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Generic Name: entrectinib

Trade Name: ROZLYTREK™

For which conditions is ROZLYTREK™ approved for? ROZLYTREK is indicated for treatment of:

· Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).

· Adult and patients 12 or older with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors who have progressive metastatic disease following treatment and are not surgical candidates.

ROZLYTREK is approved under accelerated approval and continued approval may be contingent on verification of benefit in confirmatory trials.

What is the mechanism of action? ROZLYTREK is a kinase inhibitor. A kinase is a type of protein in the body that helps control cell division. Cancer cells grow in an uncontrolled fashion, and ROZLYTREK works by interfering with the kinase to stop cancer cells from dividing and growing in solid tumors that are NTRK gene fusion-positive or ROS1-positive**.** ROZLYTREK is targeted against several biochemical pathways implicated in the growth and spread of cancer. Specifically, ROZLYTREK is targeted against the TRK A/B/C and ROS1 proteins.

How is ROZLYTREK typically given (administered)? ROZLYTREK is taken orally once daily. A missed dose can be made up unless the next dose is due within 12 hours. If you experience vomiting immediately after taking a dose of ROZLYTREK, take a dose as soon as possible.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with ROZLYTREK. Typically, blood will be drawn before and after treatment to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys, liver and heart. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy. ROZLYTREK can harm an unborn baby, so women should not become pregnant while taking this drug and for 5 weeks after your last dose of ROZLYTREK. Do not breastfeed during treatment with ROZLYTREK and for at least 1 week after the last dose of ROZLYTREK. Men who are taking ROZLYTREK should use effective birth control during treatment and for 3 months following the last dose of ROZLYTREK.

What are the most common (occur in 20% or more of patients) side effects of treatment with ROZLYTREK?

· Fatigue

· Constipation

· Dysgeusia

· Edema

· Dizziness

· Diarrhea

· Nausea

· Pain, prickling or aching sensations

· Shortness of breath

· Muscle pain

· Cognitive impairment

· Increased weight

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· Cough

· Vomiting

· Fever

· Joint pain

· Vision disorders

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

ROZLYTREK may interact with many drugs. Tell your healthcare provider about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements. Avoid grapefruit juice while taking ROZLYTREK.

Are there any special precautions patients should be aware of before starting treatment?

Talk to your doctor about all of your medical conditions including if you have liver, kidney, heart, eye, vision or nervous system problems.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Contact your healthcare professional right away if you experience any of the following:

  • Signs or symptoms of congestive heart failure;
  • Symptoms of bone fractures including pain, changes in movement or bone abnormalities;
  • Symptoms of liver problems including loss of appetite, nausea or vomiting or pain in your upper right side of your stomach area;
  • Signs of a heart rhythm condition (QT interval prolongation) which include dizziness, lightheadedness, or loss of consciousness;
  • Vision problems including double vision, blurry vision, floaters, light sensitivity, flashes of light;
  • You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.