Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Clovis Oncology Ireland Ltd., Regus Dublin Airport, Skybridge House Dublin Airport, Swords, County Dublin, K67 P6K2, Ireland
Rubraca 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.
Rubraca 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.
Treatment with rucaparib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
There is no requirement for BRCA testing prior to using Rubraca for the maintenance treatment of adult patients with relapsed high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) who are in a complete or partial response to platinum-based chemotherapy.
Before taking Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC, patients must have confirmation of deleterious germline or somatic mutations in the breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene using a validated test.
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 Rubraca no later than 8 weeks after completion of their final dose of the platinum containing regimen.
If a patient vomits after taking Rubraca, the patient should not retake the dose and should take the next scheduled dose.
If a dose is missed, the patient should resume taking Rubraca 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 (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 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 |
No adjustment is recommended to the starting dose for elderly patients (≥65 years of age) (see sections 4.8 and 5.2). 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.
No starting dose adjustment is required in patients with mild hepatic impairment (see section 5.2). There are limited clinical data in patients with moderate or severe hepatic impairment (ie, any total bilirubin greater than 1.5 times ULN), therefore rucaparib is not recommended for use in patients with moderate or severe hepatic impairment.
No starting dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2). There are no clinical data in patients with severe renal impairment (CLcr less than 30 mL/min), therefore rucaparib is not recommended for use in patients with severe renal impairment. Rucaparib may only be used in patients with severe renal impairment if the potential benefit outweighs the risk. Patients with moderate or severe renal impairment should be carefully monitored for renal function and adverse reactions.
The safety and efficacy of Rubraca in children or adolescents aged less than 18 years have not been established. No data are available.
Rubraca is for oral use and can be taken with or without food. The doses should be taken approximately 12 hours apart. See section 5.2.
There is no specific treatment in the event of Rubraca overdose, and symptoms of overdose are not established. In the event of suspected overdose, physicians should follow general supportive measures and should treat symptomatically.
Shelf life: 4 years.
This medicinal product does not require any special storage conditions.
HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets. Each carton contains one bottle.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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