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
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 parameters 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
- Hypersensitivity to cobalt, vitamin B12, or any component of Eligen B12™
- Leber’s Hereditary Optic Neuropathy: Do not use in patients with early Leber’s Hereditary Optic Neuropathy (LHON). Treatment with vitamin B12 has resulted in severe and swift optic atrophy.
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
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.
- 1. Eligen B12 [Package Insert]. Roseland, NJ: Emisphere Technologies, Inc; October 2014.
- 2. Heparin/SNAC Investigator’s Brochure. Emisphere Technologies, Inc; April 2008.
- 3. Ingredients, Packaging & Labeling. US Food and Drug Administration website. http://www.fda.gov/Food/ IngredientsPackagingLabeling/GRAS. Accessed February 2, 2015.
- 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.
4 Becker Farm Road, Suite 103, Roseland NJ 07068
April 2006 ELB034
Emisphere Technologies - All Rights Reserved. © 2018