Eligen B12™ And Safety

Convenient once-daily dosing1.

Initially, one Eligen B12™ tablet should be taken once daily in the fasted state, at least 1 hour before a meal, with 50 mL of water1.

This regimen may be adapted based on regular laboratory test, up to a maximum of 2 tablets daily. 1

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Eligen B12™ Safety Profile

SNAC Safety Profile

  • No serious adverse events have been reported in any of the clinical studies. There were no changes of clinical significance in any of the safety parameter evaluated 2
  • Minor adverse events reported included; headache, nausea, vomiting, and dizziness2
  • Both the Eligen B12™ SNAC carrier and B12 have met the requirements of GRAS* status from the FDA3

Contraindications

  • Hypersensitivity to cobalt, vitamin B12, or any component of Eligen B12™
  • Leber’s Disease: Do not use in patients with early Lieber’s Diseas (hereditary optic nerve atrophy). Treatment with vitamin B12 has resulted in server and swift optic atrophy.

Adverse Reactions

No specific adverse reactions were identified during limited Eligen B12™ clinical trials.

Generalized: Anaphylactic shock and death

Cardiovascular: Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis

Hematological: Polycythemia vera

Gastrointestinal: Mild transient diarrhea

Dermatological: Itching; transitory exanthema

Miscellaneous: Feeling of swelling of entire body

Drug Interactions

Methotrexate, pyrimethamine, and most antibiotics interfere with folic acid and vitamin B12 diagnostic blood assays, possibly leading to false results.

Colchicine, para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12. Dosing adjustment may be needed.

Screen. Treat. Protect

Now you can help maintain normal B12 levels without a needle. Eligen B12™ is the first and only once-daily oral non-prescription tablet shown to normalize B12 levels without inconvenient injections.

Screen your patients. Treat them with Eligen B12. Protect them from the dangerous effects of B12 dificiency.

References:

  1. 1. Eligen B12 [Package Insert]. Roseland, NJ: Emisphere Technologies, Inc; October 2014.
  2. 2. Heparin/SNAC Investigator’s Brochure. Emisphere Technologies, Inc; April 2008.
  3. 3. Ingredients, Packaging & Labeling. US Food and Drug Administration website. http://www.fda.gov/Food/ IngredientsPackagingLabeling/GRAS. Accessed February 2, 2015.
  4. 4. Medical Foods Guidance Documents & Regulatory Information. US Food and Drug Administration website. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods. Accessed December 15, 2014.

Learn about the risks of low B12 and how Eligen B12 can help.

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Your patients may be at greater risk for clinically low B12 levels.

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Get more information about how Eligen B12 can help.

A prescription medical food is an FDA product classification. Medical foods are formulated to be consumed or administered orally under medical supervision and are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Eligen B12™ is a medical food available by prescription for patients who have a medically diagnosed vitamin B12 deficiency, associated with a disease or condition, that cannot be managed by a modification of normal diet alone.1,4

Intended for U.S. Residents Only

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