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CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. Indication Important Safety Information Full Prescribing Information
CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. Indication Important Safety Information Full Prescribing Information
Firefighter Promise hero image
SERB STANDS WITH EMERGENCY RESPONDERS

Firefighter Promise™

The Firefighter Promise™ is SERB's pledge to support and partner with fire service agencies and other first responders in their commitment to public safety.

As a trusted partner to fire service agencies and first responders, SERB will replace CYANOKIT at no cost to the agency if administered pre-hospital, in the line of duty, for known or suspected cyanide poisoning.

How it works

After CYANOKIT is administered for known or suspected cyanide poisoning in the line of duty to a firefighter, police officer, or EMS:

What You Need to Do
Contact SERB
  • Request the Program Request Form/Letter of Affiliation (LOA) by emailing: BTGTradeOps@btgsp.com.
  • Complete the form and include a photocopy of the agency Medical Director's license and email to: BTGTradeOps@btgsp.com.
What SERB Will Do
SERB will determine eligibility
  • To be eligible for replacement, CYANOKIT must be administered in the line of duty (pre-hospital) to a firefighter, police officer, or EMS for the treatment of known or suspected cyanide poisoning due to smoke inhalation from an enclosed space fire(s).
  • The agency must submit the completed forms within six (6) months from the date of administration.
SERB fulfills order
  • After confirming eligibility of request, SERB will ship replacement product directly to the agency.
  • SERB will contact agency to confirm receipt of replaced product.
Important notes
  • A separate form must be filled out per patient administered.
  • Program requests will not be considered unless the documents are completed in their entirety and all supporting documentation is provided.
  • Please DO NOT include any protected health information concerning any treated patient.
  • If you have any questions, you can contact SERB Customer Service at 1-844-293-0007 or email BTGTradeOps@btgsp.com.
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.

SERB Logo

CYANOKIT is a registered trademark of SERB Sàrl, licensed by BTG International Inc., a SERB company.

Specialty Solutions Center® and Firefighter Promise™ are trademarks of BTG International Ltd.

©2024 SERB Pharmaceuticals. All rights reserved.
US-CYK-2400017/February 2024

If you wish to report an adverse event or product quality complaint, please call 1-877-377-3784.
You are encouraged to report side effects of prescription drugs to the FDA.
Visit https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 1-800-FDA-1088.

Specialty Solutions Center®

1-844-293-0007 (Voice) 1-877-626-9910 (Fax)

24-hour Medical Information:

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