Hydroxocobalamin (Intravenous)

Hydroxocobalamin injection is an emergency treatment (antidote) used for patients with known or suspected cyanide poisoning. Cyanide poisoning is a serious condition that needs immediate medical help. It is more likely to happen if you inhale smoke from fires in enclosed spaces, swallow or breathe in cyanide (a chemical poison), or if your skin comes into contact with cyanide. Signs and symptoms include chest tightness, confusion, dilated or enlarged pupils, nausea or vomiting, rapid or shallow breathing, difficulty breathing, or seizures.

This medicine should only be given by a doctor or under their direct supervision.

Your doctor will monitor your progress closely while you are getting this medicine. This will help your doctor see if the medicine is working properly. Blood tests will also be needed to check for side effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, chest tightness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

This medicine may cause high or low blood pressure. Tell your doctor right away if you have fast, slow, pounding, or uneven heartbeats while receiving this medicine.

This medicine may cause skin redness and make your skin more sensitive to sunlight. This effect may last for up to 2 weeks after you have received this medicine. Avoid being in the sun while your skin is red. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may cause an acne-like rash that appears 7 to 28 days after treatment. This rash will go away within a few weeks.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies have not been done to determine how age affects the effects of hydroxocobalamin injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of hydroxocobalamin injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication if you are breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Allergy to cyanocobalamin or hydroxocobalamin—Use with caution.

• Hypertension (high blood pressure) or
• Hypotension (low blood pressure)—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• redness of the skin
• slow or fast heartbeat

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• cough
• difficult or labored breathing
• difficulty with swallowing
• feeling of warmth
• hives or welts, itching, or skin rash
• large, hive-like swelling on the eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• sudden sweating
• tightness in the chest
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Blemishes on the skin
• dry, red, hot, or irritated skin
• nausea
• pimples
• red colored urine

Incidence not known

• Acid or sour stomach
• being forgetful
• belching
• diarrhea
• heartburn
• indigestion
• redness or swelling of the eyes
• restlessness
• stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cyanokit

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Cyanide Antidote

Pharmacologic Class: Vitamin B (class)

A doctor or an emergency care provider will give you this medicine. This medicine is given through a needle placed in one of your veins for 15 minutes.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.