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Overview: Rhapsido is a tablet you swallow to treat a certain skin condition that involves hives and makes you feel itchy. Common side effects from Rhapsido include headache, nausea, and stomach pain. Rhapsido may increase your risk for bleeding. Tell your health care provider if you have any increased bleeding, such as unexplained bruising or if you notice blood in your pee (may appear pink, red, or brown) or poop (may appear red or black).

Uses

What is Rhapsido used for?

Rhapsido (remibrutinib) is commonly used to treat certain people with chronic spontaneous urticaria (CSU). 

Rhapsido may also be used for other conditions as determined by your health care provider.

How does Rhapsido work (mechanism of action)?

Rhapsido is a kinase inhibitor. It blocks a protein in the body called Bruton’s tyrosine kinase (BTK). This protein is found in certain cells in your immune system. These immune cells are involved in allergic reactions and inflammation or swelling. When these immune cells are triggered, they can release chemicals like histamine that cause itching, swelling, redness, and other allergy-type symptoms. By blocking BTK, Rhapsido helps calm down these immune cells and reduces the release of histamine and other chemicals involved in chronic spontaneous urticaria.

How is Rhapsido supplied (dosage forms)?

Rhapsido is available in 25 mg oral tablets.

How should I store Rhapsido?

Rhapsido should be stored in the original container (to protect it from moisture) at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Rhapsido?

The most common side effects of Rhapsido are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Bleeding (see below)
  • Headache
  • Nausea or stomach pain

There may be other side effects of Rhapsido that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Rhapsido?

While less common, the most serious side effects of Rhapsido are described below, along with what to do if they happen.

Severe Allergic Reactions. Rhapsido may cause allergic reactions, which can be serious. Stop taking Rhapsido and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Bleeding. Rhapsido can increase your risk of bleeding. Your risk of bleeding may be higher if you take certain medicines. You may need to stop taking Rhapsido before and after surgeries or invasive procedures. Be sure all of your health care providers know that you take Rhapsido. Call your health care provider if you have any signs or symptoms of bleeding while taking Rhapsido, including any of the following.

  • Unexplained bruising
  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Feeling weak or tired
  • Headache
  • Dizziness

Warnings & Precautions

Who should not use Rhapsido?

Allergies to Ingredients. People who are allergic to any of the following should not take Rhapsido.

  • Remibrutinib
  • Rhapsido
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Rhapsido.

What should I know about Rhapsido before using it?

Do not take Rhapsido unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Rhapsido with other people, even if they have the same condition as you. It may harm them.

Keep Rhapsido out of the reach of children.

Do not chew, cut, or crush Rhapsido tablets. They should be swallowed whole.

What should I tell my health care provider before using Rhapsido?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Rhapsido is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Rhapsido. Tell your health care provider about any vaccines you have recently received or have scheduled.

Liver Problems. Rhapsido should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Recent of upcoming surgery or invasive procedure
  • Bleeding problems

Other Medicines and Supplements. Rhapsido may interact with other medicines and supplements. Before using/taking Rhapsido, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Rhapsido could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking Rhapsido, tell your health care provider. You can sign up for the Rhapsido Pregnancy Registry by calling 888-669-6682. This registry collects safety information about the use of Rhapsido during pregnancy.

Breastfeeding. It is not known if Rhapsido passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Rhapsido while breastfeeding.

How can I get more information about Rhapsido?

For more information about Rhapsido, you can visit the drugmaker’s website at www.rhapsido.com or call them at 888-669-6682.

Interactions

Does Rhapsido interact with foods or drinks?

There are no known interactions between Rhapsido and foods or drinks.

It is unknown if drinking alcohol will affect Rhapsido, but both Rhapsido and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Rhapsido interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Rhapsido.

  • A blood thinner, which is a medicine used to treat or prevent blood clots
  • An antiplatelet medicine, such as clopidogrel (Plavix), ticagrelor (Brilinta), aspirin/dipyridamole, or cilostazol, which is a medicine used to prevent blood clots
  • Ritonavir (Norvir), which is a medicine commonly used to treat HIV
  • Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Atorvastatin (Lipitor and others), which is a medicine to lower cholesterol
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Efavirenz, which is a medicine commonly used to treat HIV
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure

Many other medicines may alter the blood levels of Rhapsido, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Rhapsido. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Rhapsido?

If you or someone else has used too much Rhapsido, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Rhapsido?

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not take double or extra doses to make up a missed dose.

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