100 mg hard capsules
entrectinib
What Rozlytrek is and what it is used for
What is Rozlytrek
Rozlytrek is a cancer drug that contains the active substance entrectinib.
What Rozlytrek is used for
Rozlytrek is used to treat either:
- adults and children from the age of 12 and older with solid tumors (cancer) in different parts of the body caused by a change in the so-called neurotrophic tyrosine receptor kinase (NTRK) gene, or
- adults with a type of lung cancer called “non-small cell lung cancer” (NSCLC) caused by a change in the so-called ROS1 gene.
NTRK -gene fusion- positive cancer tumor
Used when:
- a test has shown that your cancer cells have a change in the genes called ” NTRK ” and have spread within the affected organ or to other organs in your body or if surgery to remove cancer would probably lead to severe complications (see “How” Rozlytrek works “below) and
- you have not been treated with a medicine called NTRK inhibitor
- other treatments have not worked or are not suitable for you.
ROS1 -positive non-small cell lung cancer (NSCLC)
Used if your lung cancer:
- is ” ROS1 -positive” – this means that your cancer cells have a change in a gene called ” ROS1 ” (see “How Rozlytrek works” below),
- is advanced – for example, has spread to other parts of your body (metastasized) and
- you have not been treated with a medicine called ROS1 inhibitor.
How Rozlytrek works
Rozlytrek works by blocking the effect of the abnormal enzymes that occur due to a change in the NTRK or ROS1 genes that make them up. The wrong enzymes stimulate the cancer cells to grow.
Rozlytrek can slow or stop the growth of cancer. It can also help shrink your cancer.
What you need to know before taking 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 cautions
Talk to your doctor, pharmacist, or nurse before taking Rozlytrek if:
- you have recently experienced memory loss, confusion, hallucinations, or changes in your mental state
- you have previously had bone fractures or conditions that may increase the risk of you breaking your bones, called “osteoporosis” or “osteopenia”
- you are taking medicines that lower the uric acid levels in your blood
- you have heart failure (your heart can not pump enough blood to provide oxygen to the body) – signs may include cough, shortness of breath, and swelling of the legs and arms
- you have or have had heart disease or problems with disorders of the heart’s conduction system called “prolonged QTc interval” – this is seen on an “electrocardiogram” ( ECG ), or low levels of electrolytes ( potassium, magnesium, calcium, or phosphorus) in your Blood
- you have a hereditary condition called ‘galactose intolerance’, ‘total lactase deficiency, or ‘glucose-galactose malabsorption.
Other drugs and Rozlytrek
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines. This is because Rozlytrek may affect the way some other medicines work. Some other medicines may also affect the way Rozlytrek works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- antifungal drugs ( antifungals ) – such as ketoconazole , itraconazole, voriconazole, posaconazole
- medicines used to treat AIDS / HIV infection – such as ritonavir or saquinavir
- an herbal remedy for mild depression – St. John’s wort
- medicines used to stop seizures and epileptic seizures (medicines for epilepsy ) – such as phenytoin, carbamazepine, or phenobarbital
- drugs for tuberculosis – such as rifampicin, rifabutin
- drugs used to treat cancer (solid tumors ) and cancer of the blood – topotecan, lapatinib mitoxantrone, apalutamide, methotrexate
- a drug for inflammation of the joints or autoimmune joint diseases ( rheumatoid arthritis ) – methotrexate
- a drug for migraine headaches – ergotamine
- a drug to relieve severe pain – fentanyl
- a drug for mental illness ( psychosis ) or involuntary movements and sounds, also called Tourette’s syndrome – pimozide
- a drug for an irregular heartbeat – quinidine
- drugs to prevent the formation of blood clots – warfarin, dabigatran etexilate
- drugs for acid reflux (heartburn) – cisapride, omeprazole
- drugs that lower cholesterol in the blood – atorvastatin, pravastatin, rosuvastatin
- drugs that inhibit your immune system or prevent the body from rejecting a transplanted organ – sirolimus, tacrolimus, ciclosporin
- antidepressants – paroxetine, fluvoxamine
- drugs to reduce blood sugar levels – repaglinide, tolbutamide
- medicines for high blood pressure – bosentan, felodipine, nifedipine, verapamil.
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 and do not eat grapefruit or orange while you are being treated with Rozlytrek. It can increase the amount of the drug in your blood to a harmful level.
Pregnancy, breastfeeding, and fertility
Women and contraception
You should not get pregnant while taking this medicine as it may harm your baby. If you could become pregnant, you must use a very effective contraceptive during treatment and for at least 5 weeks after stopping treatment.
It is not known if Rozlytrek can reduce the effect of contraceptives ( birth control pills or hormonal contraceptive implants). You should use another safe contraceptive against pregnancy such as a barrier method (eg condom) so that you do not become pregnant while taking Rozlytrek and for 5 weeks after stopping treatment.
Talk to your doctor about the right contraceptive for you and your partner.
Men and contraception
Your female partner must not become pregnant while taking this medicine as it may harm the baby. If your female partner may become pregnant, you must use a very effective contraceptive during treatment and for at least 3 months after stopping treatment. Talk to your doctor about the right contraceptive for you and your partner.
Pregnancy
- Do not take Rozlytrek if you are pregnant. This is because it can harm your baby.
- If you become pregnant while taking this medicine or for 5 weeks after taking your last dose, talk to your doctor immediately.
Breast-feeding
Do not breastfeed while taking this medicine. This is because it is not known if Rozlytrek can pass into breast milk and therefore can harm your baby.
Driving and using machines
Rozlytrek may affect your ability to drive and use machines. Rozlytrek can make you:
- get blurred vision
- feel dizzy
- fainting (unconsciousness)
- feeling tired
- get changes in your mental state, feel confused or see things that are not there (hallucinations).
If this happens, do not drive, cycle or use heavy machinery until the symptoms have disappeared. Talk to your doctor or pharmacist about whether you can drive or use machines.
Rozlytrek contains excipients
- 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.
- para-orange (E110) only in 200 mg hard capsules. This is a dye that can cause allergic reactions.
How to take Rozlytrek
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
Adults
- The recommended dose is 3 capsules with 200 mg once daily (a total of 600 mg).
- If you do not feel well, your doctor may sometimes lower the dose, stop the treatment for a short time or stop the treatment altogether.
Children
- Rozlytrek can be used by children from 12 years of age and older.
- Your doctor will calculate the correct dose to use – it depends on the child’s height and weight.
How to take
Take Rozlytrek with or without food. Swallow each capsule whole. The capsules must not be opened or dissolved as the contents of the capsule have a very bitter taste.
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 a hospital straight away. Take the medicine pack and this leaflet with you.
If you forget to take Rozlytrek
- If your next dose is to be taken in more than 12 hours, take the missed dose as soon as you remember.
- If it is less than 12 hours until your next dose, skip the missed dose. Then take your next dose at the usual time.
- Do not take a double dose to make up for a forgotten dose.
If you stop using Rozlytrek
Do not stop taking this medicine without talking to your doctor first. It is important to take Rozlytrek every day for as long as your doctor prescribes it for you.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
Serious side effects
Tell your doctor immediately if you notice any of the following after taking Rozlytrek. Your doctor may reduce your dose, discontinue treatment for a short time or stop treatment altogether:
- you have a cough, shortness of breath, and swelling in the legs or arms (fluid retention). This may be a sign of heart problems
- you feel confused, have changed mood, memory problems, or hallucinations (see things that are not there)
- you feel dizzy or dizzy or feel that your heartbeat is irregular or fast as this may be a sign of an abnormal heart rhythm
- you get joint pain, skeletal pain, deformities, or changes in how you move
- you have kidney problems or joint inflammation ( arthritis ), as it may be due to elevated levels of uric acid in your blood
Other side effects are
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:
- feel tired
- constipation
- changed taste
- feel unsteady or dizzy
- swelling
- diarrhea
- nausea
- abnormal sensation on the touch that feels like an itchy, stinging, or burning sensation
- lack of red blood cells ( anemia )
- shortness of breath
- weight gain
- elevated creatinine levels in the blood (a substance that is normally excreted by the kidneys into the urine)
- pain including back pain, pain in the neck, pain in muscles and bones, pain in arms and legs
- vomiting
- cough
- fever
- muscle aches
- joint pain
- headache
- low blood pressure
- elevated levels of certain liver enzymes (AST / ALT)
- abnormal discomfort in your arms or legs
- loss of muscle coordination, be unsteady when walking
- change in your normal sleep pattern
- infection of the lungs
- urinary tract infection
- muscle weakness
- decreased appetite
- dimsyn
- rash
- decreased number of a type of white blood cell called neutrophils
- abdominal pain
- inability to empty the bladder
- difficulty swallowing
Common: may affect up to 1 in 10 people:
- changed mood
- dehydration
- fluid in the lungs
- fainting
- increased sensitivity of the skin to sunlight
Uncommon: may affect up to 1 in 100 people:
- Changes in certain chemical substances in your blood are caused by the rapid breakdown of tumor cells, which can cause damage to organs including the kidneys, heart, and liver.
Tell your doctor, pharmacist, or nurse if you notice any of the side effects listed above.
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 jar after EXP. day. The expiration date is the last day of the specified month.
- Store in the original package. Close the jar tightly. Moisture sensitive.
- 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.
Contents of the packaging and other information
Content declaration
The active substance is entreating.
Rozlytrek 100 mg: Each capsule contains 100 mg of entreating.
Rozlytrek 200 mg: Each capsule contains 200 mg of entreating.
Other ingredients are:
- Capsule contents: tartaric acid, lactose (see section 2 “Rozlytrek contains lactose”), hypromellose, crospovidone, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
- Capsule cover: hypromellose, titanium dioxide (E171), yellow iron oxide (E172; for Rozlytrek 100 mg capsule), para-orange (E110; for Rozlytrek 200 mg capsule). (See section 2 “Rozlytrek contains para-orange (E110)”).
- Ink: shellac, propylene glycol, indigo carmine aluminum lacquer (E 132).
What the medicine looks like and the contents of the pack
Rozlytrek 100 mg hard capsules are opaque, yellow with ENT 100 printed in blue on the lower part.
Rozlytrek 200 mg hard capsules are opaque, orange with ENT 200 printed in blue on the lower part.
The capsules are supplied in jars containing either:
- 30 hard capsules with Rozlytrek 100 mg or
- 90 hard capsules with Rozlytrek 200 mg.
Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
Finland / Finland
Roche Oy
Puh / Tel: +358 (0) 10 554 500