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Overview: Rozlytrek is used to treat certain cancers. Common side effects include tiredness, constipation, and changes in taste. Call your health care provider right away if you get a fever, changes in your vision, chest pain, or have trouble breathing. Rozlytrek is a capsule or pellets that you will swallow. 

Uses

What is Rozlytrek used for?

Rozlytrek (entrectinib) is commonly used to treat certain kinds of non-small-cell lung cancer (NSCLC).

Rozyltrek may also be used to treat solid tumors that have a certain gene fusion. 

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

How does Rozlytrek work (mechanism of action)?

Rozlytrek is a type of medicine known as a tyrosine kinase inhibitor (TKI). It works by targeting specific receptors on cancer cells. By blocking the action of these receptors, Rozlytrek can cause cancer cells to die and can prevent cancer cells from growing or spreading.

How is Rozlytrek supplied (dosage forms)?

Brands and other names

  • Rozlytrek

Dosage forms and strengths

  • 100 mg oral capsules
  • 200 mg oral capsules
  • 50 mg/packet oral pellets

How should I store Rozlytrek?

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

Side Effects

What are the most common side effects of Rozlytrek?

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

  • Tiredness
  • Constipation
  • Changes in taste
  • Fluid retention
  • Dizziness
  • Diarrhea
  • Nausea and vomiting
  • Changes in touch sensation
  • Shortness of breath
  • Muscle pain
  • Brain or central nervous system (CNS) effects (see below)
  • Weight gain
  • Cough
  • Fever
  • Joint pain
  • Vision problems (see below)

There may be other side effects of Rozlytrek 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. 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 Rozlytrek?

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

Severe Allergic Reactions. Rozlytrek may cause allergic reactions, which can be serious. Stop taking Rozlytrek 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, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Failure. Rozlytrek may increase your risk of heart failure. Tell your health care provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Brain or Central Nervous System (CNS) Effects. Rozlytrek can affect your brain or central nervous system (CNS). Call your health care provider right away if you have the following symptoms.

  • Headache
  • Dizziness
  • Sleepiness
  • Confusion
  • Seeing or hearing things that others do not see or hear, also called hallucinations

Weak Bones. Rozlytrek can cause your bones to break (fracture) more easily. Tell your health care provider if you have bone pain, break a bone, or have changes to your ability to walk or move. 

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Rozlytrek. 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)

High Levels of Uric Acid. Rozlytrek can cause high levels of uric acid (hyperuricemia) in your body. Tell your health care provider if you have had gout in the past or had high levels of uric acid. Go to all appointments for your provider to test your blood and urine so they can be sure that Rozlytrek is safe for you.

Heart Rhythm Changes. Rozlytrek 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.

Vision Problems. Rozlytrek may increase your risk of vision problems. Keep any scheduled eye exams before starting or while taking Rozlytrek. Call your health care provider right away if you have any of the following vision problems.

  • Blurriness or shadows
  • Sensitivity to light
  • Worsening vision
  • A blind spot in the middle of your vision
  • Dull or unusually colored or tinted vision
  • Eye redness, itchiness, or pain
  • Swollen or itchy eyelids
  • Feeling like you have something in your eye
  • Eye dryness, watering, or discharge

Warnings & Precautions

Who should not use Rozlytrek?

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

  • Entrectinib
  • Rozlytrek
  • Any of the ingredients in the specific product dispensed

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

What should I know about Rozlytrek before using it?

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

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

Keep Rozlytrek out of the reach of children.

You should take Rozlytrek capsules with water. Do not open, crush, or chew the capsules. If you cannot swallow Rozlytrek, talk with your health care provider or pharmacist about options to take the medicine.

When taking Rozlytrek pellets, sprinkle the pellets on a spoonful of soft food, such as applesauce. Make sure to use the entire packet of pellets. Do not crush or chew the pellets. Drink water after swallowing a spoonful of soft food with the medicine. Take the medicine within 20 minutes of sprinkling the pellets on food.

Rozlytrek can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Rozlytrek affects you.

If you vomit right after taking your dose of Rozlytrek, take the dose again. If you have questions about whether you should take another dose, call your health care provider. 

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

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 determine if Rozlytrek 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.

  • Liver problems
  • Kidney problems
  • Nervous system or brain problems
  • Eye or vision problems
  • Heart problems, including cardiomyopathy, an abnormal heartbeat, heart failure, and QT prolongation
  • Any family members who have heart problems like QT prolongation
  • Gout or high uric acid levels
  • Bone problems, fractures, or osteoporosis

Other Medicines and Supplements. Rozlytrek may interact with other medicines and supplements. Before taking Rozlytrek, tell your healthcare 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. Rozlytrek may cause harm to a fetus. Your health care provider will give you a test to make sure you are not pregnant before you start taking Rozlytrek. If you can get pregnant, you should use birth control while taking Rozlytrek and for five weeks after your last dose. If you are able to get a partner pregnant, you should use condoms while taking Rozlytrek and for three months after your last dose. Tell your health care provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Rozlytrek passes into breast milk. Do not breastfeed while taking Rozlytrek and for seven days after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Rozlytrek?

For more information about Rozlytrek, you can visit the manufacturer’s website at www.rozlytrek.com or call them at 877-436-3683.

Interactions

Does Rozlytrek interact with foods or drinks?

Grapefruit interacts with Rozlytrek. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Rozlytrek. This is because grapefruit can interfere with your body’s ability to break down Rozlytrek, which can lead to high levels of the medicine and an increased risk of side effects. 

Rozlytrek pellets should be taken by sprinkling them on a spoonful of soft food.

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

Does Rozlytrek 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 Rozlytrek.

  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
  • Itraconazole, a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Midazolam, a medicine used to relieve anxiety before surgery
  • St. John’s wort, which is a supplement that may be used for depression
  • 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 Rozlytrek 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 Rozlytrek. 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 Rozlytrek?

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

If you miss a dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.