Active Ingredient: Rucaparib
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.
Rucaparib is indicated as 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.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
1,200 - 1,200 mg
From 600 To 600 mg 2 time(s) per day every day
The recommended dose is 600 mg rucaparib taken twice daily, equivalent to a total daily dose of 1,200 mg, until disease progression or unacceptable toxicity.
For the maintenance treatment, patients should start the maintenance treatment with rucaparib no later than 8 weeks after completion of their final dose of the platinum containing regimen.
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 1-3 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 |
| First dose reduction | 500 mg twice daily |
| Second dose reduction | 400 mg twice daily |
| Third dose reduction | 300 mg 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 x 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. |
Rucaparib is for oral use and can be taken with or without food. The doses should be taken approximately 12 hours apart.
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