Palonosetron Injection (Palonosetron Hydrochloride)

Adult administration

1) Prevention of nausea and vomiting induced by cancer 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 to patients expected to have a low likelihood of postoperative nausea and vomiting is not recommended. Administration of this medicine is recommended for patients in whom postoperative nausea and vomiting should 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. No dose adjustment is required for older adults or patients with hepatic or renal impairment. There are no clinical data in patients with end-stage renal disease undergoing dialysis. This medicine must not be mixed with other medicines. Flush the infusion line with normal saline before and after administration of this medicine.

Child administration

Children (2 months and older) 1) Prevention of acute nausea and vomiting induced by cancer 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 medicine in neonates have not been established (no data are available). Data on the use of this medicine for the prevention of nausea and vomiting induced by cancer chemotherapy in infants (younger than 24 months) are limited.

This medication should not be used in patients who have allergic reactions to this drug or its components. Caution is warranted when administering this drug to patients who have had allergic reactions to similar medications. This drug may slow intestinal motility, so patients with constipation or symptoms of bowel obstruction should be closely monitored. Additionally, patients taking serotonergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) are at risk for serotonin syndrome and should be monitored carefully. This medication is used to prevent or treat nausea and vomiting caused by chemotherapy, and side effects may include headache, constipation, diarrhea, dizziness, and fatigue. Rare cardiovascular adverse reactions such as arrhythmia and blood pressure changes have been reported, but their direct association with this drug is not clear. It should only be used during pregnancy when absolutely necessary, and in lactating women, the possibility of the drug being excreted in breast milk should be discussed with a healthcare professional before administration. Dizziness, drowsiness, and fatigue may occur, necessitating caution when driving or operating machinery. In the event of overdose, since there is no specific antidote, supportive treatment based on symptoms is crucial. This drug should be stored away from light and cold, at room temperature, and any discoloration or particles should be checked before administration. Any remaining solution after administration should be discarded, and safety and efficacy should be considered when administering to children or the elderly.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature, and it is advisable to store it away from direct sunlight or strong light to preserve its effectiveness.

Appearance

A colorless and transparent liquid in a colorless and transparent pre-filled syringe

Package unit

1.5mL x 5 pre-filled syringes 5mL x 1 pre-filled syringe