Cyanokit

What is Cyanokit?

• Cyanokit (hydroxocobalamin for injection) is cobinamide dihydroxide dihydrogen phosphate, a cyanide antidote

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Hydroxocobalamin

Hydroxocobalamin ball-and-stick animation

Hydroxocobalamin Injection

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What are the uses of this medicine?

• Cyanokit (hydroxocobalamin for injection) is prescription medicine used for the treatment of known or suspected cyanide poisoning. Cyanide is a chemical poison.

Cyanide poisoning can happen from:

• breathing smoke from household and industrial fires
• breathing or swallowing cyanide
• having your skin exposed to cyanide

• Cyanide poisoning is a life-threatening condition because cyanide stops your body from being able to use oxygen.
• You can die if your body does not have enough oxygen.

• The effectiveness of CYANOKIT was based on a study in animals, because intentionally exposing humans to cyanide is not ethical.
• The safety of CYANOKIT was studied in animals and healthy people and derived from experience in patients exposed to cyanide.

How does this medicine work?

• 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.
• Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria.
• Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis.
• The action of CYANOKIT in the treatment of cyanide poisoning is based on its ability to bind cyanide ions.
• Each hydroxocobalamin molecule can bind one cyanide ion by substituting it for the hydroxo ligand linked to the trivalent cobalt ion, to form cyanocobalamin, which is then excreted in the urine.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Formal drug interaction studies have not been conducted with CYANOKIT.

Is this medicine FDA approved?

• Initial U.S. Approval: 1975

How should this medicine be used?

• If clinical suspicion of cyanide poisoning is high, administer CYANOKIT without delay and in conjunction with appropriate airway, ventilatory, and circulatory support, oxygen administration as well as management of seizures.

Recommended dosage:

• The starting dose of CYANOKIT for adults is 5 g, administered by intravenous infusion over 15 minutes.
• One 5 g vial is a complete starting dose.
• Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered by intravenous infusion for a total dose of 10 g.

Administration:

• Your healthcare provider will give you CYANOKIT through a vein by intravenous (IV) infusion over 15 minutes.
• A second dose of CYANOKIT may be given to you if needed.
• The rate of infusion for the second 5 g dose may range from 15 minutes (for patients in extremis) to 2 hours based on patient condition.
• The recommended diluent is 0.9% Sodium Chloride injection.
• CYANOKIT requires a separate intravenous line for administration.
• The safety of administering other cyanide antidotes simultaneously with CYANOKIT has not been established. If a decision is made to administer another cyanide antidote with CYANOKIT, these drugs should not be administered concurrently in the same intravenous line.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As CYANOKIT (hydroxocobalamin for injection) for intravenous infusion

This medicine is available in fallowing brand namesː CYANOKIT

What side effects can this medication cause?

The most common side effects of this medicine include:

• red colored urine. Red colored urine redness may last up to 5 weeks after treatment with CYANOKIT.
• nausea
• headache
• reactions at the site of infusion
• acne-like rash

CYANOKIT may cause serious side effects, including:

• Allergic reactions
• Kidney problems
• Increased blood pressure

What special precautions should I follow?

• CYANOKIT may cause red colored skin. Skin redness is common during treatment with CYANOKIT and may last up to 2 weeks after treatment with CYANOKIT. You should avoid sunlight while your skin is red.
• Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Consider alternative therapies, if available.
• 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.
• Substantial increases in blood pressure may occur following CYANOKIT therapy. Monitor blood pressure during treatment.
• 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.
• Hydroxocobalamin absorbs visible light in the UV spectrum. It therefore has potential to cause photosensitivity. Patients should be advised to avoid direct sun while their skin remains discolored.
• While determination of blood cyanide concentration is not required for management of cyanide poisoning and should not delay treatment with CYANOKIT.
• Inform patients that an acneiform rash may appear anywhere from 7 to 28 days following hydroxocobalamin treatment. This rash will usually resolve without treatment within a few weeks.
• Advise women that breastfeeding is not recommended during treatment with CYANOKIT.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No data are available about overdose with CYANOKIT in adults.

Management of overdosage:

• If overdose occur, treatment should be directed to the management of symptoms.
• Hemodialysis may be effective in such a circumstance, but is only indicated in the event of significant hydroxocobalamin-related toxicity. Because of its deep red color, hydroxocobalamin may interfere with the performance of hemodialysis machines.

Can this medicine be used in pregnancy?

• 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.
• Life-sustaining therapy should not be withheld due to pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of CYANOKIT have not been established in this population.
• A dose of 70 mg/kg has been used to treat pediatric patients.

What are the active and inactive ingredients in this medicine?

Active:

• hydroxocobalamin

Inactives:

• none

Who manufactures and distributes this medicine?

Manufactured by:

• Merck Santé s.a.s., Semoy, France

• Distributed by Meridian Medical Technologies®, Inc. Columbia, MD

What should I know about storage and disposal of this medication?

Lyophilized form:

• Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F).

• CYANOKIT may be exposed during short periods to the temperature variations of usual transport (15 days submitted to temperatures ranging from 5 to 40°C (41 to 104°F), transport in the desert (4 days submitted to temperatures ranging from 5 to 60°C (41 to 140°F)) and freezing/defrosting cycles (15 days submitted to temperatures ranging from -20 to 40°C (-4 to 104°F)).

Reconstituted solution:

• Store up to 6 hours at a temperature not exceeding 40ºC (104°F).
• Do not freeze.
• Discard any unused portion after 6 hours.

• Dailymed label info on Cyanokit
• FDA Cyanokit

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