Trade Name: Cystadane

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Rare Disease Therapeutics, Inc.

Presentation: POWDER, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 6 g/1

Storage and handling

BETAINE Methylating Activity [MoA],Methylating Agent [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • Changes of Address u00a0 08/2008ntttAddress of adverse reactions u00a0 07/2010ntttChange of distributor u00a0 07/2014ntttManufactured For / Under License From u00a0 07/2014nttt
  • Cystadane is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels.u00a0 Included within the category of homocystinuria are ():n
  • Cystathionine beta-synthase (CBS) deficiency
  • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
  • Cobalamin cofactor metabolism (cbl) defectn
  • ntttCystadaneu00ae (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels.u00a0 ntttIncluded within the category of homocystinuria are:u00a0u00a0 n
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  • Usual dose in adult and pediatric patients is 6 grams per day, administered orally in divided doses of 3 grams two times a day.()
  • In children less than 3 years of age, may initiate dosing at 100 mg/kg/day, divided in twice daily doses, and then increased weekly by 50 mg/kg increments.()
  • Dose can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts.()
  • Monitor patient response by plasma homocysteine levels.()
  • Prescribed amount of Cystadane should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula, or mixed with food for immediate ingestion.()n
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  • Powder for oral solution available in bottles containing 180 grams of betaine anhydrous.()n
  • Cystadane is a white, granular, hygroscopic powder for oral solution available in bottles containing 180 grams of betaine anhydrous.n n
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  • Nonen
  • None.n
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  • Hypermethioninemia:u00a0 Cystadane may worsen elevated plasma methionine concentrations in patients with CBS deficiency.u00a0 Cerebral edema has been reported in patients receiving Cystadane.()
  • Monitoring:u00a0 Monitor plasma methionine concentrations in patients with CBS deficiency.u00a0 Keep plasma methionine concentrations below 1,000 u00b5mol/L through dietary medication and, if necessary, a reduction of Cystadane dose. ()
  • nttttttttRisk of Hypermethioninemia in Patients with CBS DeficiencynttttttttPatients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations.u00a0 nttttttttTreatment with Cystadane may further increase methionine concentrations due to the remethylation of homocysteine to methionine.ntttu00a0 tttttCerebral edema has been reported in patients with hypermethioninemia, including patients treated with Cystadane.u00a0 Plasma methionine concentrations should be monitored in patients with CBS deficiency.u00a0 nttttttttPlasma methionine concentrations should be kept below 1,000 u00b5mol/L through dietary modification and, if necessary, a reduction of Cystadane dose.ntttttttt
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  • Most common adverse reactions (incidence > 2%) were nausea and gastrointestinal distress, based on physician survey. n ntttntttTo report SUSPECTED ADVERSE REACTIONS, contact 877-828-8874, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • Pregnancy: Animal reproduction studies have not been conducted with Cystadane.u00a0 Use only if clearly needed.()
  • Nursing women: It is not known whether Cystadane is excreted in human milk.u00a0 Use only if clearly needed.()
  • Pediatrics: Pediatric patients ranging in age from 24 days to 17 years have been treated with Cystadane.u00a0 Children younger than 3 years of age may benefit from dose titration.
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  • In an acute toxicology study in rats, death occurred frequently at doses equal to or greater than 10 g/kg.n n
  • Cystadane (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria.u00a0 ntttIt contains no ingredients other than anhydrous betaine. Cystadane is a white, granular, hygroscopic powder, which is diluted in water and administered orally.u00a0 ntttThe chemical name of betaine anhydrous powder is trimethylglycine.u00a0 It has a molecular weight of 117.15.u00a0 ntttThe structural formula is:
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  • nttttttLong-term carcinogenicity and fertility studies have not been conducted with Cystadane.u00a0 nttttttNo evidence of genotoxicity was demonstrated in the following tests: metaphase analysis of human lymphocytes; bacterial reverse mutation assay; and mouse micronucleus test.ntttttt
  • Cystadane was studied in a double-blind, placebo-controlled, crossover study in 6 patients with CBS deficiency, ages 7 to 32 years at enrollment.u00a0 ntttCystadane was administered at a dosage of 3 grams twice daily, for 12 months. Plasma homocystine levels were significantly reduced (p<0.01) compared to placebo. ntttPlasma methionine levels were variable and not significantly different compared to placebo. No adverse events were reported in any patient.
  • Cystadane has also been evaluated in observational studies without concurrent controls in patients with homocystinuria due to CBS deficiency, MTHFR deficiency, or cbl defect.A review of 16 case studies and the randomized controlled trial previously described was also conducted, and the data available for each study were summarized; however, no formal statistical analyses were performed. nttttThe studies included a total of 78 male and female patients with homocystinuria who were treated with Cystadane. This included 48 patients with CBS deficiency, 13 with MTHFR deficiency, and 11 with cbl defect, ranging in age from 24 days to 53 years. The majority of patients (n=48) received 6 gm/day, 3 patients received less than 6 gm/day, 12 patients received doses from 6 to 15 gm/day, and 5 patients received doses over 15 gm/day. nttttMost patients were treated for more than 3 months (n=57) and 30 patients were treated for 1 year or longer (range 1 month to 11 years). Homocystine is formed nonenzymatically from two molecules of homocysteine, and both have be used to evaluate the effect of Cystadane in patients with homocystinuria. Plasma homocystine or homocysteine levels were reported numerically for 62 patients, and 61 of these patients showed decreases with Cystadane treatment. nttttHomocystine decreased by 83-88% regardless of pre-treatment level, and homocysteine decreased by 71-83%, regardless of the pre-treatment level. Clinical improvement, such as improvement in seizures, or behavioral and cognitive functioning, was reported by the treating physicians in about three-fourths of patients. Many of these patients were also taking other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), and folate with variable biochemical responses. nttttIn most cases, adding Cystadane resulted in a further reduction of either homocystine or homocysteine.
  • Cystadane is available in plastic bottles containing 180 grams of betaine anhydrous.u00a0 Each bottle is equipped with a plastic child-resistant cap and is supplied with a polystyrene measuring scoop.u00a0 One level scoop (1.7 mL) is equal to 1 gram of betaine anhydrous powder.
  • NDC 66621-4000-1u00a0u00a0u00a0 180 g/bottle
  • Cystadane can be ordered by calling AnovoRx Group, LLC, Customer service at 1-888-487-4703
  • Store at room temperature, 15 u2013 30 u02daC (59 u2013 86 u02daF).u00a0 Protect from moisture.
  • Patients should be advised of the following information before beginning treatment with Cystadane:
  • - Measure with the scoop provided.
  • - Measure the number of scoops as prescribed by their healthcare professional. One level scoop (1.7 mL) is equivalent to 1 gram of betaine anhydrous powder.
  • - Mix powder with 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula until completely dissolved, or mix with food, then ingest mixture immediately.
  • - Always replace the cap tightly after using, and protect powder from moisture.n
  • Manufactured For:
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of betaine (Cystadane) which is also known as Cystadane and Manufactured by Rare Disease Therapeutics, Inc.. It is available in strength of 6 g/1.

betaine (Cystadane) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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