IBSRELA (tenapanor) is a brand-name medication approved by the FDA for treating irritable bowel syndrome with constipation (IBS-C) in adults. It belongs to a class of drugs known as sodium/hydrogen exchanger 3 (NHE3) inhibitors and is available as an oral tablet. This article delves into the specifics of IBSRELA, its usage, potential side effects, and other essential information.
What is IBSRELA?
IBSRELA contains the active drug tenapanor and is specifically designed to address IBS-C in adults. It is available only as a brand-name medication and is not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication and Generics typically cost less than brand-name drugs. It requires a prescription and is not a controlled substance. The FDA approved IBSRELA in 2019.
Drug Details
- Drug Class: Sodium/hydrogen exchanger 3 inhibitor
- Drug Form: Oral tablet
- Generic Available: No
- Prescription Required: Yes
- Controlled Substance: No
- Year of FDA Approval: 2019
Dosage and Administration
The following information describes dosages that are commonly prescribed or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
IBSRELA comes as an oral tablet in one strength: 50 milligrams (mg). The typical dosage for treating IBS-C in adults is 50 mg taken orally twice per day.
About Taking IBSRELA
- When to take: Take IBSRELA twice per day, right before breakfast (or your first meal of the day) and right before dinner. This timing helps IBSRELA work effectively.
- If you miss a dose: Skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time to make up for the missed dose.
- Taking IBSRELA with food: You should take each dose of IBSRELA right before you eat. Typically, the drug is taken right before breakfast (or your first meal of the day) and again right before dinner. Taking IBSRELA with food may help the drug work effectively.
- Crushing, splitting, or chewing IBSRELA: It’s best to swallow the IBSRELA tablet whole, as the manufacturer hasn’t provided guidance about whether the drug can be safely crushed, split, or chewed.
- Length of treatment: IBSRELA is meant to be a long-term treatment. If you and your doctor determine that IBSRELA is safe and effective for you, you’ll likely take it long term.
- Length of time to work: IBSRELA starts working soon after you take your first dose. In clinical trials, people who took IBSRELA had reduced symptoms of IBS-C within the first week of treatment.
Overdose
Taking more than the recommended dosage of IBSRELA can lead to harmful effects, such as severe diarrhea, which may lead to dehydration. Do not take more IBSRELA than your doctor recommends.
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What to do in Case of Overdose
If you think you’ve taken too much of this drug, call your doctor. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.
Side Effects of IBSRELA
IBSRELA can cause mild or serious side effects. It is important to be aware of these potential effects and discuss any concerns with your doctor or pharmacist.
Mild Side Effects
Mild side effects of IBSRELA can include:
- Diarrhea
- Bloating or pressure in your abdomen
- Flatulence (gas)
- Dizziness
- Mild allergic reaction
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious Side Effects
Serious side effects from IBSRELA aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects of IBSRELA can include:
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- Severe diarrhea, which may lead to dehydration. Symptoms can include:
- Not being able to urinate
- Confusion
- A weak but fast heart rate
- Risk of serious dehydration in certain children. (Note: IBSRELA is not approved for use in children of any age.)
- Severe allergic reaction.
Allergic Reaction
As with most drugs, some people can have an allergic reaction after taking IBSRELA. Symptoms of a mild allergic reaction can include:
- Skin rash
- Itchiness
- Flushing
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- Swelling under your skin, typically in your eyelids, lips, hands, or feet
- Swelling of your tongue, mouth, or throat
- Trouble breathing
Call your doctor right away if you have an allergic reaction to IBSRELA, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.
Cost and Availability
The cost of IBSRELA can vary depending on your insurance plan, location, and the pharmacy you use.
Financial and Insurance Assistance
If you need financial support to pay for IBSRELA, or if you need help understanding your insurance coverage, help is available. A program called ArdelyxAssist is available for IBSRELA.IBSRELA isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.
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Common Questions About IBSRELA
Does IBSRELA Cause Weight Loss?
No, not directly. Weight loss wasn’t a reported side effect in clinical trials of IBSRELA. However, diarrhea is a common side effect of the drug. Rarely, this side effect can be severe. If you have diarrhea that lasts a long time or is severe, your body loses a lot of fluid. This may lead to dehydration and weight loss. If you experience severe diarrhea and weight loss while taking IBSRELA, contact your doctor right away. They may have you stop taking the drug. They may also recommend drinking extra fluids or seeking medical attention, depending on the severity of your dehydration.
How Does IBSRELA Work?
IBSRELA is prescribed to treat irritable bowel syndrome (IBS) with constipation in adults. IBSRELA works locally in the digestive tract. Specifically, IBSRELA works by blocking a receptor (a type of protein) called sodium/hydrogen exchanger 3 (NHE3). NHE3 is located on the surface of cells in the small intestine and colon. This receptor regulates how much sodium (salt) your body absorbs from your diet.
When IBSRELA blocks NHE3, your body absorbs less sodium than is typical. This results in more water entering the digestive tract, which softens stool and promotes bowel movements.
IBSRELA may also work by making the digestive tract less sensitive, reducing abdominal pain. In addition, the lining of the digestive tract in people with IBS may be more permeable. A more permeable digestive tract, also called “leaky gut,” allows more bacteria and toxins into your bloodstream. IBSRELA may work by making the digestive tract lining less permeable. This may help to reduce leaky gut, which is thought to play a role in causing IBS.
Can IBSRELA Cause Long-Term Side Effects?
IBSRELA isn’t known to cause any long-term side effects.IBSRELA was approved by the FDA in 2019. Before its approval, the drug’s safety and effectiveness were tested in clinical trials. In these trials, participants took the drug for 4-26 weeks. No long-term side effects were reported during or after these trials. As with any drug, it’s possible that long-term side effects or new risks could be identified in the future.
Alternatives to IBSRELA
Other drugs are available that can treat irritable bowel syndrome with constipation (IBS-C). If you’re interested in finding an alternative to IBSRELA, talk with your doctor. They can tell you about other medications that may work well for you. Other drugs that may be prescribed to treat IBS-C include:
- Linaclotide (Linzess)
- Lubiprostone (Amitiza)
- Plecanatide (Trulance)
- Prucalopride (Motegrity)
IBSRELA Uses
The Food and Drug Administration (FDA) approves prescription drugs such as IBSRELA to treat certain conditions. IBSRELA may also be prescribed off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for. IBSRELA is FDA-approved to treat irritable bowel syndrome (IBS) with constipation in adults.
IBSRELA and Children
IBSRELA is not FDA-approved for use in children. It’s only approved for use in people ages 18 years and older. The drug hasn’t been tested for effectiveness or safety in children of any age.IBSRELA has a boxed warning for the risk of serious dehydration in certain children.
Interactions
IBSRELA can interact with several other medications. Before taking IBSRELA, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
Medications that Interact with IBSRELA
- Enalapril (Vasotec)
- Fexofenadine (Allegra)
- Pravastatin
Alcohol Interaction
Alcohol isn’t known to interact with IBSRELA. It’s likely safe to consume alcohol while taking IBSRELA. If you have questions about how much alcohol is safe to drink while taking IBSRELA, talk with your doctor or pharmacist.
Precautions
IBSRELA comes with several precautions, including a boxed warning regarding the risk of serious dehydration in children.
FDA Warning: Risk of Serious Dehydration in Children
This drug has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
In animal studies of IBSRELA, some of the young rats died after receiving the drug. The deaths were likely due to serious dehydration. (In people, IBSRELA may cause diarrhea as a side effect. If diarrhea is severe or lasts a long time, it can lead to severe dehydration.) Keep in mind that animal studies don’t always accurately predict what will happen in people. Still, due to this risk, doctors typically won’t prescribe IBSRELA for children.
IBSRELA is not FDA-approved for use in children of any age. It’s only approved for use in people ages 18 years and older. The drug hasn’t been tested for effectiveness or safety in children.
Other Precautions
Before taking IBSRELA, discuss your health history with your doctor. IBSRELA may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- Bowel obstruction (blockage)
- Chronic kidney disease
- Past allergic reaction to this or a similar drug
- Pregnancy
- Breastfeeding
IBSRELA and Pregnancy/Breastfeeding
In general, IBSRELA is considered safe to take during pregnancy and while breastfeeding. However, you should still ask your doctor whether they feel it’s safe for you.
Real-World Evidence and Patient Experiences
Real-world surveys of patients receiving tenapanor for the treatment of IBS-C support the effectiveness of tenapanor in the management of IBS-C, with a majority of patients reporting treatment satisfaction (88%) and improvements in constipation (95%), bloating (75%), and abdominal pain (84%). More than 70% of patients reported improved ability to participate in daily activities including work, social activities and exercise.