hydroxocobalamin (Rx)

Brand and Other Names:Cyanokit
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 5g/vial

injection solution

  • 1000mcg/mL (30mL)

Cyanide Poisoning

Drug of choice in continental Europe/Australia

70 mg/kg (usually 5 g) IV infusion over 15 minutes; additional 5 g IV may be given depending on severity of poisoning and clinical response  

Not to exceed a cumulative dose of 10 g

Vitamin B12 Deficiency

Initial: 30 mcg IM qDay for 5-10 days

Maintenance: 100-200 mcg IM qmonth; may administer higher dose if critically ill or hyperthyroidism or neurologic or infectious disease present

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 5g/vial

injection solution

  • 1000mcg/mL (30mL)

Cyanide Poisoning (Off-label)

70 mg/kg (usually 5 g) IV infusion over 15 minutes; additional dose of 35 mg/kg IV may be given depending on severity of poisoning and clinical response

Vitamin B12 Deficiency

Initial: 100 mcg IM qDay for > 2 weeks (1-5 mg total dose)

Maintenance: 30-50 mcg IM qmonth

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Adverse Effects

>10 %

IV infusion

  • Increased blood pressure (18-28%)
  • Headache (6-33%)
  • Chromaturia (100%)
  • Erythema (94-100%)
  • Nausea (6-11%)
  • Decrease in lymphocytes (8-17%)
  • Local infusion site reactions (6-39%)

Frequency Not Defined

IM injection

  • Exanthema (transient)
  • Itching
  • Diarrhea (mild transient)
  • Feeling of sweating of entire body
  • Anaphylaxis

IV infusion

  • Hot flashes
  • Peripheral edema
  • Chest discomfort
  • Memory impairment
  • Dizziness
  • Restlessness
  • Urticaria
  • Pruritus
  • Hematochezia
  • Vomiting
  • Abdominal discomfort
  • Dry throat
  • Throat tightness
  • Angioneurotic edema

Postmarketing Reports

Renal injury, including renal failure with acute tubular necrosis, renal impairment, and urine calcium oxalate crystals

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Warnings

Contraindications

None listed by the manufacturer

Cautions

Consider alternative therapies, if available, in patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin

Acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals have been reported following therapy; monitor renal function for 7 days following therapy

Substantial increases in blood pressure may occur following therapy; monitor blood pressure during treatment

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Pregnancy & Lactation

Pregnancy

Available data from cases reported in published literature and postmarketing surveillance 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 pregnant woman and fetus associated with untreated cyanide poisoning

Cyanide readily crosses the placenta; cyanide poisoning is a medical emergency in pregnancy which can be fatal for pregnant woman and fetus if left untreated; life-sustaining therapy should not be withheld due to pregnancy

Animal data

  • In animal studies, hydroxocobalamin administered to pregnant rats and rabbits during the period of organogenesis caused skeletal and soft tissue abnormalities, including alterations in central nervous system, at exposures similar to human exposures at therapeutic dose

Lactation

Breastfeeding not recommended during treatment; there are no data to determine whenbreastfeeding may be safely restarted following administration of drug; hydroxocobalamin and Vitamin B12 (which is formed when hydroxocobalamin combines with cyanide) are present in human milk; there are no data on effects of hydroxocobalamin on breastfed infant or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Vitamin B12 with hydroxyl group complexed to cobalt which can be displaced by cyanide resulting in cyanocobalamin that is renally excreted

Pharmacokinetics

Protein binding: Forms cobalamin (III) complexes

Half-life: 26-31 hr

Excretion: Urine (50-60%)

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Administration

IV Preparation

Reconstitute lyophilized powder with 200 mL 0.9% NaCl; resulting concentration is 25 mg/mL

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.