Rozlytrek® 100 mg hard capsules – patient leaflet, side effects, dosage

1. What Rozlytrek is and what it is used for

What Rozlytrek is

Rozlytrek is a cancer medicine that contains the active substance ‘entrectinib’.

What Rozlytrek is used for

Rozlytrek is used to treat either:

• adults and children 12 years of age and older with solid

  tumours (cancer) in various parts of the body that are caused by a change in a gene called ‘neurotrophic tyrosine receptor kinase (NTRK)’ or

• adults with a type of lung cancer called ‘non-small cell lung

  cancer’ (NSCLC) that is caused by a change in a gene called ‘ROS1’.

This medicine is used for solid tumour cancers when: ● a test has shown that your cancer cells have a change in

genes called ‘NTRK’ (see ‘How Rozlytrek works’ below), and ● your cancer has spread within the affected organ or to

other organs in your body or if surgery to remove the cancer is likely to cause severe complications, and ● you have not previously been given medicines called

‘NTRK inhibitors’

• other treatments have not worked or are not suitable

  for you.

This medicine is used if your lung cancer (NSCLC): ● is ‘ROS1-positive’ – this means that your cancer cells have

a change in a gene called ‘ROS1’ (see ‘How Rozlytrek works’ below), and

• is advanced – for example, has spread to other parts of

  your body (metastatic), and

• you have not previously been given medicines called

  ‘ROS1 inhibitors’.

How Rozlytrek works

Rozlytrek works by blocking the action of faulty enzymes. These faulty enzymes are caused by a change in the NTRK or ROS1 genes that make them. The faulty enzymes make the cancer cells grow.

Rozlytrek may slow down or stop the growth of the cancer. It may also help to shrink your cancer.

2. What you need to know before you take Rozlytrek

Do not take Rozlytrek

• if you are allergic to entrectinib or any of the other

  ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, pharmacist or nurse before taking Rozlytrek.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Rozlytrek if:

• you have recently had memory loss, confusion,

  hallucinations, or mental status changes

• you have had fractured bones, or conditions which may

  increase your risk of breaking bones, called ‘osteoporosis’ or ‘osteopaenia’

• you take medicine to lower the uric acid in your blood ● you have heart failure (when your heart struggles to pump

  blood to supply oxygen to the body) – signs can include cough, feeling short of breath, or swelling in your legs or arms

• you have ever had heart problems or a heart conduction

  problem called ‘prolonged QTc interval’ – this is shown on an ‘electro-cardiogram’ (ECG), or by low levels of electrolytes in your blood

• you have an inherited problem called ‘galactose intolerance’,

  ‘congenital lactase deficiency’ or ‘glucose-galactose malabsorption’.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Rozlytrek.

Other medicines and Rozlytrek

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Rozlytrek can affect the way some other medicines work. Also, some other medicines can affect the way Rozlytrek works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines for:

• fungal infections (anti-fungals) – such as ketoconazole,

  itraconazole, voriconazole, or posaconazole

• AIDS/HIV infection – such as ritonavir or saquinavir ● depression – such as paroxetine, fluvoxamine, or a herbal

  medicine for depression - St. John’s Wort

• stopping seizures or fits – such as phenytoin, carbamazepine,

  or phenobarbital

• tuberculosis – such as rifampicin, or rifabutin ● solid cancers and blood cancer – topotecan, lapatinib,

  mitoxantrone, apalutamide, or methotrexate ● inflammed joints or joint autoimmune disease (rheumatoid

  arthritis) – methotrexate

• migraines – ergotamine
• severe pain – fentanyl
• mental illness (psychoses) or Tourette Syndrome – pimozide ● irregular heart rate – quinidine

• stopping the formation of blood clots – warfarin or

  dabigatran etexilate

• gastric reflux (heartburn) – cisapride or omeprazole ● lowering blood cholesterol – atorvastatin, pravastatin, or

  rosuvastatin

• suppressing your body’s immune system, or stopping your

  body from rejecting an organ transplant – sirolimus, tacrolimus, or cyclosporin

• lowering blood sugar levels – repaglinide or tolbutamide ● high blood pressure – bosentan, felodipine, nifedipine, or

  verapamil

• inflammation or nausea – dexamethasone

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Rozlytrek.

Rozlytrek with food and drink

Do not drink grapefruit juice or eat grapefruit or Seville oranges during your treatment with this medicine. It may increase the amount of the medicine in your blood to a harmful level.

Women and contraception

You must avoid becoming pregnant while taking this medicine because it could harm the baby. If you are able to become pregnant, you must use highly effective contraception: ● while on treatment, and

• for at least 5 weeks after stopping treatment.

It is not known if Rozlytrek can reduce the effect of birth control medicines (contraceptive pills or implanted hormonal contraceptives). You should use another reliable method of birth control such as a barrier method (such as a condom).

Talk to your doctor about the right methods of contraception for you and your partner.

Men and contraception

Your female partner must avoid becoming pregnant while you are taking this medicine because it could harm the baby. If your female partner is able to become pregnant, you must use highly effective contraception:

• while on treatment, and
• for at least 3 months after stopping treatment.

Talk to your doctor about the right methods of contraception for you and your partner.

Pregnancy

• Do not take Rozlytrek if you are pregnant. This is because it

  may harm your baby.

• If you become pregnant when taking the medicine or

  during the 5 weeks after taking your last dose, tell your doctor straight away.

Breast-feeding

Do not breast-feed while taking this medicine. This is because it is not known if Rozlytrek can pass over into breast milk and could therefore harm your baby.

Driving, cycling and using machines

Rozlytrek may affect your ability to drive, ride a bicycle, or use machines. Rozlytrek may cause you to:

• have blurred vision
• feel tired, dizzy, or pass out

• have changes in your mental status, feel confused or see

  things that are not there (hallucinations).

If this happens, you should not drive, ride a bicycle, or operate heavy machines until you feel better. Talk to your doctor or pharmacist about whether it is okay for you to drive, ride a bicycle, or use machines.

Rozlytrek contains:

• lactose - a type of sugar. If you have been told by your

  doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. ● sunset yellow FCF (E110) in 200 mg hard capsules

  only. This is a colouring agent, which may cause allergic reactions.

3. How to take Rozlytrek

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

For adults:

• The recommended dose is 3 capsules of 200 mg once a day

  (total amount 600 mg).

• If you feel unwell, your doctor may lower your dose, stop

  treatment for a short time or stop treatment completely.

For children:

• Rozlytrek can be used in children 12 years of age and older. ● Your child’s doctor will work out the correct dose to

  use – based on the height and weight of the child. ● Your child’s doctor will review the dose and change it as

  needed.

How to take

Rozlytrek can be taken with or without food. Swallow each capsule whole. Do not open or dissolve the capsules since the contents of the capsule are very bitter.

If you vomit after taking Rozlytrek

If you vomit immediately after taking a dose of Rozlytrek, take another dose.

If you take more Rozlytrek than you should

If you take more Rozlytrek than you should, talk to a doctor or go to hospital straight away. Take the medicine pack and this leaflet with you.

If you forget to take Rozlytrek

• If your next dose is more than 12 hours later, take the missed dose as soon as you remember.
• If there are less than 12 hours until your next dose, do not take the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Rozlytrek

Do not stop taking this medicine without talking to your doctor first. It is important to take this medicine every day for as long as your doctor prescribes it for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Serious side effects

Tell your doctor straight away if you notice any of the following serious side effects. Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if:

• you have cough, feel short of breath, or swelling in your legs or arms (fluid retention) – these can be signs of heart problems (congestive heart failure)
• you feel confused, have mood changes, memory problems or see things that are not there (hallucinations) ● you feel dizzy or light-headed, or feel your heart beating irregularly or fast – this may be a sign of an abnormal heartbeat
• you notice any joint pain, bone pain, deformities or changes in your ability to move, as this may be a sign of fractures ● you have kidney problems or arthritis – you may have high uric acid levels in your blood

Tell your doctor straight away if you notice any of the side effects above.

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people: ● feeling tired

• changes in taste
• feeling unsteady or dizzy
• blurred vision
• swelling
• diarrhoea or constipation
• being or feeling sick
• difficulty swallowing
• abnormal sense of touch which feels like itching, tingling or burning sensation
• rash
• feeling short of breath
• cough or fever
• headache
• weight gain
• vomiting
• muscle pain or weakness
• pain including back pain, neck pain, musculoskeletal pain, pain in limbs
• stomach pain
• joint pain
• abnormal unpleasant sensation in your arms or legs ● loss of muscle coordination, being unsteady when walking ● disturbance in normal sleep patterns
• lung infection
• urinary tract infection
• cannot empty your bladder completely
• loss of appetite
• low blood pressure
• decreased number of a type of white blood cell called neutrophils
• lack of enough red blood cells (anaemia)
• increased blood levels of certain liver enzymes (AST/ALT) ● increased blood level of creatinine (something normally removed by the kidneys into the urine)

Common: may affect up to 1 in 10 people:

• mood disorders
• dehydration
• fluid around your lungs
• fainting
• skin being more sensitive to sunlight

Uncommon: may affect less than 1 in 100 people: ● changes in certain chemicals in your blood caused by fast breakdown of tumour cells – this may cause damage to organs, including the kidneys, heart, and liver. ● Inflammation of the heart muscle

Tell your doctor, pharmacist or nurse if you notice any of the side effects above.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rozlytrek

• Keep this medicine out of the sight and reach of children. ● Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month.
• Store the capsules in the original package and keep the bottle tightly closed in order to protect from moisture. ● Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Rozlytrek contains

The active substance is entrectinib.

Rozlytrek 100 mg: each capsule contains 100 mg entrectinib Rozlytrek 200 mg: each capsule contains 200 mg entrectinib

The other ingredients are:

• Capsule content: tartaric acid (E334), lactose (see section

  2 ‘Rozlytrek contains lactose’), hypromellose (E464), crospovidone (E1202), microcrystalline cellulose (E460), silica, colloidal anhydrous (E551), magnesium stearate (E470b).

• Capsule shell: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172; for Rozlytrek 100 mg capsule), sunset yellow FCF (E110; for Rozlytrek 200 mg capsule). See section 2 ‘Rozlytrek contains sunset yellow FCF (E110)’. ● Printing ink: shellac, propylene glycol, indigo carmine aluminium lake (E132).

What Rozlytrek looks like and contents of the pack

Rozlytrek 100 mg hard capsules are opaque yellow with ENT 100 imprinted in blue on the body.

Rozlytrek 200 mg hard capsules are opaque orange with ENT 200 imprinted in blue on the body.

The capsules are provided in bottles containing either: ● 30 hard capsules of Rozlytrek 100 mg, or

• 90 hard capsules of Rozlytrek 200 mg.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited

6 Falcon Way, Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

This leaflet was last revised in October 2025

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

11009490 GB