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Rozlytrek

Generic Name: entrectinib
Dosage Form: Capsules
Date of Approval: August 15, 2019
Company: Genentech, Inc.

Treatment for: Non-Small Cell Lung Cancer, Solid Tumors

Medically reviewed by J. Stewart, BPharm Last updated on Sep 1, 2019.

Patient Information

Read this Patient Information before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information

Rozlytrek may cause serious side effects, including:

  • Congestive heart failure. Rozlytrek may cause congestive heart failure or make the congestive heart failure that you already have worse. Tell your healthcare provider right away if you have any of the following signs and symptoms of congestive heart failure:
    • persistent coughing or wheezing
    • trouble breathing when lying down
    • sudden weight gain
    • increasing shortness of breath
    • tiredness, weakness, or fatigue
    • swelling in ankles, feet, or legs
  • Central nervous system (CNS) effects. Rozlytrek may cause dizziness, changes in your mood, or may affect how you think and cause confusion, hallucinations, and problems with concentration, attention, memory, and sleep. Tell your healthcare provider right away if you have any of these symptoms.
  • Bone fractures. Rozlytrek may increase your risk for bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you have pain, changes in movement, or bone abnormalities.
  • Liver problems (hepatotoxicity). Your healthcare provider will do blood tests to check your liver function during treatment. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment if you develop liver problems with Rozlytrek.
  • Increased uric acid level in your blood (hyperuricemia). Rozlytrek may cause an excess of uric acid in your blood. Your healthcare provider may do tests before and during your treatment to check the uric acid level in your blood. Your healthcare provider may prescribe medications if you have high blood uric acid levels.
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will do tests before and during your treatment to check the electrical activity of your heart and your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during your treatment. These may be symptoms related to QT prolongation.
  • Vision problems. Rozlytrek may cause vision problems. Your healthcare provider may stop Rozlytrek and refer you to an eye specialist if you develop severe vision problems during treatment. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
    • double vision
    • blurry vision
    • new or increased floaters
    • seeing flashes of light

See Rozlytrek side effects for more information about side effects.

What is Rozlytrek?

Rozlytrek is a prescription medicine used to treat:

  • Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene.
  • Adults and children 12 years and older with solid tumors (cancer) that:
    • are caused by certain abnormal NTRK genes and
    • have spread or if surgery to remove their cancer is likely to cause severe complications, and
    • there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment.

It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.

Before taking Rozlytrek

Before taking Rozlytrek, tell your healthcare provider about all your medical conditions, including if you:

  • have liver or kidney problems
  • have any heart problems, including a condition called long QT syndrome
  • have nervous system (neurological) problems
  • have or have had eye or vision problems
  • are pregnant or plan to become pregnant. Rozlytrek can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment, or think you may be pregnant.
    • If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment.
    • Females who are able to become pregnant should use effective birth control during treatment, and for at least 5 weeks after the final dose.
    • Males who have female partners that are able to become pregnant should use effective birth control during treatment, and for 3 months after the final dose.
  • are breastfeeding or plan to breastfeed. It is not known if Rozlytrek passes into your breast milk. Do not breastfeed during treatment, and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Certain other medicines may affect how Rozlytrek works causing side effects. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Rozlytrek?

  • Take Rozlytrek exactly as your healthcare provider tells you to take it. Do not change your dose or stop treatment unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you develop side effects.
  • Take Rozlytrek capsules one time each day with or without food.
  • Swallow the capsules whole. Do not open, crush, chew or dissolve the capsule contents.
  • If you miss a dose, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose and take your next dose at your regular time.
  • If you vomit right after taking a dose, you may take the dose again.

What should I avoid while taking Rozlytrek?

  • You should not drink grapefruit juice or eat grapefruit during your treatment. It may increase the amount of entrectinib in your blood to a harmful level.
  • Do not drive or operate heavy machinery until you know how Rozlytrek affects you. If you experience dizziness, fainting, tiredness, blurred vision, memory loss, changes in mental status, confusion, or hallucinations, do not drive or operate heavy machines until your symptoms resolve.

Rozlytrek side effects

Rozlytrek may cause serious side effects, including:

  • See Important information

The most common side effects include:

  • tiredness
  • constipation
  • change in taste
  • swelling
  • dizziness
  • diarrhea
  • nausea
  • abnormal touch sensation
  • shortness of breath
  • muscle pain
  • confusion, mental status changes, memory problems, and hallucinations
  • weight gain
  • cough
  • vomiting
  • fever
  • joint pain
  • vision changes

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Rozlytrek?

  • Store Rozlytrek below 86°F (30°C).

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Rozlytrek.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Rozlytrek?

Active ingredient: entrectinib

Inactive ingredients: tartaric acid, lactose anhydrous, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. Yellow opaque capsule shell contains: hypromellose, titanium dioxide, and yellow iron oxide. Orange opaque capsule shell contains: hypromellose, titanium dioxide, and FD&C Yellow No. 6. Printing ink contains: shellac, propylene glycol, strong ammonia solution, and FD&C Blue No. 2 aluminum lake.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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