Tiopronin
Generic: TIOPRONIN
Basic Information
Manufacturer
BioComp Pharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
1f2eb1d6-faa6-e352-e063-6294a90a7fb5
Indications & Usage
1 INDICATIONS AND USAGE Tiopronin Delayed-Release Tablets are 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.
Tiopronin Delayed-Release Tablets are a reducing and complexing thiol 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.
(1)
Tiopronin Delayed-Release Tablets are a reducing and complexing thiol 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.
(1)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Proteinuria [see Warnings and Precautions (5.1)] • Hypersensitivity [see Warnings and Precautions (5.2)] Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.
(6) To report SUSPECTED ADVERSE REACTIONS, contact BioComp Pharma, Inc.
at toll-free phone # 1-866- 762-2365 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, 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 Tiopronin Tablets.
In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require Tiopronin Tablets withdrawal.
Table 1 presents adverse reactions ≥5% in either treatment group occurring in this trial.
Taste Disturbance A reduction in taste perception may develop.
It is believed to be the result of chelation of trace metals by tiopronin.
Hypogeusia is often self-limited.
image 6.2 Postmarketing Experience Adverse reactions have been reported from the literature, as well as during post-approval use of Tiopronin Tablets.
Because the post-approval reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Tiopronin Tablets exposure.
Adverse reactions reported during the postmarketing use of Tiopronin Tablets are listed by body system in Table 2.
Image
(6) To report SUSPECTED ADVERSE REACTIONS, contact BioComp Pharma, Inc.
at toll-free phone # 1-866- 762-2365 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, 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 Tiopronin Tablets.
In those without prior history of d-penicillamine treatment, 6% developed reactions of sufficient severity to require Tiopronin Tablets withdrawal.
Table 1 presents adverse reactions ≥5% in either treatment group occurring in this trial.
Taste Disturbance A reduction in taste perception may develop.
It is believed to be the result of chelation of trace metals by tiopronin.
Hypogeusia is often self-limited.
image 6.2 Postmarketing Experience Adverse reactions have been reported from the literature, as well as during post-approval use of Tiopronin Tablets.
Because the post-approval reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Tiopronin Tablets exposure.
Adverse reactions reported during the postmarketing use of Tiopronin Tablets are listed by body system in Table 2.
Image