Safety Information Prescribing Information

Vitamin B12 Deficiency & Pernicious Anemia*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.

Pernicious anemia causes vitamin B12 deficiency, and patients with
pernicious anemia who are on maintenance therapy, will require
prescription strength vitamin B12 supplementation for the rest of their lives.

Pernicious anemia reduces the production of a protein called intrinsic factor
that is essential for vitamin B12 absorption. As a result, vitamin B12 is not
properly absorbed in the body causing vitamin B12 deficiency.

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.

Oral absorption of vitamin B12 is considered too undependable to rely on in patients with pernicious anemia and prescription options may be necessary.


Nascobal® Nasal Spray is a prescription option that helps maintain healthy vitamin B12 levels
and may be right for you or someone you know with pernicious anemia. 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.

If you have pernicious anemia and do not have nervous system problems you will require
initial vitamin B12 shots to achieve healthy vitamin B12 levels. Once you’ve received your initial
treatment for vitamin B12 deficiency, talk to your doctor to find out if Nascobal Nasal Spray is
right for you. 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.
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