Linaclotide

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk; however, linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

If you remember the missed dose before eating, take the missed dose as soon as you remember it. If you have already eaten, check with your doctor before taking the missed dose. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you're taking, especially the diabetes drug Symlin (pramlintide).

Linaclotide is a prescription medication used in adults to treat:

• irritable bowel syndrome with constipation (IBS-C)  
• a type of constipation called chronic idiopathic constipation (CIC).  “Idiopathic” means the cause of the constipation is unknown.  

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Linaclotide falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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

• Keep linaclotide in the bottle that it comes in. The linaclotide 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 container of linaclotide tightly closed and in a dry place. 
• Keep linaclotide and all medicines out of the reach of children. 

WARNING: PEDIATRIC RISK 

Linaclotide is contraindicated in pediatric patients up to 6 years of age. Avoid use in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.

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

Linaclotide should not be given to a child younger than 6 years old. Linaclotide can cause severe dehydration in a child.

In the U.S.

• Linzess

Available Dosage Forms:

• Capsule

Therapeutic Class: Gastrointestinal Agent

It is very important that your doctor check your progress at regular visits to make sure linaclotide 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.

Use linaclotide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach.
• Take with a full glass of water at least 30 minutes before the first food, drink, or drugs of the day.
• Swallow capsule whole. Do not chew, break, or crush.
• If you have trouble swallowing, you may mix this medicine with applesauce or water. Follow how to mix as you have been told or read the package insert. If you are not sure how to mix linaclotide, call your doctor or pharmacist.
• If mixed, swallow the mixed drug right away. Do not store for use at a later time.
• Do not chew the mixture.
• Those who have feeding tubes may use this medicine. Use as you have been told. Flush the feeding tube after linaclotide is given.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

(lin AK loe tide)

Refer to adult dosing; use with caution.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flatulence. Have patient report immediately to prescriber black, tarry, or bloody stools; severe diarrhea; persistent diarrhea, abdominal edema; bloating; severe abdominal pain; or signs of dehydration (dry skin, dry mouth, dry eyes, increased thirst, tachycardia, dizziness, fast breathing, or confusion) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

145 mcg orally once a day

Comments:
-Take on an empty stomach, at least 30 minutes prior to the first meal of the day
-Swallow capsules whole; do not break apart or chew

Use: Chronic idiopathic constipation

No adjustment recommended