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PLEASE SEE IMPORTANT SAFETY INFORMATION BELOW

THE ONLY FDA-APPROVED PRESCRIPTION VITAMIN B₁₂ NASAL SPRAY

Unique intranasal delivery

Designed to bypass the GI tract and deliver vitamin B₁₂ directly into the bloodstream through the nasal mucosa¹

Not an injection
The only FDA-approved vitamin B₁₂ nasal spray²

Clinically proven to have increased and maintained healthy vitamin B₁₂ levels^3,4

Convenient, once-weekly dosing regimen

Self-administered, tasteless and odorless fine mist: 1 spray, 1 nostril, 1x a week⁴

INDICATION

Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B₁₂ deficiency not due to pernicious anemia

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.

LOOKING FOR AN INTEGRATED NUTRITIONAL SOLUTION FOR YOUR SURGICAL WEIGHT LOSS PATIENTS?

Nutrition Direct™ is designed to help make lifelong nutritional support as simple as possible for your appropriate patients.⁵ Patients receive a monthly delivery of nutritional supplements that meet the American Society for Metabolic and Bariatric Surgery (ASMBS) Nutritional Guidelines.^6*

*	ASMBS Integrated Health Nutritional Guidelines for the Surgical Weight Loss Patient — 2016 Update: Micronutrients.

^†

Patients may redeem this offer ONLY when accompanied by a valid prescription. Offer is valid up to a maximum benefit of $150. Offer is not valid for patients whose prescriptions are reimbursed in whole or in part under Medicaid, Medicare, Medigap, VA, DoD, TRICARE, or any other federal or state programs (such as medical assistance programs) or where otherwise prohibited by law. Offer is not valid in VT or where prohibited in whole or in part. This offer may be amended or ended at any time without notice.

IMPORTANT SAFETY INFORMATION FOR NASCOBAL^® NASAL SPRAY (continued)

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 full Prescribing Information.

References: 1. Pandit N. Introduction to the Pharmaceutical Sciences. 2007;1-5. 2. US Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations. 41st ed. https://www.fda.gov/media/71474/download. Accessed July 27, 2021. 3. Data on File. DOF‐NS‐02. Endo Pharmaceuticals Inc.; 2016. 4. NASCOBAL^® Nasal Spray [package insert]. Chestnut Ridge, NY: Par Pharmaceutical Companies, Inc. 5. Aills L, Blankenship J, Buffington C, Furtado M, Parrott J. ASMBS allied health nutritional guidelines for the surgical weight loss patient. Surg Obes Relat Dis. 2008;4:S73-S108. 6. Parrott J, Frank L, Rabena R, et al. American Society for Metabolic and Bariatric Surgery integrated health nutritional guidelines for the surgical weight loss patient 2016 update: micronutrients. Surg Obes Relat Dis. 2017:1-15.

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, PA 19355

NASCOBAL^® is a registered trademark of Endo International plc or one of its affiliates.
© 2022 Endo Pharmaceuticals Inc. All rights reserved. Malvern, PA 19355
NS-05653/August 2021 www.nascobal.com 1-800-462-ENDO (3636)