Paloxi Injection (Palonosetron Hydrochloride)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg as a single intravenous injection over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg as a single intravenous injection over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended in patients expected to have a low likelihood of postoperative nausea and vomiting. Administration of this drug 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: Administer 0.075 mg as a single intravenous injection over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose adjustment is necessary for elderly patients or patients with hepatic or renal impairment. There are no clinical data for patients with end-stage renal disease undergoing dialysis. This drug must not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of this drug.

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) as a single intravenous infusion over at least 15 minutes, 30 minutes before the start of chemotherapy. The safety and efficacy of this drug in neonates have not been established (no data are available). Data on the use of this drug for the prevention of nausea and vomiting induced by anticancer chemotherapy in infants (under 24 months) are limited.

This drug should not be used in patients who are allergic to this drug or its components. Patients who have had allergic reactions to similar drugs should exercise caution when using this medication. This drug may slow intestinal movement, and therefore patients with constipation or symptoms of bowel obstruction should be monitored closely while using it. Patients taking other serotonergic drugs may need careful monitoring as this drug can cause side effects like serotonin syndrome. This medication is used to prevent or treat nausea and vomiting caused by chemotherapy, and side effects such as headaches, constipation, diarrhea, dizziness, and fatigue may occur. Cardiovascular adverse reactions may rarely include arrhythmias or changes in blood pressure, so patients with heart diseases should exercise caution. When used for the prevention of postoperative nausea and vomiting, side effects such as headaches, constipation, dizziness may also occur, and the side effects may worsen if used in conjunction with other medications such as anesthetics. This drug can cause dizziness, drowsiness, and fatigue, so care should be taken when driving or operating machinery. Caution should be exercised when combined with drugs that can prolong the QT interval, as this may lead to cardiac rhythm abnormalities. Pregnant women should consult with a doctor before use and only use it if absolutely necessary, while breastfeeding women should consult with an expert as this drug may be transmitted through breast milk and determine whether to discontinue nursing. Caution is necessary for children and the elderly as safety and efficacy have not been sufficiently established. In case of overdose, as there is no specific antidote, immediate consultation with medical personnel is essential for appropriate treatment. This drug should be stored away from direct sunlight and at room temperature, and discoloration or the presence of foreign substances should be checked before administration. Any remaining solution after use should be discarded, and various cases of side effects have been reported in clinical trials and post-marketing surveys; if any abnormal symptoms occur, medical personnel should be notified immediately.

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

This medication should be stored at room temperature between 1 and 30 degrees Celsius, contained in a sealed container to prevent air ingress. It is also important to store it away from direct sunlight.

Appearance

A colorless, transparent liquid in a colorless, transparent prefilled syringe

Package unit

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