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Cystadane

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Cystadane

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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.

Nonclinical Toxicology

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

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.

Nursing Mothers

It is not known whether Cystadane (betaine anhydrous) is excreted in human milk. Use only if clearly needed.

Pediatric Use

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].

Last reviewed on RxList: 4/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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