June 13, 2016

Allergan Pharmaceuticals, LLC Launches Cetylev™

Parkway Parsippany, NJ — Allergan Pharmaceuticals announced today the launch of Cetylev (acetylcysteine) effervescent tablets for oral solution, a new acetaminophen overdose antidote with a lemon-mint taste and smell.

Acetaminophen overdose is the most common form of poisoning reported to Poison Control Centers in the United States. According to the National Institute of Health, acetaminophen overdose sends 78,414 Americans to the hospital annually. Of those visits, 33,520 result in hospitalizations for acute liver failure. National mortality files show 458 deaths occur from acetaminophen poisoning.

Cetylev prevents and reduces injury to the liver after acute and chronic toxic acetaminophen ingestion. The effervescent tablets are simply dropped into water which dissolve into a pleasant lemon-mint flavored and scented oral solution. Currently, acetylcysteine solution is available in vials intended for inhalation which pharmacists typically mix with a diet cola for ingestion orally; a practice intended to mask the reported “rotten-egg” smell and taste. Another acetylcysteine treatment comes in an intravenous formulation.

"Allergan is very excited to offer Cetylev to emergency room physicians and clinical pharmacists. Cetylev is a new and palatable approach for treating acetaminophen overdose patients for possible fatal liver damage.” said Ed Schutter, President and CEO of Allergan. “Cetylev adds to our growing portfolio of 20 FDA approved branded and generic products that improve and save patient lives."

Cetylev is now commercially available to hospitals and being promoted by Allergan’s national Hospital Specialty Sales Team.

About Cetylev

Cetylev is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).

Important Safety Information

  • Hypersensitivity reactions, including generalized urticaria have been observed in patients receiving oral acetylcysteine for acetaminophen overdose. If hypersensitivity reactions occur, Cetylev should be discontinued unless it is deemed essential for patient management and the reactions can be otherwise controlled.
  • Risk of upper gastrointestinal hemorrhage may increase due to occasional severe and persistent vomiting as a symptom of acute acetaminophen overdose. Treatment with Cetylev may aggravate the vomiting and increase the risk of upper gastrointestinal hemorrhage in at risk patients (e.g., those with esophageal varices, peptic ulcers, etc.). Consider the risk/benefit for patients at risk of hemorrhage versus the risk of developing hepatic toxicity, and treat with Cetylev as needed.
  • Cetylev tablets contain sodium. Consider the total sodium content from dietary and non-dietary sources in patients who may be sensitive to excess sodium intake, such as those with congestive heart failure, hypertension, or renal impairment.
  • Acetaminophen and acetylcysteine cross the placenta. Delaying treatment in pregnant women with acetaminophen overdose and potentially toxic acetaminophen plasma levels may increase the risk of maternal and fetal morbidity and mortality.
  • There is no information regarding the presence of acetylcysteine in human milk, or the effects of acetylcysteine on the breastfed infant or on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cetylev and any potential adverse effects on the breastfed infant from Cetylev or from the underlying maternal condition.
  • Please refer to Cetylev Prescribing Information for Recommended Dosage and Preparation and Administration Instructions in Adults and Pediatrics for Acute Acetaminophen Ingestion. For assistance with specific Cetylev dosage and administration information for acute ingestion or specific Cetylev dosage and administration information in patients with RSI, consider contacting your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

Adverse Reactions

The most common adverse reactions were nausea, vomiting, other gastrointestinal symptoms, and rash with or without fever.

Please click here for the full Prescribing Information for Cetylev or call 1-866-516-4950.

About Allergan Pharmaceuticals

Allergan Pharmaceuticals, headquartered in Parkway Parsippany, NJ, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital and pediatric markets. The company has over 600 employees including 500 sales professionals promoting its products to physicians, hospitals, and pharmacists. Allergan currently markets 20 NDA or ANDA approved products with over 35 more in development. For more information regarding Allergan Pharmaceuticals or any of its products, visit www.Allerganpharm.com or send email inquiries to info@Allerganpharm.com.