Rozlytrek is a cancer medicine that contains the active substance entrectinib

It 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:

o    are caused by certain abnormal NTRK genes and

o    have spread or if surgery to remove their cancer is likely to cause severe complications, and

o    there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment.

Before you take Rozlytrek, tell your healthcare provider about all of 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

Warnings and precautions

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:

o       persistent coughing or wheezing

o       trouble breathing when lying down

o       sudden weight gain

o       increasing shortness of breath

o       tiredness, weakness, or fatigue

o       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:

o       double vision

o       blurry vision

o       new or increased floaters

o       seeing flashes of light

o       light hurting your eyes

See “What are the possible side effects of ROZLYTREK?” for more information about side effects.

Children and adolescents

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

Other medicines and Rozlytrek

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. 

Taking Rozlytrek with food and drink

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.

Pregnancy and contraception

Before you take ROZLYTREK, tell your healthcare provider if you:

o       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.

o       are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment with Rozlytrek.

o       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.

o       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.

Breast‑feeding

Before you take Rozlytrek, 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.

Driving and using machines

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

·         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.

·         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.

If you have any further questions on the use of this product, ask your doctor, or pharmacist.

Like all medicines, Rozlytrek can cause side effects, although not everybody gets them.

Rozlytrek can cause serious side effects, including:

·         See “Warning and Precaution?”

·       The most common side effects of Rozlytrek include:

o       tiredness

o       constipation

o       change in taste

o        swelling

o       dizziness

o       diarrhea

o       nausea

o       abnormal touch sensation

o       shortness of breath

o       muscle pain

o       confusion, mental status changes, memory problems, and hallucinations

o       weight gain

o       cough

o       vomiting

o       fever

o       joint pain

o       vision changes

For more information, and if you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

-          Keep Rozlytrek out of the reach and sight of children.

-          Do not use this medicine after the expiry date which is stated on the bottle and carton (EXP). The expiry date refers to the last day of that month.

-           Do not store above 30°C.

-          Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.