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Important Safety Information and Indication

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.

The approval of ROZLYTREK was based on a study that measured response to treatment and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm the benefit of ROZLYTREK for this use.

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.

What is ROZLYTREK?

ROZLYTREK is a prescription medicine used to treat:

  • 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.

    The approval of ROZLYTREK was based on a study that measured response to treatment and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm the benefit of ROZLYTREK for this use.

Important Safety Information

What is the most important information I should know about ROZLYTREK?
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 with ROZLYTREK. 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 ROZLYTREK 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 with ROZLYTREK 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 with ROZLYTREK 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 with ROZLYTREK. 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 with ROZLYTREK. 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
    • light hurting your eyes

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 with ROZLYTREK 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 with ROZLYTREK.
    • Females who are able to become pregnant should use effective birth control during treatment with ROZLYTREK 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 with ROZLYTREK 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 with ROZLYTREK and for 7 days after the final dose of ROZLYTREK. 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.

What should I avoid while taking ROZLYTREK?

  • You should not drink grapefruit juice or eat grapefruit during your treatment with ROZLYTREK. 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.

What are some possible side effects of ROZLYTREK?

The most common side effects of ROZLYTREK 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 of ROZLYTREK. For more information on ROZLYTREK’s risks and benefits, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

  • CNS

    Central nervous system, which includes the brain and spinal cord.

  • colorectal cancer

    Cancer that develops in the colon, which is the longest part of the large intestine and/or the rectum (the last several inches of the large intestine before the anus).

  • complete response

    The disappearance of all signs of cancer, such as tumors, in response to treatment. This does not mean the cancer has been cured.

  • DNA

    Molecules within cells that carry genetic information.

  • gene fusion

    A type of gene made by joining parts of 2 different genes. Fusion genes make fusion proteins, which can be the root cause of some kinds of cancer. 

  • long QT syndrome

    A condition where the heart beats fast and irregularly. Long QT syndrome might cause a person to faint or have a seizure. In some instances, the heart can beat out of control for so long that it may cause sudden death.

  • oral

    By mouth.

  • papillary thyroid cancer

    The most common type of thyroid cancer.

  • partial response

    The decrease in the size and spread of tumors or extent of cancer in the body in response to a given treatment.

  • proteins

    A molecule that is needed for your body to function properly. Proteins are the basis of body structures, like skin and hair, and other substances in your body.

  • salivary cancer

    A rare cancer found in the tissues of the gland that makes saliva.

  • sarcoma

    A cancer that begins in the bone and soft tissue.

  • secretory breast cancer

    A rare type of breast cancer.

  • thyroid cancer

    Cancer of the thyroid. The thyroid is an organ at the base of the throat. It makes hormones that help control heart rate, blood pressure, body temperature, and weight.

  • NTRK

    An NTRK gene fusion tells the body to make abnormal versions of TRK, or tropomyosin receptor kinase, fusion proteins. TRK fusion proteins are a family of several proteins that normally plays an important role in the nervous system. People with NTRK fusion-positive solid tumors have an abnormal version of TRK called a TRK fusion protein.