Linzess (linaclotide)

Generic name: linaclotide (LIN a KLOE tide)
Brand name: Linzess
Drug class: Guanylate cyclase-C agonists

Linzess (linaclotide) works by increasing the secretion of chloride and water in the intestines, which can soften stools and stimulate bowel movements.

Linzess is a prescription medicine used used to treat chronic constipation, or chronic irritable bowel syndrome (IBS) in people who have had constipation as the main symptom.

The safety and effectiveness of Linzess has not been established in patients under 18 years of age.

Warnings

You should not use Linzess if you have a blockage in your intestines.

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal. Do not crush, chew, break, or open a capsule. Swallow it whole.

Stop using this medicine and call your doctor at once if you have severe or ongoing diarrhea, severe stomach pain, or black, bloody, or tarry stools.

Before taking this medicine

You should not use Linzess if you are allergic to linaclotide, or if you have:

  • a blockage in your intestines (bowel obstruction).

Linzess is not approved for use by anyone younger than 18 years old.

Linzess should not be given to a child younger than 6 years old. Linaclotide can cause severe diarrhea and fatal dehydration in a child. Do not give this medicine to any child or teenager without the advice of a doctor.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Linzess?

Take Linzess exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Linzess in the morning on an empty stomach, at least 30 minutes before your first meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce or bottled water. Swallow the mixture right away without chewing. Do not save it for later use.

Even if you have taken this medicine with applesauce, wait at least 30 minutes before eating a full meal.

If needed, medicine from the Linzess capsule may be given through a nasogastric (NG) or gastronomy tube.

Carefully follow instructions for mixing medicine from the capsule with applesauce or water, or giving the medicine through a feeding tube. Ask your doctor or pharmacist if you have any questions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Keep this medicine out of the reach of children. Linaclotide can be fatal to a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.

Dosing information

Usual Adult Dose for Irritable Bowel Syndrome:

290 mcg orally once a day

Comments:
-Patients should take this drug on an empty stomach, at least 30 minutes prior to the first meal of the day.
-Capsules should be swallowed whole; patients should avoid breaking apart or chewing the capsules.
-Patients with swallowing difficulties may open the capsules and administer orally (in applesauce or water) OR via nasogastric or gastrostomy tube (in water).

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

Usual Adult Dose for Constipation:

145 mcg orally once a day

Comments:
-Some patients may be given 72 mcg orally once a day based on individual characteristics and tolerability.
-Patients should take this drug on an empty stomach, at least 30 minutes prior to the first meal of the day.
-Capsules should be swallowed whole; patients should avoid breaking apart or chewing the capsules.
-Patients with swallowing difficulties may open the capsules and administer orally (in applesauce or water) OR via nasogastric or gastrostomy tube (in water).

Use: Treatment of chronic idiopathic constipation (CIC)

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Linzess side effects

Get emergency medical help if you have signs of an allergic reaction to Linzess: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Linzess and call your doctor at once if you have:

  • severe or ongoing diarrhea; or
  • diarrhea with dizziness or a light-headed feeling (like you might pass out).

Common Linzess side effects may include:

  • diarrhea;
  • stomach pain;
  • gas; or
  • bloating or full feeling in your stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Linzess?

Other drugs may interact with linaclotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.