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) defect
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.