Medically reviewed by Drugs.com. Last updated on Apr 14, 2020.
(ten A pa nor)
- Tenapanor Hydrochloride
- Sodium/Hydrogen Exchanger 3 (NHE3) Inhibitor
Tenapanor is a sodium/hydrogen exchanger 3 inhibitor, which acts locally to reduce sodium absorption from the small intestine and colon. Reduced sodium absorption results in increased intestinal lumen water secretion, accelerating intestinal transit time, and softening stool consistency. Tenapanor also decreases intestinal permeability and visceral hypersensitivity in animal models, which may reduce abdominal pain.
Hepatic via CYP3A4/5 primarily to inactive metabolite M1.
Feces (65% as unchanged drug); urine (~9% as metabolites).
Use: Labeled Indications
Irritable bowel syndrome with constipation: Treatment of irritable bowel syndrome with constipation in adults.
Patients <6 years of age; known or suspected mechanical GI obstruction.
Irritable bowel syndrome with constipation: Oral: 50 mg twice daily.
Missed dose: If a dose is missed, skip the missed dose and administer the next dose at the regular time. Do not administer 2 doses at the same time.
Refer to adult dosing.
Dosing: Adjustment for Toxicity
Severe diarrhea: Discontinue treatment.
Oral: Administer immediately prior to breakfast or the first meal of the day and immediately prior to dinner.
Store at 20°C to 25°C (68°F to 77°F) in original container; protect from moisture. Do not subdivide, repackage, or remove desiccant from bottle.
There are no known significant interactions.
>10%: Gastrointestinal: Diarrhea (15% to 16%)
1% to 10%:
Central nervous system: Dizziness (2%)
Gastrointestinal: Flatulence (3%), severe diarrhea (3%), abdominal distension (2% to 3%), abnormal bowel sounds (<2%)
Hematologic & oncologic: Rectal hemorrhage (<2%)
ALERT: U.S. Boxed WarningRisk of serious dehydration in pediatric patients
Tenapanor is contraindicated in patients <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 to <12 years of age; the safety and effectiveness of tenapanor have not been established in patients <18 years of age.
Concerns related to adverse effects:
• Diarrhea: May cause diarrhea; discontinue and rehydrate if severe diarrhea occurs.
• Renal impairment: May increase the risk for adverse reactions, including diarrhea and hyperkalemia (requiring hospitalization).
• Risk of serious dehydration in pediatric patients: [US Boxed Warning]: Tenapanor is contraindicated in patients <6 years of age; in nonclinical studies in young juvenile rats (approximate human age equivalent of <2 years of age), administration of tenapanor caused decreased body weight and deaths presumed to be due to dehydration. Avoid use of tenapanor in patients 6 to <12 years of age; safety and effectiveness of tenapanor have not been established in patients <18 years of age.
Frequency of bowel movements; signs and symptoms of dehydration in patients with diarrhea; serum potassium in patients with renal impairment.
Tenapanor has limited systemic absorption following oral administration. Use during pregnancy is not expected to result in significant exposure to the fetus.
What is this drug used for?
• It is used to treat irritable bowel syndrome with constipation (IBS-C).
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Passing gas
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Abdominal swelling
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
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