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The following safety information outlines important warnings and precautions related to the use of cyanocobalamin (Dodex). Please read carefully and discuss any concerns with your healthcare provider.

• Severe Allergic Reactions: Cyanocobalamin (Dodex) can cause severe and potentially life-threatening allergic reactions, such as facial swelling, anaphylaxis, and shock. It is advisable to undergo a test dose before starting treatment to assess your risk. Seek immediate medical attention if you experience breathing difficulties, choking sensation, swelling around the eyes, lips, or tongue, dizziness, or nausea.

• Not Suitable for Individuals with Leber's Disease: Those with Leber’s disease, a rare genetic eye condition, should avoid cyanocobalamin (Dodex) as it can cause severe eye damage. Consult your healthcare provider for alternative vitamin B12 supplements, such as hydroxocobalamin.

• Aluminum Toxicity Risk: Cyanocobalamin (Dodex) contains aluminum, and excessive intake can lead to toxicity, especially in individuals with kidney issues. Your healthcare provider may monitor your aluminum levels. Signs of aluminum poisoning include weakness, speech problems, bone pain, and seizures; contact your provider if these occur.

• Gasping Syndrome in Infants: Products containing benzyl alcohol, a preservative in cyanocobalamin (Dodex), may cause gasping syndrome in newborns and low birth weight infants. Pregnant or breastfeeding individuals should consult their provider due to potential exposure through the womb or breast milk. Immediate medical help is necessary if your child shows symptoms like gasping, slow heart rate, clammy skin, seizures, or limb weakness.

• Monitoring for Severe Pernicious Anemia: Patients with severe pernicious anemia require careful monitoring as treatment can result in low potassium and high platelet levels, which could be life-threatening. Regular blood tests will track potassium and platelet levels. Avoid additional vitamin B12 supplements unless advised by your provider. Contact your provider if you experience symptoms like headache, confusion, shortness of breath, heart palpitations, muscle weakness, cramps, or unusual bleeding.

• Masking Anemia from Low Folic Acid: Vitamin B12 may conceal anemia caused by low folic acid levels by improving red blood cell count without addressing folate deficiency. Regular folic acid level checks are recommended. This risk increases with daily vitamin B12 intake exceeding 10 mcg.

Contraindications:

• Allergy to Cobalt or Vitamin B12: Avoid using cyanocobalamin (Dodex) if you have allergies to cobalt or vitamin B12, as it poses serious health risks. Consult your healthcare provider for guidance.

When taking cyanocobalamin, some individuals may experience mild side effects such as pain or redness at the injection site, mild diarrhea, and itching. These effects are generally not serious, but if they persist or worsen, it is advisable to speak with your healthcare provider. Occasionally, a feeling of swelling throughout the body may also occur.

Cyanocobalamin can cause a drop in potassium levels, known as hypokalemia. Symptoms such as muscle cramps, weakness, or an irregular heartbeat should be reported to a healthcare professional promptly. For those with a rare blood disorder called polycythemia vera, there is a rare chance of experiencing symptoms such as chest pain, especially if accompanied by shortness of breath, sudden vision changes, or trouble speaking, and immediate medical attention is necessary.

Serious side effects, although rare, require urgent medical care. These include symptoms of heart failure like shortness of breath, swelling in the ankles or feet, unusual tiredness, or sudden weight gain. A severe allergic reaction to cyanocobalamin, characterized by a rash, severe dizziness, trouble breathing, or swelling of the face, tongue, or throat, is also rare but requires immediate medical assistance.

While most people do not experience serious side effects, it is important to monitor for any changes and consult a healthcare provider if they occur. This summary does not cover all possible side effects, so if you notice any other unusual effects, reach out to your healthcare provider for advice.