Plecanatide

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

This is not a complete list of Plecanatidedrug interactions. Ask your doctor or pharmacist for more information.

Plecanatide is used to treat chronic idiopathic constipation.

Plecanatide works by activating certain substances within your intestines that help increase fluid secretion and muscle movement. Plecanatide also causes changes in the consistency of your stools.

Plecanatide may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Chronic Idiopathic Constipation:

3 mg orally once a day

Use: Treatment of chronic idiopathic constipation (CIC)

Usual Pediatric Dose for Chronic Idiopathic Constipation:

-Under Age 6 Years: Contraindicated.
-Age 6 to Under 18 Years: Not recommended.

Other drugs may interact with plecanatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Absorption

Bioavailability

Minimally absorbed; negligible systemic bioavailability following oral administration.1

Food

Administration with meal resulted in looser stools.1

Plasma Concentrations

At recommended adult dosage, plasma concentrations are below measurable levels.1

Distribution

Extent

Expected to be minimally distributed into tissues.1

Plasma Protein Binding

Minimal or no binding to albumin or α1-acid glycoprotein.1

Elimination

Metabolism

Metabolized in GI tract to an active metabolite via lysis of the terminal leucine moiety; parent drug and active metabolite are proteolytically degraded within intestinal lumen to smaller peptides and naturally occurring amino acids.1

• Binds to GC-C receptor on luminal surface of intestinal epithelium.1 2 6 7 9 Stimulation of GC-C causes increased concentrations of cyclic guanosine monophosphate (cGMP), which activates the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel leading to secretion of chloride and bicarbonate into intestinal lumen; results in increased intestinal fluid and accelerated intestinal transit.1 2 6 7 8 9

• Reduces abdominal muscle contractions, increases fluid secretion into the GI tract, accelerates intestinal transit, and changes stool consistency in animal models.1

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:

• Severe diarrhea

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:

• Mild diarrhea

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• excess air or gas in the stomach or intestines
• fever
• full or bloated feeling
• headache
• loss of voice
• pain or tenderness around the eyes and cheekbones
• passing gas
• pressure in the stomach
• runny nose
• sneezing
• sore throat
• stuffy or runny nose
• swelling of the abdominal or stomach area
• tightness of the chest
• unusual tiredness or weakness

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.

• Store in the original container at room temperature.
• Keep lid tightly closed.
• 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take plecanatide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to plecanatide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Plecanatide and its active metabolite bind and agonize guanylate cyclase-C on the luminal surface of intestinal epithelium. Intracellular and extracellular cyclic guanosine monophosphate (cGMP) concentrations are subsequently increased resulting in chloride and bicarbonate secretion into the intestinal lumen. Intestinal fluid increases and GI transit time is increased.

Absorption

Minimal systemic availability; plasma concentrations are not measurable when used at recommended doses

Distribution

Minimal tissue distribution is expected given immeasurable plasma concentrations when used at recommended doses.

Metabolism

Metabolized within GI tract to active metabolite; parent drug and metabolite undergo proteolytic degradation within the intestinal lumen to smaller peptides and amino acids.

Chronic idiopathic constipation: Treatment of chronic idiopathic constipation (CIC) in adults

CIC: Frequency of straining during bowel movements; spontaneous bowel movement quality and frequency

Plecanatide and its metabolite are not measurable in plasma when used at recommended doses. Maternal use is not expected to result in fetal exposure.