Zofran Injection (Palonosetron Hydrochloride)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by chemotherapy: Administer a single dose of palonosetron 0.25 mg by intravenous injection over at least 30 seconds, 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer a single dose of 0.075 mg by intravenous injection over at least 10 seconds immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended for patients expected to have a low likelihood of developing 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 its occurrence is low. 3) Treatment of postoperative nausea and vomiting: Administer a single dose of 0.075 mg by intravenous injection over at least 10 seconds as soon as nausea and vomiting occur. 3. No dose adjustment is required for elderly patients or patients with hepatic or renal impairment. No clinical data are available 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 a single dose of palonosetron 0.02mg/kg (up to 1.5mg) by 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 to prevent nausea and vomiting induced by anticancer chemotherapy in infants (younger than 24 months) are limited.

This drug should not be administered to patients with hypersensitivity to this drug or any of its components. Patients who have shown hypersensitivity to other selective 5-HT3 receptor antagonists may also exhibit hypersensitivity to this drug, and caution is warranted. This drug can delay bowel transit time; therefore, patients with a history of constipation or symptoms of subacute bowel obstruction should be carefully monitored. Patients taking other serotonergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) may be at risk of serotonin syndrome and should be appropriately monitored. This drug is used for the prevention and treatment of nausea and vomiting, and side effects such as headache, constipation, diarrhea, dizziness, and fatigue may occur. Rare cardiovascular side effects include tachycardia, bradycardia, hypotension, arrhythmia, and QT interval prolongation, so patients with heart diseases should exercise caution. Skin reactions such as rash or allergic dermatitis, and itching may occur. For pregnant women, there is no evidence of teratogenicity in animal studies, but safety for use in pregnant women has not been established, and should only be used when absolutely necessary. Breastfeeding women should carefully decide whether to discontinue nursing, as this medication may be secreted in breast milk. Caution is needed when driving or operating machinery, as dizziness, drowsiness, and fatigue may occur. There are no known antidotes for overdose, so symptomatic supportive treatment should be provided, and dialysis is not effective. This drug should be stored at room temperature, avoiding freezing, and protected from light. Always check for particulate matter or discoloration before administration. Any remaining solution after opening should be discarded.

• Headache
• constipation
• diarrhea
• dizziness
• fatigue
• abdominal pain
• insomnia
• severe constipation
• nonsustained tachycardia
• bradycardia

This drug should be stored at room temperature between 1°C and 30°C, and it is important to keep it in a sealed container to prevent air ingress. It should also be stored in a dark place to protect it from light.

Appearance

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

Package unit

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