Cyanocobalamin Nasal Spray

INDICATIONS & USAGE

• 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

Limitations of Use:

• Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test).
• In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long  term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B12 deficiency and underlying disease has not been established.
• The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided.

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DOSAGE AND ADMINISTRATION

Testing and Other Considerations Prior to Dosing

Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B12, folate, and iron levels‍. Consider the potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays.‍

In patients with suspected cobalamin hypersensitivity, consider administering an intradermal test dose of parenteral vitamin B12 prior to use of Cyanocobalamin Nasal Spray.

Recommended Dosage

The recommended initial dose of Cyanocobalamin Nasal Spray is one spray (500 mcg) administered in ONE nostril once weekly. Administer Cyanocobalamin Nasal Spray 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 Cyanocobalamin Nasal Spray in patients with nasal congestion, allergic rhinitis, or upper respiratory infections until after symptoms have subsided.

Monitoring, Dosage Modifications, and Treatment Duration

Monitoring for Response and Safety

Monitor serum B12 levels periodically during therapy to establish adequacy of therapy. Obtain a serum B12 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 B12 decline after one month of treatment with Cyanocobalamin Nasal Spray, 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 B12therapy).

Treatment Duration

In patients whose underlying cause of vitamin B12 deficiency has been corrected and are deemed no longer at risk for vitamin B12 deficiency, discontinue Cyanocobalamin Nasal Spray. The safety and effectiveness of continued long-term use in these individuals has not been established.

In patients with pernicious anemia, continue appropriate vitamin B12 treatment indefinitely.

Administration of Cyanocobalamin Nasal Spray with Other Therapy

• Cyanocobalamin Nasal Spray should be administered with other therapy(ies) in:
• Patients with concurrent folate and vitamin B12 deficiency: Administer folic acid in addition to Cyanocobalamin Nasal Spray
• Patients with concurrent iron and vitamin B12 deficiency:  Administer iron in addition to Cyanocobalamin Nasal Spray
• Patients with correctible causes of vitamin B12 deficiency: Consider measures to treat the underlying condition associated with vitamin B12 deficiency in addition to treatment with Cyanocobalamin Nasal Spray

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CONTRAINDICTIONS

Cyanocobalamin Nasal Spray is contraindicated in patients with hypersensitivity to cobalt and/or vitamin B12 or any of its excipients‍. Anaphylactic shock and death have been reported after parenteral vitamin B12 administration in sensitive patients.

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Full Prescribing Information: DailyMed

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