Linzess 72mcg Capsules

Linaclotide is a guanylate cyclase-C (GC-C) agonist. It binds to the GC-C receptor on the apical surface of intestinal epithelial cells. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Increased intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, primarily through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, which results in increased intestinal fluid and accelerated transit. Increased extracellular cGMP is thought to decrease visceral pain by reducing the activity of pain-sensing nerves.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Black, tarry, or bloody stools
Swelling of the abdomen
Bloating
Severe diarrhea that requires hospitalization
Signs of dehydration, including:
+ Severe dizziness or fainting
+ Inability to urinate or changes in urine output
+ Feeling extremely tired

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:

Stomach pain or diarrhea
Gas
* Symptoms of a common cold

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a bowel blockage, as this may affect the use of this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you experience diarrhea while taking this drug, it is crucial to prevent dehydration by drinking plenty of fluids and monitoring your weight. If you notice any significant changes, consult your doctor promptly.

If a child, especially those under 2 years of age, accidentally ingests this medication, they may be at risk of severe side effects, including severe diarrhea and dehydration. In such cases, seek immediate medical attention.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.

• Diarrhea
• Abdominal pain
• Abdominal distension
• Flatulence
• Headache
• Nausea
• Vomiting
• Dehydration (especially in pediatric patients)

Linaclotide is Pregnancy Category C. Animal studies have shown adverse effects at high doses, but human data are limited. Due to minimal systemic absorption, maternal use is not expected to result in fetal exposure. Use only if the potential benefit justifies the potential risk to the fetus.

It is not known whether linaclotide or its active metabolite are excreted in human milk. However, due to minimal systemic absorption, maternal exposure is not expected to result in clinically relevant infant exposure. Consider the benefits of breastfeeding, the mother's clinical need for Linzess, and any potential adverse effects on the breastfed infant.

Contraindicated in patients less than 2 years of age due to risk of serious dehydration. Not recommended for patients 6 to less than 18 years of age due to lack of established safety and efficacy and potential risk of dehydration.

No dosage adjustment is necessary based on age. Clinical studies did not identify differences in safety or effectiveness between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to the effects of dehydration from diarrhea.

• Linzess should be taken on an empty stomach, at least 30 minutes before the first meal of the day, to optimize efficacy and minimize potential for adverse effects like diarrhea.
• The most common side effect is diarrhea, which can be severe. Patients should be counseled on managing diarrhea and signs of dehydration.
• Linzess is contraindicated in pediatric patients less than 2 years of age due to the risk of serious dehydration.
• For patients who have difficulty swallowing capsules, the capsule can be opened and the beads mixed with applesauce or water, or administered via nasogastric/gastrostomy tube.
• Improvement in symptoms may be seen within a week, but full therapeutic effect may take 1-2 weeks of consistent use.

• Plecanatide (Trulance) - another GC-C agonist
• Lubiprostone (Amitiza) - chloride channel activator
• Prucalopride (Motegrity) - serotonin 5-HT4 receptor agonist (for CIC)
• Tegaserod (Zelnorm) - serotonin 5-HT4 receptor agonist (for IBS-C in women <65 with no history of cardiovascular ischemic events)
• Laxatives (e.g., polyethylene glycol, lactulose, magnesium hydroxide) for CIC
• Fiber supplements (e.g., psyllium)
• Dietary modifications (e.g., FODMAP diet for IBS-C)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, it is vital to seek immediate medical attention by calling your local poison control center or visiting the emergency room. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will enable healthcare professionals to provide you with the most appropriate and timely care.