Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has announced that a new presentation of Cyanokit® 5 g (hydroxocobalamin) has been approved by the U.S. Food and Drug Administration (FDA). In the US, Cyanokit® is currently available in a kit comprising two 2.5 g vials as the starting dose that totals 5 g hydroxocobalamin. The new presentation contains the initial antidote dose of 5 g hydroxocobalamin in a single vial.

"The survival of a smoke inhalation victim with cyanide poisoning is highly related to the speed at which he/she receives the antidote", said Dr. Bernhard Kirschbaum, Executive Vice President Global Research and Development at Merck Serono. "As the initial dose required in the adult treatment is 5 g, we believe that emergency healthcare professionals will gain a significant amount of time to treat people who need immediate care, particularly when treating more than one patient."

Cyanokit® is indicated for the treatment of known or suspected cyanide poisoning. The drug is typically administered by fire and rescue crews at an emergency scene or in a hospital emergency room. It must be administered in conjunction with appropriate decontamination and supportive measures.

Cyanide poisoning commonly results from exposure to smoke produced from burning synthetic substances or natural materials such as cotton or paper in a closed environment. Additional causes may include accidental or intentional ingestion or exposure during industrial accidents or a terrorist attack involving cyanide.

In Europe, Cyanokit® is marketed by Merck Serono, with the exception of the Netherlands, Ireland, the United Kingdom and the Nordic and Baltic countries where the product is marketed by its partner Swedish Orphan Biovitrum. The new Cyanokit® 5 g presentation was approved in October 2010 by the European Medicines Agency (EMA).

In the US, Cyanokit® is commercialized through Merck Serono's partner Meridian Medical Technologies, Inc. that belongs to Pfizer Inc. The launch of Cyanokit® 5 g is planned towards end of 2011.

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 human subjects are transient and include: reddish discoloration of the skin, mucous membranes and urine, rash, increased blood pressure, nausea, vomiting, diarrhea, headache, and decreased white blood cell count and injection site reactions. Allergic reactions have been observed. Usage may interfere with some clinical laboratory evaluations.

The starting 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.

Merck Serono