Linzess

Linzess is a prescription medicine used to treat types of constipation, including irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation (CIC), and functional constipation (FC) in certain patients.

Linzess contains linaclotide, which belongs to the class of drugs called guanylate cyclase-C agonists. The guanylate cyclase type-C (GC-C) receptor is located on the luminal surface of the intestine. Linaclotide works to treat IBS-C, CIC, and FC by stimulating the GC-C receptor to increase fluid secretion, which softens stools and stimulates bowel movements.

Linzess is used to treat certain types of constipation. Constipation is a condition in which you may have fewer bowel movements than expected, or you may have stools that are hard, dry, lumpy, or painful or difficult to pass.

Linzess is used to treat:

• Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. IBS-C is chronic constipation that is associated with abdominal symptoms such as pain, discomfort, and bloating
• Chronic idiopathic constipation (CIC) in adults, CIC is constipation that keeps coming back or lasts for three months or more, with no known cause.
• Functional constipation (FC) in pediatric patients 2 years of age and older, FC is constipation with no known cause.

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 1 time each day on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day.

Swallow the capsule whole and do not crush or chew 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 or mixed with water, wait at least 30 minutes before eating a 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.

Irritable Bowel Syndrome with Constipation (IBS-C)

Adult dose: 290 mcg orally once a day

Pediatric dose (7 years and older): 145 mcg orally once daily

Chronic Idiopathic Constipation (CIC)

Usual adult dose: 145 mcg orally once a day or a dose of 72 mcg once daily may be used based on individual presentation or tolerability.

Functional Constipation (FC)

Usual Pediatric Dose (2 years of age and older): 72 mcg orally once a day.

Formulation

Linzess is available as 72 mcg, 145 mcg, and 290 mcg capsules.

Linzess has a boxed warning for the risk of serious dehydration in pediatric patients less than 2 years of age. It is not known if Linzess is safe and effective in children with functional constipation less than 2 years of age or in children with IBS-C less than 7 years of age.

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

Linzess should not be used (contraindicated) in patients less than 2 years of age.

Take Linzess 1 time each day on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day. Do not crush or chew 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.

You should not use Linzess:

• if you are allergic to linaclotide, or
• if you have a blockage in your intestines (bowel obstruction).

It is not known if this medicine is safe and effective in children less than 2 years of age with functional constipation, or in children less than 7 years of age with IBS-C.

Linzess should not be given to a child younger than 2 years of age. Linaclotide can cause severe diarrhea and fatal dehydration in children who are younger than 2 years of age.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or breastfeeding, as it is not known if Linzess will harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take Linzess and breastfeed.

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 a 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 the FDA at 1-800-FDA-1088.

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

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

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

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.

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep capsules in the bottle that they come in.

The bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.

Keep the bottle of LINZESS tightly closed and in a dry place.

Keep LINZESS and all medicines out of the reach of children.

Marketed by: AbbVie, Inc., North Chicago, IL 60064, and Ironwood Pharmaceuticals, Inc., Boston, MA 02110

Active ingredient:

• linaclotide

Inactive ingredients

• 145 mcg and 290 mcg capsules: calcium chloride dihydrate, hypromellose, Lleucine, and microcrystalline cellulose. Capsule shell: gelatin and titanium dioxide.
• 72 mcg capsules: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. Capsule shell: gelatin and titanium dioxide.