"The National Institutes of Health has launched DS-Connect, a Web-based health registry that will serve as a national health resource for people with Down syndrome and their families, researchers, and health care providers.
Risk of Hypermethioninemia in Patients with CBS Deficiency Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations. Treatment with Cystadane may further increase methionine concentrations due to the remethylation of homocysteine to methionine. Cerebral edema has been reported in patients with hypermethioninemia, including patients treated with Cystadane. Plasma methionine concentrations should be monitored in patients with CBS deficiency. Plasma methionine concentrations should be kept below 1,000 μmol/L through dietary modification and, if necessary, a reduction of Cystadane dose.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term carcinogenicity and fertility studies have not been conducted with Cystadane. No evidence of genotoxicity was demonstrated in the following tests: metaphase analysis of human lymphocytes; bacterial reverse mutation assay; and mouse micronucleus test.
Use In Specific Populations
Pregnancy Category C: Animal reproduction studies have not been conducted with Cystadane. It is also not known whether Cystadane can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystadane should be given to a pregnant woman only if clearly needed.
It is not known whether Cystadane is excreted in human milk. Use only if clearly needed.
The majority of case studies of homocystinuria patients treated with Cystadane have been pediatric patients, including patients ranging in age from 24 days to 17 years [see Clinical Studies]. Children younger than 3 years of age may benefit from dose titration [see DOSAGE AND ADMINISTRATION].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/5/2016
Additional Cystadane Information
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