Cystadane® is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in:
- cystathionine beta-synthase (CBS),
- 5,10-methylenatetrahydrofolate reductase (MTHFR),
- cobalamin cofactor metabolism (cbl).
Patient response to Cystadane® can be monitored by homocysteine plasma levels (see DOSAGE AND ADMINISTRATION). Response usually occurs within a week and steady state within a month.
Cystadane® has been administered concomitantly with vitamin B6 (pyridoxine), vitamin B12 (cobalamin), and folate.*
IMPORTANT SAFETY INFORMATION
The most serious adverse reaction reported with Cystadane® treatment is the development of hypermethioninemia and cerebral edema in patients with CBS Deficiency.*
In a survey study of physicians who had treated a total of 111 homocystinuria patients with Cystadane®, the types of adverse effects and the number of patients experiencing them were as follows:
Nausea (2), GI distress (2), Diarrhea (1), Bad taste (1), Caused odor (1), Questionable psychological changes (1), Aspirated the powder (1).*
*See Package Insert