Ibsrela (tenapanor)

WARNING

RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

• Ibsrela is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration.
• Avoid use of Ibsrela in patients 6 years to less than 12 years of age.
• The safety and effectiveness of Ibsrela have not been established in patients less than 18 years of age.

Ibsrela can cause serious side effects, including:

• Diarrhea is the most common serious side effect of Ibsrela, and it can sometimes be severe. Stop taking Ibsrela and call your doctor if you develop severe diarrhea.

The other most common side effects of Ibsrela include:

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

These are not all the possible side effects of Ibsrela. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.

• Take Ibsrela immediately prior to breakfast or the first meal of the day and immediately prior to 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.

No information provided

• Tenapanor is minimally absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration. Therefore, maternal use is not expected to result in fetal exposure to the drug.
• The available data on Ibsrela exposure from a small number of pregnant women have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no data available on the presence of tenapanor in either human or animal milk, its effects on milk production or its effects on the breastfed infant.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ibsrela and any potential adverse effects on the breastfed infant from Ibsrela or from the underlying maternal condition.