Palonosetron Injection (Palonosetron Hydrochloride)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg intravenously once, over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously once, over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration to patients expected to have a low likelihood of postoperative nausea and vomiting is not recommended. Administration of this product is recommended for patients in whom postoperative nausea and vomiting must be avoided, even if the likelihood of postoperative nausea and vomiting is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, administer 0.075 mg intravenously once, over at least 10 seconds. 3. No dose adjustment is required for elderly patients or patients with hepatic or renal impairment. There are no clinical data for patients with end-stage renal disease undergoing dialysis. Do not mix this product with other medicinal products. Flush the infusion line with normal saline before and after administration of this product.

Child administration

2. Pediatric patients (2 months and older) 1) Prevention of acute nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.02mg/kg (maximum 1.5mg) by intravenous infusion once, over at least 15 minutes, 30 minutes before the start of chemotherapy. The safety and efficacy of this product in neonates have not been established (no data are available). Data on the use of this product for the prevention of nausea and vomiting induced by anticancer chemotherapy in infants (under 24 months) are limited.

This medication should not be used in patients with a known allergy to it or any of its ingredients. Patients who have had allergic reactions to similar medications should also exercise caution when using this product. Since this medication may slow down intestinal movement, patients with constipation or symptoms of bowel obstruction should be closely monitored while using it. Patients taking other serotonergic agents should be cautious as serious side effects such as serotonin syndrome may occur with this medication. This medication is used to prevent or treat nausea and vomiting caused by chemotherapy, and side effects like headache, constipation, diarrhea, dizziness, and fatigue may appear after administration. Various adverse reactions, such as cardiovascular issues, skin rashes, gastrointestinal symptoms, and liver function changes, have been reported, and patients should inform healthcare professionals if such symptoms occur. Caution should be used while driving or operating machinery as dizziness or drowsiness may occur. When used with other medications that can prolong the QT interval, the risk of cardiac-related side effects may increase, so careful use is warranted. Pregnant women should only use this medication when absolutely necessary, and nursing mothers should consult with a specialist prior to use due to the potential for the drug to pass into breast milk. Special caution is warranted for use in children and the elderly, as safety and efficacy have not been fully established. In the case of overdose, there are no specific antidotes, and supportive treatment based on symptoms is required; this product should be stored avoiding freezing, direct sunlight, and kept at room temperature. Before administration, check for any discolorations or foreign substances in the solution; any remaining solution after opening should be discarded.

• headache
• constipation
• diarrhea
• dizziness
• fatigue
• abdominal pain
• insomnia
• severe constipation
• non-sustained tachycardia
• bradycardia

This product should be stored at room temperature between 1 to 30 degrees Celsius and placed in a sealed container to prevent air ingress. It is also advisable to store it in a dark place to avoid direct sunlight.

Appearance

A colorless and transparent solution contained in a colorless and transparent prefilled syringe

Package unit

1.5mL x 5 prefilled syringes, 5mL x 1 prefilled syringe