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IMPORTANT SAFETY INFORMATION FOR NASCOBAL®
Do not use NASCOBAL® if you are allergic to cobalt, vitamin B12, or any of the ingredients in NASCOBAL®.
NASCOBAL® can cause serious side effects, including:
- Weakening of your eye nerve in patients with early Leber’s disease. Tell your healthcare provider if you or your family has a history of early Leber’s disease.
- Serious allergic reactions. Serious, life-threatening allergic reactions, including death, have happened in people who have received vitamin B12 by injection or by intravenous (IV) infusion (parenteral). Tell your healthcare provider if you have ever had a reaction after you received vitamin B12 by injection or IV infusion.
- Hiding (masking) a folate deficiency. Your healthcare provider may do certain blood tests to check your vitamin B12 and folate levels.
- Low potassium levels (hypokalemia) and low blood platelets (thrombocytopenia) can happen in people with serious megaloblastic anemia. Your healthcare provider may monitor your potassium levels and platelet counts during your treatment with NASCOBAL®.
Vitamin B12 deficiency may hide signs of a blood condition called polycythemia vera. Treatment with NASCOBAL® may uncover this condition.
Tell your doctor if you are pregnant or planning to become pregnant (it is not known if NASCOBAL® will harm your unborn baby).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects include infection, headache, feeling weak, nausea, swelling of your tongue, runny nose, tingling of the hands and feet.
These are not all the possible side effects of NASCOBAL®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WHAT IS NASCOBAL®?
NASCOBAL® is a prescription medicine used:
- For maintenance therapy to treat vitamin B12 deficiency (low levels of vitamin B12) in adults with pernicious anemia who achieved healthy vitamin B12 levels after receiving vitamin B12 shots and do not have nervous system problems.
- To treat vitamin B12 deficiency caused by:
- certain food limitations,
- other medicines that cause vitamin B12 deficiency, or
- lack of absorption (malabsorption) that are not related to pernicious anemia.
- To prevent vitamin B12 deficiency in adults that need to increase their levels of vitamin B12 higher than normal levels.
NASCOBAL® should not be used for a vitamin B12 absorption test known as the Schilling test.
In people who have corrected or have fixed their short-term causes of vitamin B12 deficiency, the benefit of continued long-term use of NASCOBAL® is not known after vitamin B12 deficiency has been corrected.
It is not known if NASCOBAL® is effective in people who currently have a stuffy nose, allergies or an upper respiratory infection. You should wait until these symptoms have gone away before using NASCOBAL®.
It is not known if NASCOBAL® is safe and effective in children.
Please see the full Prescribing Information.IMPORTANT SAFETY INFORMATION FOR NASCOBAL®
Do not use NASCOBAL® if you are allergic to cobalt, vitamin B12, or any of the ingredients in NASCOBAL®.
NASCOBAL® can cause serious side effects, including:
- Weakening of your eye nerve in patients with early Leber’s disease. Tell your healthcare provider if you or your family has a history of early Leber’s disease.
- Serious allergic reactions. Serious, life-threatening allergic reactions, including death, have happened in people who have received vitamin B12 by injection or by intravenous (IV) infusion (parenteral). Tell your healthcare provider if you have ever had a reaction after you received vitamin B12 by injection or IV infusion.
- Hiding (masking) a folate deficiency. Your healthcare provider may do certain blood tests to check your vitamin B12 and folate levels.
- Low potassium levels (hypokalemia) and low blood platelets (thrombocytopenia) can happen in people with serious megaloblastic anemia. Your healthcare provider may monitor your potassium levels and platelet counts during your treatment with NASCOBAL®.
Vitamin B12 deficiency may hide signs of a blood condition called polycythemia vera. Treatment with NASCOBAL® may uncover this condition.
Tell your doctor if you are pregnant or planning to become pregnant (it is not known if NASCOBAL® will harm your unborn baby).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects include infection, headache, feeling weak, nausea, swelling of your tongue, runny nose, tingling of the hands and feet.
These are not all the possible side effects of NASCOBAL®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WHAT IS NASCOBAL®?
NASCOBAL® is a prescription medicine used:
- For maintenance therapy to treat vitamin B12 deficiency (low levels of vitamin B12) in adults with pernicious anemia who achieved healthy vitamin B12 levels after receiving vitamin B12 shots and do not have nervous system problems.
- To treat vitamin B12 deficiency caused by:
- certain food limitations,
- other medicines that cause vitamin B12 deficiency, or
- lack of absorption (malabsorption) that are not related to pernicious anemia.
- To prevent vitamin B12 deficiency in adults that need to increase their levels of vitamin B12 higher than normal levels.
NASCOBAL® should not be used for a vitamin B12 absorption test known as the Schilling test.
In people who have corrected or have fixed their short-term causes of vitamin B12 deficiency, the benefit of continued long-term use of NASCOBAL® is not known after vitamin B12 deficiency has been corrected.
It is not known if NASCOBAL® is effective in people who currently have a stuffy nose, allergies or an upper respiratory infection. You should wait until these symptoms have gone away before using NASCOBAL®.
It is not known if NASCOBAL® is safe and effective in children.
Please see the full Prescribing Information.Intended for U.S. Residents Only
Rx Only