Trulance (Plecanatide) - Oral

What Is Trulance?

Trulance (plecanatide) is used to treat chronic constipation and irritable bowel syndrome with constipation (IBS-C) in adults. It is a prescription drug only available in tablet form. Trulance is part of a class of drugs called guanylate cyclase-C agonists.

Too much fluid in the gut leads to diarrhea, whereas too little fluid causes constipation. Specific substances, such as a small peptide called uroguanylin, help to control the amount of fluid your bowel makes. Trulance works like uroguanylin. It increases fluid secretion in the gut leading to softer stools and more bowel movements. It also increases food movement through the gastrointestinal (GI) tract.

The Food and Drug Administration (FDA) has warned against using this medication in children, especially those under age 6, due to the risk of serious dehydration.

What Is Trulance Used For?

Trulance is a prescription medication. The FDA approved Trulance to treat adults with chronic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.

This medication is not approved for use in individuals under 18. In addition, the FDA issued a boxed warning, the agency’s most stringent warning, against its use in children, especially those younger than 6. Nonhuman animal studies have shown severe dehydration leading to death associated with plecanatide use in young mice.

How to Take Trulance

Take once a day with or without food as directed by your healthcare provider. Swallow the tablet whole with water. If you cannot swallow pills, you can crush the tablet and mix it with either water or applesauce. Mixing Trulance in other liquids or other soft foods has not been tested.

You can also give this medicine mixed with water through a feeding tube.

Mixing in Water

Add the tablet to a cup. Pour 1 ounce (30 milliliters [ml]) of room temperature water into the cup and swirl the cup for about 10 seconds until you see the tablet dissolve. Drink the whole mixture immediately.

If you see any residue of your pill left in the cup, add another 1 ounce of room temperature water. Swirl for 10 seconds and drink instantly. Do not save any mixture for later.

Mixing in Applesauce

Crush the pill into a powder. Add one teaspoonful (5 milliliters) of room temperature applesauce. Mix and swallow immediately. Do not keep any mixture for later.

Taking Via Feeding Tube (Nasogastric or Gastric)

Flush the feeding tube with 1 ounce (30 milliliters) of water using a proper syringe.

Mix the tablet with 30 milliliters of room temperature water in a cup. Swirl gently for at least 15 seconds. The tablet will break apart in the water. Draw up the mixture with a syringe and immediately give it through the feeding tube.

If some tablet particles are left in the cup, add another 30 milliliters of room temperature water. Swirl gently for 15 seconds, draw it up with the same syringe, and immediately give it through the feeding tube. Do not save any mixture for later.

Flush the feeding tube after giving the drug. Flush with 10 milliliters of water using a fresh syringe or the same syringe you used.

Storage

Store your medicine at room temperature (68 to 77 degrees F). During travel, you can store it between cool and mildly hot temperatures (between 59 F and 86 F).

When storing Trulance, remember to keep the pills:

• In a dry place, away from moisture (e.g., do not store it in the bathroom and do not take the anti-moisture packet out of your pill bottle)
• In their original containers (do not repackage or split up your medication into pill trays or pillboxes)
• Out of reach of children and pets

Toss any unused and expired drugs. Do not toss your pills down the drain or toilet. Contact your healthcare provider or pharmacist if you do not know the best way to get rid of your medications. Check out drug take-back programs in your area.

What Are the Side Effects of Trulance?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

A common side effect of Trulance is diarrhea. You may see this within the first month of starting this medicine.

Severe Side Effects

Call your healthcare provider as soon as possible if you have serious side effects. Follow your healthcare provider’s instructions. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency.

Most people rarely have severe reactions while on Trulance. Serious side effects can include the following:

• Itching
• Nausea and vomiting
• Skin rash
• Gas
• Swelling of stomach
• Dizziness
• Severe or persistent diarrhea

Severe or persistent diarrhea may happen within the first three days of use. Tell your healthcare provider immediately if this happens. If this occurs, your healthcare provider may advise you to stop taking the medication and drink more water to rehydrate.

Dosage: How Much Trulance Should I Take?

Modifications

For people who cannot swallow pills, plecanatide tablets can be crushed and mixed in either water or applesauce. After crushing and mixing the pill in water or applesauce, take the mixture right away. You can also take Trulance mixed with water through a feeding tube.

Trulance is not expected to cause drug-associated risks to a fetus or infant when taken during pregnancy or while breastfeeding.

Missed Dose

If you miss your Trulance dose, skip the missed dose and return to your regular schedule. Do not double up on your dose or take extra pills.

Overdose: What Happens If I Take Too Much Trulance?

Overdose symptoms may include:

• Nausea
• Vomiting
• Severe diarrhea
• Dehydration
  

Precautions

What Are Reasons I Shouldn't Take Trulance?

Trulance cannot be used in children younger than 6. It may cause bowel obstruction in this group. Its safety and effectiveness in children 6 to 17 are unknown. Avoid this drug in children under 18. It may cause death due to severe dehydration.

Do not use this drug if you are allergic to it or any parts of its formulation.

What Other Medications Interact With Trulance?

There are no known significant interactions between Trulance and other drugs. Do not start, adjust or stop any medicine without talking to your healthcare provider.

What Medications Are Similar?

There are drugs similar to Trulance that also treat chronic constipation or irritable bowel syndrome (IBS).

These drugs include:

• Amitiza (lubiprostone)
• Linzess (linaclotide) 
• Zelnorm (tegaserod)

Amitiza takes twice as long as Trulance to begin working. It also has more common side effects than Trulance.

Linzess treats constipation caused by taking opioids. It has the same onset of action but more side effects than Trulance.

Zelnorm is used to treat IBS with constipation. Unlike Trulance, people older than 65 cannot use Zelnorm. Zelnorm has more side effects than Trulance.

How Can I Stay Healthy While Taking Trulance?

Taking Trulance daily as directed by your healthcare provider will help control your symptoms by softening your stools and regulating your bowel movements. 

Lifestyle modifications, such as diet changes, can also help manage your symptoms. Pay attention to the food that you eat. Some foods can trigger or worsen your symptoms. Keep track of this by starting a food diary. It may help to eat fiber-rich foods and avoid lactose or gas-producing foods.

If this drug causes you to have diarrhea, watch for weight loss. Drink lots of fluids and talk to your healthcare provider.