BRCA mutations.
• If the plasma specimen has a negative result, consider performing further genomic testing using tumor specimens as clinically indicated.
• Administer with or without food.
• Administer doses about 12 hours apart.

• Store at 20C to 25C (68C to 77F); excursions permitted to 15C to 30C (59F to 86F).

• For information on US FDA-approved tests for detection of a BRCA mutation in patients with ovarian cancer or with prostate cancer: www.fda.gov/CompanionDiagnostics

• Hematologic: CBC for cytopenia (at baseline) and for clinically significant changes (monthly thereafter during therapy)

• Read the US FDA-approved patient labeling (Patient Information).
• Contact health care provider if you experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine/stool, laboratory findings of low blood cell counts, or a need for blood transfusions.
• Patients of childbearing potential: Inform health care provider if you are pregnant or become pregnant; use effective contraception during therapy and for 6 months after the last dose.
• Male patients with female partners of childbearing potential or who are pregnant: Use effective contraception during therapy and for 3 months after the last dose.
• Male patients: Do not donate sperm during therapy and for 3 months after the last dose.
• Use appropriate sun protection because the susceptibility to sunburn is increased during therapy.
• Do not breastfeed during therapy and for 2 weeks after the last dose.
• If a dose is missed or vomiting occurs after taking a dose, do not take an extra dose; take the next dose at the regular time.

Frequently asked questions

• What type of cancer is Rubraca used to treat?