What is Afinitor?

Afinitor (everolimus) is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. Afinitor is used to treat certain types of kidney cancer, breast cancer, or brain tumor. It is also used to treat certain types of advanced or progressive tumors of the stomach, intestines, or pancreas. Afinitor is also used to treat certain types of seizures or non-cancerous (benign) tumors of the brain or kidney in people with a genetic condition called tuberous sclerosis complex.

Always read the patient information and instructions carefully before using this medication.

• Do not change dosage forms of this medication without checking with your doctor or pharmacist.
• Take this medication by mouth as directed by your doctor, usually once daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. Swallow this medication whole with a glass of water. Do not crush or chew the tablets.
• The dosage is based on your medical condition, response to treatment, laboratory tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you are taking this medication to treat a certain type of benign brain tumor, the dosage is also based on body size.
• Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
• Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.
• Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.
• Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Make sure to tell your doctor and pharmacist:

• If you have any drug allergies.
• Which other prescription and non-prescription medications you currently take.
• Your medical history, especially of: liver disease, any recent/current infections, diabetes, high cholesterol/triglyceride levels.

Also be aware that:

• This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
• Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
• Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
• To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports
• Older adults may be more sensitive to the side effects of this drug.
• Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using everolimus. Everolimus may harm an unborn baby. Female patients should ask about reliable forms of birth control while using this medication and for 8 weeks after stopping treatment. Male patients with female partners should ask about reliable forms of birth control while using this medication and for 4 weeks after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.
• Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
• Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.
• It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Common side-effects may include but are not limited to:

• Diarrhea, nausea/vomiting, decreased appetite, weight loss, changes in taste, nosebleeds, dry skin, dizziness, and headaches.
• Pain or sores in the mouth and throat may occur. To reduce the risk of getting mouth sores when you start everolimus treatment, your doctor may prescribe a mouthwash that contains a corticosteroid medication. Brush your teeth carefully/gently and avoid using mouthwash that contains alcohol, iodine, peroxide, or thyme. Rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.
• Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Contact your doctor if you experience any of the following side-effects:

• Swelling hands/ankles/feet, missed/heavy/painful periods, easy bruising/bleeding, unusual tiredness, mental/mood changes, wound problems (such as slowed wound healing).
• Signs of kidney problems, such as a change in the amount of urine.
• Symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
• This medication may cause your cholesterol/triglycerides to increase. You may need to have your cholesterol/triglycerides checked periodically and/or take another medication to control your cholesterol/triglycerides.
• Any signs of infection (such as fever, chills, persistent sore throat, cough).
• Symptoms of lung problems, such as shortness of breath, chest pain.
• Symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellow eyes/skin.
• This medication may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes.
• This medication may affect male and female fertility. Consult your doctor for more details.
• Everolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.
• Any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Q: What special dietary instructions should I follow?

A: Do not eat grapefruit or drink grapefruit juice while taking this medication.

Q: What should I do if I forget a dose?

A: If you remember the missed dose within 6 hours of the time you were scheduled to take it, take the missed dose right away. However, if more than 6 hours have passed since the scheduled time, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.