NAPA, Calif. — Dey, L.P., a U.S. Affiliate of Merck KGaA of Darmstadt, Germany, today announced that Cyanokit(R) 5g (hydroxocobalamin for injection) ANTIDOTE is now commercially available in the United States. Cyanokit was approved by the United States Food and Drug administration in December 2006 for the treatment of known or suspected cyanide poisoning.
“The availability of Cyanokit marks an important step forward for emergency medicine,” said Christy Taylor, Executive Vice President of Sales, Marketing and Business Development, Dey, L.P. “Dey, L.P. and Merck KGaA believe that Cyanokit will have a noticeable and substantial effect on survival of people affected by cyanide poisoning from smoke inhalation and other sources, especially since Cyanokit can be used in both pre-hospital and hospital settings. Cyanokit also provides a new treatment resource for intentional release of cyanide, an identified potential chemical agent of opportunity for terrorism. We are glad to be a part of the evolving field of emergency medical care.”
Cyanokit’s mechanism of action makes possible the rapid initiation of treatment of cyanide poisoning in both pre-hospital and hospital settings. A common cause of cyanide exposure occurs through smoke inhalation, and quick response is critical. The favorable safety and efficacy profile of Cyanokit allows emergency health care professionals to administer the product to patients exhibiting signs and symptoms of cyanide poisoning at the scene of the exposure.
In addition to fire smoke, other causes of cyanide poisoning may include accidental or intentional ingestion or exposure during industrial accidents or a terrorist attack involving cyanide. Dey, L.P. will manage sales to hospitals and other emergency medical facilities through their own distribution network. Dey, L.P. has contracted with BoundTree Medical, (http://www.boundtree.com), the nation’s leading emergency medical products distributor, to provide Cyanokit to emergency medical service units, fire and police departments, and other pre-hospital service providers.
About Cyanokit
The active ingredient in Cyanokit, hydroxocobalamin, is a precursor of vitamin B12. Hydroxocobalamin works by binding directly to the cyanide ions, creating cyanocobalamin, a natural form of vitamin B12, which is excreted in the urine.
Advantages of this approach are that methemoglobin is not produced and the oxygen-carrying capacity of the victim’s blood is not lowered. Therefore, Cyanokit is suitable for use in smoke inhalation victims. The most common adverse reactions seen in clinical trials of hydroxocobalamin with healthy human subjects are transient and include: reddish discoloration of the skin and urine, rash, increased blood pressure, nausea, headache, decreased white blood cell count and injection site reactions. Allergic reactions have been observed. Usage may interfere with some clinical laboratory evaluations.
The initial dose of Cyanokit for adults is 5 g, administered by intravenous infusion. Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered up to a total dose of 10 g.
For full prescribing information, please contact 1-800-429-7751 x 3368 or visit http://www.dey.com/Pressroom/Cyanokit_PI.pdf
Important Safety Information
Cyanokit(R) 5 g (hydroxocobalamin for injection) ANTIDOTE is indicated for the treatment of known or suspected cyanide poisoning.
Most common adverse reactions (>5%) are transient and include chromaturia (red-colored urine), erythema (skin redness), rash, increased blood pressure, nausea, headache, decreased lymphocyte percent, and injection site reactions. Allergic reactions have been observed. Usage may interfere with some clinical laboratory evaluations.
About Dey, L.P.
A U.S. Affiliate of Merck KGaA of Darmstadt, Germany, Dey, L.P. develops, manufactures, and markets innovative airway, allergy and emergency medications that save and improve lives. The Company puts “patients first” through integrated healthcare delivery solutions, and facilitates efficient, cost- effective partnerships with its customers. DEY(R) is committed to investing in its employees and the communities in which they live. Additional information about Dey, L.P. is available at http://www.dey.com.