Tenapanor

What is Tenapanor?

• Tenapanor (IBSRELA) is a sodium/hydrogen exchanger 3 (NHE3) inhibitor used for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

What are the uses of this medicine?

IBSRELA is a prescription medicine used in adults to treat:

• Irritable bowel syndrome with constipation (IBS-C)

How does this medicine work?

• Tenapanor is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium.
• By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.
• Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Patients less than 6 years of age due to the risk of serious dehydration.
• Patients with known or suspected mechanical gastrointestinal obstruction.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• The recommended dosage of IBSRELA in adults is 50 mg orally twice daily.

Administration

• Take IBSRELA exactly as your doctor tells you to take it.
• Take 1 IBSRELA tablet by mouth, 2 times each day.
• Take IBSRELA immediately before breakfast or the first meal of the day and immediately before dinner.
• If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 50 mg tenapanor

This medicine is available in fallowing brand namesː

• IBSRELA

What side effects can this medication cause?

The most common side effects of this medicine include:

• swelling, or a feeling of fullness or pressure in your abdomen (distension)
• gas (flatulence)
• dizziness

IBSRELA can cause serious side effects, including:

• Diarrhea is the most common side effect of IBSRELA, and it can sometimes be severe.

= What special precautions should I follow?

• Diarrhea was the most common adverse reaction of this medicine. If severe diarrhea occurs, suspend dosing and rehydrate patient.
• IBSRELA is contraindicated in patients below 6 years of age.
• The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established.

What to do in case of emergency/overdose?

• Overdose of IBSRELA may result in gastrointestinal adverse effects such as diarrhea as a result of exaggerated pharmacology with a risk for dehydration if diarrhea is severe or prolonged.

Can this medicine be used in pregnancy?

• Maternal use is not expected to result in fetal exposure to the drug.
• It is not known if IBSRELA will harm your unborn baby.

Can this medicine be used in children?

• IBSRELA is contraindicated in patients less than 6 years of age.
• Avoid IBSRELA in patients 6 years to less than 12 years of age.
• The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tenapanor hydrochloride
• Inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

• Manufactured for and distributed by Ardelyx, Inc. Waltham, MA 02451 USA
• IBSRELA® is a registered trademark of Ardelyx, Inc.

What should I know about storage and disposal of this medication?

• Store at room temperature, between 68°F and 77°F (20°C and 25°C).
• Keep in original container and protect from moisture. Keep the container of IBSRELA tightly closed and in a dry place.
• Do not remove desiccant from the bottle.
• Do not subdivide or repackage.

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• Dailymed label info on Tenapanor
• FDA Tenapanor