Hydroxocobalamin
Generic Name: hydroxocobalamin
Brand Names:
Cyanokit
11 DESCRIPTION Hydroxocobalamin, the active ingredient in CYANOKIT, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole, an antidote. The drug substance is the hydroxylated active form of vitamin B 12 and is a large molecule in which a trivalent cobalt ion is coordinated in four positions by a tetrapyrol (or corrin) ring.
Overview
11 DESCRIPTION Hydroxocobalamin, the active ingredient in CYANOKIT, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole, an antidote. The drug substance is the hydroxylated active form of vitamin B 12 and is a large molecule in which a trivalent cobalt ion is coordinated in four positions by a tetrapyrol (or corrin) ring.
Uses
1 INDICATIONS AND USAGE CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. ( 1 )
Dosage
2 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.
Side Effects
6 ADVERSE REACTIONS Serious adverse reactions with hydroxocobalamin include allergic reactions, renal injury, and increases in blood pressure [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 )]. 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. 6.1 Clinical Studies Experience Experience in Healthy Subjects Because clinical trials were conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS Formal drug interaction studies have not been conducted with CYANOKIT. Interference with 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 [see Warnings and Precautions ( 5.5 )].
Warnings
5 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. 4 CONTRAINDICATIONS None None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary 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 (see Clinical Considerations) .
Storage
Storage Lyophilized form Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. 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 fr...
Frequently Asked Questions
What is Hydroxocobalamin used for?▼
1 INDICATIONS AND USAGE CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. ( 1 )
What are the side effects of Hydroxocobalamin?▼
6 ADVERSE REACTIONS Serious adverse reactions with hydroxocobalamin include allergic reactions, renal injury, and increases in blood pressure [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 )]. 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. 6.1 Clinical Studies Experience Experience in Healthy Subjects Because clinical trials were conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice.
Can I take Hydroxocobalamin during pregnancy?▼
8.1 Pregnancy Risk Summary 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 (see Clinical Considerations) .
What are the important warnings for Hydroxocobalamin?▼
5 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. 4 CONTRAINDICATIONS None None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.