Audio

Dr. Brenner: Hi, my name is Darren Brenner, and I’m a Professor of Medicine and Surgery and Director of Neurogastromotility and Functional Bowel programs at Northwestern University. The purpose of this short video is to provide you with some important clinical information that may assist you in achieving a successful outcome when taking LINZESS.

Narrator:

LINZESS^® (linaclotide) is a prescription medication used to treat irritable bowel syndrome with constipation (IBS-C) in adults and in children and adolescents 7 years of age and older, chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in children and adolescents 2 years of age and older. “Idiopathic” means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children with FC less than 2 years of age or in children with IBS-C less than 7 years of age.

Narrator:

IMPORTANT RISK INFORMATION

• Do not give LINZESS to children who are less than 2 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
• Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Please see Important Risk Information at the end of this video

Dr. Brenner: If you have any questions about IBS-C, CIC, FC, or LINZESS, please talk to your health care practitioner.

Dr. Brenner: When starting LINZESS, there are four key points we’d like you to be aware of.

Dr. Brenner: First, we want to explain some of the hows and whys of taking LINZESS. Second, we want to establish what you may expect regarding symptom relief. Third, we’d like you to be aware of possible side effects that may occur while taking LINZESS. And finally, we’ll address the importance of checking in with your practitioner regarding your experience with the medication.

Dr. Brenner: Let's first talk about some of the hows and whys of taking LINZESS. Take LINZESS once a day, every day, on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day.

Dr. Brenner: If you have trouble swallowing capsules, carefully open the LINZESS capsule, and sprinkle all the LINZESS beads onto applesauce, or into 1 oz, or 30 mL, of water.

Dr. Brenner: If you miss a dose, take your dose as usual the following day. Do not take 2 doses of LINZESS at the same time to make up for a missed dose. LINZESS was studied and shown to be effective for treating irritable bowel syndrome with constipation in adult and pediatric patients 7 years of age and older, chronic idiopathic constipation in adult patients, and functional constipation in pediatric patients 2 years of age and older when taken on a daily basis.

Dr. Brenner: LINZESS is a prescription medication that should be taken daily. This is different from standard over-the-counter laxatives, which are often used as needed. If you don’t take LINZESS every day, you may not experience symptom relief. And if you stop taking LINZESS, your symptoms may return.

Dr. Brenner: What about expectations? When should you begin to experience symptom relief with LINZESS? When LINZESS is taken daily, many people begin to experience relief from constipation in about 1 week. Adults with IBS-C may also begin to experience relief from belly pain and overall abdominal symptoms including pain, discomfort, and bloating in about a week, with symptoms typically improving over 12 weeks. These symptoms were studied in combination, not individually. The length of time it takes to achieve these improvements may differ from person to person.

Dr. Brenner: What are possible side effects you may experience with LINZESS? Diarrhea is the most common side effect of LINZESS, and in some cases it can be severe. When you first start taking LINZESS, it’s helpful to plan ahead for the possibility of diarrhea. Starting on a weekend when you can be near the comfort or convenience of your own bathroom may be beneficial. It’s also important to have a general understanding of what we mean by the term diarrhea, as this word means different things to different people. When you first start taking LINZESS, it's helpful to plan ahead for the possibility of diarrhea. Starting on a weekend when you can be near the comfort or convenience of your own bathroom may be beneficial. It's also important to have a general understanding of what we mean by the term diarrhea, as this word means different things to different people. 

Dr. Brenner: The Bristol Stool Form Scale shown here is commonly used by doctors to describe the different types of stools. These images are used to differentiate hard stools, normal stools, and diarrhea. Bristol Stool types one and two typically indicate  constipation, whereas type six and seven are consistent with diarrhea.

Dr. Brenner: If diarrhea is going to occur when taking LINZESS, it usually begins within the first two weeks of starting the medication. If you develop severe diarrhea, stop taking LINZESS and contact your practitioner right away.

Dr. Brenner: In addition to diarrhea, other possible side effects of LINZESS include gas, stomach-area abdominal pain and swelling, or a feeling of fullness or pressure in your abdomen, or abdominal distension. Finally, it’s important to check in with your practitioner and let them know if and how LINZESS is working for you. I usually recommend that the initial follow up occur at one month. But I also tell my patients that they should feel free to contact me at any time with questions or concerns, especially if they experience side effects. Ask your practitioner what follow up timing is best for you.

At your follow up visit, let your practitioner know specifically which of your symptoms have or have not improved, or if you’re experiencing any side effects you feel may be associated with the medication.

Based on your experience, you and your practitioner can determine the best treatment options.

Dr. Brenner: Now, let’s quickly recap the four key topics we addressed.

First, how to take LINZESS; take LINZESS once a day, every day, on an empty stomach, at least 30 minutes before a meal at approximately the same time each day.

Dr. Brenner: Second, the timing of symptom relief. When LINZESS is taken daily, relief of constipation and other symptoms of IBS-C are typically felt in about a week. The length of time it takes to achieve these improvements may differ from person to person.

Dr. Brenner: Third: what is the most common side effect? Diarrhea is the most common side effect and often begins within the first two weeks of taking LINZESS. Planning ahead for the possibility of this side effect can be helpful. If you develop severe diarrhea, stop taking LINZESS and call your practitioner right away.

Dr. Brenner: And finally, make sure that you can check in with your practitioner. Talk to your practitioner about your experience, and be as specific as possible, and if keeping track of your stool consistency or texture, provide an average Bristol Stool form, which can be very beneficial.

I’d like to thank you for taking the time to obtain a better understanding of LINZESS, an FDA-approved therapy for adults and pediatric patients 7 years of age and older with irritable bowel syndrome with constipation, adults with chronic idiopathic constipation and pediatric patients 2 years of age and older with functional constipation. I appreciate how challenging these chronic medical conditions can be and I commend you for being proactive about your health. Thank you very much for your attention.

Narrator:

LINZESS^® (linaclotide) is a prescription medication used to treat irritable bowel syndrome with constipation (IBS-C) in adults and in children and adolescents 7 years of age and older, chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in children and adolescents 2 years of age and older. “Idiopathic” means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children with FC less than 2 years of age or in children with IBS-C less than 7 years of age.

IMPORTANT RISK INFORMATION

• Do not give LINZESS to children who are less than 2 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
• Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before you take LINZESS, tell your doctor about your medical conditions, including if you are:

• Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
• Breastfeeding or plan to breastfeed. You and your doctor should decide if you will take LINZESS and breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Side Effects

LINZESS can cause serious side effects, including diarrhea, which is the most common side effect and can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.

Other common side effects of LINZESS in people with IBS-C and CIC include gas, stomach-area (abdomen) pain, and swelling, or a feeling of fullness or pressure in your abdomen (distention).

Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdomen) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.

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.

If you are having difficulty paying for your medicine, AbbVie and Ironwood may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

Please see full Prescribing Information including Boxed warning and Medication Guide at www.rxabbvie.com/pdf/linzess_pi.pdf, or visit www.LINZESS.com.

Ask your doctor about LINZESS. For more information, call 1-800-LINZESS.

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