Balsalazide Disodium (Page 2 of 6)

5.9 Interference with Laboratory Tests

Use of balsalazide disodium capsules, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and the main metabolite of mesalamine, N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in labeling:

Renal Impairment [see Warnings and Precautions (5.1)]
Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2)]
Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
Hepatic Failure [see Warnings and Precautions (5.4)]
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5)]
Upper Gastrointestinal Tract Obstruction [see Warnings and Precautions (5.6)]
Photosensitivity [see Warnings and Precautions (5.7)]
Nephrolithiasis [see Warnings and Precautions (5.8)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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.

Adult Ulcerative Colitis:

During clinical development, 259 adult patients with active ulcerative colitis were exposed to 6.75 g/day balsalazide in 4 controlled trials.

In the 4 controlled clinical trials patients receiving a balsalazide dose of 6.75 g/day most frequently reported the following adverse reactions: headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable among patients on balsalazide and placebo.

Adverse reactions reported by 1% or more of patients who participated in the 4 well-controlled, Phase 3 trials are presented by treatment group (Table 1).

The number of placebo patients (35), however, is too small for valid comparisons. Some adverse reactions, such as abdominal pain, fatigue, and nausea were reported more frequently in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

Table 1: Adverse Reactions Occurring in ≥ 1% of Adult Balsalazide Patients in Controlled Trials *
*
Adverse reactions occurring in at least 1% of balsalazide patients which were less frequent than placebo for the same adverse reaction were not included in the table.

Adverse Reaction

Balsalazide 6.75 g/day

[N=259]

Placebo

[N=35]

Abdominal pain

16 (6%)

1 (3%)

Diarrhea

14 (5%)

1 (3%)

Arthralgia

9 (4%)

0%

Rhinitis

6 (2%)

0%

Insomnia

6 (2%)

0%

Fatigue

6 (2%)

0%

Flatulence

5 (2%)

0%

Fever

5 (2%)

0%

Dyspepsia

5 (2%)

0%

Pharyngitis

4 (2%)

0%

Coughing

4 (2%)

0%

Anorexia

4 (2%)

0%

Urinary tract infection

3 (1%)

0%

Myalgia

3 (1%)

0%

Flu-like disorder

3 (1%)

0%

Dry mouth

3 (1%)

0%

Cramps

3 (1%)

0%

Constipation

3 (1%)

0%

Pediatric Ulcerative Colitis:

In a clinical trial in 68 pediatric patients aged 5 to 17 years with mildly to moderately active ulcerative colitis who received 6.75 g/day or 2.25 g/day balsalazide for 8 weeks, the most frequently reported adverse reactions were headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%), and pyrexia (6%) [see Table 2].

One patient who received balsalazide 6.75 g/day and 3 patients who received balsalazide 2.25 g/day discontinued treatment because of adverse reactions. In addition, 2 patients in each dose group discontinued because of a lack of efficacy.

Adverse reactions reported by 3% or more of pediatric patients within either treatment group in the Phase 3 trial are presented in Table 2.

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥3% of Patients in Either Treatment Group in a Controlled Study of 68 Pediatric Patients

Balsalazide

Adverse Reaction

6.75 g/day

[N = 33]

2.25 g/day

[N = 35]

Total

[N = 68]

Headache

5 (15%)

5 (14%)

10 (15%)

Abdominal pain upper

3 (9%)

6 (17%)

9 (13%)

Abdominal pain

4 (12%)

4 (11%)

8 (12%)

Vomiting

1 (3%)

6 (17%)

7 (10%)

Diarrhea

2 (6%)

4 (11%)

6 (9%)

Colitis ulcerative

2 (6%)

2 (6%)

4 (6%)

Nasopharyngitis

3 (9%)

1 (3%)

4 (6%)

Pyrexia

0 (0%)

4 (11%)

4 (6%)

Hematochezia

0 (0%)

3 (9%)

3 (4%)

Nausea

0 (0%)

3 (9%)

3 (4%)

Influenza

1 (3%)

2 (6%)

3 (4%)

Fatigue

2 (6%)

1 (3%)

3 (4%)

Stomatitis

0 (0%)

2 (6%)

2 (3%)

Cough

0 (0%)

2 (6%)

2 (3%)

Pharyngolaryngeal pain

2 (6%)

0 (0%)

2 (3%)

Dysmenorrhea

2 (6%)

0 (0%)

2 (3%)

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