Everolimus is used on its own or together with other medicines to treat certain types of neuroendocrine tumours that originate from the stomach, bowels, lungs or pancreas, advanced cancer of the breast or kidney where previous therapy has failed, and certain kidney or brain tumours due to a genetic disorder known as tuberous sclerosis complex (TSC) where surgery is not appropriate or required immediately.
This medicine can be used together with other medicines to treat a certain type of epilepsy (fits or seizures) associated with tuberous sclerosis complex.
Everolimus can also be used together with other medicines to prevent organ rejection in kidney, heart or liver transplant.
Take Everolimus exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.
You may take this medicine with or without food, but it should consistently be taken the same way (e.g. always with food or always without food). Try to take it at the same time each day.
This medicine is available as a tablet or dispersible tablet.
Consistently take only the tablets or only the dispersible tablets and never a combination of both.
If you are taking the tablet, swallow it whole with a full glass of water. Do not divide, chew or crush the tablet.
Dispersible tablets are to be taken as a suspension. The suspension may be prepared using an oral syringe or a small glass or plastic cup.
When preparing the suspension in an oral syringe, follow these steps:
- Place the required dose in a 10-mL syringe. A maximum dose of 10 mg can be prepared per syringe. If higher doses are needed, prepare an additional syringe. Do not break or crush the tablets.
- Draw approximately 5 mL of water and 4 mL of air into the syringe.
- Place the filled syringe into a container (tip up) for 3 minutes, until the tablets are in suspension.
- Gently invert the syringe 5 times immediately prior to administration. Do not shake.
- After administration of the prepared suspension, draw approximately 5 mL of water and 4 mL of air into the same syringe, and swirl the contents gently to suspend remaining particles. Administer the entire contents of the syringe.
If you are preparing the suspension in a glass or plastic cup, follow these steps:
- Place the required dose into a small drinking glass (maximum size 100 mL) containing approximately 25 mL of water. A maximum dose of 10 mg (for treatment of brain tumours and fits or seizures associated with TSC) or 1.5 mg (for organ transplant) can be prepared per glass. If higher doses are required, prepare an additional glass. Do not break or crush the tablets.
- Allow 3 minutes for a suspension to occur.
- Stir the contents gently with a spoon, immediately prior to drinking.
- After administration of the prepared suspension, add 25 mL of water and stir with the same spoon to re-suspend remaining particles. Administer the entire contents of the glass.
Administration of the dispersible tablet for suspension via nasogastric tube for the prevention of organ transplant rejection, follow these steps:
- Place the required dose in a small plastic container with 10 mL of water. Gently swirl the container until the mixture is suspended.
- Withdraw the entire mixture into a syringe then inject slowly into the nasogastric tube.
- Rinse the container and the syringe with 5 mL of water then inject into the nasogastric tube to ensure a full dose.
- Flush the tube with 10 mL of water and clamp it for at least 30 minutes after administration.
Avoid any direct contact with Everolimus when preparing the suspension. You may wear gloves and wash your hands thoroughly before and after the preparation.
If you have problems or do not understand the instructions, ask your doctor or pharmacist.
The dose of this medicine will be decided by your doctor. Your doctor will advise you on the course of your treatment depending on your condition and response to the medication.
Everolimus must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.
If you miss a dose and it is within 6 hours after your regular schedule, take the missed dose and return to your normal dosing schedule.
If it is more than 6 hours after your regular schedule, skip the missed dose and return to your normal dosing schedule.
DO NOT double a dose under any circumstances.
If you often forget to take your medicine, let your doctor and pharmacist know.
Do not take this medicine if you ever had an allergic reaction (rashes, breathlessness, swollen eyes) to Everolimus and similar medicines such as sirolimus, pimecrolimus or tacrolimus.
Do not breastfeed while you are being treated with this medicine and for 2 weeks after the last dose.
You must avoid any vaccinations without consulting with your doctor. Alert your doctor if you have been recently vaccinated or if you are planning to get vaccinated.
Inform your doctor if you have the following conditions:
- hyperlipidaemia (excessive amount of cholesterol in the blood)
- diabetes
- liver disease
- history of bleeding problems
- history of recurring infections
- kidney disease
It is important that you do not get pregnant while being treated with Everolimus. You may wish to discuss birth control methods with your doctor or pharmacist.
This medicine can sometimes reduce fertility in men. This is reversible when Everolimus is stopped. Men who plan to have children should inform their doctor.
Do not switch between different brands or dosage forms unless instructed by your doctor. This is because different brands or dosage forms have varying ways of working in your body.
If you are going to have an operation, including minor surgery and dental work, inform your doctor or dentist that you are taking this medicine.
According to research, certain genes known as single nucleotide polymorphisms may affect Everolimus blood levels, safety and tolerability in the body. Several genes were identified in the study. Individuals who have CYP3A4 rs35599367 variant AG gene type may have an increased concentration of everolimus while those with CYP3A5 rs776746 variant CC and CT gene types may have reduced everolimus clearance. Patients with ABCB1 rs1045642 variant AA gene type and RPTOR rs9906827 variant CC gene type may experience an increased risk of side effects such as bowel lining inflammation and lung inflammation, respectively. If you know you have any of these gene types, inform your doctor.
Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.
- Pregnancy tests may be done before the start of treatment to know if this medicine is suited for you to take.
- Routine blood tests (e.g. CBC, kidney and liver function, blood cholesterol/sugar levels) may be done while you are being treated with Everolimus.
- Regular monitoring for signs and symptoms of infection, lung problems, or mouth ulcers may also be needed.
Your doctor will advise you about how often you will need to have these tests.
Everolimus may make you feel unusually tired. If affected, do not drive or take part in any activity in which you need to be alert.
Other side effects include any of the following: inflammation of mouth or lips, rash, diarrhoea, fever, nausea, decreased appetite, taste alterations, itch, nose bleed, cough, difficulty sleeping, headache, high blood pressure, dry mouth, joint pain and stomach pain.
Everolimus may also make your skin more sensitive to sunlight. Apply sunscreen when going outdoors and avoid prolonged exposure to sunlight and UV lamps.
Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:
- rashes, breathlessness, swelling of the face, eyes or mouth
- fever and chills
- coughing, wheezing, difficulty breathing
- shortness of breath, chest pain or coughing up blood
- decreased urine output, swelling in the legs, feeling confused, back pain
- excessive thirst, increased urination, increased appetite but with weight loss
- persistent stomach pain, yellowing of the skin or eyes, dark coloured urine, pale stools
This medicine will cause the level of your red blood cells, white blood cells and platelets to drop.
Red blood cells carry oxygen around your body. A fall in the level of red blood cells may make you feel tired and worn out.
White blood cells help your body to fight infections. A fall in the level of your white blood cells may put you at higher risk for infections, such as coughs, colds and flu, which may lead to more serious infections. Avoid crowded places and people who are sick. Alert your doctor if you have a fever or a cough or flu that does not go away.
Platelets help your blood to clot when there is a cut in the skin. A fall in the level of your platelets may put you at risk of bleeding more than usual. Do not take part in activities where you may fall or get injured, such as contact sports. Alert your doctor if you get any unusual bruising (large bruises or several bruises, especially if the bruises appeared on their own) or bleeding that takes a long time to stop (for example, too much bleeding when you floss or brush your teeth).
Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.
Avoid vaccinations during treatment with this medicine. Alert your doctor if you have been recently vaccinated or if you are planning to get vaccinated.
Inform your doctor and pharmacist if you are taking any of these medicines:
- medicines used in organ transplant or certain immune disorders e.g. ciclosporin
- medicines for fungal infection e.g. ketoconazole, fluconazole, itraconazole
- certain antibiotics e.g. erythromycin, clarithromycin
- rifampicin (medicine to treat TB)
- medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenobarbital, phenytoin
- medicines for high blood pressure e.g. ramipril, lisinopril, enalapril, verapamil, diltiazem
- medicines to treat HIV infection e.g. ritonavir, efavirenz, nevirapine, fosamprenavir
- St John’s wort (herbal medicine used to treat depression and other conditions)
- dronedarone (medicine for heart disease)
- nefazodone (medicine to treat depression)
This list does not include all medicines that may interact with Everolimus.
Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements and medicines that you buy without a prescription.
Avoid alcohol.
Avoid excessive consumption of grapefruit or grapefruit juice.
Store in a cool, dry place away from the reach of children. Protect from light and moisture.
Medicines must not be used past the expiry date.
Do not throw away any unused suspension via wastewater or household waste. Ask your doctor or pharmacist on how to properly dispose this medicine.
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