Lucius LuciTena Tenapanor 30mg

Product Information

• Product name: LuciTena Tenapanor 30mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Tenapanor
• Current strength: 30mg
• SKU: LU-ITEM-156
• Site category: other cancer

Product Summary

LuciTena Tenapanor 30mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Tenapanor is the active ingredient used for this product page. Public prescribing information for Tenapanor was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

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. Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models.

Reference Indications

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

Reference Dosage and Administration

Recommended dosage of Tenapanor in adults is 50 mg orally twice daily. Take immediately prior to breakfast or the first meal of the day and immediately prior to dinner.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS Tenapanor 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 Tenapanor in patients 6 years to less than 12 years of age . The safety and effectiveness of Tenapanor have not been established in patients less than 18 years of age . WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See for complete boxed warning. Tenapanor is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. ( 4 , 8.4 ) Avoid use of Tenapanor in patients 6 years to less than 12 years of age.

Common Adverse Reactions and Monitoring

The safety data described below reflect data from 1203 adult patients with IBS-C in two randomized, double-blind, placebo-controlled clinical trials (Trial 1 and Trial 2). Patients were randomized to receive placebo or Tenapanor 50 mg twice daily for up to 52 weeks. Demographic characteristics were comparable between treatment groups in the two trials . Adverse Reaction of Special Interest – Severe Diarrhea Severe diarrhea was reported in 2.5% of Tenapanor-treated patients compared to 0.2% of placebo-treated patients during the 26 weeks of Trial 1 and the 12 weeks of Trial 2 .

Drug Interactions and Special Populations

OATP2B1 Substrates: Potential for reduced exposure of the concomitant drug (e.g., enalapril). Monitor for signs related to loss of efficacy and adjust the dosage of the concomitantly administered drug as needed. Drugs which are substrates of OATP2B1 may have reduced exposures when concomitantly taken with Tenapanor. Monitor for signs related to loss of efficacy and adjust the dosage of concomitantly administered drug as needed. Enalapril is a substrate of OATP2B1. When enalapril was coadministered with tenapanor (30 mg twice daily for five days, a dosage 0.6 times the recommended dosage), the peak exposure (C max ) of enalapril and its active metabolite, enalaprilat, decreased by approximately 70% and total systemic exposures (AUC) decreased by approximately 50% to 65% compared to when enalapril was administered alone .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: IBSRELA public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.