Route of Administration:
Dosage Form / Strength:
Each vial contains: 1 × 5 g powder for infusion
Final concentration after reconstitution is 25 mg/mL
Clinically Relevant Nonmedicinal Ingredients: For a complete listing see Dosage Forms, Composition and Packaging section of the Product Monograph.
INDICATIONS AND CLINICAL USE
Cyanokit contains hydroxocobalamin, an antidote indicated for the treatment of known or suspected cyanide poisoning.
Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Identifying patients with cyanide poisoning:
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide containing compounds, including smoke from closed space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogens, including cyanogenic plants, aliphatic nitriles, or prolonged exposure to sodium nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Cyanokit should be administered without delay.
WARNINGS AND PRECAUTIONS
Emergency Patient Management – 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. Consideration should be given to decontamination measures based on the route of exposure. Cyanokit does not substitute for oxygen therapy and must not delay the set up of the above measures.
Transient, generally asymptomatic, increase in blood pressure may occur in patients receiving hydroxocobalamin. The maximal increase in blood pressure has been observed toward the end of infusion.
Known hypersensitivity to hydroxocobalamin or vitamin B12 must be taken into benefit-risk consideration before administration of Cyanokit, since hypersensitivity reactions may occur in patients receiving hydroxocobalamin. Allergic reactions may include anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea and rash.
Based on its vasopressor effect, hydroxocobalamin may cause vasoconstriction of the renal vasculature. Calcium oxalate crystals have been observed in the urine of both healthy volunteers given hydroxocobalamin and patients treated with hydroxocobalamin following suspected cyanide poisoning. Cases of acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals present have been reported in patients treated with hydroxocobalamin following known or suspected cyanide poisoning. In some situations, hemodialysis was required to achieve recovery (see ADVERSE REACTIONS). Regular monitoring of renal function, including but not limited to blood urea nitrogen (BUN) and serum creatinine, should be performed for 7 days following Cyanokit therapy.
For Full Product Information, please review the Cyanokit Canadian Product Monograph.
Date of preparation: February 1, 2018