Balsalazide Disodium

Dosage Forms And Strengths

GIAZO is available as yellow, oval, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.

Storage And Handling

GIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.

Bottles of 180 Tablets NDC 65649-102-02

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Manufactured for: Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LC Bridgewater, NJ 08807 USA. Revised: June 2016

• Instruct patients not to take GIAZO if they have a hypersensitivity to salicylates (e.g., aspirin).
• Instruct patients to take GIAZO with or without food.
• Advise patients who need to control sodium intake that the recommended dosing of GIAZO (6.6 g/day) provides about 756 mg of sodium per day.
• Instruct patients to contact their health care provider if they experience a worsening of their ulcerative colitis symptoms, because it could be due to a reaction to GIAZO.
• Instruct patients to make sure they let their health care provider know:
  • If they have or are later diagnosed with renal dysfunction. Damage to the kidney has been observed in some people given medications similar to GIAZO.
  • If they have or are later diagnosed with liver disease. Worsening liver disease has been observed in some people given medications similar to GIAZO.

Administration

Oral Administration

Administer orally 3 times daily.1

Dosage

Available as balsalazide disodium; dosage expressed in terms of the salt.6

Daily dosage of 6.75 g is equivalent to mesalamine 2.4 g.1

Adults

2.25 g (three 750-mg capsules) 3 times daily for 8 weeks.1 9 Some patients may require up to 12 weeks of therapy.1

2–6 g daily may be used.12

Prescribing Limits

Adults

Safety and efficacy not established beyond 12 weeks.1

Specific Drugs

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 placebocontrolled 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

Data collected from all three trials (placebo-controlled, active-controlled, and openlabel) 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

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

Read the entire FDA prescribing information for Giazo (Balsalazide Disodium)