SETTING EXPECTATIONS TRANSCRIPT

[On screen]
Dr. Darren Brenner
Dr. Brenner is a compensated advisor to AbbVie and Ironwood Pharmaceuticals

Darren Brenner: Hi, my name is Darren Brenner, and I'm an Associate Professor of Medicine and Surgery, and an Irene D. Pritzker Research Scholar at the Northwestern University Feinberg School of Medicine. I'm also the Director of Neurogastromotility and Functional Bowel programs and the Montelli GI Physiology Laboratory. 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.

[Text on screen and voiceover]
Dr. Brenner:  LINZESS is a prescription medication used in adults to treat two chronic medical conditions: irritable bowel syndrome with constipation (or IBS-C) and chronic idiopathic constipation (or CIC.) Idiopathic means the cause of the constipation is unknown.

Do not give LINZESS to children who are less than two years of age, it may harm them. LINZESS can cause severe diarrhea, and your child could get severe dehydration. Do not take LINZESS if a doctor has told you that you have a bowel blockage.

Please review the important safety information about LINZESS at the end of this video. If you have any questions about IBS-C, CIC or LINZESS, please talk to your health care practitioner.

[On screen]
4 key things to understand

  • Hows and whys of taking LINZESS
  • What you may expect regarding symptom relief
  • Possible side effects of LINZESS
  • Importance of checking in with your practitioner

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

[On screen]
How to take LINZESS

  • Once a day, every day
  • On an empty stomach
  • At least 30 minutes before the first meal of the day

Darren Brenner: Let's first talk about some of the hows and whys of taking LINZESS. LINZESS should be taken once a day, every day on an empty stomach, at least 30 minutes before your first meal of the day or as prescribed by your practitioner. If you miss a dose of LINZESS, skip the missed dose and take the next dose at your regular time the next day. Do not take two doses at the same time. LINZESS was studied and shown to be effective for treating both irritable bowel syndrome with constipation and chronic idiopathic constipation when taken on a daily basis. 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.

[On screen]
How to take LINZESS

  • 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.
  • If you stop taking LINZESS, your symptoms may return.

Darren Brenner: What about expectations? When should you begin to experience relief and how long might it take to obtain symptom relief of LINZESS? When LINZESS is taken daily, constipation relief is typically felt in about one week. IBS-C patients may also begin to experience relief from belly pain and overall abdominal symptoms in about a week, with symptoms typically improving over 12 weeks. The length of time it takes to achieve these improvements may differ from person to person.

[On screen]
When to expect symptom relief

  • When LINZESS is taken daily, constipation relief is typically felt in about 1 week.
  • IBS-C patients may also begin to experience relief from belly pain and overall abdominal symptoms in about 1 week, with symptoms typically improving over 12 weeks.
  • The length of time it takes to achieve these improvements may differ from person to person.

Darren Brenner: What are possible side effects you may experience with LINZESS? Diarrhea is the most common side effects of LINZESS, and in some cases it can be severe. In clinical studies, diarrhea occurred in 16 to 22 percent of LINZESS patients and 2 to 5 percent of patients experiencing diarrhea stop taking the medication.

[On screen]
Most common side effects

  • Diarrhea is the most common side effect
  • When you first start taking LINZESS, it's helpful to plan ahead for the possibility of diarrhea by starting on a weekend.

Darren Brenner: 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.

[On screen]
Bristol Stool Scale

  1. Small, hard lumps
  2. Log-like but lumpy
  3. Log-like with surface cracks
  4. Smooth & snake-like
  5. Soft blobs with clear-cut edges
  6. Fluffy with ragged edges
  7. Watery, no solid pieces

Darren Brenner: The Bristol Stool 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, and type six and seven are consistent with diarrhea.

[On screen]
Most common side effects

  • Diarrhea is the most common side effects
  • When you first start taking LINZESS, it's helpful to plan ahead for the possibility of diarrhea by starting on a weekend
  • If diarrhea is going to occur when taking LINZESS, it usually begins within the first 2 weeks of starting the medication

Darren 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. In addition to diarrhea, other possible side effects of LINZESS include increased gas, abdominal pain and swelling, or a feeling of fullness or pressure in the abdomen. Finally, it's important to check in with your practitioner and inform them about if and how LINZESS is working for you. I usually recommend that the initial follow up occur 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, however, have not improved. And if you're experiencing any side effects that you feel may be associated with the medication.

Darren Brenner: Based on your experience, you and your practitioner can determine the best treatment options for you. Now, let's quickly recap the four key topics we addressed.

Darren Brenner: First, how to take LINZESS; LINZESS should be taken once a day, every day on an empty stomach at least 30 minutes before the first meal of the today.

[On screen]
How to take LINZESS

  • Once a day, every day
  • On an empty stomach
  • At least 30 minutes before the first meal of the day

Darren Brenner: Second, the timing of symptom relief; when LINZESS is taken daily, constipation relief is typically felt in about a week. IBS-C patients may also begin to experience relief from belly pain and overall abdominal symptoms in about one week, with symptoms typically improving over 12 weeks.

[On screen]
When to expect symptoms relief

  • When LINZESS is taken daily, constipation relief is typically felt in about 1 week.
  • IBS-C patients may also begin to experience relief from belly pain and overall abdominal symptoms in about 1 week, with symptoms typically improving over 12 weeks.

Darren 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.

[On screen]
Most common side effects

  • Diarrhea is the most common side effects
  • If diarrhea is going to occur when taking LINZESS, it usually begins within the first 2 weeks of starting the medication
  • When you first start taking LINZESS, it's helpful to plan ahead for the possibility of diarrhea by starting on a weekend.
  • If you develop severe diarrhea, stop taking LINZESS and call your practitioner right away.

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

Darren Brenner: I’d like to thank you for taking the time to obtain a better understanding of LINZESS, an FDA approved therapy for adults with irritable bowel syndrome with constipation and chronic idiopathic 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.

[Text on-screen with voiceover]

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:

  • 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, the most common side effect, which 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 include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension).

Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) 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. 

Please see full Prescribing Information including Boxed Warning and Medication Guide at www.LINZESS.com

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

[On screen]
US-LIN-210935 12/21
LINZESS Logo
AbbVie and Ironwood Logos