帕洛诺司琼胶囊的不良反应有哪些?

Palonosetron capsules are indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of cancer chemotherapy (including but not limited to highly emetogenic chemotherapy) in adults in combination with dexamethasone. Palonosetron capsules are a compound preparation of Palonosetron and Netupitant: Palonosetron can prevent nausea and vomiting in the acute phase after cancer chemotherapy, and Netupitant can prevent nausea and vomiting in the acute and delayed phases after cancer chemotherapy.

In clinical trials, the overall safety of palonosetron capsules was evaluated in 1,538 cancer patients and healthy subjects. The data below reflect exposure to palonosetron in 1169 cancer patients who received at least one cycle of cancer chemotherapy from 3 active controlled trials, with 782 patients exposed to at least 4 cycles of palonosetron and 321 patients exposed to at least 6 and up to 12 cycles of chemotherapy.

The median age was 55 years, 79% were female, 83% were white, 13% were Asian, and 4% were Hispanic. All patients received a single oral dose of palonosetron 1 hour before the start of each chemotherapy cycle. In all studies, dexamethasone was administered with palonosetron.

Cisplatin-based highly pathogenic chemotherapy

In a single-cycle study of patients receiving highly emetogenic cisplatin-based chemotherapy, 136 patients received palonosetron. Table 1 shows adverse reactions with an incidence of at least 3% and with a greater incidence of palonosetron than palonosetron alone.

Table 1: Adverse reactions occurring in ≥3% of cancer patients receiving palonosetron

Highly pathogenic chemotherapy capsules containing cisplatin (cycle 1)

Anthracycline- and cyclophosphamide-based chemotherapy

In a study of patients receiving anthracycline- and cyclophosphamide-based chemotherapy, 725 patients received palonosetron capsules in cycle 1, and 635 patients continued treatment for up to 8 cycles in a multicycle extension. Table 2 shows adverse reactions with a reported incidence of at least 3% and with a greater incidence in the palonosetron capsule group than in the palonosetron monotherapy group in cycle 1. The adverse reaction profile in subsequent cycles was similar to that observed in Cycle 1.

Table 2: Adverse reactions occurring in ≥3% of cancer patients receiving palonosetron

Capsule- and anthracycline- and cyclophosphamide-based chemotherapy (cycle 1)

The above is the relevant content about the adverse reactions of palonosetron. For more details, please read the drug instructions. It is recommended to take medication according to the doctor's instructions and treat symptoms accordingly.

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