Serious adverse GI effects reported, including ischemic colitis and serious complications of constipation, that have resulted in serious injury or death. (See Warnings under Cautions.)
Discontinue immediately and contact clinician if manifestations of constipation or ischemic colitis develop.
Do not resume alosetron in patients who develop ischemic colitis.
Contact clinician if constipation does not resolve after discontinuance of alosetron. If constipation resolves after discontinuance, resume therapy only on advice of clinician.
Restricted Distribution Program
Voluntarily withdrawn from US market by manufacturer in November 2000 because of numerous reports of severe adverse effects, including ischemic colitis, severely obstructed or ruptured bowel, and death; FDA approved a supplemental New Drug Application (sNDA) for alosetron in June 2002, permitting remarketing under restricted conditions of use.
Approved only for severe diarrhea-predominant irritable bowel syndrome (IBS) in women with chronic symptoms who have not responded adequately to conventional therapy. (See Uses.)
May be prescribed only by clinicians who have enrolled in the Prescribing Program for Lotronex®. Before therapy is initiated, clinician must provide and patient must read the Medication Guide for Lotronex® and Patient-Physician Agreement for Lotronex® and both must sign the Agreement. (See Restricted Distribution Program under Dosage and Administration.)
REMS:
FDA approved a REMS for alosetron to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of alosetron and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
ALOSETRON (al OH se tron) is used to treat irritable bowel syndrome (IBS) in women. It is reserved for those women who have severe diarrhea as the main symptom and who have not had success with other treatments. This medicine has not been shown to work in men with IBS. It is available only from health care providers who participate in a special Prescribing Program because this drug may cause serious side effects. Your health care provider will discuss your condition and these side effects with you prior to prescribing this drug.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine is not for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, skip that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Constipation is a common and serious side effect of this medicine. Stop taking this medicine and call your health care provider immediately if you become constipated. Only restart this medicine if your constipation has resolved and you and your doctor have agreed to restart treatment. You should not start taking this medicine if you are already constipated or constipated most of the time.
Ischemic colitis is a serious and potentially life-threatening condition that has been rarely reported with this medicine. If you experience new or worsening abdominal pain, bloody diarrhea or blood in the stool, immediately stop taking this medicine and contact your doctor or health care professional.
This medicine may not work for all women who take it. For women who are helped by this medicine, relief may occur within the first week or within four weeks of starting the drug. If you stop taking this medicine, it is likely that your symptoms will return within one week.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can increase drowsiness or dizziness. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional immediately:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
Sign up with Facebook
