Everolimus (By mouth)

Introduction

Everolimus (e-ver-OH-li-mus)

Treats advanced kidney cancer. Also used with other medicines to keep your body from rejecting a transplanted kidney. Also treats subependymal giant cell astrocytoma (SEGA) and angiomyolipoma in patients with tuberous sclerosis complex (TSC). Also treats pancreatic neuroendocrine tumor (PNET).

Brand Name(s)

Zortress, Afinitor

How to Use This Medicine

Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Take this medicine the same way every day. This means take it at the same time and take it consistently, either with or without food.
• Swallow the tablet whole with a glass of water. Do not break, crush, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.
• If you cannot swallow the tablets, you may dissolve the tablets in a glass (30 mL) of water. Gently stir it before you drink the medicine. Rinse the glass with the same amount of water and drink it immediately.
• If you have a kidney transplant, you may have to take this medicine for the rest of your life to prevent rejection of the kidney. Do not change your dose or stop taking this medicine without first checking with your doctor.
• If you have a kidney transplant, this medicine will be given together with another medicine called cyclosporine. Take both medicines at the same time.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.If you miss a dose of this medicine and it is less than 6 hours from the time you normally take it, you may still take the dose. If it is more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you use St John's wort, medicine to treat an infection (such as clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, rifabutin, rifampin, rifapentine, telithromycin, voriconazole, Biaxin®, Diflucan®, Ery-Tab®, Ketek®, Mycobutin®, Nizoral®, Priftin®, Rifadin®, Rimactane®, Sporanox®, or Vfend®), or medicine for a heart condition or high blood pressure (such as captopril, diltiazem, enalapril, fosinopril, nicardipine, quinapril, ramipril, verapamil, Accupril®, Calan®, Capoten®, Cardene®, Cardizem®, Isoptin®, Monopril®, or Verelan®).
• Tell your doctor if you also use aprepitant (Emend®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), dexamethasone (Decadron®, DexPak®), midazolam (Versed®), nefazodone (Serzone®), octreotide (Sandostatin®), medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), or medicine for HIV or AIDS (such as amprenavir, atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, Agenerase®, Crixivan®, Fortovase®, Invirase®, Lexiva®, Norvir®, Rescriptor®, Reyataz®, Sustiva®, Viracept®, or Viramune®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine

• You can harm your unborn baby if you use this medicine while you are pregnant. Use an effective form of birth control during treatment and for at least 8 weeks after you stop treatment. Tell your doctor right away if you think you have become pregnant.
• Talk with your doctor before you use this medicine if you are a man and plan to have children. Some men who have used this medicine have become infertile (not able to have children).
• Make sure your doctor knows if you are breastfeeding or if you have kidney problems, liver problems, any type of infection (such as hepatitis B), blood clotting problems, diabetes, high cholesterol, lung or breathing problems, or a history of skin cancer or lymphoma. Tell your doctor if you are lactose intolerant or have Lapp lactase deficiency or glucose-galactose malabsorption.
• This medicine may cause a serious lung problem called noninfectious pneumonitis. Check with your doctor right away if you have chest pain, chills, a cough, a fever, or trouble breathing.
• This medicine may weaken your immune system and you may get infections more easily. Call your doctor right away if you have symptoms of an infection, such as a fever, chills, cloudy urine, or a cough that does not go away.
• Check with your doctor right away if you have swelling, unusual tiredness, or less urine than normal. These may be symptoms of kidney failure.
• This medicine may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain or open sores in your mouth while you are using this medicine.
• This medicine may increase blood sugar levels. Tell your doctor if you have increased hunger or thirst, changes in how much you urinate, or unusual weight loss. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
• This medicine may increase your risk for certain types of cancer, such as lymphoma and skin cancer. If you have any questions about this, check with your doctor.
• If you have a kidney transplant, this medicine may increase your risk for blood clots in the new kidney. This usually occurs within the first 30 days after the transplant. Check with your doctor right away if you have dark-colored urine, a fever, nausea or vomiting, or pain in your groin, lower back, side, or stomach.
• If you are taking this medicine after a kidney transplant, it may increase your risk for a rare and serious infection called BK virus-associated nephropathy (BKVAN). The BK virus can affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have more than one of these symptoms: bloody urine, changes in how much or how often you urinate, lower back or side pain, nausea or vomiting, swelling, trouble breathing, unusual tiredness or weakness, or weight gain.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or trouble breathing
• Decrease in how much or how often you urinate, painful urination, cloudy or bloody urine
• Dry mouth, increased thirst or hunger, muscle cramps, confusion, nausea, vomiting
• Fast, slow, uneven, or pounding heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
• Lightheadedness, dizziness, or fainting
• Lumps in your neck, armpits, or groin
• Numbness or tingling in your hands or feet
• Pain in your lower back or side
• Seizures
• Sores, ulcers, or white patches on your lips, mouth, or throat
• Unexplained weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Acne or a rash
• Diarrhea, loss of appetite, or stomach pain
• Earache or headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine in the original package until you are ready to use it.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.