Tenapanor

Tenapanor is a prescription medication used for the treatment irritable bowel syndrome with constipation (IBS-C) in adults. 

• Tenapanor is available under the following different brand names: Ibsrela.

Common side effects of Tenapanor include:

• Diarrhea,
• Abdominal distension,
• Gas (flatulence), and
• Dizziness.

Serious side effects of Tenapanor include:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out.
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

Rare side effects of Tenapanor include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 50 mg

Irritable Bowel Syndrome with Constipation

Adult dosage

• 50 mg orally two times a day immediately before breakfast and dinner

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tenapanor has severe interactions with no other drugs.
• Tenapanor has serious interactions with no other drugs.
• Tenapanor has moderate interactions with the following drugs.
  • atorvastatin
  • bosentan
  • conjugated estrogens
  • enalapril
  • fexofenadine
  • fluvastatin
  • glyburide
  • pravastatin
  • rosuvastatin
• Tenapanor has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Children aged below 6 years owing to the risk of serious dehydration
• Known or suspected mechanical GI obstruction.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tenapanor?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tenapanor?”

Cautions

• Diarrhea may occur; if severe, suspend dosing and rehydrate the patient
• Contraindicated in children aged below 6 years; avoid use in children aged 6-12 years owing to the risk of dehydration in young children
• Drug interaction overview
  • Inhibitor of intestinal uptake transporter, OATP2B1
    • OATP2B1 substrates
    • Monitor for signs related to loss of efficacy and adjust OATP2B1 substrate dose accordingly.
    • Tenapanor may reduce systemic exposure to OATP2B1 substrates.
• When enalapril was administered with tenapanor (30 mg orally two times a day for 5 days, a dosage 0.6x the recommended dosage), peak exposure of enalapril and its active metabolite, enalaprilat, decreased by approximately 70% and total systemic AUC decreased by approximately 50- 65% compared to when enalapril was administered alone.
• Monitor blood pressure and increase the dosage of enalapril, if needed

Pregnancy and Lactation

• Tenapanor is minimally absorbed systemically, with plasma concentrations below the limit of quantification
• Maternal use is not expected to result in fatal drug exposure.
• Lactation
  • Data are not available regarding the presence of either human or animal milk, its effects on milk production, or its effects on the breastfed infant.
  • The minimal systemic absorption of tenapanor will not result in clinically relevant exposure to breastfed infants