CYANOKIT Treatment for Cyanide Poisoning Now Available in 5g, Single-Vial Dose

CYANOKIT Treatment for Cyanide Poisoning Now Available in 5g, Single-Vial Dose

Press Release Oct 31, 2011

October 27, 2011

COLUMBIA, MD–Meridian Medical Technologies™, Inc., a Pfizer company, today announced the U.S. launch of a new single-vial dose of CYANOKIT® (hydroxocobalamin for injection) 5g. In this new presentation of CYANOKIT®, the entire starting dose of 5g hydroxocobalamin is now provided in a single vial, replacing the previous kit containing two, 2.5g vials. CYANOKIT® is approved by the U.S. Food and Drug Administration for the treatment of either known or suspected cyanide poisoning.[i]

“Cyanide may be found within the smoke of some closed-space fires and is an important factor in some deaths caused by smoke inhalation. Cyanide poisoning is a life-threatening situation requiring immediate medical attention. The ability of first responders to recognize symptoms and treat victims of known or suspected cyanide poisoning quickly and efficiently—meaning, on the scene—could mean the difference between life and death,” said Rob Schnepp[*], chief of special operations with the Alameda County (Calif.) Fire Department.

In addition to the full starting dose of CYANOKIT® 5g now contained in a single vial, the new packaging is more compact than the previous presentation.[2] The new dose also features a 20 percent greater shelf life (36 months from the date of formulation). CYANOKIT 5g is available for sale beginning this month.

“Meridian has a long history of supplying emergency care products to first responders and the medical community,” said Tom Handel, senior vice president of Commercial Pharmaceuticals for Meridian Medical Technologies, Inc. “Offering a new single-vial dose of CYANOKIT® is consistent with our company’s mission, as it will help streamline the administration process in a situation that requires an immediate response.”

About Cyanide Poisoning
Cyanide (CN) can be released by virtually any material containing carbon and nitrogen when burned under high temperature and low oxygen conditions.[ii],[iii] There is potential for CN toxicity due to the increased use of synthetic materials that produce CN during combustion in closed-space fires.2,3 Moderate to high concentrations of cyanide can cause severe injury and death within minutes.[iv]

Currently, there is no diagnostic test to confirm CN poisoning within the limited window for initiating potentially lifesaving intervention.2,3 In addition, CN poisoning can be difficult to differentiate with carbon monoxide (CO) poisoning due to common signs and symptoms.2
Because CN poisoning prevents cells from using oxygen (O2), signs and symptoms of CN poisoning also mimic those of O2 deprivation.[v]

CN poisoning should be suspected in smoke inhalation victims if the following manifestations are present[3]1,4:

  • Exposure to fire or smoke in an enclosed area
  • Soot around mouth, nose, or back of mouth
  • Altered mental status (e.g., confusion, disorientation)

About CYANOKIT®
CYANOKIT® is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT® is administered intravenously after being reconstituted with sodium chloride for injection. Hydroxocobalamin, the main component in CYANOKIT®, strongly binds the cyanide directly, forming a natural form of vitamin B12, cyanocobalamin, which is excreted in the urine.4

The starting dose of CYANOKIT® for adults is 5g, administered by intravenous infusion over 15 minutes. Depending upon the severity of the poisoning and the clinical response, a second dose of 5g may be administered by intravenous infusion for a total dose of 10g.

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CYANOKIT® was approved by the U.S. Food and Drug Administration in 2006. It has been generally well-tolerated, even in cases where cyanide poisoning is not present.

To learn more about CYANOKIT®, please visit www.CYANOKIT.com.

Indication
CYANOKIT® (hydroxocobalamin for injection) 5g for intravenous infusion is indicated for the treatment of known or suspected cyanide poisoning. If clinical suspicion of cyanide poisoning is high, CYANOKIT® should be administered without delay.

Important Safety Information
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure. Prior to administration of CYANOKIT®, smoke-inhalation victims should be assessed for: exposure to fire or smoke in an enclosed area; presence of soot around the mouth, nose, or oropharynx, and altered mental status. In addition to CYANOKIT®, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of any seizure activity.

Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, rash, and angioneurotic edema. Substantial increases in blood pressure may occur following CYANOKIT® therapy. Usage may interfere with some clinical laboratory evaluations. Also, because of its deep red color, hydroxocobalamin may cause hemodialysis machines to shut down due to an erroneous detection of a "blood leak." This should be considered before hemodialysis is initiated in patients treated with hydroxocobalamin. Due to potential photosensitivity, patients should avoid direct sun until erythema resolves.

CYANOKIT® is Pregnancy Category C and should be used during pregnancy only if the potential benefit justifies the potential risk. Safety and effectiveness of CYANOKIT® have not been established in pediatric patients. The most common adverse reactions (>5%) are transient and include chromaturia, erythema, rash (predominantly acneiform), increased blood pressure, nausea, headache, decreased lymphocyte percentage, and injection site reactions.

Please see full Prescribing Information for CYANOKIT® two 2.5g vials, or full Prescribing Information for CYANOKIT® 5g vial.

About Meridian
Meridian Medical Technologies™, Inc., has more than 50 years of experience creating specialized products for emergency responders and military personnel around the globe. Meridian’s antidotes are stocked by the U.S. Department of Defense, the U.S. Department of Homeland Security, emergency medical services personnel and more than 30 nations around the world. Designed to meet the unique needs of patients in emergency situations, Meridian’s auto-injectors allow for rapid administration of a specific dose of medication(s) and are appropriate for use in the pre-hospital setting. Meridian became a part of Pfizer’s Established Products business unit in March 2011, when Pfizer completed its acquisition of King Pharmaceuticals®, Inc., Meridian’s former parent company. Meridian’s executive offices are located in Columbia, Maryland. For more information, please call 1-800-638-8093.

About Pfizer
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

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