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Overview: Atebrioz is used to treat certain people with a rare genetic condition that causes extra bones to form where they should not be. It works by blocking signals that trigger the growth of abnormal bone. Common side effects may include headache, joint pain, infection in the nose or throat, sore throat, or common cold symptoms, nosebleeds, or nausea. Atebrioz should not be taken during pregnancy or while breastfeeding. It is a tablet that is taken by mouth.

Uses

What is Atebrioz used for?

Atebrioz (zilurgisertib) is used to reduce the formation of extra bone in certain people with fibrodysplasia ossificans progressiva (FOP). FOP is a rare genetic condition where bone forms in areas of the body where bone is not normally present. The extra bone is called heterotopic ossification (HO). This often happens in areas where ligaments, tendons and muscles normally are. 

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

How does Atebrioz work (mechanism of action)?

People with FOP have a faulty gene that leads to too much activity of a protein called activin A. Activin A triggers the growth of extra bone where it does not belong. 

Atebrioz is a type of medicine called an activin receptor-like kinase-2 (ALK2) inhibitor. It blocks activin A from attaching to its receptors. This prevents activin A from sending the signals that trigger the growth of extra bone, which helps prevent new abnormal bones from forming. Atebrioz is not a cure for FOP. It does not remove bone that has already formed.

How is Atebrioz supplied (dosage forms)?

Brands and other names

  • Atebrioz

Dosage forms and strengths

  • 25 mg oral tablets

How should I store Atebrioz?

Atebrioz should be stored 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. Keep the medicine in its original container with the lid tightly closed.

Side Effects

What are the most common side effects of Atebrioz?

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

  • Headache
  • Joint pain
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Nosebleeds
  • Nausea

There may be other side effects of Atebrioz 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 Atebrioz?

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

Severe Allergic Reactions. Atebrioz may cause allergic reactions, which can be serious. Stop taking Atebrioz 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

Warnings & Precautions

Who should not use Atebrioz?

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

  • Atebrioz 
  • Zilurgisertib
  • Any of the ingredients in the specific product dispensed

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

Pregnancy. Do not take Atebrioz if you are pregnant. If you become pregnant, stop taking Atebrioz and contact your health care provider right away. See the Pregnancy section for more details.

What should I know about Atebrioz before using it?

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

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

Keep Atebrioz out of the reach of children.

Atebrioz tablets should either be swallowed whole or crushed and mixed into liquid or soft food before swallowing. If you crush the tablets, follow your health care provider’s instructions about how to mix your dose with water, orange juice, apple sauce, or plain yogurt.

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

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 Atebrioz is right for you.

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

Other Medicines and Supplements. Atebrioz may interact with other medicines and supplements. Before taking Atebrioz, 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. Atebrioz can cause harm to a fetus and should not be taken during pregnancy. You must not be pregnant before starting Atebrioz. If you can get pregnant, you should use effective birth control while taking Atebrioz and for one week after your last dose. Stop taking Atebrioz and tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. Do not breastfeed while you are taking Atebrioz and for at least one week after your last dose. It is not known if Atebrioz passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Atebrioz?

For more information about Atebrioz, you can visit the drugmaker’s website at www.atebrioz.com or call them at 855-676-4968.

Interactions

Does Atebrioz interact with foods or drinks?

You should not take Atebrioz with grapefruit, pomelo, or the juices of these fruits. Grapefruit and pomelo may increase the amount of Atebrioz in your body and raise the risk of side effects.

It is unknown if drinking alcohol will affect Atebrioz.

Does Atebrioz 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 Atebrioz.

  • Ritonavir (Norvir), lopinavir/ritonavir (Kaletra), or nelfinavir (Viracept), which is a medicine commonly used to treat HIV
  • Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Clarithromycin, which is a medicine used for bacterial infections
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenytoin (Dilantin, Phenytek, and others), phenobarbital, or primidone, which is a medicine to control seizures 
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Efavirenz, which is a medicine commonly used to treat HIV 
  • St. John’s wort, which is a supplement that may be used for depression

Many other medicines may alter the blood levels of Atebrioz, 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 Atebrioz. 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 Atebrioz?

If you or someone else has used too much Atebrioz, 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 Atebrioz?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.