Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 28 February 2017

Indication(s)

1 INDICATIONS AND USAGE GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Limitations of Use: •Effectiveness of GIAZO in the treatment of female patients was not demonstrated in clinical trials [see Clinical Trials (14.1)]. •Safety and effectiveness of GIAZO therapy beyond 8 weeks have not been established. GIAZO is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. (1) Limitations of Use •Effectiveness in female patients was not demonstrated in clinical trials. (1) •Safety and effectiveness of GIAZO beyond 8 weeks have not been established. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS GIAZO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of GIAZO tablets [see Description (11)]. Patients with hypersensitivity to salicylates or to any of the components of GIAZO tablets or balsalazide metabolites. (4)
Adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) in male UC patients are anemia, diarrhea, pharyngolaryngeal pain, and urinary tract infection. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 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 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. The data described below reflect exposure of GIAZO in 565 ulcerative colitis patients with mildly to moderately active disease. GIAZO was evaluated in one placebo-controlled trial (168 treated with GIAZO), one active-controlled trial (210 treated with GIAZO); and a subset of these patients also participated in an uncontrolled, open-label, extension study (additional 187 treated with GIAZO). The population studied had a mean age of 43.1 (range: 18-80) years; approximately 94% of patients were < 65 years old, 49% were male, and 84% were white. In the placebo-controlled trial, the most common adverse reactions with GIAZO in male patients were headache, nasopharyngitis, anemia, diarrhea, fatigue, pharyngolaryngeal pain, and urinary tract infection. 10% of patients in the GIAZO group and 13% of patients in the placebo group discontinued treatment due to an adverse reaction. The majority of adverse reactions were mild to moderate in severity. The most common serious adverse reactions in both the placebo and GIAZO groups were gastrointestinal disorders, which were mainly associated with symptoms of ulcerative colitis. Adverse reactions occurring in at least 2% of male patients and at a rate numerically higher than placebo in the placebo-controlled trial are listed in Table 1. Table 1: Adverse Reactions Experienced by at Least 2% of GIAZO –Treated Male Patients and at a Rate Numerically Greater than Placebo in a Placebo-Controlled Trial Adverse Reaction GIAZO 6.6 g/day N=82 PLACEBO N=37 Anemia 3.7% 0% Diarrhea 3.7% 0% Pharyngolaryngeal Pain 3.7% 0% Urinary Tract Infection 3.7% 0% Arthralgia 2.4% 0% Insomnia 2.4% 0% Musculoskeletal Pain 2.4% 0% Data collected from all three trials (placebo-controlled, active-controlled, and open-label) showed that female patients reported adverse reactions more frequently than did male patients (76% and 66%, respectively). The following adverse reactions, presented by body system, were reported by less than 1% of GIAZO-treated ulcerative colitis patients in controlled trials. Cardiovascular and Vascular: increased blood pressure, increased heart rate Dermatological: erythema nodosum, rash Respiratory, Thoracic and Mediastinal Disorders: dyspnea Gastrointestinal Disorders: abdominal pain, constipation, defecation urgency, diarrhea, dry mouth, hard feces, flatulence, gastroesophageal reflux disease, vomiting Hepatobiliary Disorders: increased aspartate aminotransferase Infections and Infestations: gastroenteritis, upper respiratory infection Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain, myalgia Nervous System Disorders: dizziness, lethargy General Disorders and Administrative Site Disorders: face edema, fatigue, malaise, pain, pyrexia, swelling 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to products which contain or are metabolized to mesalamine, including balsalazide. Cardiovascular and Vascular: myocarditis, pericarditis, vasculitis Respiratory: alveolitis, pleural effusion, pneumonia (with and without eosinophilia) Gastrointestinal: pancreatitis Renal: interstitial nephritis, renal failure. Hepatobiliary Disorders: elevated liver enzymes (AST, ALT, GGT, LDH, alkaline phosphatase), elevated bilirubin, jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure, Kawasaki-like syndrome including hepatic dysfunction. Some of these cases were fatal. Dermatological: alopecia, pruritus

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The dose is three 1.1 g GIAZO tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks. Three 1.1 g GIAZO tablets 2 times a day (6.6 g/day) with or without food for up to 8 weeks. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B. Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.5 and 4.9 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. Mesalamine, a metabolite of GIAZO, is known to cross the placental barrier. 8.3 Nursing Mothers It is not known whether balsalazide disodium or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GIAZO is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of GIAZO in pediatric patients have not been established. 8.5 Geriatric Use Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia and pancytopenia, in patients who were 65 years or older who were taking mesalamine-containing products. GIAZO is converted into mesalamine in the colon. Caution should be taken to closely monitor blood cell counts during therapy. Clinical trials of GIAZO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing GIAZO.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether balsalazide disodium or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GIAZO is administered to a nursing woman.

Interactions

7 DRUG INTERACTIONS Based on in vitro studies, balsalazide and its metabolites [5‑aminosalicylic acid (5-ASA), N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), 4‑aminobenzoyl-ß-alanine (4-ABA), and N-acetyl-4-aminobenzoyl-ß-alanine (N‑Ac‑4‑ABA)] are not expected to inhibit the metabolism of other drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5.

More information

Category Value
Authorisation number NDA022205
Orphan designation No
Product NDC 65649-102
Date Last Revised 22-06-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1243583
Marketing authorisation holder Salix Pharmaceuticals, Inc