London, 29 March 2018 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), announces that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp. (West-Ward), has launched Palonosetron Hydrochloride (HCl) Injection, 0.25mg/2mL.
West-Ward’s Palonosetron HCI Injection is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for:
- Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses
- Highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses
According to IQVIA, US sales of Palonosetron HCI Injection were approximately $447 million in the 12 months ending January 2018.
Riad Mechlaoui, Chief Executive Officer, Injectables Division, said, “We are very pleased to add Palonosetron HCI Injection to our oncology portfolio. The launch of this product further expands our broad Injectables portfolio, bringing value to our customers and patients in the US hospital setting, as well as driving long-term, sustainable growth for our business.”
Important Safety Information
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be taken when administering Palonosetron Hydrochloride Injection:
- Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists.
- Serotonin syndrome has been reported with 5-HT3 receptor antagonists. Signs and symptoms include: mental status change, autonomic instability, neuromuscular symptoms, and seizures, with or without gastrointestinal symptoms. Inform patient of the increased risk.
Palonosetron HCl Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components. In clinical trials of palonosetron hydrochloride, the most common adverse reactions were headache, constipation, diarrhea, and dizziness.
Infrequent adverse reactions include, hypertension, myocardial ischemia, rash, hearing and vision irritation, diarrhea, dry mouth, fatigue, flu-like syndrome, asymptomatic increases in AST and/or ALT and bilirubin, hyperglycemia, anorexia, arthralgia, dizziness, insomnia, anxiety, urinary retention and vein discoloration.
Very rare cases of hypersensitivity reactions including anaphylaxis and anaphylactic shock and injection site reactions, including burning, induration, discomfort and pain, have been reported from post approval use.
Patient Counselling Information should be shared with the patient prior to administration. Patients should be advised to read the FDA-approved Patient Information.