Tenapanor
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
See full prescribing information for complete Boxed Warning.
Tenapanor is contraindicated in patients less than 6 years of age due to the risk of serious dehydration. Avoid use in patients 6 years to less than 12 years of age.
|
Overview
Tenapanor is a Sodium/Hydrogen Exchanger 3 (NHE3) Inhibitor that is FDA approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Also it v=can be used for reduction of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Diarrhea (16% in IBS-C patients; 43-53% in CKD patients); If severe diarrhea occurs, suspend dosing and rehydrate the patient. Abdominal distension, Flatulence, and Dizziness is also common adverses reactions of this drug..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Tenapanor FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tenapanor in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tenapanor in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Tenapanor FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tenapanor in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tenapanor in pediatric patients.
Contraindications
There is limited information regarding Tenapanor Contraindications in the drug label.
Warnings
|
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
See full prescribing information for complete Boxed Warning.
Tenapanor is contraindicated in patients less than 6 years of age due to the risk of serious dehydration. Avoid use in patients 6 years to less than 12 years of age.
|
There is limited information regarding Tenapanor Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Tenapanor Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Tenapanor Postmarketing Experience in the drug label.
Drug Interactions
OATP2B1 Substrates: Co-administration may reduce the 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.
Sodium Polystyrene Sulfonate (SPS): Separate administration by at least three hours to avoid potential interactions.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tenapanor in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tenapanor in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tenapanor during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tenapanor in women who are nursing.
Pediatric Use
Tenapanor is contraindicated in patients less than 6 years of age due to the risk of serious dehydration. Avoid use in patients 6 years to less than 12 years of age. The safety and effectiveness of tenapanor have not been established in pediatric patients less than 18 years of age.
Geriatic Use
There is no FDA guidance on the use of Tenapanor in geriatric settings.
Gender
There is no FDA guidance on the use of Tenapanor with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tenapanor with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tenapanor in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tenapanor in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tenapanor in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tenapanor in patients who are immunocompromised.
Administration and Monitoring
Administration
For IBS-C: Dosage: 50 mg orally twice daily. Timing: Take immediately prior to breakfast or the first meal of the day and immediately prior to dinner.
For Hyperphosphatemia in CKD Patients on Dialysis: Dosage: 30 mg orally twice daily. Timing: Take just prior to the first and last meals of the day.
Monitoring
Serum Phosphorus Levels: Monitor serum phosphorus levels in CKD patients on dialysis and adjust the dosage as needed to manage gastrointestinal tolerability.
IV Compatibility
Tenapanor is administered orally and is not intended for intravenous use.
Overdosage
In case of overdose, provide symptomatic and supportive treatment. There is no known antidote for tenapanor overdose.
Pharmacology
There is limited information regarding Tenapanor Pharmacology in the drug label.
Mechanism of Action
Tenapanor is a minimally absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients
Structure
There is limited information regarding Tenapanor Structure in the drug label.
Pharmacodynamics
The inhibition of NHE3 by tenapanor leads to an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.
Pharmacokinetics
Absorption: Tenapanor has minimal systemic absorption, acting locally within the gastrointestinal tract.
Metabolism: Due to its minimal absorption, systemic metabolism is negligible.
Elimination: The primary route of elimination is fecal excretion.
Nonclinical Toxicology
There is limited information regarding Tenapanor Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Tenapanor Clinical Studies in the drug label.
How Supplied
50 mg tablets: Oval, white to off-white, debossed with "5791" on one side and "50" on the other side.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F). Keep the bottle tightly closed to protect from moisture. Dispense in the original container with a desiccant to protect from moisture.
Images
Drug Images
{{#ask: Page Name::Tenapanor |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Tenapanor |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Tenapanor Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Tenapanor interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Tenapanor is marketed under the brand name IBSRELA for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Tenapanor is also marketed under the brand name XPHOZAH for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
Look-Alike Drug Names
There is limited information regarding Tenapanor Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.