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MEDICATION GUIDE

LOTRONEX®
(LOW-trah-nex)
(alosetron hydrochloride) Tablets

Read this Medication Guide carefully before you sign the Patient-Physician Agreement. You must sign the Patient-Physician Agreement before you start LOTRONEX (alosetron hydrochloride) . Read the Medication Guide you get with each refill for LOTRONEX (alosetron hydrochloride) . There may be new information. This Medication Guide does not take the place of talking with your doctor.

1. What is the most important information I should know about LOTRONEX (alosetron hydrochloride) ?

LOTRONEX (alosetron hydrochloride) is a medicine only for some women with severe chronic IBS whose:

• main problem is diarrhea and
• IBS symptoms have not been helped enough by other treatments.

A. Some patients have developed serious bowel side effects while taking LOTRONEX (alosetron hydrochloride) . Serious bowel (intestine) side effects can happen suddenly, including the following two:

1. Serious complications of constipation: About 1 out of every 1,000 women who take LOTRONEX (alosetron hydrochloride) may get serious complications of constipation. These complications may lead to a hospital stay, and in rare cases, blood transfusions, surgery, and death. People who are older, who are weak from illness, or who take other constipating medicines may be more likely to have serious constipation problems with LOTRONEX (alosetron hydrochloride) .

To lower your chances of getting serious complications of constipation do the following:

• If you are constipated, do not start taking LOTRONEX (alosetron hydrochloride) .
• If you get constipated while taking LOTRONEX (alosetron hydrochloride) , stop taking it right away and call your doctor.
• If your constipation does not get better after stopping LOTRONEX (alosetron hydrochloride) , call your doctor again.
• If you stopped taking LOTRONEX (alosetron hydrochloride) , do not start taking LOTRONEX (alosetron hydrochloride) again unless your doctor tells you to do so.

2. Ischemic colitis (reduced blood flow to the bowel): About 3 out of every 1,000 women who take LOTRONEX (alosetron hydrochloride) over a 6-month period may get a serious problem where blood flow to parts of the large bowel is reduced. This is called ischemic colitis. The chance of getting ischemic colitis when you take LOTRONEX (alosetron hydrochloride) for more than 6 months is not known. Ischemic colitis may lead to a hospital stay, and in rare cases, blood transfusions, surgery, and death.

To lower your chances of getting serious complications of ischemic colitis, stop taking LOTRONEX (alosetron hydrochloride) and call your doctor right away if you get:

• new or worse pain in your stomach area (abdomen) or
• blood in your bowel movements.

B. Is LOTRONEX (alosetron hydrochloride) right for you?

LOTRONEX (alosetron hydrochloride) may be right for you if all of these things are true about you:

• Your doctor has told you that your symptoms are due to IBS.
• Your IBS bowel problem is diarrhea.
• Your IBS has lasted for 6 months or longer.
• You tried other IBS treatments and they didn't give you the relief you need.
• Your IBS is severe.

You can tell if your IBS is severe if at least 1 of the following is true for you:

• You have lots of painful stomach cramps or bloating.
• You often can't control the need to have a bowel movement, from diarrhea or bowel movements.
• You can't lead a normal home or work life because you

Enough testing has not been done to confirm LOTRONEX (alosetron hydrochloride) works in men or children under age 18.

C. There is a special prescribing program for LOTRONEX (alosetron hydrochloride) .

Only doctors who have signed up with the company that makes LOTRONEX (alosetron hydrochloride) should write prescriptions for LOTRONEX (alosetron hydrochloride) . As part of signing up, these doctors have said that they understand about IBS and the possible side effects of LOTRONEX (alosetron hydrochloride) . They have agreed to use a special sticker on all prescriptions for LOTRONEX (alosetron hydrochloride) , so the pharmacist will know that the doctors have signed up with the company.

You may be taught about LOTRONEX (alosetron hydrochloride) by your doctor or healthcare provider under a you to sign a Patient-Physician Agreement after you read this Medication Guide for the first time. Signing the Agreement means that you understand the benefits and risks of LOTRONEX (alosetron hydrochloride) and that you have read and understand this Medication Guide.

2. What is LOTRONEX (alosetron hydrochloride) ?

LOTRONEX (alosetron hydrochloride) is a medicine only for some women with severe chronic IBS whose:

• main problem is diarrhea and
• IBS symptoms have not been helped enough by other treatments.

LOTRONEX (alosetron hydrochloride) does not cure IBS, and it may not help every person who takes it. For those who are helped, LOTRONEX (alosetron hydrochloride) reduces lower stomach area (abdominal) pain and discomfort, the sudden need to have a bowel movement (bowel urgency), and diarrhea from IBS. If you stop taking LOTRONEX (alosetron hydrochloride) , your IBS symptoms may return within 1 or 2 weeks.

3. Who should not take LOTRONEX (alosetron hydrochloride) ?

LOTRONEX (alosetron hydrochloride) is not right for everyone. Do not take LOTRONEX (alosetron hydrochloride) if any of the following apply to you:

• Your main IBS problem is constipation or you are constipated most of the time.
• You have had a serious problem from constipation.
• You have had serious bowel blockages.
• You have had blood flow problems to your bowels, such as ischemic colitis.
• You have had blood clots.
• You have had Crohn's disease, ulcerative colitis, diverticulitis,
• You do not understand this Medication Guide or the Patient-Physician Agreement, or you are not willing to follow them.
• You are allergic to LOTRONEX (alosetron hydrochloride) or any of its ingredients. (See the list of ingredients at the end of this Medication Guide.)
• You are taking fluvoxamine (LUVOX®)

If you are constipated now, do not start taking LOTRONEX (alosetron hydrochloride) .

4. What should I talk about with my doctor before taking LOTRONEX (alosetron hydrochloride) ?

Talk with your doctor:

• about the possible benefits and risks of LOTRONEX (alosetron hydrochloride) .
• about how much of a problem IBS is in your life and what treatments you have tried.
• about any other illnesses you have and medicines you take or plan to take. These include prescription and non-prescription medicines, supplements, and herbal remedies. Certain illnesses and medicines can increase your chance of getting serious side effects while taking LOTRONEX (alosetron hydrochloride) . Other medicines may interact with how the body handles LOTRONEX (alosetron hydrochloride) . excursions permitted to 15-30°C
• if you are pregnant, planning to get pregnant, or breastfeeding.

5. How should I take LOTRONEX (alosetron hydrochloride) ?

• Take LOTRONEX (alosetron hydrochloride) exactly as your doctor prescribes it. You can take LOTRONEX (alosetron hydrochloride) with or without food.
• Begin with 0.5 mg two times a day for 4 weeks to see how LOTRONEX (alosetron hydrochloride) affects you. You and your doctor may decide that you should keep taking this dose if you are doing well.
• Check with your doctor 4 weeks after starting LOTRONEX (alosetron hydrochloride) :
  • If you try 0.5 mg two times a day for 4 weeks, it may not control your symptoms. If you do not get constipation or other side effects from LOTRONEX (alosetron hydrochloride) , your doctor may increase your dose up to 1 mg two times a day.
  • If 1 mg two times a day does not work after 4 weeks, LOTRONEX (alosetron hydrochloride) is not likely to help you. You should stop taking it and call your doctor.
• If you miss a dose of LOTRONEX (alosetron hydrochloride) , just skip that dose. Do not take 2 doses the next time. Wait until the next time you are supposed to take it and then take your normal dose.
• Follow the important instructions in the section “What is the most important information I should know about LOTRONEX (alosetron hydrochloride) ?” about when you must stop taking the drug and when you should call your doctor.
• If you see other doctors about your IBS or side effects from LOTRONEX (alosetron hydrochloride) , let the doctor who prescribed LOTRONEX (alosetron hydrochloride) know.

6. What are the possible side effects of LOTRONEX (alosetron hydrochloride) ?

Constipation is the most common side effect among women with IBS who take LOTRONEX (alosetron hydrochloride) . Some patients have developed serious bowel side effects while taking LOTRONEX (alosetron hydrochloride) . Read the section “What is the most important information I should know about LOTRONEX (alosetron hydrochloride) ?” at the beginning of this Medication Guide for information about the serious side effects you may get with LOTRONEX (alosetron hydrochloride) .

This Medication Guide does not tell you about all the possible side effects of LOTRONEX (alosetron hydrochloride) . Your doctor or pharmacist can give you a more complete list.

7. General information about the safe and effective use of LOTRONEX (alosetron hydrochloride)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any questions or concerns about LOTRONEX (alosetron hydrochloride) , ask your doctor. Do not use LOTRONEX (alosetron hydrochloride) for a condition for which it was not prescribed. Do not share your medicine with other people. It may harm them.

Your doctor or pharmacist can give you more information about LOTRONEX (alosetron hydrochloride) that was written for healthcare professionals. You can also contact the company that makes LOTRONEX (alosetron hydrochloride) (toll free) at 1-888-423-5227 or at www.lotronex (alosetron hydrochloride) .com.

8. What are the ingredients of LOTRONEX?

Active Ingredient: alosetron hydrochloride

Inactive Ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film-coat for the 0.5-mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film-coat for the 1-mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.

This Medication Guide has been approved by the US Food and Drug Administration.

PATIENT-PHYSICIAN AGREEMENT FOR LOTRONEX

LOTRONEX® (alosetron hydrochloride) is only for women with severe irritable bowel syndrome (IBS) whose main problem is diarrhea and who did not get the relief needed from other treatments. LOTRONEX (alosetron hydrochloride) has not been shown to help men with IBS or patients under age 18.

My doctor, or a healthcare provider under a doctor's direction answered my questions about treatment with LOTRONEX (alosetron hydrochloride) . I have read and I understand the Medication Guide for LOTRONEX (alosetron hydrochloride) , and

• I understand that some patients using LOTRONEX (alosetron hydrochloride) have had serious bowel conditions (ischemic colitis and complications of constipation). I understand that these serious conditions can happen suddenly, and that they may lead to a hospital stay, and in rare cases, blood transfusions, surgery, and death. I also understand that certain patients may be more likely to develop a serious bowel condition while taking LOTRONEX (alosetron hydrochloride) . These include older patients, those who have other health problems and those who take other medicines that may cause constipation.
• My doctor and I agree that my IBS is severe and that other treatments have not given me the relief that I need. I also agree that I meet all of the requirements described in the section of the Medication Guide “What is the most important information I should know about LOTRONEX (alosetron hydrochloride) ?” I understand that these requirements help to make sure that LOTRONEX (alosetron hydrochloride) is used only by patients who are likely to have more benefit from treatment than risk.
• I don't have any problems listed in the section of the me from taking LOTRONEX (alosetron hydrochloride) .
• I will follow instructions in the Medication Guide about:
  • telling my doctor, before taking LOTRONEX (alosetron hydrochloride) , about any illnesses I have, or other medicines I am taking or planning to take.
  • taking LOTRONEX (alosetron hydrochloride) exactly as my doctor prescribes it.
  • stopping LOTRONEX (alosetron hydrochloride) and calling my doctor right away if I get constipated, if I have new or worse pain in my abdomen, or if I see blood in my bowel movements.
  • calling my doctor again if the constipation I called about before has not gotten better.
  • not starting LOTRONEX (alosetron hydrochloride) again unless my doctor tells me to do so, if I stopped taking it because I got constipated.
  • talking with my doctor 4 weeks after starting LOTRONEX (alosetron hydrochloride) to recheck my IBS symptoms.
  • stopping LOTRONEX (alosetron hydrochloride) and calling my doctor if my IBS symptoms have not improved after 4 weeks of taking 1 mg 2 times a day.

I understand that LOTRONEX (alosetron hydrochloride) should be prescribed only by doctors who have signed up with the company that makes the drug. Doctors in the program must:

• fully discuss the drug's benefits and risks with each
• sign this agreement with each patient before giving the initial prescription. It is not necessary to sign an agreement more than once.
• use a special sticker on all LOTRONEX (alosetron hydrochloride) prescriptions so that pharmacists know the doctor has signed up.

If I see other doctors about my IBS or possible side effects from LOTRONEX (alosetron hydrochloride) , I will let the doctor who prescribed LOTRONEX (alosetron hydrochloride) know.

My signature below indicates I have read, understood, and agree with all the statements made above. I would like to begin treatment with LOTRONEX (alosetron hydrochloride) .

________________________
Name of Patient (print)

_______________________                   _____________________
         Signature                                                        Date

SECTION FOR THE PHYSICIAN

I am enrolled in the Prescribing Program for LOTRONEX (alosetron hydrochloride) , and I will continue to follow the requirements of the Program.

I, or a healthcare provider under a physician's direction,

• a copy of the Medication Guide for LOTRONEX (alosetron hydrochloride) , and instructed the patient to read it carefully before signing this Agreement, and to take it home.
• counseling about the benefits and risks of LOTRONEX (alosetron hydrochloride) .
• appropriate instructions for taking LOTRONEX (alosetron hydrochloride) .
• answers to all of the patient's questions about treatment
• a prescription for LOTRONEX (alosetron hydrochloride) that has the program sticker affixed on it to alert pharmacists I am enrolled in the Prescribing Program for LOTRONEX (alosetron hydrochloride) .

The patient signed the Patient-Physician Agreement in my presence after I counseled the patient, asked if the patient had any questions about treatment with LOTRONEX (alosetron hydrochloride) , and answered all questions to the best of my ability.

_______________________
Name of Physician (print)

_______________________                    _____________________
           Signature                                                                     Date

After the patient and the physician sign this Patient-Physician Agreement, give a copy to the patient and put the original signed form in the patient's medical record.

PRESCRIBING PROGRAM FOR LOTRONEX (alosetron hydrochloride) ™: PHYSICIAN ENROLLMENT FORM

The Prescribing Program for LOTRONEX (alosetron hydrochloride) was implemented to help reduce risks of serious gastrointestinal adverse events, some fatal, associated with this medicine. The program is intended to help physicians and their patients understand the benefits and risks of treatment with LOTRONEX (alosetron hydrochloride) in order to make fully informed decisions.

I wish to participate in the Prescribing Program for LOTRONEX (alosetron hydrochloride) (PPL) and acknowledge that I have read the complete Prescribing Information for LOTRONEX (alosetron hydrochloride) and understand and will follow the requirements of the PPL described below.

• For safety reasons, LOTRONEX (alosetron hydrochloride) is approved only for women with severe, diarrhea-predominant irritable bowel syndrome (D-IBS) who have:
  • Chronic IBS symptoms (generally lasting for 6 months or longer),
  • had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
  • not responded adequately to conventional therapy.

  Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:

  • Frequent and severe abdominal pain/discomfort
  • Frequent bowel urgency or fecal incontinence
  • Disability or restriction of daily activities due to IBS
• Physicians who enroll in the PPL should be able to diagnose and manage IBS, ischemic colitis, constipation, and complications of constipation, or refer patients to a specialist as needed.
• Patients considering treatment with LOTRONEX (alosetron hydrochloride) must be educated on the benefits and risks of the drug, given a copy of the Medication Guide, instructed to read it, and encouraged to ask questions. The patient may be educated by the enrolled physician or a healthcare provider under a physician's direction
• After reviewing the Medication Guide prior to the initial prescription, the physician and the patient must both sign the Patient-Physician Agreement form. The original signed form must be placed in the given to the patient.
• Program stickers must be affixed to all prescriptions for LOTRONEX (alosetron hydrochloride) (i.e., the original and all subsequent prescriptions). Stickers will be provided as part of the Prometheus Prescribing Program for LOTRONEX (alosetron hydrochloride) . Refills are permitted to be written on prescriptions.
• All prescriptions for LOTRONEX (alosetron hydrochloride) must be written and not transmitted by telephone, facsimile, or computer.
• Prescribers must report all serious adverse events with LOTRONEX (alosetron hydrochloride) to Prometheus at 1-888-423-5227 or to the Food and Drug Administration at 1-800-FDA-1088.

______________________
Name of Physician (print)

____________________                               _____________________
 Signature                                                          Date

DEA Number ________________________________

Office Address:              ________________________________

                                       ________________________________

                                       ________________________________

Office Phone Number: ________________________________

Office Fax Number: ________________________________

Upon enrollment, you will receive a prescribing kit for LOTRONEX (alosetron hydrochloride) with the complete Prescribing Information, Prescribing Program for LOTRONEX (alosetron hydrochloride) stickers, multiple copies of the Medication Guide and Patient-Physician Agreement for LOTRONEX (alosetron hydrochloride) , and instructions for ordering additional supplies of Program materials.

You only need to enroll once, and you are under no obligation to prescribe LOTRONEX (alosetron hydrochloride) . have given the patient named above:

If you have any questions, please call the Prescribing Program for LOTRONEX (alosetron hydrochloride) at 1-888-423-5227 or visit www.lotronex (alosetron hydrochloride) . com.

TO ENROLL, VISIT WWW.LOTRONEX (alosetron hydrochloride) .COM OR PHONE 1-888-423-5227 OR COMPLETE THIS FORM IN ITS ENTIRETY AND MAIL OR FAX TO THE FOLLOWING ADDRESS: with LOTRONEX (alosetron hydrochloride) .

Prescribing Program for Lotronex (alosetron hydrochloride) , 9410 Carroll Park Drive San Diego, CA 92121 1-888-423-5227. Fax Number: 1-858-824-0896. January 2008

Last reviewed on RxList: 5/16/2008
This monograph has been modified to include the generic and brand name in many instances.