CYANOKIT is being distributed by BTG as of December 15, 2021. To order CYANOKIT, please click here.

The product information provided in this site is intended only for emergency personnel and healthcare professionals in the United States.
The products discussed herein may have different product labeling in different countries.

References

  1. CYANOKIT [package insert]. BTG International Inc.; 2021.
  2. Baud FJ, Borron SW, Mégarbane B, et al. Value of lactic acidosis in the assessment of the severity of acute cyanide poisoning. Crit Care Med. 2002;30(9):2044-2050.
  3. Eckstein M, Maniscalco PM. Focus on smoke inhalation–the most common cause of acute cyanide poisoning. Prehosp Disaster Med. 2006;21(2):s49-s55.
  4. Guidotti T. Acute cyanide poisoning in prehospital care: new challenges, new tools for intervention. Prehosp Disaster Med. 2005;21(2):s40-s48.
  5. Stevens J, El-Shammaa E. Carbon monoxide and cyanide poisoning in smoke inhalation victims. Relias Media website. https://www.reliasmedia.com/articles/16787-carbon-monoxide-and-cyanide-poisoning-in-smoke-inhalation-victims-a-review. Accessed July 20, 2021.
  6. Borron SW, Baud FJ, Barriot P, Imbert M, Bismuth C. Prospective study of hydroxocobalamin for acute cyanide poisoning in smoke inhalation. Ann Emerg Med. 2007;49(6):794-801.
  7. FDA Press Release. FDA approves drug to treat cyanide poisoning. US Food and Drug Administration. December 15, 2006.
  8. Borron SW, Baud FJ, Megarbane B, Bismuth C. Hydroxocobalamin for severe acute cyanide poisoning by ingestion or inhalation. Am J Emerg Med.2007;25(5):551-558.
  9. Lee-Chiong TL Jr. Smoke inhalation injury: when to suspect and how to treat. Postgrad Med. 1999;105(2):55-62.
  10. FEMA. Authorized equipment list. https://www.fema.gov/authorized-equipment-list-item/09ph-05-cobl. Accessed July 20, 2021.
  11. European Medicines Agency. EPAR summary for the public: Cyanokit. https://www.ema.europa.eu/en/documents/overview/cyanokit-epar-summary-public_en.pdf. Updated June 2015. Accessed July 20, 2021.
  12. Uhl W, Nolting A, Golor G, Rost KL, Kovar A. Safety of hydroxocobalamin in healthy volunteers in a randomized, placebo-controlled study. Clin Toxicol (Phila). 2006;44(suppl 1):17-28.
  13. Walsh DW, Eckstein M. Hydrogen cyanide in fire smoke: an underappreciated threat. Emerg Med Serv. 2004;33(10):160-163.
  14. Research Triangle Institute International. Cyanide: understanding the risk, enhancing preparedness. Clin Toxicol (Phila). 2006;44(suppl 1):S47-S63.
  15. Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325
INDICATION
CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.
Important Safety Information and Indication
WARNINGS AND PRECAUTIONS

Emergency Patient Management

  • In conjunction with CYANOKIT, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration should be given to decontamination measures based on the route of exposure.

Risk of Anaphylaxis and Other Hypersensitivity Reactions
  • Consider alternative therapies, if available, in patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin.
  • 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.

Risk of Renal Injury
  • Acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals have been reported following CYANOKIT therapy. Monitor renal function for 7 days following CYANOKIT therapy.

Risk of Increased Blood Pressure
  • Substantial increases in blood pressure may occur following CYANOKIT therapy. Monitor blood pressure during therapy.

Laboratory Tests
  • Because of its deep red color, hydroxocobalamin has been found to interfere with colorimetric determination of certain laboratory parameters (e.g., clinical chemistry, hematology, coagulation, and urine parameters). Be aware of this when reporting and interpreting laboratory results.
  • While determination of blood cyanide concentration is not required for management of cyanide poisoning and should not delay treatment with CYANOKIT, collecting a pretreatment blood sample may be useful for documenting cyanide poisoning as sampling post-CYANOKIT use may be inaccurate.

Clinical Methods
  • 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.

Photosensitivity
  • Hydroxocobalamin absorbs visible light in the UV spectrum. It therefore has potential to cause photosensitivity. While it is not known if the skin redness predisposes to photosensitivity, patients should be advised to avoid direct sun while their skin remains discolored.

Pregnancy and Lactation
  • Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes. There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning. In animal studies, hydroxocobalamin administered to pregnant rats and rabbits during the period of organogenesis caused skeletal and soft tissue abnormalities, including alterations in the central nervous system, at exposures similar to human exposures at the therapeutic dose.
  • Breastfeeding is not recommended during treatment with CYANOKIT.

ADVERSE REACTIONS
  • The most common adverse reactions (>5%) include transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache and infusion site reactions.

INDICATION

CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.
Important Safety Information and Indication
WARNINGS AND PRECAUTIONS

Emergency Patient Management

  • In conjunction with CYANOKIT, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration should be given to decontamination measures based on the route of exposure.

Risk of Anaphylaxis and Other Hypersensitivity Reactions
  • Consider alternative therapies, if available, in patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin.
  • 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.

Risk of Renal Injury
  • Acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals have been reported following CYANOKIT therapy. Monitor renal function for 7 days following CYANOKIT therapy.

Risk of Increased Blood Pressure
  • Substantial increases in blood pressure may occur following CYANOKIT therapy. Monitor blood pressure during therapy.

Laboratory Tests
  • Because of its deep red color, hydroxocobalamin has been found to interfere with colorimetric determination of certain laboratory parameters (e.g., clinical chemistry, hematology, coagulation, and urine parameters). Be aware of this when reporting and interpreting laboratory results.
  • While determination of blood cyanide concentration is not required for management of cyanide poisoning and should not delay treatment with CYANOKIT, collecting a pretreatment blood sample may be useful for documenting cyanide poisoning as sampling post-CYANOKIT use may be inaccurate.

Clinical Methods
  • 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.

Photosensitivity
  • Hydroxocobalamin absorbs visible light in the UV spectrum. It therefore has potential to cause photosensitivity. While it is not known if the skin redness predisposes to photosensitivity, patients should be advised to avoid direct sun while their skin remains discolored.

Pregnancy and Lactation
  • Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes. There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning. In animal studies, hydroxocobalamin administered to pregnant rats and rabbits during the period of organogenesis caused skeletal and soft tissue abnormalities, including alterations in the central nervous system, at exposures similar to human exposures at the therapeutic dose.
  • Breastfeeding is not recommended during treatment with CYANOKIT.

ADVERSE REACTIONS
  • The most common adverse reactions (>5%) include transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache and infusion site reactions.