Trulance (plecanatide)

Trulance is a prescription medicine used in adults to treat:

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

It is not known if Trulance is safe and effective in children less than 18 years of age.

Trulance can cause serious side effects, including:

• Diarrhea is the most common side effect of Trulance, and it can sometimes be severe.
  • Diarrhea often begins within the first 4 weeks of Trulance treatment.

Stop taking Trulance and call your doctor if you develop severe diarrhea.

These are not all the possible side effects of Trulance.

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

The recommended dosage of Trulance for the treatment of CIC and IBS-C is 3 mg taken orally once daily.

Preparation And Administration Instructions

• Take Trulance with or without food.
• If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time.
• Swallow a tablet whole for each dose.
• For adult patients with swallowing difficulties, Trulance tablets can be crushed and administered orally either in applesauce or with water or administered with water via a nasogastric or gastric feeding tube. Mixing Trulance crushed tablets in other soft foods or in other liquids has not been tested.

Oral Administration In Applesauce

1. In a clean container, crush the Trulance tablet to a powder and mix with 1 teaspoonful of room temperature applesauce.
2. Consume the entire tablet-applesauce mixture immediately. Do not store the mixture for later use.

Oral Administration In Water

1. Place the Trulance tablet in a clean cup.
2. Pour approximately 30 mL of room temperature water into the cup.
3. Mix by gently swirling the tablet and water mixture for at least 10 seconds. The Trulance tablet will fall apart in the water.
4. Swallow the entire contents of the tablet water mixture immediately.
5. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 10 seconds, and swallow immediately.
6. Do not store the tablet-water mixture for later use.

Administration With Water Via A Nasogastric Or Gastric Feeding Tube

1. Place the Trulance tablet in a clean cup with 30 mL of room temperature water.
2. Mix by gently swirling the tablet and water mixture for at least 15 seconds. The Trulance tablet will fall apart in the water.
3. Flush the nasogastric or gastric feeding tube with 30 mL of water using a catheter tip syringe.
4. Draw up the mixture using the syringe and immediately administer via the nasogastric or gastric feeding tube. Do not reserve for future use.
5. If any portion of the tablet is left in the cup, add another 30 mL of water to the cup, swirl for at least 15 seconds, and using the same syringe, administer via the nasogastric or gastric feeding tube.
6. Using the same or a fresh syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water.

No Information Provided

• Plecanatide and its active metabolite are negligibly absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug.
• The available data on Trulance use in pregnant women are not sufficient to inform any drug-associated risks for major birth defects and miscarriage.
• There is no information regarding the presence of plecanatide in human milk, or its effects on milk production or the breastfed infant.
• No lactation studies in animals have been conducted. Plecanatide and its active metabolite are negligibly absorbed systemically following oral administration.