WARNING

Alosetron is a medication used to treat severe irritable bowel syndrome (IBS) with diarrhea (IBS-D) in women who have not responded to conventional therapies. While it can be effective for some patients, it comes with significant risks. Here are the main risks associated with Alosetron:

• Severe Constipation: This is one of the most common side effects and can lead to serious complications, including bowel obstruction, impaction, and perforation. Patients may experience abdominal pain, bloating, and severe constipation.
• Ischemic Colitis: Alosetron has been associated with a risk of ischemic colitis, a condition where blood flow to the colon is reduced, leading to inflammation and damage. Symptoms include abdominal pain, bleeding, and diarrhea.
• Bowel Perforation: This is a rare but serious risk where a hole forms in the wall of the intestine, which can lead to severe infection and requires immediate medical attention.
• Risk of Death: Although rare, there have been reports of serious and sometimes fatal complications associated with Alosetron. These complications are often related to bowel obstruction or ischemic colitis.
• Drug Interactions: Alosetron can interact with other medications, potentially increasing the risk of side effects or reducing the effectiveness of either drug. It’s important to inform your healthcare provider of all medications you are taking.
• Monitoring Requirements: Due to these risks, Alosetron is usually prescribed under strict conditions. Patients are often required to undergo regular monitoring and follow-up appointments to manage and mitigate potential risks.

Because of these risks, Alosetron is typically prescribed only after other treatments have failed and with careful consideration of the benefits and potential harms. It’s essential to follow your healthcare provider’s instructions and report any unusual symptoms or side effects promptly.

Why is this medication prescribed

Alosetron is prescribed primarily for the treatment of severe irritable bowel syndrome (IBS) in women, particularly those whose primary symptom is diarrhea (IBS-D). It is usually prescribed when other treatments have failed to provide relief. Alosetron works by blocking serotonin receptors in the gut, which helps slow the movement of stools through the intestines, reducing diarrhea and abdominal pain.

How should this medicine be used?

Alora (generic estradiol transdermal patch) should be used according to the following guidelines:

• Application: Apply the patch to a clean, dry area of skin on the lower abdomen or buttocks. Avoid areas where the skin is irritated, broken, or oily. Do not apply the patch to the breasts.
• Frequency: Change the patch twice a week, typically every 3 to 4 days. Follow the specific schedule prescribed by your healthcare provider.
• Rotation: Place each new patch on a different area of skin to reduce the risk of irritation. Avoid reusing the same spot for several weeks.
• Handling: When applying or removing the patch, handle it by the edges to avoid touching the sticky side. Press the patch firmly in place with the palm of your hand for about 10 seconds to ensure it adheres properly.
• Removal: Remove the old patch before applying a new one. Fold it in half with the sticky sides together and dispose of it according to local guidelines.
• Other Considerations: Avoid using lotions, oils, or powders on the area where the patch will be applied, as these can affect adhesion. If the patch falls off, apply a new one as soon as possible.

Always follow the specific instructions provided by your healthcare provider and the product’s label for the best results and to ensure safety.

Other uses for this medicine

Other Uses for Alosetron:

• Chronic Diarrhea Not Related to IBS: In rare cases, Alosetron may be considered for chronic diarrhea not linked to IBS, particularly if other treatments have failed.
• Other Functional Gastrointestinal Disorders: Some doctors may consider using Alosetron for other functional gastrointestinal disorders where symptoms are similar to IBS-D, but this is not a standard practice and is generally done with caution.

What special precautions should I follow?

Special Precautions to Follow for Alosetron:

• Understand the Risks: Before starting Alosetron, you should understand the risks, particularly the potential for serious complications like severe constipation or ischemic colitis (reduced blood flow to the intestines). It’s essential to weigh these risks against the potential benefits.
• Medical History: Inform your doctor about your complete medical history, especially if you have a history of severe constipation, bowel obstruction, diverticulitis, Crohn’s disease, ulcerative colitis, or any other serious gastrointestinal conditions. Alosetron is contraindicated in patients with these conditions.
• Monitoring: Regular monitoring is crucial while taking Alosetron. Report any signs of severe constipation, abdominal pain, or bloody stools immediately to your healthcare provider. These symptoms can indicate serious complications.
• Pregnancy and Breastfeeding: Alosetron should be used during pregnancy only if clearly needed. It is unknown whether Alosetron passes into breast milk, so breastfeeding women should consult their doctor before using the medication.
• Medication Interactions: Alosetron may interact with other medications, so provide your healthcare provider with a list of all the drugs you are taking, including over-the-counter medications and supplements.
• Avoid Certain Activities: Since gastrointestinal discomfort can affect your ability to perform activities like driving, use caution until you know how Alosetron affects you.
• Dosage Adherence: Follow the prescribed dosage strictly. Do not increase or decrease the dose without consulting your healthcare provider.
• Discontinuation: If you need to stop taking Alosetron due to side effects or lack of effectiveness, do so under your doctor’s guidance.
• Emergency Situations: If you experience severe side effects, such as extreme constipation, severe abdominal pain, or rectal bleeding, seek medical attention immediately.

Always follow your healthcare provider’s instructions and consult them if you have any concerns or experience unusual symptoms while using Alosetron.

What special dietary instructions should I follow?

• Maintain a Normal Diet: There are no specific dietary restrictions while taking alosetron unless your doctor advises otherwise.
• Stay Hydrated: Drink plenty of fluids, especially if you experience constipation, to help maintain regular bowel function.
• High-Fiber Foods: While not specifically required, increasing fiber intake can help manage mild constipation, but be cautious as too much fiber may worsen bloating or gas. Consult your doctor for personalized advice.

What should I do if I forget a dose?

• Take It as Soon as You Remember: If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do Not Double Dose: Do not take a double dose to make up for a missed one. Simply continue with your regular dosing schedule.
• Consult Your Doctor: If you frequently forget to take your medication, discuss it with your healthcare provider. They may offer strategies or alternatives to help you stay on track.

What side effects can this medication cause?

Alosetron, commonly known by its brand name Lotronex, is primarily used to treat severe irritable bowel syndrome (IBS) with diarrhea in women. It works by slowing the movement of stools through the intestines, but it can have some side effects, including serious ones.

Common Side Effects:

• Constipation
• Stomach pain or discomfort
• Nausea
• Fatigue
• Headache

Serious Side Effects (require immediate medical attention):

• Severe Constipation: Can lead to complications such as bowel obstruction.
• Ischemic Colitis: Reduced blood flow to the intestines, which can cause abdominal pain, bloody diarrhea, or bloody stools.
• Rectal Bleeding
• Severe Abdominal Pain or Swelling
• New or worsening abdominal pain
• Allergic Reactions: Rash, itching, swelling, dizziness, or trouble breathing.
• Severe Intestinal Problems: Including perforation or tears in the intestines.

Due to the risk of severe side effects, especially constipation and ischemic colitis, alosetron is generally prescribed under a restricted program and requires careful monitoring by healthcare providers. If you have any of these symptoms, it’s important to seek medical attention right away.

What should I know about storage and disposal of this medication?

Storage and Disposal of Alosetron:

Storage:

• Store alosetron at room temperature (68°F to 77°F or 20°C to 25°C).
• Keep the medication in its original container, tightly closed, and out of reach of children.
• Store away from excess heat, moisture, and light (do not store in the bathroom).

Disposal:

• Do not flush alosetron down the toilet or pour it into a drain unless instructed to do so.
• Dispose of the medication through a medicine take-back program if available.
• If a take-back program is not available, mix the medication with an undesirable substance (like coffee grounds or cat litter) in a sealed plastic bag and dispose of it in the household trash.

In case of emergency/overdose

Signs of Overdose:

• Severe constipation
• Severe abdominal pain or swelling
• Difficulty breathing or swallowing
• Extreme drowsiness or confusion

What to Do:

• Call Poison Control: Immediately contact your local poison control center at 1-800-222-1222 in the United States or your country’s equivalent number.
• Seek Emergency Medical Attention: Go to the nearest emergency room or call emergency services if symptoms are severe.
• Provide Information: Be prepared to give information about the amount taken, the time of ingestion, and any symptoms.

What other information should I know?

• Regular Medical Monitoring: Alosetron is only prescribed under a restricted program (REMS – Risk Evaluation and Mitigation Strategy) due to the risk of severe side effects. Regular follow-ups with your healthcare provider are necessary.
• Inform Your Healthcare Provider: Let your doctor know if you have a history of severe constipation, bowel obstructions, Crohn’s disease, diverticulitis, ischemic colitis, blood clots, or liver disease, as alosetron may not be suitable for you.
• Medication Interactions: Inform your healthcare provider about all medications, vitamins, and herbal supplements you are taking, as alosetron can interact with other drugs, including those that affect the liver.
• Do Not Share Medication: Alosetron should only be used by the person for whom it was prescribed and should never be shared with others, even if they have similar symptoms.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and resume your regular schedule. Do not double the dose to catch up.

Always follow your healthcare provider’s instructions and consult them if you have any questions or experience issues related to your use of Alosetron.