Vitamindosage

Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B 12, folate, and iron levels. The recommended initial dose is one spray (500 mcg) in one nostril once weekly. Administer at least one hour before or one hour after ingestion of hot foods or liquids. Monitor serum B12 levels periodically.Obtain a serum B12 level and peripheral blood count one month after treatment initiation, then subsequently at intervals of 3 to 6 months. If serum levels of B12 decline after one month of treatment, consider increasing the dose. Assess serum B12 level one month after each dose adjustment.If serum B12 levels are persistently low, consider alternative therapy (e.g., intramuscular or subcutaneous vitamin B12 therapy). See Full Prescibing Information to see what other therapies should be administered with NASCOBAL.

2.1 Testing and

Other Considerations Prior to Dosing Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B 12, folate, and iron levels. Consider the potential for concomitant drugs to interfere with vitamin B 12 and folate diagnostic blood assays. In patients with suspected cobalamin hypersensitivity, consider administering an intradermal test dose of parenteral vitamin B 12 prior to use of NASCOBAL.

2.2 Recommended

Dosage The recommended initial dose of NASCOBAL is one spray (500 mcg) administered in ONE nostril once weekly. Administer NASCOBAL at least one hour before or one hour after ingestion of hot foods or liquids since hot foods may cause nasal secretions and a resulting loss of medication. Defer use of NASCOBAL in patients with nasal congestion, allergic rhinitis, or upper respiratory infections until after symptoms have subsided.

2.3 Monitoring,

Dosage Modifications, and Treatment Duration Monitoring for Response and Safety Monitor serum B 12 levels periodically during therapy to establish adequacy of therapy. Obtain a serum B 12 level and peripheral blood count one month after treatment initiation, then subsequently at intervals of 3 to 6 months. Dosage Modifications If serum levels of B 12 decline after one month of treatment with NASCOBAL, consider increasing the dose. Assess serum B 12 level one month after each dose adjustment. If serum B 12 levels are persistently low, consider alternative therapy (e.g., intramuscular or subcutaneous vitamin B 12 therapy). Treatment Duration In patients whose underlying cause of vitamin B 12 deficiency has been corrected and are deemed no longer at risk for vitamin B 12 deficiency, discontinue NASCOBAL. The safety and effectiveness of continued long-term use in these individuals has not been established. In patients with pernicious anemia, continue appropriate vitamin B 12 treatment indefinitely.

2.4 Administration of NASCOBAL with

Other Therapy NASCOBAL should be administered with other therapy(ies) in: Patients with concurrent folate and vitamin B 12 deficiency:Administer folic acid in addition to NASCOBAL Patients with concurrent iron and vitamin B 12 deficiency:Administer iron in addition to NASCOBAL Patients with correctible causes of vitamin B 12 deficiency:Consider measures to treat the underlying condition associated with vitamin B 12 deficiency in addition to treatment with NASCOBAL