FREQUENTLY ASKED QUESTIONS

Get answers to some of the common questions asked about AMITIZA and the types of chronic constipation it treats. Talk to your doctor if you have additional questions, and ask if AMITIZA is right for you.

General information about AMITIZA

What is AMITIZA?

AMITIZA 24 mcg twice daily is a prescription drug for adults used to treat Chronic Idiopathic Constipation. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. It is a soft, orange, oval gelatin capsule. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids, 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 twice daily is approved to treat Irritable Bowel Syndrome with Constipation in women 18 years of age and older. It is a soft, pink, oval gelatin capsule.

Where can I find more information about AMITIZA?

If you would like more information, talk to your doctor about AMITIZA. You can also read the full Prescribing Information or call 1-877-825-3327.

What are the ingredients in AMITIZA?

Active ingredient: lubiprostone, 24 mcg or 8 mcg.
Inactive ingredients: medium-chain triglycerides, gelatin, sorbitol and purified water. The 24 mcg (orange) capsules also contain the dyes FD&C Red #40 and D&C Yellow #10. The 8 mcg (pink) capsules also contain the dyes ferric oxide and titanium dioxide.

The types of chronic constipation AMITIZA treats

What is Chronic Idiopathic Constipation (CIC)?

Chronic Idiopathic Constipation is a condition in which symptoms include infrequent bowel movements and difficulty passing stools for at least 6 months. "Idiopathic" means that the cause of the constipation is unknown and not due to an underlying illness or medication. The signs and symptoms associated with Chronic Idiopathic Constipation may include straining during bowel movements, hard or lumpy stools, abdominal bloating and discomfort, feeling like your bowel is never completely empty, feeling like your bowel is blocked, and fewer than 3 bowel movements a week.

What is Irritable Bowel Syndrome with Constipation (IBS-C)?

Irritable Bowel Syndrome with Constipation (IBS-C) is just one form of Irritable Bowel Syndrome (IBS) in which the predominant symptom, abdominal pain/discomfort, is associated with constipation. You may be living with IBS-C if you have experienced the following symptoms in the last 3 months, starting at least 6 months ago:

  • Reccurring abdominal pain or discomfort at least 3 days a month in the past 3 months associated with 2 or more of the following:
    • Improvement with a bowel movement
    • Changes in the number of bowel movements
    • Changes in stool appearance
  • Hard or lumpy stools at least 25% of the time and loose or watery stools in less than 25% of bowel movements (without the use of anti-diarrhea medications or laxatives)

What is Opioid-Induced Constipation (OIC)?

Opioids are commonly prescribed to help alleviate pain. However, people taking opioids may develop constipation as a side effect. Your doctor may call this Opioid-Induced Constipation (OIC).

Talk to your doctor if you're experiencing the following symptoms while taking an opioid medication for chronic, non-cancer pain:

  • Less than 3 bowel movements per week with at least 25% of bowel movements associated with one or more of the following:
    • Moderate to very severe straining
    • Hard to very hard stools
    • Feeling like your bowel is never completely empty

Safety and side effect information

Who should not take AMITIZA?

Do not take AMITIZA if:

  • You know or suspect you have a bowel blockage. If you are unsure, your doctor should check your condition before starting AMITIZA.
  • You have severe diarrhea.
  • You are pregnant or become pregnant, unless you have discussed this with your doctor. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used in pregnancy if the potential benefit justifies the potential risks to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your doctor to evaluate the risks to the fetus. Tell your doctor if you are breastfeeding, and monitor infants for diarrhea.

You are allergic to AMITIZA or any of its ingredients. See the ingredients in AMITIZA.

What other important safety information should I know about AMITIZA?

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

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 doctor if you experience these symptoms.

Tell your doctor 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 healthcare provider to evaluate the risks to the fetus. Tell your doctor if you are nursing and monitor infants for diarrhea.

Tell your doctor if you have liver problems.

What should I tell my doctor before starting AMITIZA?

Before you take AMITIZA, tell your doctor if you:

  • Are taking a diphenylheptane opioid (e.g., methadone).
  • Are pregnant or plan to become pregnant. AMITIZA has not been studied in pregnant women and 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 doctor to evaluate the risks to the fetus.
  • Are breastfeeding or planning to breastfeed. If breastfeeding while taking AMITIZA, you should monitor the breastfed infant for diarrhea.
  • Have liver problems.
  • Cannot swallow a capsule.

Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

You and your doctor should regularly assess the need for continued therapy.

What are the side effects of AMITIZA 24 mcg twice daily for Chronic Idiopathic Constipation?

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. These are not all the side effects associated with AMITIZA.

Tell your doctor about any side effects you have. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects.

What are the side effects of AMITIZA 24 mcg twice daily for Opioid-Induced Constipation?

The most common side effects of taking AMITIZA 24 mcg twice daily are nausea and diarrhea for patients treated for OIC. These are not all the side effects associated with AMITIZA.

Tell your doctor about any side effects you have. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects.

What are the side effects of AMITIZA 8 mcg twice daily for IBS-C?

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 doctor about any side effects you have. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects.

Will AMITIZA interfere with other medications?

AMITIZA may affect how other medicines work and other medicines may affect how AMITIZA works. Only your doctor can decide whether AMITIZA may be right for you. Tell your doctor if you are taking a diphenylheptane opioid (e.g., methadone).

How to take and store AMITIZA

How should I take AMITIZA?

AMITIZA is to be taken twice a day or as prescribed by your healthcare professional with food and water. Swallow the gelatin capsule whole. Capsules should not be broken apart or chewed.

What should I do if I miss a dose?

If you miss a dose of AMITIZA, just skip that dose. Do not take 2 capsules to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.

How do I store AMITIZA?

Store AMITIZA at room temperature and protect from light and extreme temperatures. AMITIZA should be stored in a tightly closed, child-proof container and kept out of the reach of children. Do not use AMITIZA past the expiration date shown on the package.

Savings and support

Is there any way to save on my prescription or refills of AMITIZA?

The AMITIZA Savings Program can help appropriate patients pay $0* for 30- or 90-day prescriptions. Members of the program also receive emails full of tips and information to help manage chronic constipation. Join the AMITIZA Savings Program to save on your next prescription.

*Subject to maximum benefit. You must meet Eligibility Requirements.

What are the eligibility requirements for the AMITIZA Savings Program?

The AMITIZA Savings Card offer cannot be used if you are a beneficiary of, or any part of your prescription is covered by:

  1. any federal or state healthcare program (Medicare, Medicaid, TriCARE, etc.), including a state pharmaceutical assistance program;
  2. the Medicare Prescription Drug Program (Part D), or if you are currently in the coverage gap, or;
  3. insurance that is paying the entire cost of the prescription.

Terms & Conditions
You must meet Eligibility Requirements. You agree to report your use of this offer to any Third Party that reimburses you or pays for any part of the prescription price. Use of this offer is confirmation that you are permitted, under the terms and conditions of the health benefit plan(s) covering your prescriptions, to take advantage of co-pay coverage programs. You additionally agree that you will not submit the cost of any portion of the product dispensed pursuant to this offer to a federal or state healthcare program for purposes of counting it toward your out-of-pocket expenses. This savings card covers out-of-pocket expenses up to a maximum benefit of $75 for a 30-day prescription or up to $225 for a 90-day prescription. For mail order prescriptions, a mail-in rebate form is available at www.patientrebateonline.com or by calling 1-866-279-8995. This coupon is not valid with any other program, discount, or incentive involving AMITIZA (lubiprostone). Offer expires 03/31/2017. This offer may be rescinded, revoked, or amended without notice. No reproductions. This offer is void where prohibited by law, taxed, or restricted. Limit one offer per purchase. Cash value of 1/100 of 1¢. For questions about this offer, call the Customer Service Center at 1-866-279-8995.

I’ve already paid for my AMITIZA prescription. Is there a mail-in rebate available?

Patient mail-in rebate forms and information on how to complete and submit them are available at www.patientrebateonline.com. You may also request one by calling 1-866-279-8995.

If I am ineligible to receive the AMITIZA Savings Card, can I still get support from the AMITIZA Savings Program?

Yes. If you are ineligible for the savings card you can still register for the AMITIZA Savings Program to receive emails with information about AMITIZA and tips to help manage chronic constipation.

Taking
AMITIZA

Find out what to expect when taking AMITIZA.

Learn more

Helpful tools
& resources

These guides can help you prepare for your next doctor visit and track how you're doing with AMITIZA.

Download the guides

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.

Create your guide

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.