Trulance

The active ingredient in Trulance is plecanatide. The mechanism of action of plecanatide is that it acts as a laxative. Plecanatide is structurally similar to human uroguanylin, and both are guanylate cyclase-C (GC-C) agonists. Plecanatide binds to GC-C, resulting in an increase in chloride and bicarbonate in the intestines. This causes fluid secretion in the intestines, thus softening the stool and speeding up the movement of food through your GI tract. This helps manage chronic constipation and increases the number of bowel movements.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Trulance. However, the following is a synopsis of the general guidelines for the use of Trulance:

• Trulance is taken once daily, with or without food.
• If you forget to take a dose, skip the missed dose and take the next dose at the regular time.
• Swallow the tablet whole.

If you have swallowing problems, the tablets can be crushed and mixed in applesauce or water. To take Trulance in applesauce, crush the tablet until it is a powder. Mix the powder with 1 teaspoon of applesauce. When fully combined, swallow the entire powder and applesauce mixture immediately. To take Trulance in water, put the tablet in a cup and pour 30 ml of room-temperature water into the cup. Mix the mixture for at least 10 seconds, and then swallow the mixture right away. If part of the tablet is still left, add another 30 ml of water, mix, and swallow. For both the applesauce and water, do not store the mixtures for future use.

Trulance can be administered via a nasogastric or gastric feeding tube with water. Contact your healthcare provider for instructions on how to crush and safely administer Trulance tablets.

The most common side effects of Trulance seen in clinical trials as compared to placebo include:

• Diarrhea.
• Sinus infection.
• Upper respiratory tract infection.
• Stomach pain or discomfort.
• Bloating.
• Gas.
• Nausea.
• Urinary tract infection.

Some individuals may experience serious side effects while using Trulance. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe diarrhea.
• Allergic reactions.

These are not all of the possible side effects of Trulance. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Trulance, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you are:

• Pregnant or planning to become pregnant.
• Breastfeeding or planning to breastfeed.
• Boxed Warning

There is a risk of serious dehydration in pediatric patients with the use of Trulance. Be aware that Trulance is contraindicated in patients less than 6 years of age, and avoid using Trulance in patients less than 18 years of age. In nonclinical studies of young juvenile mice, administration of a single dose of plecanatide resulted in death due to dehydration. The safety and efficacy of Trulance in patients less than 18 years haveage has not yet been established.

• Known or suspected GI blockage
• Patients less than 6 years of age due to the risk of serious dehydration

Trulance takes up to 24 hours to start working. In some patients, it may take one week for the full effects.

When Trulance is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Idelalisib. It may increase the risk of severe diarrhea.

Trulance (plecanatide) is available in the following dosage form and strength: 3 mg tablets.

Store Trulance at room temperature, away from light and moisture. Keep out of reach of children.

Bausch Health manufactures Trulance.

Trulance is the brand name of plecanatide. There are currently no generic versions of Trulance available.

Do not stop taking Trulance without talking to your healthcare provider. Your constipation may return if you stop taking it.

According to the manufacturer, the use of Trulance is unlikely to result in fetal exposure. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Trulance is unlikely to be present in breast milk. However, according to the manufacturer, the benefits of breastfeeding, the benefits of Trulance, and the risks of Trulance to the infant should all be considered. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.