Safety Information Prescribing Information

Vitamin B12 Deficiency & Diabetes

Type 1 Diabetes
Type 1 diabetes is associated with pernicious anemia†People with pernicious anemia who do not have nervous system problems will require initial vitamin B12 shots to achieve healthy vitamin B12 levels before they can begin taking Nascobal Nasal Spray as their primary vitamin B12 treatment. For people with pernicious anemia with nervous system involvement, Nascobal Nasal Spray should not be taken., a condition
that may cause vitamin B12 deficiency.

People with type 1 diabetes are at risk of developing specific antibodies that may cause vitamin B12 absorption problems. When these antibodies are produced in excess they may potentially block vitamin B12 absorption, leading to pernicious anemia.


People with type 1 diabetes should be aware that they may be at risk for developing pernicious anemia and may require treatment for vitamin B12 deficiency.

If you or someone you know has diabetes, you may need vitamin B12 supplementation. Only your doctor can determine if you’re vitamin B12 deficient. Start by talking to your doctor about testing and monitoring your vitamin B12 levels.

It’s important to have enough vitamin B12 in your body to keep you healthy. If left untreated, vitamin B12 deficiency can lead to serious problems with the blood and nervous system. Vitamin B12 deficiency has also been linked to psychiatric symptoms such as impaired memory, irritability, and depressed mood.

Nascobal® Nasal Spray helps maintain healthy vitamin B12 levels and may be an option for you or someone you know with diabetes who needs vitamin B12 supplementation. Talk to your doctor to find out if this needle-free option is right for you.

† People with pernicious anemia who do not have nervous system problems will require initial vitamin B12 shots to achieve healthy vitamin B12 levels before they can begin taking Nascobal Nasal Spray as their primary vitamin B12 treatment. For people with pernicious anemia with nervous system involvement, Nascobal Nasal Spray should not be taken.

Available by prescription only.
INDICATION

* Nascobal® (Cyanocobalamin, USP) Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.

Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies including: dietary deficiency of vitamin B12 occurring in strict vegetarian diets; malabsorption of vitamin B12 resulting from conditions including HIV infection, AIDS, and Crohn's disease; inadequate secretion of intrinsic factor resulting from lesions that destroy the gastric mucosa and other conditions associated with gastric atrophy including multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy; total gastrectomy; competition for vitamin B12 by intestinal parasites or bacteria; and inadequate utilization of vitamin B12 that may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.

IMPORTANT SAFETY INFORMATION

Nascobal® (Cyanocobalamin, USP) Nasal Spray is a prescription, man-made form of vitamin B12.

Nascobal Nasal Spray is used to keep healthy levels of B12. It is used to treat patients with pernicious anemia who do not have nervous system problems and who achieved healthy vitamin B12 levels following vitamin B12 shots.

Nascobal Nasal Spray is used to keep healthy vitamin B12 levels in: strict vegetarians, people who cannot absorb vitamin B12 because of damage to their stomach or intestine from diseases (HIV/AIDS, Crohn's disease and sprue) or surgery, infections caused by parasites or bacteria, and patients who cannot process vitamin B12 because of certain cancer treatments.

Do not take Nascobal if you are sensitive to cobalt and/or vitamin B12 or any ingredients in the medication. In patients with Leber's disease, treatment with vitamin B12 can damage their sight (optic nerve atrophy). In patients with too many red blood cells (a condition called polycythemia vera), treatment with vitamin B12 may cause this condition to return. In patients with severe anemia treated with vitamin B12, low potassium levels (hypokalemia) and sudden death may occur.

Some patients will need a weekly spray of Nascobal in their nostril for the rest of their lives. Do not stop taking your medication without talking to your doctor. If you stop taking vitamin B12, anemia could return, or you could develop permanent nerve damage.

Side effects thought to be related to Nascobal use are usually mild and include headache, nausea, and rhinitis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

For more information about Nascobal Nasal Spray, call 1-800-828-9393 (Option 2).

©2012 Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.
Nascobal is a registered trademark of Par Pharmaceutical, Inc.
NAS00 0237