Palonosetron Hydrochloride Injection

Palonosetron is a selective antagonist of the 5-HT3 receptor with strong affinity, and has no affinity or low affinity for other receptors. The 5-HT3 receptor is located in the central and peripheral vagus nerve endings of the emetic chemotherapy receptor area in the medulla oblongata. Chemotherapy drugs stimulate the release of 5-HT by chromaffin cells in the small intestine, and 5-HT then activates the 5-HT3 receptors of the vagal afferent nerves, producing a vomiting reflex.

The main ingredient of this product is palonosetron hydrochloride, chemical name: 2-[1-azabicyclo[2,2,2]oct-3S-yl]-2,3,3aS,4,5,6-hexahydro-1H-benzo[de]isoquinolin-1-one hydrochloride.

This product is a colorless clear liquid.

1. Prevent acute nausea and vomiting caused by highly emetogenic chemotherapy. 2. Prevent nausea and vomiting caused by moderately emetogenic chemotherapy.

The recommended dose is a single intravenous injection of 0.25 mg of palonosetron about 30 minutes before chemotherapy, with an injection time of more than 30 seconds. Since the safety and effectiveness of frequent (daily continuous or alternate day) dosing have not been evaluated, repeated use within 7 days is not recommended.

According to foreign clinical research reports: 1,374 adult patients participated in a clinical study of palonosetron to prevent nausea and vomiting caused by moderate or highly emetogenic chemotherapy. The results showed that the incidence and severity of adverse reactions caused by palonosetron were similar to those of ondansetron or dolasetron.

Contraindicated in patients with known hypersensitivity to the drug or any of its components.

Precautions for children: The safety and efficacy of this product for patients under 18 years of age have not been determined by research and are not recommended. Precautions for pregnancy and lactation: No adequate randomized controlled clinical trials have been conducted in pregnant women, and no pregnant or laboring women have used palonosetron. Therefore, its effects on the mother and fetus are unclear, so this product should be used with caution during pregnancy. It is not clear whether palonosetron is secreted through breast milk. Given that most drugs are excreted through human breast milk, they have potential serious adverse reactions to infants, and potential carcinogenicity has been found in rat carcinogenicity studies. Therefore, the necessity of using the drug should be fully considered before deciding whether to stop breastfeeding or stopping the drug. Precautions for the elderly: According to literature reports: In clinical studies of 1,374 adult cancer patients with palonosetron, 316 (23%) were ≥65 years old and 71 (5%) were ≥75 years old. Except for some elderly individuals who are more sensitive, there is no difference in the safety and efficacy of palonosetron in elderly patients and young patients. Therefore, no dosage adjustment or special monitoring is required for the use of palonosetron in elderly patients.

Palonosetron is eliminated in vivo through two pathways: renal excretion and metabolism involving multiple CYP enzymes. Further in vitro studies have shown that palonosetron is neither an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4/5 (CYP2C19 has not been studied), nor does it induce the activity of CYP1A2, CYP2D6, or CYP3A4/5. Therefore, the possibility of significant clinical drug interactions with palonosetron is low. In a study in which healthy volunteers were given a single intravenous dose of 0.75 mg palonosetron and oral metoclopramide (10 mg four times a day) during the stable period, no significant pharmacokinetic effects were found. Clinical studies have shown that palonosetron can be safely used with corticosteroids, analgesics, antiemetics, antispasmodics, and anticholinergics. Studies in mouse tumor models showed that palonosetron did not inhibit the antitumor activity of the five chemotherapeutic drugs studied (cisplatin, cyclophosphamide, cytarabine, doxorubicin, and mitomycin C).

Store in a sealed container at room temperature (10~30℃), away from light and freezing.

5ml:0.25mg

24 months

Hangzhou Jiuyuan Genetic Biopharmaceutical Co., Ltd.

• Founded in:

  1993-12-31

• Address:

  No. 23, No. 8 Street, Baiyang Street, Qiantang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100609130315G

• Registered Funds:

  245.3988 million yuan

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