Pronunciation:

lin-AK-loe-tide

Brand Names:

• Linzess

Dosage Forms:

• Capsule

Warnings:

Linaclotide is contraindicated in pediatric patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration .

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Guanylate Cyclase-C Agonist

Uses of This Medicine:

Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). It works by increasing intestinal fluid secretion, which helps ease the passage of stools and relieve the symptoms of constipation.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

This medicine should not be used in children younger than 2 years of age because it may increase the risk of serious dehydration. Safety and efficacy have not been established in the pediatric population.

Older adults—

Although appropriate studies on the relationship of age to the effects of linaclotide have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Stomach or bowel blockage, or history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine on an empty stomach, at least 30 minutes before breakfast or the first meal of the day.

Swallow the capsule whole. Do not crush, break, or chew it.

If you have trouble swallowing the capsule, you may mix the contents with applesauce or water.

• To mix with applesauce: Open the capsule and sprinkle the beads on 1 teaspoonful of applesauce in a clean container. Swallow the mixture right away without chewing. Do not store the mixture for future use.
• To mix with water: Pour 30 mL (1 ounce) of water into a clean cup. Open the capsule and sprinkle the beads into the cup. Swirl the bead-water mixture for at least 20 seconds. Swallow the mixture right away. If there are beads remaining in the cup, you may repeat the same procedure. Do not store the mixture for future use.
• You may also take the bead-water mixture using a nasogastric or gastric feeding tube. After the mixture is given, flush the tube with an additional 10 mL (2 teaspoons) of water.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For chronic idiopathic constipation:
    • Adults—145 micrograms (mcg) once a day. Some patients may need 72 mcg once a day.
    • Children 2 years of age and older—Use and dose must be determined by your doctor.
    • Children younger than 2 years of age—Use is not recommended.
  • For irritable bowel syndrome with constipation:
    • Adults—290 micrograms (mcg) once a day.
    • Children 2 years of age and older—Use and dose must be determined by your doctor.
    • Children younger than 2 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the original bottle until you are ready to use it. The bottle contains a desiccant packet that helps to protect the capsules from moisture. Do not remove the desiccant packet from the bottle.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Call your doctor right away if you have severe diarrhea with feeling of lightheadedness, dizziness, or fainting.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Severe diarrhea

stomach pain

Less common

Heartburn

loss of appetite

nausea

vomiting

weakness

Incidence not known

Bleeding from the rectum

bloody, black, or tarry stools

chest tightness

confusion

cough

decreased urination

difficulty swallowing

dizziness

dry mouth

fainting

fast heartbeat

hives or welts, itching, skin rash or redness

increase in heart rate

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lightheadedness

loss of bowel control

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

rapid breathing

sunken eyes

thirst

trouble breathing

unusual tiredness or weakness

wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

chills

ear congestion

excess air or gas in the stomach or intestines

fever

full or bloated feeling

headache

loss of voice

passing gas

sneezing

sore throat

stuffy or runny nose

Less common

Acid or sour stomach

belching

indigestion

pain or tenderness around the eyes and cheekbones

pressure in the stomach

stomach discomfort or upset

swelling of the stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.