Clinical Information
Gen. Code and Des.
67836 hydroxocobalamin INTRAVEN VIAL 5 G
GCN and Des.
30447 hydroxocobalamin INTRAVEN VIAL 5 G
Strength
5GM
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
92120000 ANTIDOTES
Active Ingredients
1044 hydroxocobalamin 13422510
These highlights do not include all the information needed to use CYANOKIT safely and effectively. See full prescribing information for CYANOKIT.
CYANOKIT® (hydroxocobalamin for injection) for intravenous infusion
Initial U.S. Approval: 1975
INDICATIONS AND USAGE
CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. (1)
DOSAGE AND ADMINISTRATION
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. (2.1)
The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222. (2.1)
Dosing:
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. (2.2)
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. (2.2)
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. (2.2)
The recommended diluent is 0.9% Sodium Chloride injection. (2.3)
CYANOKIT requires a separate intravenous line for administration. (2.4)
DOSAGE FORMS AND STRENGTHS
CYANOKIT (hydroxocobalamin for injection) for intravenous infusion consists of 1 vial, containing 5 g lyophilized hydroxocobalamin dark red crystalline powder for injection. After reconstitution, the vial contains hydroxocobalamin for injection, 25 mg/mL. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Risk of Anaphylaxis and Other Hypersensitivity Reactions: Consider alternative therapies, if available, in patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. (5.2)
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. (5.3)
Risk of Increased Blood Pressure: Substantial increases in blood pressure may occur following CYANOKIT therapy. Monitor blood pressure during treatment. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (>5%) include transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache, and infusion site reactions. (6.1)
To report SUSPECTED ADVERSE REACTIONS contact BTG at 1-877-377-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal studies, may cause fetal harm; however, CYANOKIT administration for cyanide poisoning may be lifesaving for the pregnant woman and fetus. Treatment should not be withheld due to pregnancy (8.1)
Lactation: Breastfeeding not recommended (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2021
