HOW AMITIZA CAN HELP

If you've been experiencing constipation symptoms, or if you've already been diagnosed with chronic constipation, you may not have found a treatment that works. This page discusses how AMITIZA can help and how it works differently than the laxatives or fiber you may have tried before. And when you're ready, talk to your doctor about a treatment plan.

 

AMITIZA CAN HELP TREAT 3 DIFFERENT TYPES OF CHRONIC CONSTIPATION

Since there are different types of chronic constipation, your doctor will prescribe a medicine for your specific condition. AMITIZA is the first and only FDA-approved prescription medication for the treatment of Chronic Idiopathic Constipation (CIC) in adults, Irritable Bowel Syndrome with Constipation (IBS-C) in adult women, and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain.

AMITIZA may help adults with CIC

Take a look at the results from the CIC clinical studies below to see how AMITIZA has helped other patients.

CIC results from clinical studies

In two 4-week clinical studies:

  • Patients taking AMITIZA averaged 5–6 bowel movements per week compared to 3–4 for patients taking placebo (a pill with no active ingredient)
  • A majority of patients had a bowel movement within 24 hours
    • 57% and 63% of patients had a spontaneous bowel movement within 24 hours after taking AMITIZA vs 37% and 32% of patients taking placebo, respectively
  • Patients also showed improvement in signs and symptoms related to constipation such as:
    • Straining
    • Stool consistency
    • Abdominal discomfort
    • Abdominal bloating
    • Constipation severity ratings

AMITIZA (24 mcg) twice daily is approved to treat Chronic Idiopathic Constipation in adults. If you have CIC, AMITIZA may help you find the relief you're looking for.

Individual results may vary.

Already taking AMITIZA? Track how you're doing

 
I had been ignoring the signs [of chronic constipation]. I went to my doctor and she was very supportive.”
- Miho

Individual results may vary.

Watch Miho's story

Learn more about CIC

AMITIZA can help adult women with IBS-C

When people diagnosed with Irritable Bowel Syndrome also experience frequent constipation, it is known as Irritable Bowel Syndrome with Constipation, or IBS-C. Learn more about these clinical studies below.

IBS-C results from clinical studies

In 2 different clinical studies, AMITIZA improved the overall symptoms of IBS-C in adult women which includes:

  • Abdominal discomfort
  • Abdominal pain
  • Bowel habits
  • Other IBS symptoms

AMITIZA (8 mcg) twice daily is an approved prescription treatment for IBS-C in women 18 years of age and older. If your doctor diagnoses you with IBS-C, AMITIZA may be able to help.

Individual results may vary.

Already taking AMITIZA? Track how you're doing

 
I tried adjusting my diet, exercise, laxatives and stool softeners. They helped some but my symptoms came back.”
- Suzanne

AMITIZA may help adults with OIC for chronic, non-cancer pain

People taking opioids, a commonly prescribed pain reliever, can develop constipation as a side effect. This is referred to as Opioid-Induced Constipation, or OIC. The effects of AMITIZA in patients with OIC were evaluated in 3 clinical studies. See results from these 3 studies below.

OIC results from
clinical studies

AMITIZA was evaluated in 3 12-week clinical studies. Patients were taking opioid therapy for chronic, non-cancer pain, and experiencing symptoms of OIC.

  • Study 1 did not include patients who were taking a diphenylheptane opioid (e.g., methadone)
  • Studies 2 and 3 included patients taking a diphenylheptane opioid (e.g., methadone)
  • Spontaneous bowel movements were defined as any bowel movement that occurred without the need for additional constipation treatments, such as stool softeners and laxatives, within the previous 24 hours

Study 1
Comparing patients taking AMITIZA (24 mcg twice daily) to patients taking a placebo, more AMITIZA patients experienced an overall spontaneous bowel movement response

  • Overall spontaneous bowel movement responders were those patients who experienced ≥1 spontaneous bowel movement improvement compared to the start of the study. This applied to all treatment weeks for which data were available. In addition, ≥3 spontaneous bowel movements per week were reported for at least 9 of 12 treatment weeks

Studies 2 and 3
Measuring the difference in spontaneous bowel movement frequency over an 8-week period between patients taking AMITIZA (24 mcg twice daily) vs patients taking a placebo:

  • In Study 2, more AMITIZA patients improved the frequency of spontaneous bowel movements
  • Study 3 did not show a difference in improvement in the frequency of spontaneous bowel movements

The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone).

AMITIZA (24 mcg) twice daily is approved to treat constipation caused by opioids in adults with chronic, non-cancer pain. If you have OIC and chronic, non-cancer pain, AMITIZA may be able to help.

Individual results may vary.

Already taking AMITIZA? Track how you're doing

 
Some people taking opioids develop constipation as a side effect.

The science behind how AMITIZA works

AMITIZA isn’t a fiber or a laxative and it works differently than the laxative treatments you may have tried.

Chloride channels regulate fluid balance, a key factor in your body’s ability to pass stool. AMITIZA works locally in the intestines to activate these chloride channels, which helps:

  • Pass stool by increasing fluid in the bowels
  • Address the constipating effects of certain opioids
  • Improve the function of the protective (mucosa) layer in the intestinal lining

The way AMITIZA works for IBS-C is not fully understood.

 
Take a deeper look at how AMITIZA works

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Talking to
your doctor

Sharing your history with chronic constipation helps your doctor find the treatment plan that is right for you. The Doctor Discussion Guide can help make the conversation more productive.

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Taking
AMITIZA

Find out what to expect when taking AMITIZA.

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Uses & Important Safety Information

AMITIZA is for CIC in adults, OIC in adults with chronic, non-cancer pain, and IBS-C in women ≥ 18 years. Effectiveness in patients taking methadone has not been established.

Important Safety Information

AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider (HCP) should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.

Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food and water, if it becomes severe, tell your HCP. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your HCP if you experience these symptoms.

The most common side effects of taking AMITIZA (24 mcg) twice daily are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas for patients treated for CIC; nausea and diarrhea for patients treated for Opioid-Induced Constipation. The most common side effects of taking AMITIZA (8 mcg) twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.

Tell your HCP if you are taking a diphenylheptane opioid (e.g. methadone).

AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea.

Tell your HCP if you have liver problems.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids (OIC), a type of prescription pain medicine, in adults with chronic, non-cancer pain. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA 8 mcg capsules twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.

Please click here for complete Prescribing Information.