Zelnorm®
(tegaserod maleate) Tablets
(pronounced ZEL-norm, te-gas-a-rod mal- -ate)

Frequently Asked Questions About The Treatment IND?

What is the Zelnorm treatment IND program?
This program, called a "treatment IND," allows restricted access to Zelnorm if there is no comparable alternative drug or therapy available to treat the disease in the intended patient population. Under the Zelnorm treatment IND program, female patients with IBS-C or CIC will be considered to receive the medication if they meet the FDA approved criteria.

Who will qualify for the Zelnorm treatment IND program?
To be considered for access to Zelnorm through the treatment IND, female patients under 55 with IBS-C or CIC must meet the specific criteria outlined in the treatment IND protocol approved by the FDA.

What about patients who do not qualify for the Zelnorm treatment IND?
There may be an alternative access option available through the FDA for patients who do not meet the criteria of the treatment IND but have an urgent need for Zelnorm based on a life-threatening or severely debilitating condition. Physicians may inquire about this potential access option by contacting the FDA CDER Division of Drug Information at 301-827-4570 or www.fda.gov/cder.

How do patients/physicians enroll in the treatment IND program?
Female IBS-C or CIC patients under 55 seeking to enroll should contact their physicians to inquire about the protocol and evaluate if they meet the FDA-approved criteria. For further details of the program's protocol, physicians can call 866-248-1348 or 888-669-6682.

What is the cost of Zelnorm through this treatment IND?
If a patient is approved for the Zelnorm treatment IND , Novartis will provide Zelnorm at no cost to the patient.

How much medication will a patient receive?
If approved to participate in the treatment IND, Novartis will provide each patient with one month's supply of 6mg Zelnorm. Reauthorization from the physician will be required for an additional supply of Zelnorm to be sent to the patient.

How long will the treatment IND be available?
The treatment IND program is available now for patients with IBS-C or CIC who meet the approved inclusion/exclusion criteria. As Novartis is continuing to work with the FDA on the safety and benefit assessment of Zelnorm, we can not speculate at this time how long this new treatment IND program will be open.

Should patients take Zelnorm under the treatment IND program given the reported cardiovascular events?
This program was established in response to requests to Novartis and the FDA from patients and physicians following the marketing suspension earlier in the year. The program materials are designed to help ensure that physicians are fully informed of the potential risks and benefits of Zelnorm, and can make appropriate medical judgments about whether the drug makes sense for their individual patients. Patients will also receive materials about the potential risks and benefits, to allow them to make an informed consent to participate. In addition, the treatment IND will not include patients who have cardiovascular ischemic disease or cardiovascular risk factors.

What are the Zelnorm treatment IND inclusion criteria?

Key inclusion criteria include:

• Women under the age of 55 years
• Currently suffering with IBS-C or Chronic Idiopathic Constipation
• No satisfactory response to other available treatments and/or patients who had satisfactory improvement of their symptoms with prior Tegaserod treatment

Key exclusion criteria include:

• History or current diagnosis of cardiovascular ischemic disease
• Symptoms suggestive of cardiovascular ischemic disease
• Presence of any cardiovascular risk factors according to NIH guidelines
• Uncompensated depression or anxiety or suicidal ideation or behavior

To become part of this program, patients should contact their physicians to inquire about the protocol and evaluate if they meet the criteria.

Read this information carefully before you start taking Zelnorm® (ZEL-norm). Read the information you get each time you get more Zelnorm. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

If you get new or worse abdominal (stomach) pain, or blood in your stools, stop taking Zelnorm right away and tell your doctor. Your doctor may need to do tests to find out if you have a serious problem with your bowel that may require special treatment or hospitalization.

Sometimes Zelnorm causes diarrhea. Stop taking Zelnorm and call your doctor right away if you get so much diarrhea that you get lightheaded, dizzy, or faint.

Zelnorm is a medicine for:

· the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem. Zelnorm does not work for all women who use it. Zelnorm has not been shown to work in men with IBS with constipation.

· the treatment of patients less than 65 years of age with chronic idiopathic constipation. Chronic constipation means constipation lasting over 6 months. Idiopathic constipation means constipation not due to other diseases or drugs. Zelnorm has not been shown to work in patients with chronic idiopathic constipation who are 65 years of age or older. Zelnorm increases the movement of stools (bowel movement) through the bowels. Zelnorm does not cure IBS with constipation or chronic idiopathic constipation. For those with IBS with constipation who are helped, Zelnorm reduces pain and discomfort in the abdominal area, bloating, and constipation. For those with chronic idiopathic constipation, Zelnorm increases bowel movements, reduces straining, bloating and abdominal discomfort If you stop taking Zelnorm, your symptoms may return within 1 or 2 weeks.

You should not start taking Zelnorm if:

• You now have diarrhea or have diarrhea often.

• You have bad kidney or liver disease.

• You have ever had bowel obstruction (intestinal blockage), symptomatic gallbladder disease, or abdominal adhesions causing pain and/or intestinal blockage.

• You are allergic to Zelnorm or any of its ingredients. The active ingredient in Zelnorm is tegaserod maleate. The inactive ingredients are listed at the end of this leaflet.

• Are pregnant or plan to become pregnant. Zelnorm is not recommended for use by pregnant women.

• Are breast-feeding. Do not breast-feed while you are taking Zelnorm. The drug is likely to pass into breast milk.

• Are taking or planning to take any other medicines, including those you can get without a prescription.

· You should take Zelnorm twice a day on an empty stomach shortly before you eat a meal, or as your doctor prescribes it.

· For IBS with Constipation: You should take Zelnorm for 4 to 6 weeks to treat your IBS symptoms. If you feel better, your doctor may prescribe an additional 4 to 6 weeks of Zelnorm.

· For Chronic Idiopathic Constipation: You should talk to your doctor regularly about whether you need to stay on Zelnorm.

· If you miss a dose of Zelnorm, just skip that dose. Do not take two tablets to make up the missed dose. Instead, just wait until the next time you are supposed to take it and then take your normal dose.

Headache and diarrhea were the most common side effects seen with Zelnorm.

Diarrhea was an occasional side effect of treatment with Zelnorm. Most people who got diarrhea had it during the first week after starting Zelnorm. Typically, diarrhea went away with continued therapy. If you get bad diarrhea, or if you get diarrhea together with bad cramping, abdominal pain, fainting, or dizziness, tell your doctor. Your doctor may tell you to stop taking Zelnorm or suggest other ways to manage your diarrhea.

There have been rare cases of rectal bleeding and severe abdominal pain in patients treated with Zelnorm. Some of these problems were related to insufficient blood flow to part of the bowel. It is not known if this was related to Zelnorm use.

In studies a very small number of patients were reported to have abdominal surgery. In IBS with constipation studies there were a few more reports of abdominal surgery in patients taking Zelnorm than in patients taking a sugar pill. Most of these were related to the gallbladder. It is not known if Zelnorm may increase your chance of abdominal surgery. Gallbladder surgery has been reported to occur more often in IBS patients than in the general population.

This list is not complete. Your doctor or pharmacist can give you a more complete list of possible side effects. Talk to your doctor about any side effects you may have.

Keep Zelnorm at room temperature. Do not use Zelnorm past the expiration date shown on the package.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Zelnorm for a condition for which it was not prescribed. Do not give Zelnorm to other people, even if they have the same symptoms that you have. This leaflet summarizes the most important information about Zelnorm. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zelnorm that is written for health professionals. You can also contact the company that makes Zelnorm at 1-866-427-6682 or www.zelnorm.com.

Zelnorm is available for oral use in the following tablet formulations:

· 2 mg and 6 mg tablets (blister packs) containing the following inactive ingredients: crospovidone, glyceryl monostearate, hypromellose, lactose monohydrate, poloxamer 188, and polyethylene glycol 4000

· 6 mg tablets (bottles) containing the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, colloidal silicon dioxide.

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