Rozlytrek

Rozlytrek is a prescription medication used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Rozlytrek is also used to treat solid tumors caused by certain abnormal genes that have spread and there is no satisfactory alternative treatment option.

Rozlytrek belongs to a group of drugs called kinase inhibitors. These drugs work by interfering with kinase, a type of protein in the body that helps control cell division. This interferes with the ability of cancer cells to grow and divide.

This medication comes in capsule form. Rozlytrek is taken once daily, with or without food. Do not open, crush, chew or dissolve the capsule contents.

Common side effects include tiredness, constipation, changes in taste, nausea and vomiting. Do not drive or operate heavy machinery until you know how Rozlytrek affects you.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported. See "Rozlytrek Precautions" section.

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, 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.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• nefazodone (Serzone)
• itraconazole (Sporanox)
• ketoconazole (Nizoral)
• voriconazole (Nizoral)
• atazanavir (Reyataz)
• indinavir (Crixivan)
• nelfinavir (Viracept)
• ritonavir (Norvir)
• saquinavir (Invirase)
• clarithromycin (Biaxin)
• telithromycin (Ketek)

This is not a complete list of Rozlytrek drug interactions. Ask your doctor or pharmacist for more 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 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:

You should not drink grapefruit juice or eat grapefruit during your treatment with Rozlytrek. It may increase the amount of this drug 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.

Grapefruit and grapefruit juice may interact with Rozlytrek and lead to potentially dangerous effects. Grapefruit increases Rozlytrek plasma concentrations, which could increase the frequency or severity of adverse reactions. Discuss the use of grapefruit products with your doctor.

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.

Tell your healthcare provider if you 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.

Tell your healthcare provider if you 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.

• Take Rozlytrek exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Rozlytrek unless your healthcare provider tells you to.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Rozlytrek if you develop side effects.
• Take Rozlytrek 1 time each day with or without food.
• Swallow whole Rozlytrek capsules. Do not open, crush, chew or dissolve the capsule contents.
• If you miss a dose of Rozlytrek, 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 of Rozlytrek, you may take the dose again.

Take Rozlytrek exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily. 
• Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors:
  • Adults: 600 mg orally once daily 
  • Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below 
    • BSA greater than 1.50 m2: 600 mg once daily
    • BSA 1.11 to 1.50 m2: 500 mg once daily
    • BSA 0.91 to 1.10 m2: 400 mg once daily

If you take too much Rozlytrek contact your doctor right away or call your local Poison Control Center.

Store ROZLYTREK below 86°F (30°C).
Keep ROZLYTREK and all medicines out of the reach of children.