EVEROLIMUS (AFINITOR)

(E ver OH li mus (a FIN i tor)) Brand: Afinitor, Afinitor Disperz

What is the most significant information I must know about Afinitor?

• You must not use this medicine if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

What is everolimus (Afinitor)?

• Everolimus is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body.

• The Afinitor brand of everolimus is used to treat determined types of kidney cancer, breast cancer, or brain tumor. Afinitor is generally given after another cancer medications have been tried without successful treatment.

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

• This medicine manual provides information about the Afinitor brand of everolimus. Zortress is other brand of everolimus used to prevent organ rejection after a kidney transplant.

• Everolimus may also be used for purposes not listed in this medicine guide.

What must I discuss with my health care provider till taking Afinitor?

• You must not use this medicine if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

• To create certain you can safely take everolimus, speak your doctor if you have any of these another conditions:

· a breathing mess, such as asthma or COPD (chronic obstructive pulmonary disease);

· liver malady, or a history of hepatitis B;

· kidney disease;

· an active infection;

· diabetes or tall blood sugar; or

· tall cholesterol.

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

• Everolimus can affect fertility (your capacity 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 child. You must not breast-feed while you are taking everolimus.

How must I take Afinitor?

• Follow all directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results. Do not take this medication in larger or less amounts or for longer than recommended.

• Everolimus must be taken at the same time every day. You may take everolimus with or without food, but take it the same way every time.

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

• Do not crush, chew, or interrupt an Afinitor regular tablet. Swallow the pill intact.

• Do not swallow the dispersible tablet (Afinitor Disperz) intact. Seat it into a glass with about 2 tablespoons of water and let the tablet to disperse in the liquid for at least 3 minutes. Stir gentry and drink this mixture right away. To create certain you get the entire doze, add a few 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: Seat 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 little container and let 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.

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

• Store at room temperature in the original container, away from moisture, heat, and easy. Hold every tablet in its blister pack before you are ready to take it.

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

What happens if I miss a dose?

• If you are smaller than 6 hours late in taking your medication, take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking Afinitor?

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

• Body fluids must 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 commodity while taking Afinitor.

What are the possible side effects of Afinitor?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your person, 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, weary feeling, cool or flu symptoms;

· seizure (convulsions);

· swelling, rapid weight gain, urinating smaller than normal or not at all;

· pain or burning when you urinate;

· pain or fullness in your ear, hearing problems;

· pale skin, light bruising, unusual bleeding; 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).

• General 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect Afinitor?

• Much drugs can interact with Afinitor. Not all possible interactions are listed here. Speak 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 much another drugs can interact with Afinitor. This includes prescription and over-the-counter medicines, vitamins, and herbal commodity. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about everolimus (Afinitor).

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.