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Details with Side Effects
No information provided. Please see PRECAUTIONS below and SIDE EFFECTS.
Exacerbations of Colitis
In the adult clinical trials, 3 out of 259 patients reported exacerbation of the symptoms of ulcerative colitis. In the pediatric clinical trials, 4 out of 68 patients reported exacerbation of the symptoms of ulcerative colitis.
Observe patients closely for worsening of these symptoms while on treatment.
Patients with pyloric stenosis may have prolonged gastric retention of COLAZAL (balsalazide) capsules.
Renal toxicity has been observed in animals and patients given other mesalamine products. Therefore, caution should be exercised when administering COLAZAL (balsalazide) to patients with known renal dysfunction or a history of renal disease. [See Nonclinical Toxicology]
Use in specific Populations
Pregnancy Category B. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether balsalazide disodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when COLAZAL (balsalazide) is administered to a nursing woman.
Use of COLAZAL (balsalazide) in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by:
- extrapolation of results from clinical studies that supported the approval of COLAZAL (balsalazide) for adults.
- a clinical trial of 68 patients ages 5-17 years comparing two doses of COLAZAL (balsalazide) (6.75 g/day and 2.25 g/day), and
- a pharmacokinetic study performed on a subset of the pediatric study population. [See Adverse Reactions, Clinical Pharmacology, and Clinical Studies].
Based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day.
Safety and efficacy of COLAZAL (balsalazide) in pediatric patients below the age of 5 years have not been established.
Non Clinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month rat (Sprague Dawley) carcinogenicity study, oral (dietary) balsalazide disodium at doses up to 2 g/kg/day was not tumorigenic. For a 50-kg person of average height this dose represents 2.4 times the recommended human dose on a body surface area basis. Balsalazide disodium was not genotoxic in the following in vitro or in vivo tests: Ames test, human lymphocyte chromosomal aberration test, and mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or mouse micronucleus test. However, it was genotoxic in the in vitro Chinese hamster lung cell (CH V79/HGPRT) forward mutation test.
4-aminobenzoyl-β-alanine, a metabolite of balsalazide disodium, was not genotoxic in the Ames test and the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test but was positive in the human lymphocyte chromosomal aberration test. N-acetyl-4-aminobenzoyl-β-alanine, a conjugated metabolite of balsalazide disodium, was not genotoxic in Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or the human lymphocyte chromosomal aberration test. Balsalazide disodium at oral doses up to 2 g/kg/day, 2.4 times the recommended human dose based on body surface area, was found to have no effect on fertility and reproductive performance in rats.
Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.
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