Everolimus

Everolimus (Afinitor) is used to treat advanced renal cell carcinoma (RCC; cancer that begins in the kidneys) that has already been treated unsuccessfully with other medications. Everolimus (Afinitor) is also used to treat subependymal giant cell astrocytoma (SEGA; a type of brain tumor) that cannot be treated with surgery in patients with tuberous sclerosis (TS; a genetic condition that causes tumors to grow in many organs). Everolimus (Zortress) is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person who received the organ) in certain adults who have received kidney transplants. Everolimus is in a class of medications called kinase inhibitors. Everolimus treats cancer by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Everolimus prevents transplant rejection by decreasing the activity of the immune system.

Everolimus comes as a tablet to take by mouth. When everolimus is taken to treat RCC or SEGA, it is usually taken once a day. When everolimus is taken to prevent transplant rejection, it is usually taken twice a day (every 12 hours) at the same time as cyclosporine. Everolimus should either always be taken with food or always without food. Take everolimus at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take everolimus exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Everolimus tablets come in individual blister packs that can be opened with scissors. Do not open a blister pack until you are ready to swallow the tablet it contains. Swallow the tablets whole with a full glass of water; do not split, chew, or crush them. If you are not able to swallow the tablets, ask your doctor or pharmacist what to do. Your doctor may adjust your dose of everolimus during your treatment depending on the results of your blood tests, your response to the medication, side effects you experience, and changes in other medications that you take with everolimus. If you are taking everolimus to treat SEGA, your doctor will adjust your dose not more often than once every 2 weeks, and if you are taking everolimus to prevent transplant rejection, your doctor will adjust your dose not more often than once every 4-5 days. Your doctor may stop your treatment for a time if you experience severe side effects. Talk to your doctor about how you are feeling during your treatment with everolimus.

<p></p> <p></p> <p></p> <p>Everolimus may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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diarrhea</li>
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constipation</li>
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change in ability to taste food</li>
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weakness</li>
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headache</li>
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nosebleed</li>
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dry skin</li>
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acne</li>
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pain in the arms or legs</li>
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changes in personality</li></ul></p> <p></p> <p>Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

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hives</li>
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itching</li>
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swelling of the eyes, face, mouth, lips, tongue, or throat</li>
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hoarseness</li>
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difficulty breathing or swallowing</li>
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wheezing</li>
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flushing</li>
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chest pain</li>
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extreme thirst or hunger</li>
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unusual bleeding or bruising</li>
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pale skin</li>
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fast or irregular heartbeat</li>
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dizziness</li>
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seizures</li></ul>Everolimus may decrease fertility in men and women. Talk to your doctor about the risks of taking everolimus.Everolimus may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at <a href='http://www.fda.gov/Safety/MedWatch'>http://www.fda.gov/Safety/MedWatch</a>] or by phone [1-800-332-1088].</p>

Before taking everolimus, tell your doctor and pharmacist if you are allergic to everolimus, sirolimus (Rapamune), temsirolimus (Torisel), any other medications, or any of the ingredients in everolimus tablets. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors; aprepitant (Emend); certain antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., E-Mycin, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, in Rifamate, in Rifater), rifapentine (Priftin), and telithromycin (Ketek); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); cholesterol-lowering medications such as lovastatin (Altoprev, Mevacor, in Advicor) and simvastatin (Zocor, in Simcor, in Vytorin); digoxin (Digitek, Lanoxicaps, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac); certain medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) including amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (in Atripla, Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); medications that suppress the immune system; nefazodone; nicardipine (Cardene); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with everolimus, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. tell your doctor what herbal products you are taking, especially St. John's wort. tell your doctor if you have or have ever had diabetes; high levels of cholesterol or triglycerides in your blood; liver disease; or any condition that prevents you from digesting foods containing sugar, starch, or dairy products normally. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking everolimus. do not have any vaccinations without talking to your doctor. During your treatment with everolimus, you should avoid close contact with other people who have recently been vaccinated. you should know that you may develop sores or swelling in your mouth during your treatment with everolimus. Tell your doctor if you develop sores or feel pain in your mouth. Your doctor may recommend a mouthwash or gel to relieve your symptoms. However, you should not use any mouthwash without talking to your doctor or pharmacist because certain types of mouthwash that contain alcohol or peroxide can worsen the sores and swelling. you should know that wounds or cuts, including the cut in the skin made during a kidney transplant may heal more slowly than normal or may not heal properly during your treatment with everolimus. Call your doctor right away if the cut in the skin from your kidney transplant or any other wound becomes warm, red, painful, or swollen, fills with blood, fluid, or pus, or begins to open.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.