Palonosetron Hydrochloride Injection

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg by intravenous injection over at least 30 seconds as a single dose 30 minutes before the start of chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg by intravenous injection over at least 10 seconds as a single dose 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. This medicine is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the likelihood of its occurrence is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, administer 0.075 mg by intravenous injection over at least 10 seconds as a single dose. 3. No dose adjustment is necessary for elderly patients or patients with hepatic or renal impairment. No clinical data are available for patients with end-stage renal disease receiving dialysis. This medicine must not be mixed with other medicines. Flush the infusion line with normal saline before and after administering this medicine.

Child administration

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

This drug should not be used in patients with known allergic reactions to this drug or its components. Patients who have had allergic reactions to similar types of medications should exercise caution when using this drug. This drug may slow intestinal motility; therefore, close observation is necessary in patients with constipation or symptoms of intestinal obstruction. Patients currently taking other serotonin-related medications should be cautious as the risk of serotonin syndrome, a serious side effect, may arise when used together with this drug. When using this drug, side effects such as headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, and insomnia may occur. Especially in patients receiving chemotherapy, side effects such as abnormal heart rhythms, skin rashes, abnormalities in the eyes and ears, dyspepsia, and general weakness have been reported when this drug is administered. It is also used to prevent postoperative nausea and vomiting, in which case side effects such as ECG abnormalities, bradycardia, headaches, and constipation may occur. This drug can cause dizziness, drowsiness, and fatigue; care should be taken when driving or operating machinery. Patients at risk for QT interval prolongation or those who will be used together with medications that can prolong the QT interval should be closely monitored. Pregnant women should only use this drug when absolutely necessary, and nursing women should consult with experts before use as the medication may be transmitted through breast milk. It can also be used in children and the elderly, but safety and effectiveness in children have not been fully established, while elderly patients may use it without specific dosage adjustments. In case of overdose, as there are no specific antidotes, supportive treatment based on symptoms is necessary, and dialysis is not effective. This drug is sensitive to light and heat, so it must be stored in a sealed container that prevents air exposure, away from direct sunlight, at room temperature. Before use, check for discoloration or foreign substances. Any remaining solution after use must be discarded, and the possibility of interactions with other drugs is low; however, caution is advised when using with other serotonergic drugs due to the potential for side effects.

• Headache
• constipation
• diarrhea
• dizziness
• fatigue
• abdominal pain
• insomnia
• non-persistent tachycardia
• bradycardia
• hypotension

This medication should be stored at room temperature between 1°C and 30°C, and in a sealed container to prevent air exposure. Also, it is important to store it in a place away from direct light to maintain its effectiveness.

Appearance

A colorless and transparent liquid in a colorless and transparent glass vial injection.

Package unit

5 vials of 1.5mL, 1 vial of 5mL