Do not take Rozlytrek
- You are allergic to Rozlytrek (entrectinib) or
- You are allergic to any of the other ingredients of this medicine
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Rozlytrek if:
- you have recently experienced memory loss, confusion, hallucinations, or mental status changes
- you have a history of fractured bones, or conditions which may increase your risk of breaking bones, called ‘osteoporosis’ or ‘osteopaenia’
- you take medication to lower the levels of uric acid in your blood
- you have heart failure (an inability for your heart to adequately pump blood to supply oxygen to the body) – signs can include cough, shortness of breath, and swelling in your legs or arms
- you have or had heart disorders or a heart conduction problem called ‘prolonged QTc interval’ – this is shown on an ‘electro cardiogram’ (ECG), or low levels of electrolytes (potassium, magnesium, calcium or phosphorus) in your blood
- you have an inherited problem called ‘galactose intolerance’, ‘congenital lactase deficiency’ or ‘glucose-galactose malabsorption’.
Other medicines and Rozlytrek
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional 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:
- medicines for fungal infections (anti-fungals) – such as ketoconazole, itraconazole, voriconazole, posaconazole
- medicines to treat Acquired Immune Deficiency Syndrome (AIDS)/Human immunodeficiency virus (HIV) infection – such as ritonavir or saquinavir
- a herbal medicine for depression – St. John’s Wort
- medicines to stop seizures or fits (anti-epileptics) – such as phenytoin, carbamazepine, or phenobarbital
- medicines for tuberculosis – such as rifampicin, rifabutin
- medicines to treat solid cancers and blood cancer – topotecan, lapatinib, mitoxantrone, apalutamide, methotrexate
- a medicine for inflammation of joints or joint autoimmune disease (rheumatoid arthritis) – methotrexate
- a medicine for migraine-type headaches – ergotamine
- a medicine for relief of severe pain – fentanyl
- a medicine for mental illness (psychoses) or involuntary movements and sounds, also called Tourette Syndrome – pimozide
- a medicine for irregular heart rate –quinidine
- medicines to prevent formation of blood clots – warfarin, dabigatran etexilate
- medicines for gastric reflux (heartburn) – cisapride, omeprazole
- medicines to reduce blood cholesterol – atorvastatin, pravastatin, rosuvastatin
- medicines to suppress your body’s immune system, or prevent the body from rejecting an organ transplant – sirolimus, tacrolimus, cyclosporin,
- medicines for depression – paroxetine, fluvoxamine
- medicines 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 or eat grapefruit or Seville oranges during your treatment with Rozlytrek. It may increase the amount of the medicine in your blood to a harmful level.
Pregnancy, breast-feeding and fertility
Women and contraception
You should not become 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 (pills or implanted hormonal contraceptives). You should use another reliable method of birth control such as a barrier method (e.g. condom) so you do not become pregnant while you are taking Rozlytrek and for 5 weeks after you stop treatment. Talk to your doctor about the right methods of contraception for you and your partner.
Men and contraception
Your female partner should not become 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 and using machines
Rozlytrek may affect your ability to drive or use machines. Rozlytrek may cause you to:
- have blurred vision
- feel dizzy
- pass out (lose consciousness)
- feel tired
- have changes in your mental status, feel confused or see things that are not there (hallucinations).
If this happens, you should not drive, use a bicycle, or operate heavy machinery until your symptoms resolve. Talk to your doctor or pharmacist about whether it is okay for you to drive 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.
