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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. Consideration should be given to use of alternative therapies, if available. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, and rash. Allergic reactions including angioneurotic edema have also been reported in postmarketing experience.
Substantial increases in blood pressure may occur following CYANOKIT therapy. Elevations in blood pressure (≥180 mmHg systolic
or ≥110 mmHg diastolic) were observed in approximately 18% of healthy subjects receiving hydroxocobalamin 5 g and 28% of subjects receiving 10 g.
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.
Please see single 5-g vial full Prescribing Information.
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