Everolimus, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain kinds of cancer, or to prevent rejection after a kidney or liver transplant. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe lung or breathing problems, and increase your risk for skin cancer. It may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: everolimus, oral; Afinitor; Afinitor Disperz; Zortress

What is this medicine used for?

Afinitor is taken by mouth to treat:

• A type of pancreatic cancer (PNET) that has progressed and cannot be treated with surgery
• Advanced kidney cancer (renal cell carcinoma) when other medicines have not worked.
• A type of brain tumor called tuberous sclerosis (TS)
• A type of breast cancer called hormone-receptor positive, HER2-negative

Zortress is taken by mouth to prevent rejection after a kidney or liver transplant.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to castor oil
• A heart, kidney, or liver transplant
• Breathing problems or lung disease
• Diabetes
• High cholesterol
• Kidney or liver disease, including hepatitis B
• Lapp lactase deficiency or glucose-galactose malabsorption
• Skin cancer

Also tell your healthcare provider if you are scheduled to have any live vaccine or have close contact with someone who has recently received a live vaccine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use effective birth control while taking this medicine and for 8 weeks after stopping this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using Afinitor in children under age 1.

Check with your provider before using Zortress in children under age 18.

You may take this medicine with or without food, but you should take it the same way each time, either with food or without food. Do not break, crush, or chew the tablets. Swallow them whole with a full glass of water.

What if I miss a dose?

If you miss a dose, you may still take it for up to 6 hours after the time you normally take this medicine. If it is more than 6 hours after you normally take this medicine, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You will need to have regular tests to find out how this medicine affects you. Keep all appointments for these tests.

This medicine may cause serious problems in people who have had an organ transplant. Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. If you have had a heart transplant, an infection while taking this medicine may be fatal.

If you have had hepatitis B or are a carrier of hepatitis B virus, this medicine could cause the virus to become active again. This may cause life-threatening liver problems.

While taking this medicine there is an increased risk of certain cancers, including skin cancer caused by exposure to sunlight or sunlamps. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. Ask your pharmacist for the most protective sunscreen lotion.

This medicine can cause severe lung or breathing problems. Tell your healthcare provider right away if you have a new or worsening cough, shortness of breath, or wheezing.

This medicine may cause mouth ulcers and sores. Tell your healthcare provider if you have pain, discomfort, or open sores in your mouth while you are using this medicine. Your provider can prescribe a special mouthwash or mouth gel to treat these mouth sores. Don’t use mouthwashes that contain alcohol, peroxide, iodine or thyme.

This medicine may affect your ability to have children in the future. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may lead to diabetes in some people. Notify your healthcare provider if you develop increased thirst or hunger or need to urinate more often.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing, wheezing, shortness of breath, trouble urinating; fast, slow, pounding, or irregular heartbeat; numbness or tingling in hands or feet; fever, cough, chills, sore throat, seizures, ringing in the ears, yellowing of the skin or eyes, unusual tiredness or weakness, unusual bruising or bleeding; mouth sores; swelling in hands, ankles, or feet or any unexplained swelling.

Other: Trouble sleeping, constipation, vomiting, itching, rash, dry skin, stomach pain, back pain, blurred vision, abnormal dreams, muscle cramps, diarrhea, nausea, loss of appetite, change in sense of taste, dizziness, headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace)
• Antibiotics such as azithromycin (Zithromax, Zmax), chloramphenicol, clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, rifabutin (Mycobutin), rifampin (Rifadin), telithromycin (Ketek), and tetracycline
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), clozapine (Clozaril, FazaClo), haloperidol, iloperidone (Fanapt), olanzapine (Zyprexa), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Aprepitant (Emend) and fosaprepitant (Emend)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Corticosteroids such as betamethasone (Celestone), dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Doxepin (Silenor)
• Echinacea
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide, dofetilide (Tikosyn), dronedarone (Multaq), mexiletine, propafenone (Rythmol), and quinidine
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), and zidovudine (Retrovir)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), pimecrolimus (Elidel), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic), and temsirolimus (Torisel)
• Isoniazid
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Metronidazole
• Paroxetine (Brisdelle, Paxil, Pexeva)
• St. John's wort
• Vaccines

The effects of this medicine may be dangerously increased if you drink grapefruit juice or eat grapefruit. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.