"The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluatio"...
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 (betaine anhydrous) 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 (betaine anhydrous) . 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 (betaine anhydrous) dose.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity and fertility studies have not been conducted with Cystadane (betaine anhydrous) . 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 (betaine anhydrous) . It is also not known whether Cystadane (betaine anhydrous) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystadane (betaine anhydrous) should be given to a pregnant woman only if clearly needed.
It is not known whether Cystadane (betaine anhydrous) is excreted in human milk. Use only if clearly needed.
The majority of case studies of homocystinuria patients treated with Cystadane (betaine anhydrous) 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: 4/22/2010
Additional Cystadane Information
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