What are the precautions for Rucaparib?

In clinical studies of Rucaparib, patients may develop myelodysplastic syndrome/acute myeloid leukemia, embryo-fetal toxicity and other warnings and precautions.

1. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML): This may be a potentially fatal adverse reaction when patients are treated with rucapani. The duration of treatment with rucaparib ranged from <2 months to approximately 72 months before diagnosis of myelodysplastic syndrome/acute myeloid leukemia. These cases are typical of secondary MDS/cancer therapy-related AML. In all cases, the patients had received prior platinum-containing chemotherapy regimens and/or other DNA-damaging agents.

Do not initiate rucaparib until the patient has recovered from hematologic toxicity (≤Grade 1) from prior chemotherapy. Monitor complete blood counts for cytopenias at baseline and for clinically significant changes monthly during treatment. For long-term hematologic toxicity (>4 weeks), interrupt rucaparib or reduce the dose according to instructions and monitor blood counts weekly until resolution. If levels have not returned to Grade 1 or lower after 4 weeks, or if MDS/AML is suspected, tests such as bone marrow analysis and cytogenetic blood samples should be performed. If MDS/AML is confirmed, discontinue rucaparib.

2. Embryo-Fetal Toxicity: According to the mechanism of action of rucapanib and the results of animal studies, pregnant women taking rucapanib may cause harm to the fetus. In an animal reproduction study, rucapanib resulted in embryonic-fetal lethality when administered to pregnant rats during the period of organogenesis at an exposure that was 0.04 times the 0-24 hour AUC in patients receiving the recommended human dose of 600 mg twice daily.

Inform pregnant women of potential risks to the fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 6 months after the last dose of rucaparib. Based on the results of genotoxicity and animal reproduction studies, it is recommended that male patients with a female partner of reproductive potential or who are pregnant use effective contraception during treatment and for 3 months after the last dose of rucaparib.

The original drug Rucapani has not yet been marketed in the country, so it has not entered the medical insurance coverage standards. The European version of rucapani original drug, specifications300mg*60 tablets sold overseas may cost more than 20,000 yuan per box (the price may fluctuate due to exchange rate effects), which is relatively expensive. There are also cheap rucapani generic drugs available overseas, and their drug ingredients are basically the same as those of the original rucapani drug. For example, the price of 300mg*60 tablets produced by BDR Pharmaceuticals in India may be more than 6,000 yuan per box (the price may fluctuate due to the exchange rate). For more drug information and specific prices, please consult a medical consultant.