Active Ingredient: Rucaparib
Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 600 milligrams rucaparib, 2 times daily.
The recommended dose of rucaparib is 600 mg taken twice daily, equivalent to a total daily dose of 1 200 mg.
Patients should start the maintenance treatment with rucaparib no later than 8 weeks after completion of their final dose of the platinum containing regimen.
Patients can continue treatment until disease progression, unacceptable toxicity or completion of 2 years treatment.
Patients can continue treatment until disease progression or unacceptable toxicity.
If a patient vomits after taking rucaparib, the patient should not retake the dose and should take the next scheduled dose.
If a dose is missed, the patient should resume taking rucaparib with the next scheduled dose.
Adverse reactions may be managed through dose interruptions and/or dose reductions for moderate to severe reactions (i.e. CTCAE Grade 3 or 4) such as neutropenia, anaemia and thrombocytopenia.
Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient. Grade 1 to 3 elevations in AST/ALT can be managed without change to the rucaparib dose, or with treatment modification (interruption and/or dose reduction). Grade 4 reactions require treatment modification (see Table 2).
Other moderate to severe non-haematological adverse reactions such as nausea and vomiting, can be managed through dose interruption and/or reductions, if not adequately controlled by appropriate symptomatic management.
Table 1. Recommended dose adjustments:
| Dose reduction | Dose |
|---|---|
| Starting dose | 600 mg twice daily (two 300 mg tablets twice daily) |
| First dose reduction | 500 mg twice daily (two 250 mg tablets twice daily) |
| Second dose reduction | 400 mg twice daily (two 200 mg tablets twice daily) |
| Third dose reduction | 300 mg twice daily (one 300 mg tablet twice daily) |
Table 2. Management of Treatment-emergent AST/ALT Elevations:
| Grade of AST/ALT Elevation | Management |
|---|---|
| Grade 3 without other signs of liver dysfunction | Monitor LFTs weekly until resolution to Grade ≤ 2 Continue rucaparib provided bilirubin is < ULN and alkaline phosphatase is < 3 × ULN Interrupt treatment if AST/ALT levels do not decline within 2 weeks until Grade ≤ 2, then resume rucaparib at the same or at a reduced dose |
| Grade 4 | Interrupt rucaparib until values return to Grade ≤ 2; then resume rucaparib with a dose reduction and monitor LFTs weekly for 3 weeks |
No adjustment is recommended to the starting dose for elderly patients (≥65 years of age). Greater sensitivity of some elderly patients (≥65 years of age) to adverse events cannot be ruled out. There are limited clinical data in patients aged 75 or over.
The doses should be taken approximately 12 hours apart.
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