cystadane

Adults and Pediatric Patients 3 Years of Age and Older The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. ( 2.1 ) Pediatric Patients Less than 3 Years of Age The recommended starting dosage is 100 mg/kg/day, administered orally in divided doses of 50 mg/kg twice daily, and then increased weekly by 50 mg/kg increments. ( 2.1 ) Monitor patient response by plasma homocysteine concentrations. ( 2.1 ) Increase the dosage gradually until the plasma total homocysteine concentration is undetectable or present only in small amounts. ( 2.1 ) Preparation and Administration Instructions 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 until completely dissolved, or mixed with food for immediate ingestion. ( 2.2 ) 2.1 Dosage Therapy with CYSTADANE should be directed by physicians knowledgeable in the management of patients with homocystinuria. Adults and Pediatric Patients 3 Years of Age and Older The recommended dosage is 6 grams per day, administered orally in divided doses of 3 grams twice daily. Pediatric Patients Less than 3 Years of Age The recommended starting dosage is 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments. Monitoring Monitor patient response to CYSTADANE by homocysteine…

The following serious adverse reactions are described elsewhere in labeling: Hypermethioninemia and cerebral edema in patients with CBS deficiency [ see Warnings and Precautions ( 5.1 ) ]. Most common adverse reactions (> 2%) are: nausea and gastrointestinal distress, based on physician survey. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with CYSTADANE. Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey. Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions were reported (Table 1): Table 1: Number of Patients with Adverse Reactions to CYSTADANE by Physician Survey Adverse Reactions Number of Patients Nausea 2…

None. None ( 4 )

There is no information on CYSTADANE overdose in humans. In an acute toxicology study in rats, death occurred frequently at doses equal to or greater than 10 g/kg.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.