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.

CYANOKIT FAQs

1. What is CYANOKIT?
CYANOKIT contains hydroxocobalamin, an antidote indicated for the treatment of known or suspected cyanide poisoning. The active ingredient in CYANOKIT is hydroxocobalamin, the hydroxylated active form of vitamin B12. Learn more about CYANOKIT.1

2. How long has CYANOKIT been available?
CYANOKIT was FDA approved in the United States in 2006. CYANOKIT has been formally licensed in France since 1996 to treat known or suspected cyanide poisoning. Marketing authorization was granted throughout the European Union in 2007.6,7,11

3. How is CYANOKIT dosed and administered?
The initial dose of CYANOKIT for adults is 5 g. It is administered by IV infusion over 15 minutes. Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered by IV infusion up to a total dose of 10 g. The rate of infusion for a potential second dose may range from 15 minutes (for patients in extremis) to 2 hours, as clinically indicated. Learn more about CYANOKIT preparation and administration.1

4. What is the mechanism of action of CYANOKIT?
CYANOKIT contains the active ingredient hydroxocobalamin, which detoxifies cyanide through the irreversible formation of cyanocobalamin (a form of vitamin B12) that is excreted from the body. Learn more about the CYANOKIT mechanism of action.1,6

5. How is CYANOKIT packaged?
CYANOKIT contains one colorless 250-mL glass vial, containing 5 g dark red lyophilized hydroxocobalamin, pH adjusted with hydrochloric acid, one transfer spike, one intravenous administration set, one quick-use reference guide, and one package insert. Diluent is not included.1

6. What are the most common adverse reactions with CYANOKIT?
Most common adverse reactions (>5%) included transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache, and infusion site reactions.1

Please see Important Safety Information below and full Prescribing Information for more detail.

7. When would a patient be administered CYANOKIT?
Timely intervention for acute cyanide poisoning often requires that an antidote be given in the prehospital or hospital setting on the basis of a presumptive diagnosis. CYANOKIT 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.1,12

8. Can CYANOKIT be given to pregnant patients?
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.1

9. Have the safety and effectiveness of CYANOKIT been established in pediatric patients?
The safety and effectiveness of CYANOKIT have not been established in this population.1

Please see Important Safety Information below and full Prescribing Information for more detail.

Cyanide Poisoning FAQs

1. What are the potential sources of cyanide poisoning?
Fire smoke—cyanide can be released by virtually any material containing carbon and nitrogen when burned under high temperature and low oxygen conditions. It is frequently found in the smoke of closed-space fires. Learn more about a toxin in closed-space fire smoke.13

Industrial exposure—cyanide is also widely used in many industries primarily as an intermediary in industrial processes. The frequent use of cyanide by industry increases the potential for accidental exposure.14

Terrorist attack—because cyanide is readily available and does not require special skills for effective deployment, it has the potential for use as a terrorist weapon.14

2. What are the potential effects of cyanide poisoning?
Cyanide is an extremely toxic poison. In the absence of rapid and adequate treatment, exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration.1

Cyanide poisoning may also cause central nervous system side effects, including intellectual impairment, parkinsonism, and personality changes.9

3. How can a cyanide poisoning diagnosis quickly be confirmed?
Currently there is no rapid test to confirm cyanide poisoning within the limited window necessary for initiating potential lifesaving treatment. Find out more about recognizing the signs and symptoms of cyanide poisoning.3
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.