CYSTADANE® (betaine anhydrous for oral solution) drug shortage has been resolved
IMPORTANT DRUG INFORMATION UPDATE
March 5, 2018
Dear Health Care Provider,
Recordati Rare Diseases Inc. (Recordati) is pleased to announce that effective March 12, 2018 the CYSTADANE® drug shortage has been resolved.
There had been a manufacturing issue with CYSTADANE in December 2017, which resulted in an interim shortage of the product in the U.S. market. In order to alleviate the shortage of CYSTADANE in the U.S., Recordati coordinated with the Food and Drug Administration (FDA) to import CYSTADANE product approved for use in the United Kingdom into the U.S. market.
The manufacturing issue has been identified and successfully remediated, normal product manufacturing for U.S. FDA-approved CYSTADANE has resumed, and the drug shortage situation has been successfully resolved. The U.S. specialty pharmacy AnovoRx Group LLC will resume dispensing the U.S. FDA-approved CYSTADANE.
CYSTADANE (betaine anhydrous for oral solution) is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are:
- Cystathionine beta-synthase (CBS) deficiency
- 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
- Cobalamin cofactor metabolism (cbl) defect
Important Safety Information
- Hypermethioninemia: CYSTADANE may worsen elevated plasma methionine concentrations in patients with CBS deficiency. Cerebral edema has been reported in patients receiving CYSTADANE.
- Monitoring: Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 μmol/L through dietary modification and, if necessary, a reduction of CYSTADANE dose.
- Most common adverse reactions (incidence > 2%) were nausea and gastrointestinal distress, based on physician survey.
- Pregnancy: Animal reproduction studies have not been conducted with CYSTADANE. Use only if clearly needed.
- Nursing women: It is not known whether CYSTADANE is excreted in human milk. Use only if clearly needed.
- Pediatrics: Pediatric patients ranging in age from 24 days to 17 years have been treated with CYSTADANE. Children younger than 3 years of age may benefit from dose titration.
Reporting of Adverse Events
Any adverse effects or medication issues resulting from the use of this drug or quality issues should be reported to Recordati Rare Diseases Inc. at 1-888-575-8344.
Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Please refer to the FDA-approved package insert for Full Prescribing Information.
We are committed to helping address patients’ unmet needs through our corporate mission. If you have questions or concerns regarding this product, please call AnovoRx Group, the specialty pharmacy that dispenses CYSTADANE, at 1-888-487-4703 or Recordati Rare Diseases Medical Information at 1-888-575-8344.
Sincerely,
Steven R. Peltier
Vice President, Regulatory & Quality Compliance
Chief Compliance Officer
Recordati Rare Diseases Inc.