Motegrity (prucalopride): Side effects, dosage, uses, and more (original) (raw)

Motegrity is a brand-name prescription drug that’s approved for use in adults to treat chronic idiopathic constipation (CIC). This is constipation that lasts for at least 3 months and has no known cause.

Drug details

Motegrity belongs to the drug class selective serotonin (5-HT4) receptor agonists. It comes as a tablet that you take by mouth once per day. It’s available in two strengths: 1 mg and 2 mg.

Effectiveness

In clinical studies lasting 12 weeks, between 19% and 38% of people taking Motegrity had at least three bowel movements per week. These improvements occurred within the first week of treatment.

FDA approval

The Food and Drug Administration (FDA) approved Motegrity in December 2018.

Motegrity contains the active drug prucalopride.

Prucalopride isn’t currently available in generic form. It only comes as Motegrity.

Motegrity can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Motegrity. This list doesn’t include all possible side effects.

For more information on possible side effects of Motegrity, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Motegrity can include:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Motegrity aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Motegrity. Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

Call your doctor right away if you have a severe allergic reaction to Motegrity. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Weight loss (not a side effect)

Weight loss wasn’t a side effect of Motegrity in clinical studies. (For more information, see “Motegrity for weight loss” below in the “Motegrity Uses” section.)

Other drugs are available that can treat constipation. Some may be better suited for you than others. If you’re interested in finding an alternative to Motegrity, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat constipation.

Examples of other drugs or supplements that may be used to treat chronic idiopathic constipation (CIC) include:

As with all medications, the cost of Motegrity can vary. The actual price you’ll pay depends on your insurance coverage, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Motegrity, help is available.

Shire, the company that makes Motegrity, offers a Savings Card program. For more information and to find out if you’re eligible for support, call 844-447-2582. Or you can visit the program website.

The Food and Drug Administration (FDA) approves prescription drugs such as Motegrity to treat certain conditions.

Motegrity for constipation

Motegrity is FDA-approved for use in adults to treat chronic idiopathic constipation (CIC). This is constipation that lasts at least 3 months and has no known cause.

According to the American College of Gastroenterology, CIC often causes the following symptoms:

Motegrity for other conditions

In addition to the use listed above, Motegrity may be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Motegrity for gastroparesis

Motegrity isn’t FDA-approved to treat gastroparesis but it may be used off-label for it. When you have gastroparesis, your stomach takes too long to empty food. This condition can cause:

Two clinical studies found that Motegrity may help treat gastroparesis. But more research is needed to fully understand whether Motegrity works to treat this condition.

Motegrity for IBS

Motegrity isn’t FDA-approved to treat irritable bowel syndrome (IBS), but it may be used off-label for this purpose.

There’s currently a study underway to see if Motegrity works to treat IBS with constipation. But researchers aren’t sure when the results will be available.

Motegrity for opioid-induced constipation

Motegrity isn’t FDA-approved to treat opioid-induced constipation (OIC). However, it may be used off-label for this condition.

A small clinical trial tested whether Motegrity may help relieve OIC. Over 4 weeks, 40.3% of people who took 4 mg of Motegrity once a day had improvement. They had at least one more bowel movement per week than before they took the drug.

Motegrity for weight loss (not an appropriate use)

Motegrity isn’t FDA-approved for use as a weight-loss aid. No studies are currently testing whether Motegrity has an effect on weight.

Some people may try to lose weight by taking medication used to treat constipation. You should only take Motegrity as prescribed by your doctor. It may cause serious side effects if you use it to lose weight. Here are some side effects that can occur if you take constipation drugs to lose weight:

If you’d like to lose weight, talk with your doctor. Together you can create a weight loss plan that’s safe and effective for you.

The Motegrity dosage your doctor prescribes will depend on how well your kidneys are working.

The following information describes dosages that are commonly used or recommended.

However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Motegrity comes as a tablet that you take by mouth. It’s available in two strengths: 1 mg and 2 mg.

Dosage for constipation

The usual dosage for chronic idiopathic constipation (CIC) is 2 mg, taken once per day. This is also the drug’s maximum recommended dosage.

Your doctor may prescribe a lower dosage if you have severe kidney disease.

What if I miss a dose?

If you miss a dose, take it as soon as you remember.

But if it’s almost time for your next dose, skip the missed dose. Take only the next dose at the regular time. Don’t take extra medication to make up for the missed dose.

Will I need to use this drug long term?

It depends. If you find that Motegrity is effective and safe for you, your doctor may prescribe it for you long term.

You may wonder how Motegrity compares to other medications that are prescribed for similar uses. Here we look at how Motegrity and Amitiza are alike and different.

Motegrity contains the drug prucalopride. Amitiza contains the drug lubiprostone.

Uses

Motegrity and Amitiza are both FDA-approved to treat adults with chronic idiopathic constipation (CIC).

Amitiza is also approved to treat:

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Drug forms and administration

Motegrity comes as a tablet that you take by mouth. The tablets come in two strengths: 1 mg and 2 mg.

The usual recommended dosage of Motegrity is 2 mg once a day. You can take it with or without food.

Amitiza comes as a capsule that you take by mouth. These capsules are also available in two strengths: 8 mcg and 24 mcg. Amitiza’s usual recommended dosage for CIC is 24 mcg twice a day. You should take it with food and water.

Side effects and risks

Motegrity and Amitiza contain different drugs, but they treat the same condition. Therefore, they can cause both similar and different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Motegrity, with Amitiza, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Motegrity, with Amitiza, or with both drugs (when taken individually).

Effectiveness

These two drugs haven’t been directly compared in clinical studies. But separate studies found that both Motegrity and Amitiza are effective for treating CIC.

The American College of Gastroenterology recommends both drugs as treatment options for CIC.

Costs

Motegrity and Amitiza are both available as brand-name drugs. They don’t have generic forms. Brand-name medications usually cost more than generics. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Here are answers to some frequently asked questions about Motegrity.

Can Motegrity cause gastroparesis?

No. You shouldn’t expect to develop gastroparesis while taking Motegrity.

Gastroparesis is a condition in which your stomach empties too slowly. It wasn’t found to be a side effect of Motegrity in clinical studies. Motegrity actually works by increasing how quickly food moves through your intestines.

Will Motegrity stop working after a while?

It’s possible. In some studies of the drug, Motegrity seemed to have effect throughout the studies, but another study showed a different result.

After taking Motegrity for 12 weeks during clinical studies, 19% to 38% of people had three or more complete bowel movements per week. These people had similar results throughout the 12-week period.

Also, a long-term, open-label study tested long-term use of Motegrity. (“Open-label” means that people knew which drug they were taking during the study.) Motegrity eased constipation for at least 18 months in up to 67.4% of people who took the drug.

However, a 24-week study of Motegrity and a placebo (a treatment with no active drug) had different results. Motegrity wasn’t more effective than the placebo at increasing the number of bowel movements people had.

More studies need to be done to determine how well Motegrity works long term.

If I have depression, can I take Motegrity?

It depends. It’s not known if Motegrity worsens depression or causes suicidal thoughts and behavior. But this has happened in a very small number of people in clinical trials.

Tell your doctor if you have a history of depression, suicidal thoughts, or suicide attempts. They’ll talk with you about the risks and benefits of taking Motegrity. They may also monitor you more closely to make sure your depression doesn’t get worse.

Call your doctor right away if you’re taking Motegrity and your depression gets worse. Also, tell them right away if you have unusual changes in your mood or behavior. They’ll likely have you stop taking Motegrity.

Can Motegrity cause serotonin syndrome?

Serotonin syndrome wasn’t reported as a side effect in clinical studies of Motegrity. (This condition occurs when levels of serotonin build up in your body.)

In some cases, serotonin syndrome can be severe and even life threatening. But this drug isn’t known to cause serotonin syndrome.

Will Motegrity cause diarrhea?

It might. Diarrhea was a common side effect in clinical studies of Motegrity.

Over 12 weeks of treatment, 13% of people who took Motegrity had diarrhea. Most people had this side effect within the first week of treatment. For many of them, the diarrhea went away within a few days. One percent of people who took Motegrity stopped taking the drug because of diarrhea.

If you have diarrhea while taking Motegrity, talk with your doctor. They can suggest ways to manage this side effect.

Can I take Motegrity with other constipation medications?

It depends. Motegrity is likely safe to take with over-the-counter (OTC) constipation medications, such as stool softeners and laxatives. But be sure to talk with your doctor before using Motegrity with other medications, whether they’re OTC or prescription drugs.

Motegrity doesn’t appear to interact with alcohol. However, drinking alcohol can cause many of the same unwanted effects as Motegrity. Some of these effects include:

Therefore, drinking alcohol while taking Motegrity may increase your risk for these effects. If you drink alcohol, talk with your doctor about whether it’s safe for you to drink alcohol while taking Motegrity.

Motegrity doesn’t appear to have interactions that affect how well it works or what side effects you could have.

But before you take Motegrity, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also mention any vitamins, herbs, and supplements you take. They’ll use this information to make sure your medications aren’t causing your constipation or making it worse.

You should take Motegrity as your doctor or another healthcare professional tells you to.

When to take

Take Motegrity once a day, at any time. Choose a time that you’re most likely to remember to take your medication.

Using a reminder tool can help you remember to take Motegrity every day.

Taking Motegrity with or without food

You can take Motegrity with or without food.

Can Motegrity be crushed or split?

It’s not known whether crushing or splitting Motegrity affects the way the drug works.

If you have trouble swallowing Motegrity tablets, talk with your doctor or pharmacist. They can suggest ways to make it easier for you to take your medication.

Motegrity treats chronic idiopathic constipation. This is constipation that lasts at least 3 months and has no known cause.

Muscles in your intestines contract (tighten) and relax to move food through your digestive system. These movements make up a process called peristalsis. When it works well, peristalsis helps you have bowel movements. But if the muscles move too slowly or don’t tighten enough, you may have constipation.

Motegrity eases constipation by increasing the movement of these digestive muscles. It does this by attaching to certain receptors (molecules on the walls of cells) in the lining of your intestines. When this attachment happens, nerve cells in your intestines release chemicals that tell your digestive muscles to contract.

These contractions increase movement in the intestine and help food move through your system. They also give you the feeling that you need to have a bowel movement.

How quickly does it start working?

Motegrity will likely help you have a bowel movement within a few days.

In clinical studies, people took either Motegrity or a placebo (treatment with no active drug). The Motegrity group had more bowel movements within the first week of taking the drug. Many people had a complete bowel movement within 1.4 to 4.7 days of starting Motegrity.

There haven’t been enough studies in humans to know whether Motegrity is safe to take during pregnancy.

In animal studies, there were no harmful effects in infants born to females who received the drug. However, animal studies don’t always reflect what will happen in humans.

Talk with your doctor about whether Motegrity is safe for you to take during pregnancy.

If you and your doctor decide you’ll take Motegrity while pregnant, consider joining Motegrity’s pregnancy registry. It helps gather information about people who use certain medications while pregnant. This lets healthcare professionals learn more about the safety of medication use during pregnancy.

You can learn more about the drug’s registry, including how to sign up, by calling 877-311-8972. Or you can check out the registry’s website.

Motegrity does pass into breast milk in humans. However, it’s not known how this might affect a child who is breastfed.

Talk with your doctor about whether Motegrity is safe for you to take while breastfeeding. They may suggest other treatments for your constipation while you breastfeed.

Before taking Motegrity, talk with your doctor about your health history. Motegrity may not be right for you if you have certain medical conditions. These include:

Note: For more information about potential negative effects of Motegrity, see the “Motegrity side effects” section above.

Taking too much Motegrity can increase your risk for serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Motegrity from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist. They can let you know if you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Store Motegrity tablets at room temperature in a tightly sealed container. Avoid storing it in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Motegrity and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website has several useful tips on medication disposal. You can also ask your pharmacist for tips on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Motegrity is FDA-approved to treat chronic idiopathic constipation (CDC).

Mechanism of action

Motegrity is a selective serotonin (5-HT4) receptor agonist. It stimulates colonic peristalsis and bowel motility by causing acetylcholine release in gastrointestinal neurons.

Pharmacokinetics and metabolism

Motegrity has absolute bioavailability of greater than 90 percent following oral administration. Approximately 30 percent is bound to plasma proteins.

It’s metabolized by CYP3A4 to seven minor metabolites. Elimination occurs primarily by the kidneys (about 65 percent), followed by the fecal route. Terminal half-life is approximately one day.

Contraindications

Motegrity is contraindicated in patients with a history of hypersensitivity reactions to Motegrity. It’s also contraindicated for people with:

Storage

Motegrity should be stored at room temperature between 68°F and 77°F (20°C and 25°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.