IBSRELA Tablet (2020)

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Ardelyx, Inc.

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BOXED WARNING SECTION

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 ...

1. Indications and Usage

IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

2. Dosage and Administration

The recommended dosage of IBSRELA in adults is 50 mg orally twice daily. Administration Instructions: Take IBSRELA immediately prior to breakfast or the first meal of the day and immediately prior ...

3. Dosage Forms and Strengths

Tablets: 50 mg tenapanor supplied as an oval, white to off-white tablet debossed with " 50" on one side and 5791 on the other side.

4. Contraindications

IBSRELA is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. Patients with known ...

5. Warnings and Precautions

5.1 Risk of Serious Dehydration in Pediatric Patients 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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

8.1. Pregnancy

Risk Summary Tenapanor is minimally absorbed systemically, with plasma concentrations below the limit of quantification (less than 0.5 ng/mL) following oral administration [see Clinical Pharmacology ...

8.2. Lactation

Risk Summary 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. Tenapanor is minimally absorbed ...

8.4. Pediatric Use

IBSRELA is contraindicated in patients less than 6 years of age. Avoid IBSRELA in patients 6 years to less than 12 years of age [see Contraindications (4), Warnings and Precautions (5.1)]. The ...

8.5. Geriatric Use

Of the 1203 patients in placebo-controlled clinical trials of IBSRELA, 100 (8%) were 65 years of age and older. No overall differences in safety or effectiveness were observed between elderly and younger ...

10. Overdosage

Based on nonclinical data, 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 ...

11. Description

IBSRELA (tenapanor) tablets contain tenapanor hydrochloride as an active ingredient. Tenapanor hydrochloride is a sodium/hydrogen exchanger 3 (NHE3) inhibitor for oral use. The chemical name for tenapanor ...

12.1. 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 ...

12.2. Pharmacodynamics

Cardiac Electrophysiology At 3 times the mean maximum exposure of M1 at the recommended dosage, there were no clinically relevant effects on the QTc interval. Food Effect Administration of IBSRELA 5 to ...

12.3. Pharmacokinetics

Absorption Tenapanor is minimally absorbed following repeated twice daily oral administration. Plasma concentrations of tenapanor were below the limit of quantitation (less than 0.5 ng/mL) in the majority ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis The carcinogenic potential of tenapanor was assessed in a 6-month carcinogenicity study in Tg rasH2 mice and in a 2-year carcinogenicity study in rats. Tenapanor was not tumorigenic at oral ...

14. Clinical Studies

The efficacy of IBSRELA for the treatment of IBS-C was established in two double-blind, placebo-controlled, randomized, multicenter trials in adult patients: Trial 1 (TEN-01-302; NCT02686138) and Trial ...

16.1. How Supplied

IBSRELA tablets contain 50 mg tenapanor and are oval, white to off-white, debossed with " 50" on one side and 5791 on the other side. IBSRELA is supplied in a white, opaque, high-density polyethylene ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

Advise the patients to read the FDA-approved patient labeling (Medication Guide). Diarrhea Instruct patients to stop IBSRELA and contact their healthcare provider if they experience severe diarrhea ...