Cyanokit injection

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

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;

• a light-headed 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).

Common side effects may include:

• nausea;

• headache;

• acne, skin rash or redness;

• red coloring of your urine (may last 2 to 5 weeks); 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.

Other drugs may interact with hydroxocobalamin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

If possible before you receive Cyanokit, tell your caregivers if you have high blood pressure, heart disease, congestive heart failure, liver disease, or kidney disease (or if you are on dialysis).

Also tell your caregivers if you have ever had a severe allergic reaction to hydroxocobalamin, Vitamin B12, or cyanocobalamin (Nascobal, Cobolin, Cyomin, and others).

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received Cyanokit.

Cyanokit can cause unusual results with certain medical tests. Tell any doctor who treats you that you have recently received a Cyanokit injection. You may develop an acne-like skin rash within 1 to 4 weeks after you are treated with this medicine. This rash should go away without treatment. Call your doctor if you have a rash that lasts longer than 4 weeks. If your skin turns red after receiving this medication, avoid exposure to sunlight or tanning beds. Cyanokit can make you sunburn more easily while your skin is still red. Wear protective clothing and use sunscreen (SPF 30 or higher) until your skin color returns to normal.

Cyanokit is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Cyanokit must be given slowly, and the IV infusion can take at least 15 minutes to complete.

Cyanokit is usually given only once. However, you may receive a second dose if needed.

Your breathing, blood pressure, oxygen levels, heart function, and other vital signs will be watched closely while you are receiving Cyanokit.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you have recently received a Cyanokit injection.

Get emergency medical help if you have any of these signs of an allergic reaction to Cyanokit: 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 Cyanokit. 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;

• a light-headed 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).

Common Cyanokit side effects may include:

• nausea;

• headache;

• acne, skin rash or redness;

• red coloring of your urine (may last 2 to 5 weeks); 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.

There may be other drugs that can interact with Cyanokit. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Hydroxocobalamin has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. The manufacturer states hydroxocobalamin is only recommended for use during pregnancy when benefit outweighs risk. However, there are reports which suggest severe maternal Vitamin B12 deficiency may result in infertility and/or poor pregnancy outcome as a result of megaloblastic anemia. Less severe maternal deficiency may be common in the course of pregnancy and usually does not pose a risk to mother or fetus. Many sources recommend Vitamin B12 therapy during pregnancy up to the RDA.