Linzess

The active ingredient in Linzess is linaclotide. It is a GC-C or guanylate cyclase-C agonist. These receptors are found on our intestinal lining. Activation of these receptors by Linzess increases fluid secretion into the intestines helping restore regular bowel movements.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Linzess. However, the following is a synopsis of the general guidelines for the use of Linzess:

• Linzess is typically taken daily at the same time every day on an empty stomach or 30 minutes before your first meal of the day. Take Linzess capsules whole. Do not crush or chew Linzess.
• If you have trouble swallowing, Linzess capsules can be opened and either sprinkled onto applesauce or dissolved using bottled water. It is unknown if Linzess is safe or effective to use when it is taken in these ways.
• Linzess can be taken via a nasogastric or gastrostomy feeding tube. If you are taking it this way, your healthcare provider will demonstrate how to do so before you administer it for the first time.
• If you miss a dose, skip the missed dose and continue with your regular dosing schedule for your next dose.

The most common side effects of Linzess seen in clinical trials as compared to placebo include:

• Diarrhea
• Flatulence (gas)
• Stomach pain
• Swelling in the abdominal area
• Bloating or pressure in your abdomen

Some individuals may experience serious side effects while using Linzess. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe diarrhea that could lead to dehydration
• Severe abdominal pain
• Blood in stools
• Black, tarry stools
• Symptoms of an allergic reaction as swelling of the face/lips/tongue, difficulty breathing, severe and widespread rash, hives, fainting, or heart palpitations.

These are not all of the possible side effects of Linzess. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse reactions to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Linzess, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you:

• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• Do not use Linzess in patients less than 2 years of age due to a risk of serious dehydration. Clinical studies in neonatal mice have shown increased rates of death due to dehydration from Linzess use.

Do not use Linzess if:

• <2 years of age
• Known or suspected bowel blockage or mechanical gastrointestinal obstruction

The timeline of benefits from Linzess varies from person to person but in general, you can expect relief within about a week. Symptoms will typically continue to improve over several weeks of regular use.

When Linzess is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid drug interactions.

Linzess is available in the following dosage forms and strengths:

• 72 mcg capsules
• 145 mcg capsules
• 290 mcg capsules

Linzess should be stored at room temperature in its original container. Moisture can damage the capsules and reduce the effectiveness of the medication so keep the desiccant packet to keep the capsules dry. Keep Linzess tightly closed and out of reach of children.

Linzess is manufactured by the pharmaceutical company Ironwood Pharmaceuticals.

No, there is not a generic version of Linzess available yet.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Linzess.

It is not known if Linzess will harm your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

In clinical studies, Linzess did not pass into the breast milk. However, talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.