About the API
Palonosetron, the active ingredient of palonosetron hydrochloride, belongs to the class of substances termed antiemetics, which are used to treat nausea and vomiting.
There are two distinct types of CINV: acute, which occurs within 24 hours of initiation of chemotherapy and delayed, which begins afterwards and may continue for several days. Palonosetron is prescribed for both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy.
It is approved for acute CINV alone in patients receiving highly emetogenic chemotherapy, or in children from the age of one month to less than 17 years. It is the first such treatment approved for use in ages one to six months. For treatment of PONV, palonosetron may be used during the first 24 hours following surgery.
Palonosetron was approved by the FDA in 2003 and by the EMA in 2005. An oral formulation was approved by the FDA in 2008, but is no longer marketed. It is produced through a multi-step chemical process.