Cyanokit Side Effects
Generic Name: hydroxocobalamin
Please note - some side effects for Cyanokit may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Cyanokit - for the Consumer
Cyanokit Kit
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cyanokit Kit:
Seek medical attention right away if any of these SEVERE side effects occur when using Cyanokit Kit:Acne-like rash; headache; nausea; red-colored urine; skin redness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; chest discomfort; dizziness; dryness or tightness of the throat; eye irritation, redness, or swelling; fast or irregular heartbeat; flushing; memory problems; pain or redness at the injection site; restlessness; severe or persistent diarrhea, nausea, vomiting, or stomach pain; severe or persistent headache; shortness of breath; swelling of the ankles or feet; trouble swallowing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCyanokit Side Effects - for the Professional
Cyanokit
Serious adverse reactions with hydroxocobalamin include allergic reactions and increases in blood pressure
[see Warnings and Precautions (5.2),(5.3)].
Clinical Studies Experience
Because clinical trials are 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-ascending-dose (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.
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*Rashes were predominantly acneiform |
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| 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 | |
| Injection site reaction | 4 (6) | 0 | 7 (39) | 0 | |
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.
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects have included mild transient diarrhea and nausea.
Other
Other side effects have included itching and feeling of swelling of the entire body.
Dermatologic
Dermatologic side effects have included transitory exanthema and erythema.
Hypersensitivity
Hypersensitivity side effects have rarely included anaphylactic reactions.
Local
Local side effects have included infusion site reaction and pain with injection.
Renal
Renal side effects have included chromaturia.
Cardiovascular
Cardiovascular side effects, following intravenous administration, have included increased blood pressure.
TopMore Cyanokit resources
- Cyanokit Consumer Overview
- Cyanokit Kit MedFacts Consumer Leaflet (Wolters Kluwer)
- Cyanokit Prescribing Information (FDA)
- Hydroxocobalamin Prescribing Information (FDA)
- Hydroxocobalamin MedFacts Consumer Leaflet (Wolters Kluwer)
- Hydroxocobalamin Professional Patient Advice (Wolters Kluwer)
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