THIOLA- tiopronin tablet, sugar coated
Mission Pharmacal Company
THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.
Pediatrics: The recommended initial dosage in pediatric patients weighing 20 kg and greater is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].
Assess for proteinuria before treatment and every 3 to 6 months during treatment [see Warnings and Precautions (5.1)].
THIOLA is contraindicated in patients with hypersensitivity to tiopronin or any other components of THIOLA [see Warnings and Precautions (5.2)].
Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria [see Dosage and Administration (2.2), Adverse Reactions (6.1, 6.2) Use in Specific Populations (8.4)]. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria [see Dosage and Administration (2.2)].
Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported [see Contraindications (4)].
- Proteinuria [see Warnings and Precautions (5.1)]
- Hypersensitivity [see Warnings and Precautions (5.2)]
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of the drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring at an incidence of ≥5% in an uncontrolled trial in 66 patients with cystinuria age 9 to 68 years are shown in the table below. Patients in group 1 had previously been treated with d-penicillamine; those in group 2 had not. Of those patients who had stopped taking d-penicillamine due to toxicity (34 out of 49 patients in group 1), 22 were able to continue treatment with THIOLA. In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require THIOLA withdrawal.
Table 1 presents adverse reactions ≥5% in either treatment group occurring in this trial.
|Table 1:||Adverse Reactions Occurring in One or More Patients|
|System Organ Class||Adverse Reaction||Group 1 Previously treated with d‑penicillamine (N = 49)||Group 2 Naïve to d‑penicillamine (N = 17)|
|Blood and Lymphatic System Disorders||anemia||1 (2%)||1 (6%)|
|Gastrointestinal Disorders||nausea||12 (25%)||2 (12%)|
|diarrhea/soft stools||9 (18%)||1 (6%)|
|abdominal pain||–||1 (6%)|
|oral ulcers||6 (12%)||3 (18%)|
|General Disorders and Administration Site Conditions||fever||4 (8%)||–|
|weakness||2 (4%)||2 (12%)|
|peripheral (edema)||3 (6%)||1 (6%)|
|chest pain||–||1 (6%)|
|Metabolism and Nutrition Disorders||anorexia||4 (8%)||–|
|Musculoskeletal and Connective Tissue Disorders||arthralgia||–||2 (12%)|
|Renal and Urinary Disorders||proteinuria||5 (10%)||1 (6%)|
|Respiratory, Thoracic and Mediastinal Disorders||cough||–||1 (6%)|
|Skin and Subcutaneous Tissue Disorders||rash||7 (14%)||2 (12%)|
|pruritus||2 (4%)||1 (6%)|
|skin wrinkling||3 (6%)||1 (6%)|
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