Important Safety Information
Full Prescribing Information

Check us out in the Today’s Dietitian virtual exhibit hall!

Learn more about the only FDA-approved prescription vitamin B₁₂ Nasal Spray¹

Our monthly nutritional supplement program may be right for your bariatric patients

INDICATIONS

• 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

• NASCOBAL^® 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 NASCOBAL^® following adequate correction of vitamin B₁₂ deficiency and underlying disease has not been established.
• The effectiveness of NASCOBAL^® in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with NASCOBAL^® should be deferred until symptoms have subsided.

IMPORTANT SAFETY INFORMATION FOR NASCOBAL^® NASAL SPRAY

NASCOBAL^® is contraindicated in patients with sensitivity to cobalt, vitamin B₁₂, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B₁₂. Consider administering an intradermal test dose of parenteral vitamin B₁₂ to patients suspected of cyanocobalamin hypersensitivity prior to starting NASCOBAL^®.

Please see additional Important Safety Information below.

PRACTICE RESOURCES AND PATIENT EDUCATION

IMPORTANT SAFETY INFORMATION FOR NASCOBAL^® NASAL SPRAY

NASCOBAL^® is contraindicated in patients with sensitivity to cobalt, vitamin B₁₂, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B₁₂. Consider administering an intradermal test dose of parenteral vitamin B₁₂ to patients suspected of cyanocobalamin hypersensitivity prior to starting NASCOBAL^®.

Patients with Leber’s disease who were treated with vitamin B₁₂ suffered severe and swift optic atrophy. NASCOBAL^® is not recommended for use in patients with Leber’s optic atrophy.

Doses of vitamin B₁₂ exceeding 10 mcg daily may produce hematologic response in patients with folate-deficient megaloblastic anemia, and may therefore mask a previously unrecognized folate deficiency. NASCOBAL^® is not a substitute for folic acid. Assess both vitamin B₁₂ and folate levels prior to initiating therapy with NASCOBAL^®.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B₁₂. Serum potassium levels and platelet count should be monitored.

Treatment with vitamin B₁₂ may unmask signs of polycythemia vera. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation.

Hematocrit, reticulocyte count, vitamin B₁₂, folate and iron levels should be obtained prior to treatment. Consider the potential for concomitant drugs to interfere with vitamin B₁₂ and folate diagnostic blood assays. Vitamin B₁₂ and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL^®, consider alternative therapy.

If NASCOBAL^® is used concomitantly with chloramphenicol, monitor for reduced efficacy and, if needed, consider an alternative therapy.

The limited available data on NASCOBAL^® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

The most common adverse reactions (≥4%) were infection, headache, glossitis, paresthesia, asthenia, nausea and rhinitis.

Please see the full Prescribing Information.

Reference: 1. US Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. 41st ed. https://www.fda.gov/media/71474/download. Accessed March 3, 2021.

In accordance with the Colorado WAC Disclosure Law, you can access the required information by clicking on the following link: www.endowac.com/nutrition.

Endo Pharmaceuticals Inc.
1400 Atwater Drive
Malvern, PA19355

NASCOBAL^® is a registered trademark of Endo International plc or one of its affiliates.
© 2021 Endo Pharmaceuticals Inc.  All rights reserved.  Malvern, PA 19355
NS-05593/March 2021  www.nascobal.com  1-800-462-ENDO (3636)