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Overview: Ibtrozi is used to treat a certain type of lung cancer. It works by slowing the growth of cancer cells. The most common side effects are diarrhea, nausea, vomiting, and dizziness. Tell your health care provider right away if you have new or worsening coughing or breathing problems, sudden swelling of your big toe or joints, unusual pain or trouble moving, yellowing of your skin or eyes, or unexplained muscle pain. Ibtrozi comes as a capsule that you will take by mouth on an empty stomach.

Uses

What is Ibtrozi used for?

Ibtrozi (taletrectinib) is commonly used to treat non-small cell lung cancer (NSCLC) in certain people. NSCLC is the most common type of lung cancer.

Learn more about Ibtrozi for Non-Small-Cell Lung Cancer.

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

How does Ibtrozi work (mechanism of action)?

Ibtrozi blocks a protein called ROS1. This protein helps regulate signals that tell the cancer cells to grow out of control. By blocking ROS1, Ibtrozi can slow the growth of cancer. 

How is Ibtrozi supplied (dosage forms)?

Ibtrozi is available in a 200 mg capsule that is taken by mouth.

How should I store Ibtrozi?

Ibtrozi 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.

Side Effects

What are the most common side effects of Ibtrozi?

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

  • Diarrhea
  • Nausea or vomiting
  • Dizziness
  • Rash
  • Constipation
  • Tiredness

There may be other side effects of Ibtrozi 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 Ibtrozi?

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

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

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Ibtrozi. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Lung Inflammation. Ibtrozi can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have new or worsening symptoms such as trouble breathing, cough, fever, or chest pain.

High Uric Acid Levels. Ibtrozi can increase uric acid levels in your body, which can raise the risk of having a gout flare. Keep all appointments to have your blood checked. Tell your health care provider right away if you have any of the following symptoms

  • Sudden pain, warmth, or swelling in your big toes or other joints
  • Pain in your abdomen
  • Nausea or vomiting
  • Brown or pink urine (pee) 

Heart Rhythm Changes. Ibtrozi may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Muscle Problems. Ibtrozi may cause muscle problems. Muscle problems may be found by an increase of a protein in your blood called creatine phosphokinase. Keep all appointments to have your blood checked. Tell your health care provider right away if you have any new or unusual muscle pain, soreness, or weakness. 

Weak Bones. Ibtrozi can cause your bones to break (fracture) more easily. Tell your health care provider if you have any pain or changes that make you less able to move or walk.

Warnings & Precautions

Who should not take Ibtrozi?

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

  • Ibtrozi
  • Taletrectinib
  • Any of the ingredients in the specific product dispensed

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

What should I know about Ibtrozi before taking it?

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

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

Keep Ibtrozi out of the reach of children.

Swallow Ibtrozi capsules whole. Do not chew, cut, or open the capsules. 

Check with your health care provider before taking any medicines for heartburn, indigestion, or upset stomach while taking Ibtrozi. If you take antacids, it is important to take the antacid at least two hours before or two hours after you take your dose of Ibtrozi. 

Ibtrozi can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin. It is important to protect your skin during Ibtrozi treatment and for at least five days after your last dose.

You will need to get regular blood work before and while taking Ibtrozi. It is important that you attend all appointments, so your health care provider can make sure this treatment is safe for you.

If you could get pregnant, you should use effective birth control while taking Ibtrozi and for three weeks after your last dose. If your partner could become pregnant, use effective birth control (such as condoms) during Ibtrozi treatment and for three weeks after your last dose. 

Ibtrozi may make it hard for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before taking Ibtrozi?

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 Ibtrozi is right for you.

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

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

  • Lung or breathing problems
  • Heart problems, such as heart failure, long QT syndrome, or other heart rhythm problems
  • Liver problems
  • Weak bones (osteoporosis)
  • Gout or high uric acid levels

Other Medicines and Supplements. Ibtrozi may interact with other medicines and supplements. Before taking Ibtrozi, 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. Ibtrozi may cause harm to an unborn baby. Your health care provider may give you a test to make sure you are not pregnant before you start Ibtrozi. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Ibtrozi passes into breast milk. You should not breastfeed while taking Ibtrozi and for three weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Ibtrozi?

For more information about Ibtrozi, you can visit the drugmaker’s website at www.ibtrozi.com or call them at 844-688-4550.

Interactions

Does Ibtrozi interact with foods or drinks?

Ibtrozi should be taken on an empty stomach. Food can increase the medicine’s side effects. Take your dose of Ibtrozi at least two hours before you eat or at least two hours after you eat. 

Avoid eating grapefruit or drinking grapefruit juice while taking Ibtrozi. The combination can increase the effects of the medicine and raise the risk of side effects. 

It is unknown if drinking alcohol will affect Ibtrozi, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Ibtrozi 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 Ibtrozi.

  • An antacid, such as calcium carbonate (Alka-Seltzer, Tums) or Maalox
  • An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or chest pain
  • St. John’s wort, which is a supplement that may be used for depression
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Many other medicines may alter the blood levels of Ibtrozi. 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 Ibtrozi. 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 take too much Ibtrozi?

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

If you miss a dose of Ibtrozi, skip the missed dose. Take your regular dose on the next day at the usual time. Do not take double or extra doses.

If you vomit after taking Ibtrozi, do not take another dose. Take your regular dose at the next scheduled time.