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.
Nascobal® (Cyanocobalamin, USP) Nasal Spray is contraindicated in patients with sensitivity to cobalt and/or vitamin B12 or any component of the medication. If a patient is not properly maintained with Nascobal Nasal Spray, intramuscular vitamin B12 is necessary. Vitamin B12 concentrations must be monitored.
Patients with pernicious anemia should be instructed that they will require weekly administration of Nascobal Nasal Spray for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with vitamin B12 suffered severe and swift optic atrophy. Vitamin B12 deficiency may suppress the signs of polycythemia vera. Treatment with vitamin B12 may unmask this condition. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12.
Side effects thought to be related to Nascobal use are usually mild and include headache, nausea, and rhinitis.
Please see full Prescribing Information.
©2010 Strativa Pharmaceuticals, a division of Par Pharmaceutical Companies, Inc.
NAS00 0058.1