alosetron (oral)

What is the most important information I should know about alosetron?

Alosetron should be used only by women with severe irritable bowel syndrome and diarrhea as the main symptom.

If you stop taking alosetron for any reason, do not start taking it again without your doctor's advice.

What is alosetron?

Alosetron blocks the action of a chemical called serotonin in the intestines. This slows the movement of stools (bowel movements) through the intestines.

Alosetron is used to treat severe, chronic irritable bowel syndrome (IBS) in women with diarrhea as the main symptom for at least 6 months. Alosetron is given after other treatments have failed.

Alosetron is not a cure for irritable bowel syndrome. After you stop taking this medicine, your symptoms may return within 1 week.

Alosetron has not been shown to be effective in men with IBS.

Alosetron may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking alosetron?

• constipation (especially if it is your main IBS symptom);
• a history of severe or ongoing constipation;
• obstruction or perforation of your intestines;
• Crohn's disease, ulcerative colitis, or diverticulitis;
• blood clots, or circulation problems affecting your intestines;
• severe liver disease; or
• a condition for which you also take fluvoxamine (Luvox).

Tell your doctor if you are pregnant or breastfeeding.

How should I take alosetron?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take alosetron with or without food.

Alosetron does not improve the symptoms of IBS for everyone. This medicine can help reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or all symptoms may improve within 1 to 2 weeks of treatment.

If you stop taking alosetron for any reason, do not start taking it again without your doctor's advice.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking alosetron?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of alosetron?

Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines).

• new or worsening constipation;
• stomach pain;
• bright or dark red blood in your stools; or
• bloody diarrhea.

You may need to permanently discontinue alosetron if you have these side effects.

Older adults and those who are ill or debilitated may be more likely to have serious complications from constipation.

Common side effects may include:

• constipation;
• nausea; or
• pain or discomfort in your stomach or intestines.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alosetron?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect alosetron, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about alosetron.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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