Contact Information

Contact: Endo Pharmaceuticals

Website: https://www.nascobal.com/vitaminb12

Currently Enrolling Trials

General Information

Nascobal is a vitamin B12.

Nascobal is specifically indicated for:

Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement
Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia
Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal

Nascobal is a self-administered nasal gel. The recommended dose of Nascobal in subjects with vitamin B-12 malabsorption who are in remission following injectable B-12 therapy is 500 mcg/0.ImL administered intranasally once weekly. It is recommended that subjects treated with Nascobal be monitored at one month after start of treatment, and then at intervals of three to six months to insure adequate levels of vitamin B-12. The vitamin is effectively absorbed through the nasal mucosa, resulting in therapeutic blood levels being maintained throughout the course of treatment. The product will be available as a metered-dose gel in 5mL bottles at a dosage strength of 500 mcg/0.ImL.

Mechanism of Action

Vitamin B12 can be converted to coenzyme B12 in tissues, and as such is essential for conversion of methylmalonate to succinate and synthesis of methionine from homocysteine, a reaction which also requires folate. In the absence of coenzyme B12, tetrahydrofolate cannot be regenerated from its inactive storage form, 5-methyltetrahydrofolate, and a functional folate deficiency occurs. Vitamin B12 also may be involved in maintaining sulfhydryl (SH) groups in the reduced form required by many SH-activated enzyme systems. Through these reactions, vitamin B12 is associated with fat and carbohydrate metabolism and protein synthesis.