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Cyanokit

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Cyanokit

Cyanokit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cyanokit (hydroxocobalamin) is used in an emergency to treat cyanide poisoning. This type of poisoning can occur if you are exposed to smoke from a house or industrial fire, if you swallow or breathe in cyanide, or if you get cyanide on your skin. It is a form of vitamin B-12. Common side effects include red coloring of your skin or urine (this may last up to 2 weeks), nausea, vomiting, diarrhea, stomach pain, acne, skin rash or itching, warmth or redness under your skin, dry throat, trouble swallowing, headache, dizziness, memory problems, restless feeling, pain, swelling, or irritation of your skin where the injection was given, or eye redness or irritation.

The starting dose of Cyanokit for adults is 5 g administered as an intravenous infusion over 15 minutes (approximately 15 mL/min). 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. Cyanokit is usually given in an emergency, so you may not have time to tell your caregivers about any other medications you are using. You will need follow-up medical care after receiving this drug. Tell your doctor all medications and supplements you use. During pregnancy, Cyanokit should be used only if prescribed. It may be harmful to a fetus. It is not known if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Cyanokit (hydroxocobalamin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cyanokit in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat.

You may develop an acne-like skin rash within 1 to 4 weeks after you are treated with hydroxocobalamin. This rash should go away without treatment. Call your doctor if you have a rash that lasts longer than 4 weeks.

Call your doctor at once if you have a serious side effect such as:

  • bright red blood in your stools;
  • chest pain, fast or uneven heart rate;
  • severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus;
  • swelling in your feet or ankles;
  • feeling like you might pass out; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • red coloring of your urine (may last up to 5 weeks);
  • red coloring of your skin (may last up to 2 weeks);
  • eye redness or irritation;
  • acne, mild skin rash;
  • nausea, vomiting, diarrhea, stomach pain;
  • dry throat, trouble swallowing;
  • headache, dizziness, memory problems, restless feeling;
  • hot flashes; or
  • pain, swelling, or irritation of your skin where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cyanokit (Hydroxocobalamin for Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cyanokit FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Serious adverse reactions with hydroxocobalamin include allergic reactions and increases in blood pressure [see WARNINGS AND PRECAUTIONS].

Clinical Studies Experience

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.

Experience in Healthy Subjects

A double-blind, randomized, placebo-controlled, single-ascendingdose (2.5, 5, 7.5, and 10 g) study was conducted to assess the safety, tolerability, and pharmacokinetics of hydroxocobalamin in 136 healthy adult subjects. Because of the dark red color of hydroxocobalamin, the two most frequently occurring adverse reactions were chromaturia (red-colored urine) which was reported in all subjects receiving a 5 g dose or greater; and erythema (skin redness), which occurred in most subjects receiving a 5 g dose or greater. Adverse reactions reported in at least 5% of the 5 g dose group and corresponding rates in the 10 g and placebo groups are shown in Table 3.

Table 3 Incidence of Adverse Reactions Occurring in > 5% of Subjects in 5 g Dose Group and Corresponding Incidence in 10 g Dose Group and Placebo

ADR 5 g Dose Group 10 g Dose Group
Hydroxocobalamin
N=66
n (%)
Placebo
N=22
n (%)
Hydroxocobalamin
N=18
n (%)
Placebo
N=6
n (%)
Chromaturia (red colored urine) 66 (100) 0 18 (100) 0
Erythema 62 (94) 0 18 (100) 0
Rash* 13 (20) 0 8 (44) 0
Blood pressure increased 12 (18) 0 5 (28) 0
Nausea 4 (6) 1 (5) 2 (11) 0
Headache 4 (6) 1 (5) 6 (33) 0
Lymphocyte percent decreased 5 (8) 0 3 (17) 0
Infusion site reaction 4 (6) 0 7 (39) 0
* Rashes were predominantly acneiform

In this study, the following adverse reactions were reported to have occurred in a dose-dependent fashion and with greater frequency than observed in placebo-treated cohorts: increased blood pressure (particularly diastolic blood pressure), rash, nausea, headache and infusion site reactions. All were mild to moderate in severity and resolved spontaneously when the infusion was terminated or with standard supportive therapies.

Other adverse reactions reported in this study and considered clinically relevant were:

  • Eye disorders: swelling, irritation, redness
  • Gastrointestinal disorders: dysphagia, abdominal discomfort, vomiting, diarrhea, dyspepsia, hematochezia
  • General disorders and administration site conditions: peripheral edema, chest discomfort
  • Immune system disorders: allergic reaction
  • Nervous system disorders: memory impairment, dizziness
  • Psychiatric disorders: restlessness
  • Respiratory, thoracic and mediastinal disorders: dyspnea, throat tightness, dry throat
  • Skin and subcutaneous tissue disorders: urticaria, pruritus
  • Vascular disorders: hot flush
Experience in Known or Suspected Cyanide Poisoning Victims

Four open-label, uncontrolled, clinical studies (one of which was prospective and three of which were retrospective) were conducted in known or suspected cyanide-poisoning victims. A total of 245 patients received hydroxocobalamin treatment in these studies. Systematic collection of adverse events was not done in all of these studies and interpretation of causality is limited due to the lack of a control group and due to circumstances of administration (e.g., use in fire victims). Adverse reactions reported in these studies listed by system organ class included:

  • Cardiac disorders: ventricular extrasystoles
  • Investigations: electrocardiogram repolarization abnormality, heart rate increased
  • Respiratory, thoracic, and mediastinal disorders: pleural effusion

Adverse reactions common to both the studies in known or suspected cyanide poisoning victims and the study in healthy volunteers are listed in the healthy volunteer section only and are not duplicated in this list.

Read the entire FDA prescribing information for Cyanokit (Hydroxocobalamin for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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