• Full Prescribing Information
  • Important Safety Information
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  • Full Prescribing Information
  • Important Safety Information
  • For Healthcare Professionals

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IMPORTANT SAFETY INFORMATION

Warnings and Precautions
Hypermethioninemia in Patients with CBS Deficiency: Betaine Anhydrous may worsen high methionine blood levels and accumulation of excess fluid in the brain has been reported. If you have been told you have CBS deficiency, your doctor will be monitoring your methionine blood levels to see if changes in your diet and dosage are necessary.

Adverse Reactions
Most common side effects were nausea and gastrointestinal distress, based on a survey of doctors. To report a suspected adverse event related to Betaine Anhydrous, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE
Betaine anhydrous for oral solution is indicated in children and adults for the treatment of homocystinuria to decrease high homocysteine blood levels. Homocystinuria is a rare genetic disorder in which there is an abnormal accumulation of the amino acid homocysteine in the blood and urine. The following are considered to be homocystinuria disorders:

  • Cystathionine beta-synthase (CBS) deficiency
  • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
  • Cobalamin cofactor metabolism (cbl) defect

Please see full Prescribing Information for more information.

LAB-1469-v1

    Reference: 1. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. Accessed March 3, 2023. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm

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