Generic Name: plecanatide
Dosage Form: Tablets
Date of Approval: January 19, 2017
Company: Synergy Pharmaceuticals Inc.
Treatment for: Chronic Idiopathic Constipation
FDA Approves Trulance
The U.S. Food and Drug Administration (FDA) has approved Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). It works by replicating the function of uroguanylin, a human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in stool consistency associated with regular bowel function.
Read this Patient Information before you start taking treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
- Do not give Trulance to children who are less than 6 years of age. It may harm them.
- You should not give Trulance to children 6 years to less than 18 years of age. It may harm them.
What is Trulance?
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. It is not known if this medicine is safe and effective in children less than 18 years of age.
Who should not take Trulance?
- Do not give Trulance to children who are less than 6 years of age.
- Do not take Trulance if a doctor has told you that you have a bowel blockage (intestinal obstruction).
Before you start treatment, tell your doctor about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.
- Talk with your doctor about the best way to feed your baby during treatment.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I take Trulance?
- Take Trulance exactly as your doctor tells you to take it.
- Take the tablets by mouth, one time each day with or without food.
- If you miss a dose, skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
- The tablets should be swallowed whole
- Adults who cannot swallow the tablets whole may crush the tablet and mix with applesauce or dissolve the tablet in water before swallowing. The tablets may also be taken with water by adults through a nasogastric or gastric feeding tube.
- It is not known if Trulance is safe and effective when crushed and mixed with other foods or dissolved in other liquids.
Taking Trulance in applesauce:
- Crush the tablet in a clean container until it is a powder and mix with one teaspoon of room temperature applesauce.
- Swallow all of the Trulance and applesauce mixture right away. Do not keep the applesauce mixture for future use.
Taking Trulance in water:
- Place the tablet in a clean cup and pour one ounce (30 mL) of room temperature water into the cup.
- Gently swirl the tablet and water for at least 10 seconds. The tablet will fall apart in the water.
- Swallow all of the Trulance tablet and water mixture right away. Do not keep the mixture for future use.
- If you see any part of the tablet left in the cup, add another 1 ounce (30 mL) of water to the cup, swirl for at least 10 seconds, and swallow right away.
Taking Trulance through a nasogastric or gastric feeding tube:
Gather the supplies you will need to take your Trulance dose. Your doctor should tell you what size catheter tipped syringe you will need for your dose. Ask your doctor if you have any questions.
- Place the tablet in a clean cup with one ounce (30 mL) of room temperature water.
- Gently swirl the tablet and water for at least 15 seconds. The tablet will fall apart in the water.
- Flush the nasogastric or gastric feeding tube with one ounce (30 mL) of water.
- Draw up the Trulance tablet and water mixture into a catheter tipped syringe and give right away through the nasogastric or gastric feeding tube. Do not keep the mixture for future use.
- If you see any part of the tablet left in the cup, add another one ounce (30 mL) of water to the cup, swirl for at least 15 seconds and use the same catheter tipped syringe to give the mixture through the nasogastric or gastric feeding tube.
- Using the same or another catheter tipped syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water.
Trulance side effects
Trulance can cause serious side effects, including:
- See Important Information
- Diarrhea is the most common side effect, and it can sometimes be severe.
- Diarrhea often begins within the first 4 weeks of treatment. Stop taking this medicine and call your doctor if you develop severe diarrhea.
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.
How should I store Trulance?
- Store Trulance tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep the tablets in a secure place and in the bottle or blister pack that it comes in.
- The tablet bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.
- The bottle contains a polyester coil to help protect the tablets during shipping. Remove the polyester coil from the bottle and throw it away when you are ready to start taking the tablets.
- Keep the tablet bottle tightly closed and in a dry place.
- Safely throw away Trulance that is out of date or no longer needed.
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Trulance.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Trulance for a condition for which it was not prescribed. Do not give Trulance to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information that is written for health professionals.
What are the ingredients?
Active ingredient: plecanatide
Inactive ingredients: magnesium stearate and microcrystalline cellulose