Treating Homocystinuria
Creating an alternate remethylation pathway with CYSTADANE
On the way to lowering homocysteine levels
Lowering homocysteine
concentrations with CYSTADANE
Learn about treating homocystinuria caused by CBS deficiency, MTHFR deficiency, and cbl defect.
INDICATIONS AND USAGE
Cystadane is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. Included within the category of homocystinuria are:
- Cystathionine beta-synthase (CBS) deficiency
- 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
- Cobalamin cofactor metabolism (cbl) defect
IMPORTANT SAFETY INFORMATION
- Hypermethioninemia in Patients with CBS Deficiency: CYSTADANE may worsen elevated plasma methionine concentrations and cerebral edema has been reported. Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 micromol/L through dietary modification and, if necessary, a reduction of CYSTADANE dosage.
- Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey.
- To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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IMPORTANT SAFETY INFORMATION
- Hypermethioninemia in Patients with CBS Deficiency: CYSTADANE may worsen elevated plasma methionine concentrations and cerebral edema has been reported. Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 micromol/L through dietary modification and, if necessary, a reduction of CYSTADANE dosage.
- Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey.