Loading…
IBSRELA is a brand name for Tenapanor, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Irritable Bowel Syndrome with Constipation (IBS-C) IBSRELA® (tenapanor) is indicated for the treatment of irritable bowel syndrome with constipation (IBS- C) in adults. 1.1 Pediatrics Pediatrics (< 18 years of age): IBSRELA is contraindicated in children up to 6 years of age and is not recommended in children between…
Verbatim from this product's HC label. Tap a section to expand.
2 mg of tenapanor hydrochloride). 2 Recommended Dose and Dosage Adjustment The recommended dosage in adults is 50 mg, oral twice daily. 73m2. 73m2), were excluded from the pivotal studies. 4 Drug-Drug Interactions].
Pediatrics:
Health Canada has not authorized an indication for pediatric use. 4 Administration Take IBSRELA immediately prior to breakfast or the first meal of the day and immediately prior to dinner. Swallow IBSRELA tablets whole and do not crush or chew.
5 Missed Dose In the event that a dose is missed, the patient should skip that dose. Do not take two tablets to account for the missed dose. Wait until it is time for the next dose and then take the usual dose.
]. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data]. 1 Pregnant Women Product Monograph IBSRELA (tenapanor) Page 7 of 24 IBSRELA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
There are no adequate and well-controlled studies with IBSRELA in pregnant women. In an embryofetal development study in rats, tenapanor was administered orally to pregnant rats during the period of organogenesis at dose levels of 1, 10 and 30 mg/kg/day.
Tenapanor doses of 10 and 30 mg/kg/day were not tolerated and were associated with mortality and moribundity with body weight loss. The 10 and 30 mg/kg dose group animals were sacrificed early, and the fetuses were not examined for intrauterine parameters and fetal morphology.
8 times the maximum recommended human dose, based on body surface area). 7 times the maximum recommended human dose, based on body surface area) had no adverse effects on pre-and post-natal development with the exception of tenapanor-related lower mean body weight gains and mean body weight in pups throughout the pre-weaning periods at doses of 60 and 200 mg/kg/day.
2 Breast-feeding Tenapanor and its major metabolite, M1, were not detected in the breast milk of lactating women. Maternal use of IBSRELA is not expected to result in exposure to tenapanor or its metabolite in breastfed infants. There is no information on the effects of IBSRELA on milk production.
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.
3 Pharmacokinetics]. 1 Pediatrics, 2 CONTRAINDICATIONS, 3 SERIOUS WARNINGS AND PRECAUTIONS BOX]. In nonclinical studies, deaths occurred in young juvenile rats (< 1 to 3 week-old rats; approximately equivalent to human pediatric patients less than 2 years of age) following administration of single daily oral doses of IBSRELA [See 16 NON-CLINICAL TOXICOLOGY, Juvenile ].
2 Breast-feeding [07/2025] TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS ...............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 4 1 INDICATIONS ................................................................................................................
1 Pediatrics ............................................................................................................... 2 Geriatrics ...............................................................................................................
4 2 CONTRAINDICATIONS .................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration .......................................................................................................
5 Missed Dose .......................................................................................................... 5 5 OVERDOSAGE...............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 5 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of IBSRELA in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics The safety profile of IBSRELA in patients > 65 years of age (7%) was consistent with the safety profile of the overall IBS-C study population.
2 Geriatrics]. 1 Adverse Reaction Overview The safety of IBSRELA for the treatment of irritable bowel syndrome with constipation (IBS-C) was evaluated in 1,073 patients exposed to IBSRELA 100 mg per day (either 100 mg QD or 50 mg BID) in the Phase 2 and 3 clinical studies and 738 patients exposed to placebo.
The incidence of patients reporting a treatment-emergent adverse event (TEAE) was 44% in the IBSRELA 100 mg dose group and 33% in the placebo group. 3% in the placebo group. 3% of patients in the IBSRELA 100 mg dose group and placebo group, respectively.
1% patients with serious adverse events in the IBSRELA 100 mg dose group and placebo group, respectively. 3% of patients administered placebo, often occurring during the first week of treatment. 2%) patients were discontinued due to adverse events in the IBSRELA 100 mg dose group and placebo group, respectively.
5%). Most often, this diarrhea was mild to moderate in severity. 14% (1 of 738) of patients receiving placebo. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The data described below reflect exposure to IBSRELA in two Phase 3 double-blind, placebo-controlled clinical trials (TEN-01-301 and TEN-01-302) involving 602 adult patients with IBS-C treated with tenapanor 100 mg per day.
Demographic characteristics were comparable between treatment groups across all studies. Patients were randomized […]
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 7 8 ADVERSE REACTIONS ...................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ......................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .............................................................................................................. 5 Post-Market Adverse Reactions ............................................................................
9 Product Monograph IBSRELA (tenapanor) Page 3 of 24 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview .................................................................................
3 Drug-Behavioural Interactions............................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 11 10 CLINICAL PHARMACOLOGY ........................................................................................
1 Mechanism of Action........................................................................................... 2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................
11 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 13 PART II: SCIENTIFIC INFORMATION ........................................................................................
14 13 PHARMACEUTICAL INFORMATION ............................................................................. 14 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication .................................................................................. 15 15 MICROBIOLOGY .........................................................................................................
18 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 18 PATIENT MEDICATION INFORMATION ...................................................................................
20 Product Monograph IBSRELA (tenapanor) Page 4 of 24 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Irritable Bowel Syndrome with Constipation (IBS-C) IBSRELA® (tenapanor) is indicated for the treatment of irritable bowel syndrome with constipation (IBS- C) in adults.
1 Pediatrics Pediatrics (< 18 years of age): IBSRELA is contraindicated in children up to 6 years of age and […]