Nascobal Gel (Cyanocobalamin, USP)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved November 1996

Specific Treatments:

vitamin B-12 deficiency

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General Information

Nascobal (TM) (Cyanocobalamin, USP) Gel for Intranasal Administration has been approved as therapy for vitamin B-12 deficiency, including pernicious anemia, a disorder associated with increased morbidity and mortality when untreated. Subjects requiring more than the normal amount of vitamin B-12 due to pregnancy, hepatic or renal disease can also be treated with Nascobal.

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.

Additional Information

Vitamin B-12 deficiency has a number of causes, including malabsorption of vitamin B-12 resulting from structural or functional damage to the gastrointestinal system and dietary deficiency of vitamin B-12 in strict vegetarians. It is estimated that one percent of the US population, or 2,750,000 people, will develop pernicious anemia in their lifetime. It is further estimated that over eight million vitamin B-12 injections are administered in the United States each year.

Vitamin B-12 deficiency is found in up to ten percent of patients over 60 years old. Current maintenance treatment calls for injections of Vitamin B-12, once per month for life. This chronic need for vitamin B-12 replacement therapy often requires frequent trips to a health care professional’s office or visit by a home health care professional to receive injections