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Drug overview for IBSRELA (tenapanor hcl):
Generic name: tenapanor HCl (ten-A-pa-nor)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents
Tenapanor is a locally acting inhibitor of sodium/hydrogen exchanger isoform 3 (NHE3), a protein that facilitates absorption of intestinal sodium through proton exchange.
No enhanced Uses information available for this drug.
Generic name: tenapanor HCl (ten-A-pa-nor)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents
Tenapanor is a locally acting inhibitor of sodium/hydrogen exchanger isoform 3 (NHE3), a protein that facilitates absorption of intestinal sodium through proton exchange.
No enhanced Uses information available for this drug.
DRUG IMAGES
IBSRELA 50 MG TABLET
The following indications for IBSRELA (tenapanor hcl) have been approved by the FDA:
Indications:
Constipation predominant irritable bowel syndrome
Professional Synonyms:
Constipation predominant IBS
Indications:
Constipation predominant irritable bowel syndrome
Professional Synonyms:
Constipation predominant IBS
The following dosing information is available for IBSRELA (tenapanor hcl):
Dosage of tenapanor hydrochloride is expressed in terms of tenapanor.
The recommended adult dosage of tenapanor for the symptomatic treatment of irritable bowel syndrome (IBS) with constipation is 50 mg twice daily.
The recommended adult dosage of tenapanor for the symptomatic treatment of irritable bowel syndrome (IBS) with constipation is 50 mg twice daily.
Tenapanor hydrochloride is administered orally twice daily, immediately prior to breakfast or the first meal of the day and immediately prior to dinner. Administration of tenapanor 5-10 minutes before a meal increases 24-hour stool sodium excretion compared with administration under fed or fasting conditions. If a dose is missed, the missed dose should be omitted and the next dose taken at the regularly scheduled time.
Two doses should not be taken at the same time to make up for a missed dose. Tenapanor should be stored at 20-25degreesC in the original container in a dry place; protect from moisture.
Two doses should not be taken at the same time to make up for a missed dose. Tenapanor should be stored at 20-25degreesC in the original container in a dry place; protect from moisture.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| IBSRELA 50 MG TABLET | Maintenance | Adults take 1 tablet (50 mg) by oral route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for IBSRELA (tenapanor hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for IBSRELA (tenapanor hcl):
Drug contraindication overview.
*Pediatric patients younger than 6 years of age due to the risk of serious dehydration. *Known or suspected mechanical GI obstruction.
*Pediatric patients younger than 6 years of age due to the risk of serious dehydration. *Known or suspected mechanical GI obstruction.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Gastrointestinal obstruction |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for IBSRELA (tenapanor hcl):
Adverse reaction overview.
Adverse effects reported in 2% or more of patients receiving tenapanor include diarrhea, abdominal distension, flatulence, and dizziness.
Adverse effects reported in 2% or more of patients receiving tenapanor include diarrhea, abdominal distension, flatulence, and dizziness.
There are 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Dehydration Rectal bleeding |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Diarrhea Dizziness Flatulence |
None. |
| Rare/Very Rare |
|---|
|
Bowel sounds hyperactive Pruritus of skin Skin rash Urticaria |
The following precautions are available for IBSRELA (tenapanor hcl):
Tenapanor is contraindicated in pediatric patients younger than 6 years of age and should be avoided in children 6 years to younger than 12 years of age. Safety and efficacy of the drug have not been established in patients younger than 18 years of age. Tenapanor has caused deaths in toxicology studies in young juvenile rats (age approximately equivalent to a human age of younger than 2 years).
Data are lacking in older juvenile rats (age approximately equivalent to a human age of 2 years to younger than 12 years). One toxicology study in neonatal rats was terminated early because of deaths and decreases in body weight (reductions of 24-33% compared with placebo) at tenapanor dosages of 5-10 mg/kg daily. In a second study, neonatal rats received tenapanor at dosages of 0.1-5
mg/kg daily on postnatal days 5-24. Treatment-related deaths were observed at dosages of 0.5-5 mg/kg daily and occurred as early as postnatal day 8, with most of the deaths occurring between postnatal days 15 and 25.
At a dosage of 5 mg/kg daily, mean body weight was reduced by 35-47% compared with control animals. Slight (5-11%) reductions in mean tibial length were observed in animals receiving tenapanor 0.5-5 mg/kg daily and correlated with the decrements in body weight observed at these dosages.
Decreased spleen, thymus, and/or ovary weight; GI distension; and microscopic findings of increased osteoclasts, eroded bone, and/or decreased bone in the sternum and/or femorotibial joint also were observed at dosages of 0.5-5 mg/kg daily.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Data are lacking in older juvenile rats (age approximately equivalent to a human age of 2 years to younger than 12 years). One toxicology study in neonatal rats was terminated early because of deaths and decreases in body weight (reductions of 24-33% compared with placebo) at tenapanor dosages of 5-10 mg/kg daily. In a second study, neonatal rats received tenapanor at dosages of 0.1-5
mg/kg daily on postnatal days 5-24. Treatment-related deaths were observed at dosages of 0.5-5 mg/kg daily and occurred as early as postnatal day 8, with most of the deaths occurring between postnatal days 15 and 25.
At a dosage of 5 mg/kg daily, mean body weight was reduced by 35-47% compared with control animals. Slight (5-11%) reductions in mean tibial length were observed in animals receiving tenapanor 0.5-5 mg/kg daily and correlated with the decrements in body weight observed at these dosages.
Decreased spleen, thymus, and/or ovary weight; GI distension; and microscopic findings of increased osteoclasts, eroded bone, and/or decreased bone in the sternum and/or femorotibial joint also were observed at dosages of 0.5-5 mg/kg daily.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Since tenapanor is minimally absorbed following oral administration (i.e., plasma concentrations are below the limit of quantification), the drug is not expected to result in fetal exposure if administered to pregnant women. Limited data regarding tenapanor exposure during pregnancy have not identified any drug-associated risk for major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes. In reproduction studies in pregnant rats and rabbits, no adverse fetal effects were observed at dosages of 0.1
and up to 8.8 times, respectively, the maximum recommended human dosage. In a prenatal and postnatal developmental study in mice, no adverse developmental effects were observed at tenapanor dosages up to approximately 9.7 times the maximum recommended human dosage.
and up to 8.8 times, respectively, the maximum recommended human dosage. In a prenatal and postnatal developmental study in mice, no adverse developmental effects were observed at tenapanor dosages up to approximately 9.7 times the maximum recommended human dosage.
It is not known whether tenapanor is distributed into milk, affects milk production, or affects the breast-fed infant. Tenapanor is minimally absorbed following oral administration (i.e., plasma concentrations are below the limit of quantification), and the manufacturer states that the minimal systemic absorption will not result in clinically important exposure in breast-fed infants. The benefits of breast-feeding should be considered along with the woman's clinical need for tenapanor and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
In placebo-controlled clinical trials of tenapanor for symptomatic treatment of IBS with constipation, 8% of patients were 65 years of age or older. Although no overall differences in efficacy or safety were observed between geriatric patients and younger adults, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
The following prioritized warning is available for IBSRELA (tenapanor hcl):
WARNING: This medication must not be used by children younger than 6 years. It is not recommended for use by children who are 6 to less than 18 years due to the risk for harm (especially serious dehydration). Talk to your doctor for details.
WARNING: This medication must not be used by children younger than 6 years. It is not recommended for use by children who are 6 to less than 18 years due to the risk for harm (especially serious dehydration). Talk to your doctor for details.
The following icd codes are available for IBSRELA (tenapanor hcl)'s list of indications:
| Constipation predominant irritable bowel syndrome | |
| K58.1 | Irritable bowel syndrome with constipation |
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