Ask Your Doctor for
the Only FDA-Approved
Prescription Betaine Medication
CYSTADANE is a prescription medication that only contains the active ingredient betaine anhydrous (powder).
Betaine is produced naturally by the body. Some foods contain tiny amounts of betaine. CYSTADANE is manufactured according to the high quality and consistency standards required for prescription drugs.
INDICATIONS AND USAGE
CYSTADANE (betaine anhydrous for oral solution) is indicated 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) defects
IMPORTANT SAFETY INFORMATION
- Hypermethioninemia: CYSTADANE may worsen high methionine blood levels in patients with CBS deficiency. Accumulation of excess fluid in the brain has been reported.
- Monitoring: 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.
- Most common side effects were nausea and gastrointestinal distress, based on a survey of doctors.
- To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch.
- Pregnancy: The effects of CYSTADANE on pregnancy and an unborn baby are not known.
- Nursing women: Breast-feeding by a patient taking CYSTADANE is not recommended.
- Pediatrics: Patients ranging in age from 24 days to 17 years have been treated with CYSTADANE. Children younger than 3 years of age may benefit from slowly adjusting the dose until the desired medical result is achieved.
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IMPORTANT SAFETY INFORMATION
- Hypermethioninemia: CYSTADANE may worsen high methionine blood levels in patients with CBS deficiency. Accumulation of excess fluid in the brain has been reported.
- Monitoring: 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.