Palonosetron

What it is and how it works

Mechanism of Action Palonosetron is a 5-HT 3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT 3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema.

Indications

Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ( 1 .1) Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy Chemotherapy-Induced Nausea and Vomiting in Adults Palonosetron Hydrochloride Injection is indicated for: Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses Highly emetogenic cancer chemotherapy -- prevention o…

Dosage and administration (summary)

Chemotherapy-Induced Nausea and Vomiting *Note different dosing units in pediatrics Age Dose* Infusion Time Adults 0 . 2 5 mg x 1 Infuse over 30 seconds beginning approx. 30 min before the start of chemo Pediatrics (1 month to less than 17 years) 2 0 micrograms per k ilogram (max 1.5 mg) x 1 Infuse over 15 minutes beginning approx. 30 min before the start of chemo Postoperative Nausea and Vomiting Adult Dosage: a single 0.075 mg intravenous dose administered over 10 seconds immediately before the induction of anesthesia. Recommended Dosing Chemotherapy-Induced Nausea and Vomiting *Note different dosing units in pediatrics Age Dose* Infusion Time Adults 0 .

Contraindications

Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [ see Adverse Reactions ]. Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components

Warnings and precautions

Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT 3 receptor antagonists Serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs Hypersensitivity Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT 3 receptor antagonists. Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists.

Pregnancy

Pregnancy Pregnancy Category B Risk Summary Adequate and well controlled studies with Palonosetron Hydrochloride Injection have not been conducted in pregnant women. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1894…

Storage and supply

69097-927-35, Palonosetron Hydrochloride Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton. Storage Store at controlled temperature of 20–25°C (68°F–77°F). Excursions permitted to 15–30°C (59-86°F). Protect from freezing. Protect from light.

Source: Palonosetron Hydrochloride (Palonosetron Hydrochloride) — US FDA prescribing information, 2022-01-13, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.