Brand Name: AFINITOR
Contents: Avirolimus
Form: Tablets
Strength: 5 MG, 10 MG
Manufactured By: Novartis
Packing: 28 tabs

Afinitor (everolimus) is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

The Afinitor brand of everolimus is used to treat certain types of kidney cancer, breast cancer, or brain tumor. It is usually given after other cancer medications have been tried without successful treatment.

Afinitor is also used to treat non-cancerous (benign) kidney tumors, and certain types of advanced or progressive tumors of the pancreas.

This medication guide provides information about the Afinitor brand of everolimus. Zortress is another brand of everolimus used to prevent organ rejection after a kidney transplant.

Important information

You should not use Afinitor if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

Do not use Afinitor if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 8 weeks after your treatment ends.

Before taking Afinitor, tell your doctor if you have a breathing disorder such as asthma or COPD, liver disease (or a history of hepatitis B), an active infection, diabetes or high blood sugar, or high cholesterol.

Do not receive a “live” vaccine while using this medicine. The vaccine may not work as well during this time, and may not fully protect you from disease.

There are many other drugs that can interact with Afinitor. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

While using Afinitor, you may need blood tests at your doctor’s office. Visit your doctor regularly.

Before taking this medicine

You should not use Afinitor if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

To make sure you can safely take Afinitor, tell your doctor if you have any of these other conditions:

• a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
• liver disease, or a history of hepatitis B;
• kidney disease;
• an active infection;
• diabetes or high blood sugar; or
• high cholesterol.

FDA pregnancy category D. Do not take Afinitor if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 8 weeks after your treatment ends.

Afinitor can affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking everolimus.

How should I take Afinitor?

Take Afinitor exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Afinitor should be taken at the same time each day. You may take Afinitor with or without food, but take it the same way each time.

Do not take an Afinitor regular tablet together with the dispersible tablet. Use only one form of this medicine.

Do not crush, chew, or break an regular tablet. Swallow the pill whole.

Do not swallow the dispersible tablet (Afinitor Disperz) whole. Place it into a glass with about 2 tablespoons of water and allow the tablet to disperse in the liquid for at least 3 minutes. Stir gently and drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

The Afinitor Disperz tablet may also be taken with an oral syringe as follows: Place a tablet into the oral syringe and draw 5 milliliters (cc) of water and 4 milliliters (cc) of air into the syringe. Set the syringe with the tip up in a small container and allow the tablet to disperse in the liquid for at least 3 minutes. Turn the syringe upside down 5 times and then empty the syringe into your mouth. Refill the syringe with water, shake gently, and empty into your mouth.

Afinitor can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using Afinitor. Your surgical incisions or other wounds may take longer to heal while you are taking this medicine.

Store at room temperature in the original container, away from moisture, heat, and light. Keep each tablet in its blister pack until you are ready to take it.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using this medicine.

What happens if I miss a dose?

If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Everolimus can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Do not receive a “live” vaccine while using 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), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Grapefruit and grapefruit juice may interact with Afinitor and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

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.

Stop using Afinitor and call your doctor at once if you have:

• new or worsening cough, wheezing, feeling short of breath;
• fever, swollen gums, painful mouth sores, pain when swallowing, tired feeling, cold or flu symptoms;
• seizure (convulsions);
• swelling, rapid weight gain, urinating less than usual or not at all;
• pain or burning when you urinate;
• pain or fullness in your ear, hearing problems;
• pale skin, easy bruising, unusual bleeding;
• a skin wound that is swollen, red, warm, bleeding, or oozing;
• any wound that will not heal; or
• nausea, pain in your upper stomach, itching, joint pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Common Afinitor side effects may include:

• mild skin rash;
• headache; or
• diarrhea, mild stomach pain or nausea.

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. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Afinitor, especially:

• bosentan, imatinib, nefazodone, St. John’s wort;
• an antibiotic–clarithromycin, erythromycin, telithromycin; antifungal medication–itraconazole, ketoconazole, posaconazole, voriconazole; heart medication–nicardipine, quinidine;
• hepatitis C medications–boceprevir, telaprevir; HIV/AIDS medication–atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;
• seizure medication–carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; tuberculosis medication–isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with Afinitor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.