Alosetron

(Lotronex) was approved for marketing by the FDA in February, 2000, but was withdrawn from the market in November, 2000, because of serious, life-threatening, gastrointestinal side effects. In June 2002, it was approved again by the FDA for marketing but in a restricted manner as part of a drug company-sponsored program for managing the risks associated with treatment. Use of alosetron is allowed only among women with severe, diarrhea-predominant, irritable bowel syndrome (IBS) who have failed to respond to conventional treatment for IBS.

Why is this medication prescribed?

Alosetron is used to treat diarrhea, pain, cramps, and the feeling of an urgent need to have bowel movements caused by irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea) in women who have diarrhea as their main symptom and have not been helped by other treatments. Alosetron is in a class of medications called serotonin antagonists. Alosetron works by slowing the movement of stool (bowel movements) through the intestines.

How should this medicine be used?

Alosetron comes as a tablet to take by mouth. It is usually taken twice a day with or without food. Take alosetron at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alosetron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of alosetron. Your doctor will want to talk to you after you have taken the low dose for 4 weeks. If your symptoms are not controlled but you are not experiencing serious side effects of alosetron, your doctor may increase your dose . If you take the increased dose for 4 weeks and your symptoms are still not controlled, alosetron is not likely to help you. Stop taking alosetron and call your doctor.

Alosetron may control IBS but will not cure it. If you and your doctor agree that you should continue to take alosetron after the initial trial period, do not stop taking alosetron without talking to your doctor. If you stop taking alosetron, your IBS symptoms may return within 1 or 2 weeks.

Other uses for this medicine

Alosetron should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking alosetron,

• tell your doctor and pharmacist if you are allergic to alosetron or any other medications.
• do not take fluvoxamine (Luvox) while you are taking alosetron.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and amiodarone (Cordarone, Pacerone); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend);aprepitant (Emend); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac);cyclosporine (Neoral, Sandimmune); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E.E.S., E-Mycin, Erythrocin);fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), others;fluoxetine (Prozac, Sarafem); hormonal contraceptives (birth control pills, implants, injections, rings, and patches); hydralazine (apresoline); isoniazid (INH, Nydrazid);lovastatin (Advicor, Altocor, Mevacor);certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz),delaviridine (Rescriptor); efavirenz (Sustiva);indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), ritonavir (Norvir, in Kaletra),and saquinavir (Fortovase, Invirase);nefazodone; procainamide (Procanbid, Pronestyl);sertraline (Zoloft); telithromycin (Ketek); ticlopidine (Ticlid);troleandomycin (TAO);verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate).Many other medications may also interact with alosetron, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had the conditions listed in the IMPORTANT WARNING section or any stomach or bowel problems, surgery to your stomach or bowels, or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking alosetron, call your doctor.

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do if I forget a dose?

Do not take a missed dose when you remember it. Skip the missed dose and take the next dose at the regularly scheduled time. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Alosetron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• hemorrhoids

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• difficulty in breathing
• quiet behavior
• wobbliness, difficulty in walking
• shaking of a part of your body that you cannot control
• seizures

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Lotronex®

Alosetron may cause serious gastrointestinal (GI; affecting the stomach or intestines) side effects including ischemic colitis (decreased blood flow to the bowels) and severe constipation that may need to be treated in a hospital and may rarely cause death. Tell your doctor if you are taking any of the following medications: antihistamines; certain antidepressants ('mood elevators') called tricyclic antidepressants; or certain medications to treat asthma, diarrhea, lung disease, mental illness, motion sickness, overactive bladder, pain, Parkinson's disease, stomach or intestinal cramps, ulcers and upset stomach. Tell your doctor if you are constipated now, if you often have constipation, or if you have had problems resulting from constipation. Also tell your doctor if you have a blockage in your bowels, ischemic colitis, blood clots, or any disease that causes inflammation of the bowels such as Crohn's disease (swelling of the lining of the digestive tract), ulcerative colitis (sores or swelling in the lining of the large intestine), or diverticulitis (small pouches in the lining of the large intestine that can become inflamed). Stop taking alosetron and call your doctor right away if you experience any of the following symptoms: constipation, new or worse pain in the abdomen (stomach area), or blood in your bowel movements. Call your doctor again if your constipation does not get better after you stop taking alosetron. Once you have stopped taking alosetron because of these symptoms, do not start taking it again unless your doctor tells you that you should. Only certain doctors who are registered with the company that makes alosetron and who are aware of the possible side effects can write prescriptions for this medication. Your doctor will give you the manufacturer's patient information sheet (Medication Guide) before you begin treatment with alosetron and your pharmacist will give you a copy each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions.After you read the Medication Guide for the first time, your doctor will ask you to sign an agreement that says that you understand the benefits and risks of taking alosetron and that you will follow the directions for taking alosetron safely. If you do not understand or can not follow the directions in the Medication Guide you should not take alosetron. You also can obtain the Medication Guide from the Food and Drug Administration (FDA) website (http://www.fda.gov) or the manufacturer's website.Talk to your doctor about the risks of taking alosetron.