Rezurock (belumosudil)

What is Rezurock?

Rezurock is a brand-name prescription drug. It’s FDA-approved to treat chronic graft-versus-host disease (GVHD) in adults and children ages 12 years and older. (Chronic GVHD is a condition that may occur between 3 months and 1 year after a stem cell transplant.)

Rezurock is used when chronic GVHD has not improved after treatment with at least two other therapies.

For details, see the “Rezurock for chronic graft-versus-host disease” section below.

Drug details

Rezurock contains the active drug belumosudil. It belongs to a drug class called kinase inhibitors.

Rezurock comes as an oral tablet. It’s available in one strength: 200 milligrams (mg).

FDA approval

The Food and Drug Administration (FDA) approved Rezurock in 2021. This is the first FDA-approved drug to block a specific pathway in the body related to chronic GVHD. For more information, see the “How Rezurock works” section below.

Effectiveness

For information about the effectiveness of Rezurock, see the “Rezurock for chronic graft-versus-host disease” section below.

Rezurock generic

Rezurock is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Rezurock side effects

Rezurock can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Rezurock. These lists do not include all possible side effects.

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

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Rezurock, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Rezurock. To learn about other mild side effects, talk with your doctor or pharmacist, or view Rezurock’s prescribing information.

Mild side effects of Rezurock can include:

• digestive problems, such as abdominal pain, nausea, or diarrhea
• bleeding, such as nosebleeds or blood in the urine
• weakness
• cough
• shortness of breath
• muscle or joint pain
• headache
• swelling in the arms, legs, or face
• changes in certain lab tests, such as low blood levels of phosphate or white blood cells
• mild infection, such as sinus infection
• 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.

* For more information about allergic reaction and Rezurock, see “Allergic reaction” below.

Serious side effects

Serious side effects from Rezurock 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 you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• High blood pressure, which doesn’t typically cause symptoms unless it’s very high. Symptoms of very high blood pressure can include:
  • headache
  • nosebleed
  • sweating
• Increased levels of liver enzymes (a type of protein), which may be a sign of liver damage. Symptoms of liver damage can include:
  • nausea and vomiting
  • abdominal pain
  • jaundice
  • dark urine
• Serious infection, such as pneumonia or cellulitis. Symptoms can vary depending on the specific infection but can include:
  • fever or chills
  • fatigue
  • cough
  • shortness of breath
  • swelling, warmth, or pain around an infected area of skin
• Severe allergic reaction.*

* For details about allergic reaction and Rezurock, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Rezurock. This side effect wasn’t reported in clinical trials of this drug but can still occur.

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 Rezurock, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Rezurock cost

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

Keep in mind that you may be able to get a 90-day supply of Rezurock. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

It’s important to note that you’ll have to get Rezurock at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Rezurock, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Rezurock, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Rezurock, or if you need help understanding your insurance coverage, help is available.

A program called Kadmon ASSIST is available for Rezurock. For more information and to find out whether you’re eligible for support, call 844-523-6661 or visit the program website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Rezurock may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Rezurock, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Rezurock is not 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.

Rezurock dosage

The Rezurock dosage your doctor prescribes will depend on several factors. These include:

• other medications you take
• any side effects you may have

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 fit your needs.

Drug forms and strengths

Rezurock comes as an oral tablet. It’s available in one strength: 200 milligrams (mg).

Dosage for chronic graft-versus-host disease

Rezurock is approved to treat chronic graft-versus-host disease (GVHD). For this use, the typical dosage of Rezurock is 200 mg once per day, taken with food.

Children’s dosage

Rezurock is approved to treat chronic GVHD in children ages 12 years and older.

The dosage of Rezurock used in children is the same as for adults. For details, see “Dosage for chronic graft-versus-host disease” above.

What if I miss a dose?

If you miss a dose of Rezurock, take your missed dose as soon as you remember. If it’s almost time for your next dose, skip your missed dose and continue your typical dosage schedule.

Do not take an extra dose of Rezurock to make up for a missed dose. Doing so may increase your risk of side effects with the drug. (For more information about possible side effects, see the “Rezurock side effects” section above.)

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to use this drug long term?

Rezurock is meant to be a long-term treatment. If you and your doctor determine that Rezurock is safe and effective for you, you’ll likely take it long term.

Rezurock use for chronic graft-versus-host disease

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

Rezurock is FDA-approved to treat chronic graft-versus-host disease (GVHD) in adults and children ages 12 years and older.

Rezurock is prescribed when chronic GVHD has not improved after treatment with at least two other therapies. Examples of these therapies include:

• immunosuppressants, such as tacrolimus (Astagraf XL, Envarsus XR, Prograf) and sirolimus (Rapamune)
• other kinase inhibitors, such as ibrutinib (Imbruvica) and ruxolitinib (Jakafi)

Chronic graft-versus-host disease explained

Chronic GVHD is a condition that may occur between 3 months and 1 year after a stem cell transplant. (A stem cell transplant involves injecting healthy stem cells to replace damaged stem cells in blood or bone marrow.)

With GVHD, donated stem cells attack healthy cells in your body. This can cause your immune system to become overactive and mistakenly attack your organs.

Symptoms of chronic GVHD may range from mild to severe and could affect many different parts of your body. In severe cases, chronic GVHD can lead to permanent organ damage or become life threatening.

Examples of chronic GVHD symptoms include:

• hair loss
• mouth ulcers (sores)
• dry, red, or irritated eyes
• skin discoloration, dryness, or scaling
• joint stiffness
• shortness of breath

Effectiveness for chronic graft-versus-host disease

Rezurock has been found effective for treating chronic GVHD. The drug is included as a treatment option for chronic GVHD in the National Comprehensive Cancer Network (NCCN) guidelines for GVHD.

To find out how the drug performed in clinical trials, see Rezurock’s prescribing information. You can also view details on the drug manufacturer’s website.

Rezurock and children

Rezurock is approved to treat chronic GVHD in children ages 12 years and older.

For details about chronic GVHD, see the “Chronic graft-versus-host disease explained” section above.

Rezurock interactions

Rezurock can interact with several other medications and certain supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. Drug-condition interactions can also cause certain effects. For information about these interactions, see the “Rezurock precautions” section below.

Rezurock and other medications

Below is a list of medications that can interact with Rezurock. This list does not contain all drugs that may interact with Rezurock.

Before taking Rezurock, 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.

Taking Rezurock with certain medications could make Rezurock less effective. Types of drugs that may lower Rezurock’s effectiveness include:

• Proton pump inhibitors (PPIs). These medications are used to treat conditions such as gastroesophageal reflux disease (GERD) or heartburn. Examples of PPIs include:
  • pantoprazole (Protonix)
  • esomeprazole (Nexium)
  • lansoprazole (Prevacid)
• Certain cancer drugs. These medications are used to treat specific cancers, including prostate cancer and leukemia. Cancer drugs that may interact with Rezurock include:
  • apalutamide (Erleada)
  • enzalutamide (Xtandi)
  • ivosidenib (Tibsovo)
• Certain seizure drugs. These medications are used to treat conditions that cause seizures, such as epilepsy. Seizure drugs that may interact with Rezurock include carbamazepine (Carbatrol, Tegretol, others) and phenytoin (Dilantin, Phenytek).
• Certain antibiotics. These medications are used to treat bacterial infections. Rifampin (Rifadin, Rimactane) is an antibiotic that may interact with Rezurock.

Before starting Rezurock treatment, be sure your doctor knows if you take any of the medications above. They may give you a higher dosage of Rezurock than what is typically prescribed. (For dosage details, see the “Rezurock dosage” section above.)

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Rezurock and herbs and supplements

Doctors will likely recommend that you avoid taking Rezurock with St. John’s wort. (St. John’s wort is an herbal supplement with several uses, including the easing of depression symptoms.)

Taking Rezurock with St. John’s wort could make Rezurock less effective.

To help avoid possible interactions, check with your doctor or pharmacist before taking any herbs or supplements during Rezurock treatment.

Rezurock and foods

There aren’t any foods that have been specifically reported to interact with Rezurock. If you have any questions about eating certain foods with Rezurock, talk with your doctor.

Rezurock and alcohol

There’s no known interaction between Rezurock and alcohol.

If you have questions about drinking alcohol while taking Rezurock, talk with your doctor or pharmacist.

Common questions about Rezurock

Here are answers to some frequently asked questions about Rezurock.

How does Rezurock compare with Jakafi?

Below are a few ways Rezurock compares with Jakafi.

To learn more about how Rezurock compares with Jakafi, talk with your doctor or pharmacist.

Does Rezurock cause long-term side effects?

Most of Rezurock’s side effects are expected to be temporary. They should last only a few days or weeks and will likely go away shortly after you start or stop taking the drug.

However, certain serious side effects have occurred with Rezurock. Examples include high blood pressure and serious infection, such as cellulitis. In extreme cases, these conditions can cause long-term complications.

Keep in mind that how long Rezurock’s side effects last will vary from person to person.

If you have questions about long-term side effects with Rezurock, talk with your doctor.

Will Rezurock cure graft-versus-host disease?

Not necessarily.

Chronic GVHD is a condition that may occur between 3 months and 1 year after a stem cell transplant. With GVHD, donated stem cells attack healthy cells in your body. This can cause your immune system to become overactive and mistakenly attack your organs. In severe cases, chronic GVHD can lead to permanent organ damage.

Rezurock works by helping stabilize the activity of your immune system. In doing so, the drug can help ease symptoms of chronic GVHD and prevent further organ damage. Rezurock won’t reverse organ damage that has already occurred. (To learn more about how the drug works, see the “How Rezurock works” section below.)

If you have questions about what to expect while taking Rezurock, talk with your doctor.

How to take Rezurock

You should take Rezurock according to the instructions your doctor gives you.

Rezurock comes as an oral tablet. You should take the tablet with a meal.

For more information about how to take Rezurock, visit the drug manufacturer’s website.

When to take

You’ll likely take Rezurock once per day. Try to take Rezurock doses at the same time each day. Doing so helps keep a steady level of the drug in your body. This helps Rezurock work effectively.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

If you have trouble opening medication bottles, ask your pharmacist if they can put Rezurock in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.

Taking Rezurock with food

You should take Rezurock with food. The drug’s manufacturer advises that you take the drug with a full meal, such as lunch or dinner.

Can Rezurock be crushed, split, or chewed?

Rezurock oral tablets should not be crushed, split, or chewed. You should swallow them whole.

If you have trouble swallowing Rezurock tablets, talk with your doctor or pharmacist. You can also see suggestions in this article.

How Rezurock works

Rezurock is used to treat chronic graft-versus-host disease (GVHD).

Chronic GVHD is a condition that may occur between 3 months and 1 year after a stem cell transplant. With GVHD, your immune system becomes overactive and mistakenly attacks your organs. (For details, see the “Rezurock for chronic graft-versus-host disease” section above.)

Rezurock belongs to a class of drugs called kinase inhibitors. The drug works by blocking a pathway called ROCK2 in your body. This pathway is thought to play a role in your immune system becoming overactive with chronic GVHD.

By blocking ROCK2, Rezurock helps stabilize the activity of your immune system. In doing so, Rezurock helps ease the symptoms of chronic GVHD. And by easing the symptoms of this condition, Rezurock may help prevent chronic GVHD from causing more organ damage.

To learn more about how Rezurock works, see the drug manufacturer’s website.

How long does it take to work?

It may take several weeks for the symptoms of your condition to ease after starting Rezurock treatment.

In clinical trials, more than half of people reported an easing of their chronic GVHD symptoms after 4 to 8 weeks of Rezurock treatment.

Rezurock and pregnancy

It may not be safe to take Rezurock during pregnancy.

Rezurock hasn’t been studied during human pregnancy. However, because of how Rezurock works in your body, the drug may not be safe to use while pregnant.

In addition, animal studies have shown harm to offspring born to animals given the drug during pregnancy. Keep in mind that animal studies don’t always predict what will happen in humans.

To be safe, your doctor will likely recommend that you don’t take Rezurock while you’re pregnant.

If you’re able to become pregnant, your doctor will likely have you take a pregnancy test before you start Rezurock treatment. This is to confirm that you’re not pregnant.

If you’re pregnant or planning a pregnancy, talk with your doctor before taking Rezurock. They can recommend other treatment options for you.

Rezurock and fertility

Animal studies have shown that Rezurock may affect fertility in males and females.* However, the drug’s effect on human fertility has not been studied.

If you have concerns about fertility, talk with your doctor before starting Rezurock treatment.

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

Rezurock and birth control

It may not be safe to take Rezurock during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Rezurock.

For more information about taking Rezurock during pregnancy, see the “Rezurock and pregnancy” section above.

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

For females using Rezurock

Females who can become pregnant should use birth control while taking Rezurock and for at least 1 week after their last dose.

To learn more, talk with your doctor about the birth control method that’s best for you.

For males using Rezurock

Males with a sexual partner who can become pregnant should use birth control while taking Rezurock. And they should continue using birth control for at least 1 week after their last dose.

To learn more, talk with your doctor about birth control options that may be best for you.

Rezurock and breastfeeding

It may not be safe to breastfeed while taking Rezurock. It isn’t known whether Rezurock can pass into breast milk.

However, due to the risk of side effects in a breastfed child, your doctor will likely recommend that you do not breastfeed while taking Rezurock. To be safe, they may advise you to wait until at least 1 week after your last dose of Rezurock before breastfeeding.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can recommend ways to feed your child during Rezurock treatment.

Rezurock precautions

This drug comes with several precautions. These are considered drug-condition interactions.

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

• Severe liver problems. Before taking Rezurock, tell your doctor if you have a severe liver problem, such as liver failure. Clinical trials of Rezurock did not include people with severe liver problems. It isn’t known for certain whether the drug is safe for people with this condition. In addition, Rezurock may cause increased levels of liver enzymes (a type of protein), which could worsen any liver problems you already have. If you have a severe liver problem, your doctor may recommend a treatment other than Rezurock.
• Severe kidney problems. Before starting Rezurock treatment, be sure to tell your doctor if you have a severe kidney problem, such as kidney failure. Clinical trials of Rezurock did not include people with severe kidney problems. It isn’t known whether the drug is safe for people with this condition. If you have a severe kidney problem, your doctor may recommend a treatment other than Rezurock.
• Allergic reaction. If you’ve had an allergic reaction to Rezurock or any of its ingredients, your doctor will likely not prescribe Rezurock. Ask your doctor what other medications may be better options for you.
• Pregnancy. It may not be safe to take Rezurock during pregnancy. For more information, see the “Rezurock and pregnancy” section above.
• Breastfeeding. It may not be safe to breastfeed while taking Rezurock. For more information, see the “Rezurock and breastfeeding” section above.

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

Rezurock overdose

Do not take more Rezurock than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Rezurock

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.