AMITIZA May Help Your Chronic Constipation

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.

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. AMITIZA works to enhance the body’s natural function by increasing fluid in the bowels to help pass stool.

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 Irritable Bowel Syndrome with Constipation (IBS-C) is not fully understood.

Patients with chronic idiopathic constipation who took AMITIZA did not experience a clinically significant change in their electrolyte levels in clinical studies.

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 pain not caused by active cancer.

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AMITIZA may help adults with Chronic Idiopathic Constipation (CIC)

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

  • AMITIZA may help adults, including those 65 and older, go more regularly and find relief from chronic idiopathic constipation*

    In two 4-week clinical studies:

    • Patients with chronic constipation who had previously averaged 1–2 bowel movements per week before treatment had an average of 5–6 per week with AMITIZA. Patients taking a placebo (sugar pill) averaged 3–4 bowel movements per week
    • Patients showed improvement in signs and symptoms related to constipation:
      • Straining
      • Stool consistency
      • Abdominal discomfort
      • Abdominal bloating
      • Constipation severity ratings
         

    *"Relief" is defined as improvement in CIC symptoms: abdominal bloating, abdominal discomfort, stool consistency, straining, and constipation severity. “Go more regularly” is defined as having an average of ≥ 3 spontaneous bowel movements per week.

    5-6 BOWEL MOVEMENTS PER WEEK

    AMITIZA may provide predictable relief

    In two 4-week clinical studies:

    • 57% (Study 1) and 63% (Study 2) of patients had an SBM within 24 hours after taking AMITIZA vs 37% (Study 1) and 32% (Study 2) of patients taking placebo 

    "Predictable relief" is defined as a spontaneous bowel movement (SBM) within 24 hours.

    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

Miho, chronic idiopatic constipation (CIC) patient

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

Individual results may vary.

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AMITIZA can help adult women with Irritable Bowel Syndrome with Constipation (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.

  • 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

Suzanne, irritable bowel syndrome with constipation (IBS-C) patient


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

Individual results may vary.

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AMITIZA may help adults with Opioid-Induced Constipation (OIC) for chronic pain not caused by active cancer

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.

  • AMITIZA was evaluated in 3 12-week clinical studies. Patients were taking opioid therapy for chronic pain not caused by active cancer, 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
       

    In Study 1, more AMITIZA patients experienced an overall spontaneous bowel movement response

    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
       

    In Study 2, AMITIZA patients improved the frequency of their 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 pain not caused by active cancer. If you have OIC and chronic pain not caused by active cancer, 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.

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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

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AMITIZA is used for 3 types of chronic constipation: CIC in adults, OIC in adults with chronic pain that is not caused by active cancer, 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.

Some patients taking AMITIZA may experience nausea. Take AMITIZA with food and water to reduce the occurrence of nausea.

Do not take AMITIZA if you have severe diarrhea. Some patients taking AMITIZA may experience diarrhea. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP.

Patients may experience fainting and low blood pressure after taking the first dose or repeated doses of AMITIZA. Stop taking AMITIZA and tell your HCP if these reactions occur. Symptoms usually go away before the next dose but may recur with repeated use. Tell your HCP if you are taking any medications to lower blood pressure. Other side effects such as diarrhea or vomiting may increase the risk of fainting and low blood pressure.

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 for CIC are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas. The most common side effects of taking AMITIZA 24 mcg twice daily for Opioid-Induced Constipation are nausea and diarrhea. 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.

Indications

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, a type of prescription pain medicine, in adults with chronic pain that is not caused by active cancer. 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.

Please click here for complete Prescribing Information.

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