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Cystadane (Betaine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Cystadane® (betaine anhydrous for oral solution) is 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


DOSAGE AND ADMINISTRATION

Dosage

The usual dosage in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams twice daily.  In pediatric patients less than 3 years of age, dosage may be started at 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments. 
Therapy with Cystadane should be directed by physicians knowledgeable in the management of patients with homocystinuria.  Patient response to Cystadane can be monitored by homocysteine plasma levels.  Dosage in all patients can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts. Response (by homocysteine plasma levels) usually occurs within several days and steady state within a month.  Plasma methionine concentrations should be monitored in patients with CBS deficiency [See Warnings and Precautions].

Dosages of up to 20 grams per day have been necessary to control homocysteine levels in some patients.  However, one pharmacokinetic and pharmacodynamic in vitro simulation study indicated minimal benefit from exceeding a twice-daily dosing schedule and a 150 mg/kg/day dosage for Cystadane.

Administration

The prescribed amount of Cystadane should be measured with the measuring scoop provided (one level 1.7 mL scoop is equal to 1 gram of betaine anhydrous powder) and then dissolved in 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula, or mixed with food for immediate ingestion.

DOSAGE FORMS AND STRENGTHS

Cystadane is a white, granular, hygroscopic powder for oral solution available in bottles containing 180 grams of betaine anhydrous.

HOW SUPPLIED/STORAGE AND HANDLING

Cystadane is available in plastic bottles containing 180 grams of betaine anhydrous.  Each bottle is equipped with a plastic child-resistant cap and is supplied with a polystyrene measuring scoop.  One level scoop (1.7 mL) is equal to 1 gram of betaine anhydrous powder.

NDC 66621-4000-1    180 g/bottle

Cystadane can be ordered by calling AnovoRx Group, LLC, Customer service at 1-888-487-4703

Storage

Store at room temperature, 15 – 30 ˚C (59 – 86 ˚F).  Protect from moisture.

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