Cyanokit (Hydroxocobalamin)

Brand Name

Cyanokit

Generic Name

Hydroxocobalamin

View Brand Information

FDA approval date: November 12, 2010

Classification: Antidote

Form: Injection

What is Cyanokit (Hydroxocobalamin)?

CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.

Approved To Treat

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Brand Information

Cyanokit (Hydroxocobalamin)

1INDICATIONS AND USAGE

CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.

2DOSAGE 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

3CONTRAINDICATIONS

None

4ADVERSE REACTIONS

Serious adverse reactions with hydroxocobalamin include allergic reactions, renal injury, and increases in blood pressure

4.1Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CYANOKIT. Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Cases of acute renal failure with acute tubular necrosis, renal impairment, and urine calcium oxalate crystals have been reported in patients treated with CYANOKIT.

5DRUG INTERACTIONS

Formal drug interaction studies have not been conducted with CYANOKIT.

6OVERDOSAGE

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

7DESCRIPTION

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

CYANOKIT (hydroxocobalamin for injection) for intravenous infusion is a cyanide antidote package which contains one colorless 250 mL glass vial, containing 5 g dark red lyophilized hydroxocobalamin, pH adjusted with hydrochloric acid, one transfer spike, one intravenous administration set, one quick use reference guide and one package insert.

The 5 g vial of hydroxocobalamin for injection is to be reconstituted with 200 mL of 0.9% NaCl, to give a dark red injectable solution (25 mg/mL). If 0.9% NaCl is not readily available, 200 mL of either Lactated Ringers injection or 5% Dextrose injection (D5W) may be used as the diluent. Diluent is not included in the CYANOKIT. The pH of the reconstituted product ranges from 3.5 to 6.0.

8HOW SUPPLIED/STORAGE AND HANDLING

Each CYANOKIT carton (NDC 50633-310-11) consists of the following:

One 250 mL glass vial, containing lyophilized hydroxocobalamin for injection, 5 g
One sterile transfer spike
One sterile intravenous infusion set
One quick use reference guide
One package insert

Diluent is not included.

9PATIENT COUNSELING INFORMATION

CYANOKIT is indicated for cyanide poisoning and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information.