July 30, 2016
Recommended Topic Related To:


"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Hereditary angioede"...





Included as part of the PRECAUTIONS section.


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 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].

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/22/2010


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Women's Health

Find out what women really need.

Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations