Xevirol 5

Indications

Everolimus is a prescription medicine used in two quite different ways. In cancer care, it is used for certain types of advanced breast cancer (hormone receptor positive, HER2 negative, usually together with Exemestane), advanced kidney cancer (renal cell carcinoma) after other treatment, and some neuroendocrine tumours of the pancreas, gut or lung. It is also used for some growths linked to tuberous sclerosis complex, a genetic condition. At lower doses, Everolimus is used after kidney or liver transplantation to help stop the body from rejecting the new organ.

How It Works

Everolimus blocks a protein inside cells called mTOR (mammalian target of rapamycin). mTOR acts like a control switch for cell growth, division and the making of new blood vessels. By turning this switch down, Everolimus slows the growth of cancer cells and reduces the blood supply that tumours need. In transplant patients, the same action calms down the immune cells (T cells) that would otherwise attack the new organ.

Dosage and Administration

The dose depends on the condition being treated and is decided by a specialist doctor. Take it exactly as prescribed. For cancer, it is usually taken once a day; after a transplant, it is usually taken twice a day together with other anti-rejection medicines, and the dose is adjusted using blood level tests.

• Swallow the tablet whole with a glass of water, at the same time each day, either always with food or always without food.
• Do not crush or chew the tablets. Carers should avoid touching crushed or broken tablets.
• If you miss a dose, follow your doctor's advice. Do not take a double dose.
• Do not stop or change the dose without speaking to your doctor.

Interactions

Many medicines change the amount of Everolimus in the blood. Tell your doctor about every medicine, supplement and herbal product you use.

• Strong blockers of the liver enzyme CYP3A4, such as Ketoconazole, Itraconazole, Clarithromycin and Ritonavir, can raise Everolimus levels to unsafe amounts.
• Medicines such as Rifampicin, Carbamazepine, Phenytoin and St John's wort can lower its levels and make it less effective.
• Grapefruit and grapefruit juice should be avoided.
• Live vaccines should be avoided during treatment.
• ACE inhibitors such as Ramipril may increase the risk of swelling of the face and throat (angioedema).
• In transplant patients, Ciclosporin and Tacrolimus doses need careful adjustment alongside Everolimus.

Contraindications

Do not take Everolimus if you are allergic to Everolimus, Sirolimus or any related medicine, or to any ingredient in the tablet.

Side Effects

Common side effects include mouth sores and ulcers (stomatitis), tiredness, diarrhoea, rash, loss of appetite, nausea, swelling of the hands or feet, cough, infections, nosebleeds, raised blood sugar, raised cholesterol and fats in the blood, and low blood counts. Some people develop inflammation of the lungs (non-infectious pneumonitis), which causes cough or breathlessness. Kidney function can also be affected.

Get urgent medical help if you have new or worsening cough or shortness of breath, fever or chills or other signs of infection, swelling of the face, lips, tongue or throat, unusual bleeding or bruising, or very little urine.

Pregnancy and Lactation

Everolimus can harm an unborn baby. Women who could become pregnant should use reliable contraception during treatment and for at least 8 weeks after the last dose; men should also use contraception as advised by the doctor. It may reduce fertility in both men and women. Do not breastfeed while taking Everolimus and for 2 weeks after the last dose.

Precautions and Warnings

• Your doctor will check your blood counts, blood sugar, blood fats, kidney and liver function regularly.
• Everolimus weakens the immune system, so infections, including old hepatitis B infection, can flare up.
• An alcohol-free mouthwash may help reduce mouth sores; avoid mouthwashes containing alcohol or peroxide.
• Wounds may heal more slowly; tell your doctor before any surgery.
• People with liver problems may need a lower dose.
• Avoid close contact with people who have recently received live vaccines.

Overdose

If too much Everolimus has been taken, contact a doctor or go to hospital straight away and take the medicine pack with you. There is no specific antidote; treatment is supportive and includes monitoring of blood tests.

Therapeutic Class

Antineoplastic agent and immunosuppressant (mTOR inhibitor).

Storage

Store below 30°C in a dry place, in the original pack to protect from light and moisture, and out of the reach of children.