FAQs
CYSTADANE is a prescription medicine indicated to lower high levels of homocysteine in your blood due to a genetic disorder that causes homocystinuria. High blood levels of homocysteine may cause many different symptoms and lead to serious, lifelong health problems.
CYSTADANE is the only prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat homocystinuria. CYSTADANE is made according to the high quality and consistency standards required for prescription drugs and contains only the active ingredient betaine anhydrous
Ask your healthcare provider about including CYSTADANE as part of your treatment plan. If CYSTADANE is right for you, your healthcare provider will fax a CYSTADANE prescription form to Anovo, a specialty pharmacy that dispenses CYSTADANE. Anovo will mail CYSTADANE to your home every month. Anovo will call you when you need a refill of CYSTADANE. It is important to call Anovo back to talk about the refill or it will not be sent.
Many prescription insurance plans cover CYSTADANE. The team at Anovo specialty pharmacy will help determine your insurance coverage.
The distributor of CYSTADANE also offers several assistance programs:
• Copay Assistance Program to assist with copays or co-insurance cost
• Patient Assistance Program to assist people with no insurance or whose insurance does not cover CYSTADANE
The Anovo team can help you find out if you qualify for these programs.
Call your healthcare provider if you have questions about your homocystinuria treatment plan.
Call Anovo at 1-888-487-4703 if you have questions about how to get, pay for, or take CYSTADANE.
INDICATIONS AND USAGE
CYSTADANE (betaine anhydrous for oral solution) is indicated in children and adults for the treatment of homocystinuria to decrease high homocysteine blood levels. Homocystinuria is a rare genetic disorder in which there is an abnormal accumulation of the amino acid homocysteine in the blood and urine. The following are considered to be homocystinuria disorders:
- Cystathionine beta-synthase (CBS) deficiency
- 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
- Cobalamin cofactor metabolism (cbl) defect
IMPORTANT SAFETY INFORMATION
- Hypermethioninemia in Patients with CBS Deficiency: CYSTADANE may worsen high methionine blood levels and accumulation of excess fluid in the brain has been reported. If you have been told you have CBS deficiency, your doctor will be monitoring your methionine blood levels to see if changes in your diet and dosage are necessary.
- Most common side effects were nausea and gastrointestinal distress, based on a survey of doctors.
- To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
IMPORTANT SAFETY INFORMATION
- Hypermethioninemia in Patients with CBS Deficiency: CYSTADANE may worsen high methionine blood levels and accumulation of excess fluid in the brain has been reported. If you have been told you have CBS deficiency, your doctor will be monitoring your methionine blood levels to see if changes in your diet and dosage are necessary.
- Most common side effects were nausea and gastrointestinal distress, based on a survey of doctors.