Trulance

Pregnancy

Data are insufficient to assess drug-associated risks for major birth defects and miscarriage in humans

Plecanatide and its active metabolite are negligibly absorbed systemically, and maternal use is not expected to result in fetal exposure to the drug

Lactation

Unknown if distributed in human breast milk

Plecanatide and its active metabolite are negligibly absorbed systemically, and maternal use is not expected to result in fetal exposure to the drug

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

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.

Plecanatide is used in adults to treat chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Plecanatide is in a class of medications called guanylate cyclase-C agonists. It works by increasing the movement of food and waste through the stomach and intestines.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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

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.

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.

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

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.

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.

Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.

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

• To mix with applesauce: Crush the tablet to a powder and mix with 1 teaspoonful of applesauce. Swallow the mixture immediately without chewing. Do not store it for later use.
• To mix with water: Place the tablet in a clean cup and pour 30 mL of water on it. Mix by gently swirling the tablet and water mixture in the cup for at least 10 seconds. Swallow the entire mixture immediately. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup and swirl for at least 10 seconds. Drink the water right away to make sure all of the medicine is taken. Do not store it for later use.
• The water mixture may also be used with a nasogastric or gastric feeding tube. After the mixture is given, flush the tube with an additional 30 mL 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 (tablets):
  • For chronic idiopathic constipation:
    • Adults—3 milligrams (mg) once a day.
    • Children 6 years of age and older—Use and dose must be determined by your doctor.
    • Children younger than 6 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 a dry place. Protect from moisture. Keep the tablets in the original bottle until you are ready to use it. The bottle contains a desiccant packet that helps protect the tablets from moisture. Do not remove the packet from the bottle.

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.

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

• Take with or without food.
• Swallow whole with a drink of water.
• If you cannot swallow Trulance whole, it may be crushed and mixed with applesauce. You may also dissolve it in water. Follow how to mix as you have been told by your doctor.
• After mixing, take your dose right away. Do not store for future use.
• Those who have feeding tubes may use this medicine. Use as you have been told. Flush the feeding tube after Trulance 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.

Trulance is indicated in adults for the treatment of chronic idiopathic constipation (CIC).

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.