Clinical Efficacy

ZELNORM PROVIDES PROVEN EFFICACY TO ADDRESS CONSTIPATION, ABDOMINAL PAIN, AND BLOATING ASSOCIATED WITH IBS-C1


ZELNORM is proven effective based on three 12-week, double-blind, placebo-controlled trials comprising 2470 adult women with at least a 3-month history of IBS-C symptoms, including abdominal pain, bloating, and constipation.1

Patient relief was measured by Subject’s Global Assessment (SGA): a global measure that includes overall well-being, abdominal pain/discomfort, and bowel function.2

MORE PATIENTS TAKING ZELNORM REPORTED EXPERIENCING “CONSIDERABLE” OR “COMPLETE” RELIEF THAN THOSE ON PLACEBO

Weekly Proportion of Patients With Relief in 3 Placebo-Controlled IBS-C Trials1

Weekly proportion of patients with relief in 3 placebo controlled IBS-C trials Weekly proportion of patients with relief in 3 placebo controlled IBS-C trials

PATIENTS ON ZELNORM SAW SIGNIFICANT IMPROVEMENTS IN THE SYMPTOMS OF IBS-C1-4

IBS-C symptoms improvements check marks with ZELNORM

IMPROVED MOTILITY3

 

ZELNORM demonstrated significant improvements from baseline versus placebo in number of bowel movements per 28 days (+9.8 vs +6.6, P<0.05), stool consistency score (-0.91 vs -0.62, P<0.0001), and number of days with straining (-4.3 vs -2.9, P<0.001).

IBS-C symptoms improvements check marks with ZELNORM

REDUCED ABDOMINAL PAIN1

 

8% to 11% more patients on ZELNORM than on placebo experienced reduced abdominal pain in the first 4 weeks.

IBS-C symptoms improvements check marks with ZELNORM

REDUCED BLOATING1,4

 

9% to 12% more patients on ZELNORM than on placebo experienced reduced bloating in the first 4 weeks.

IBS-C symptoms improvements check marks with ZELNORM

QUICK ONSET OF ACTION2

 

In as early as the first week of treatment, patients treated with ZELNORM experienced a significant increase in number of bowel movements and relief from abdominal pain and constipation.

Indication

ZELNORM (tegaserod) is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).

Important Safety Information

ZELNORM should be used in females under 65 years of age who do not have a history of ischemic cardiovascular disease and who have no more than one CVD risk factor. CVD risk factors are defined as active smoking, current hypertension/history of antihypertensive treatment, current hyperlipidemia/history of lipid-lowering medication, history of diabetes mellitus, age ≥55 years, or obesity (BMI >30 kg/m2).

Contraindications:

ZELNORM is contraindicated in patients with:

  • History of myocardial infarction (MI), stroke, transient ischemic attack (TIA), or angina
  • History of ischemic colitis or other forms of intestinal ischemia
  • Severe renal impairment (eGFR< 15 mL/min/1.73 m2) or end-stage renal disease
  • Moderate and severe hepatic impairment (Child-Pugh B or C)
  • History of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
  • Hypersensitivity to ZELNORM

Warnings and Precautions

Cardiovascular Ischemic Events, Including Major Adverse Cardiovascular Events (MACE): Stroke, MI, and cardiovascular death have been reported in adults taking ZELNORM who had an increased risk of developing an adverse cardiovascular event based on their medical history.

Female patients less than 65 years of age should be assessed for a history of cardiovascular disease and cardiovascular risk factors prior to treatment with ZELNORM.

Discontinue ZELNORM in patients who experience an MI, stroke, TIA, or angina. Evaluate the risks and benefits of continued use of ZELNORM in patients who develop evidence of cardiovascular ischemic heart disease (e.g., coronary artery disease) and/or experience changes in health status that could increase cardiovascular risk during treatment with ZELNORM.

Ischemic Colitis: Ischemic colitis and other forms of intestinal ischemia have been reported postmarketing in patients receiving ZELNORM. Discontinue ZELNORM in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.

Volume Depletion Associated with Diarrhea: In postmarketing experience, serious consequences of diarrhea including hypovolemia, hypotension, and syncope have been reported in patients treated with ZELNORM. Avoid use of ZELNORM in patients who are currently experiencing or frequently experience diarrhea. Instruct patients to discontinue ZELNORM and contact their healthcare provider if severe diarrhea, hypotension, or syncope occur.

Suicidal Ideation and Behavior: Monitor all ZELNORM-treated patients for clinical worsening of depression and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment. Counsel family members and caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Instruct patients to immediately discontinue ZELNORM and contact their healthcare provider if their depression is persistently worse or they are experiencing emergent suicidal thoughts or behaviors.

Common Adverse Reactions (incidence >2% and greater than placebo)

The most common adverse reactions in 3 placebo-controlled trials of ZELNORM in female IBS-C patients less than 65 years of age: headache (14% vs 10% placebo), abdominal pain (11% vs 10%), nausea (8% vs 7%), diarrhea (8% vs 3%), flatulence (6% vs 5%), dyspepsia (4% vs 3%), and dizziness (4% vs 3%).

Use in Specific Populations

  • Pregnancy: Safety and effectiveness not established
  • Lactation: Breastfeeding not recommended
  • Pediatric use: Safety and effectiveness not established
  • Geriatric use: Not indicated for patients 65 years of age and older
  • Severe renal conditions: Contraindicated
  • Moderate to severe hepatic conditions: Contraindicated

Please click here for full Prescribing Information.

Indication and Important Safety Information
 
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References: 1. ZELNORM (tegaserod) [package insert]. Covington, LA: Alfasigma USA, Inc. 2019. 2. Müller-Lissner SA, Fumagalli I, Bardhan KD, et al. Tegaserod, a 5-HT(4) receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther. 2001;15(10):1655-1666. 3. Novick J, Miner P, Krause R, et al. A randomized, double-blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Aliment Pharmacol Ther. 2002;16(11):1877-1888. 4. Tack J, Müller-Lissner S, Bytzer P, et al. A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut. 2005;54(12):1707-1713.