Avenacy debuts generic Aloxi
Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, has launched palonosetron hydrochloride injection, which is a generic of Eisai’s Aloxi.
Palonosetron hydrochloride injection is indicated as an antiemetic.
Avenacy's palonosetron hydrochloride injection is available in 0.25 mg/5 mL (0.05 mg per mL) single-dose vials.
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The company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards, Avenacy said.
Palonosetron hydrochloride injection had a market value of approximately $20 million for the 12 months ending in June 2023, per IQVIA.
Approved indications:
For Adult Use:
Palonosetron hydrochloride injection is indicated in adults for prevention of:
- Acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy,
- Acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy,
- Postoperative nausea and vomiting for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.
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For Pediatric Use:
- Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:
- Acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.