Afinitor

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Treatment & Uses
Side Effects
Treating Overdose
Safety Information
Before Using

Generic Name: everolimus (E ver OH li mus)
Brand Names: Afinitor

What is Afinitor?

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Afinitor (everolimus) is used to treat advanced kidney cancer. Everolimus is a kinase inhibitor and works by preventing the growth of cancer cells.

Afinitor is usually given after sorafenib (Nexavar) or sunitinib (Sutent) have been tried without successful treatment of symptoms.

Afinitor may also be used for other purposes not listed in this medication guide.

Important information about Afinitor

You should not use Afinitor if you are allergic to everolimus or sirolimus (Rapamune). Do not use Afinitor without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before taking Afinitor, tell your doctor if you have a breathing disorder, such as asthma or COPD, liver disease, diabetes, or high cholesterol.

Do not receive a "live" vaccine while you are being treated with Afinitor, and avoid coming into contact with anyone who has recently received a live vaccine (including measles, mumps, rubella, oral polio, chickenpox, BCG, and nasal flu vaccine).

There are many other medicines that can interact with Afinitor. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

To be sure Afinitor is not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you have a serious side effect such as stabbing chest pain, feeling short of breath, fever, chills, cough, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, or unusual weakness.

Before taking Afinitor

You should not use Afinitor if you are allergic to everolimus or sirolimus (Rapamune).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Afinitor:

a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
liver disease;
diabetes; or
high cholesterol or triglycerides.

FDA pregnancy category D. Do not use Afinitor without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. Do not use Afinitor without telling your doctor if you are breast-feeding a baby.

How should I take Afinitor?

Take Afinitor exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Afinitor should be taken at the same time each day.

Take this medication with a full glass (8 ounces) of water. Swallow the tablet whole. Do not crush or chew.

You may take Afinitor with or without food.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Store Afinitor at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Afinitor overdose symptoms are not known.

What should I avoid while taking Afinitor?

Do not receive a "live" vaccine while you are being treated with Afinitor, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Afinitor side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Afinitor: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, cough with yellow or green mucus;
stabbing chest pain, feeling short of breath;
white patches or sores inside your mouth or on your lips; or
other signs of infection such as sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, or unusual weakness.

Less serious Afinitor side effects may include:

tired feeling;
headache;
stomach pain, diarrhea;
swelling, weight gain;
dry skin; or
sleep problems (insomnia);

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Afinitor?

Many drugs can interact with Afinitor. Below is just a partial list. Tell your doctor if you are using:

aminoglutethimide (Cytadren);
aprepitant (Emend);
bosentan (Tracleer);
conivaptan (Vaprisol);
dexamethasone (Decadron, Hexadrol);
diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
enoxacin (Penetrex);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
phenylbutazone (Azolid, Butazolidin);
St. John's wort;
an antidepressant such as nefazodone;
an antibiotic such as clarithromycin (Biaxin), clotrimazole (Mycelex Troche), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), telithromycin (Ketek), or voriconazole (Vfend);
a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton);
heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan);
HIV or AIDS medication such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase);
medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and there are many other medicines that can interact with Afinitor. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about Afinitor.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.