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Afinitor (Oral)

Pronunciation

Generic Name: everolimus (Oral route)

e-ver-OH-li-mus

Oral route(Tablet)

Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Immunosuppression increases susceptibility to infection and risk of malignancies, such as lymphoma and skin cancer. Increased risk of kidney arterial and venous thrombosis resulting in graft loss was reported within the first 30 days posttransplantation. To avoid nephrotoxicity, reduce doses of cyclosporine when used in combination with everolimus and monitor cyclosporine and everolimus whole blood trough concentrations. Do not use in heart transplantation; serious infections and increased mortality within the first 3 months posttransplant was observed .

Commonly used brand name(s)

In the U.S.

  • Afinitor
  • Afinitor Disperz
  • Zortress

Available Dosage Forms:

  • Tablet for Suspension
  • Tablet

Therapeutic Class: Antineoplastic Agent

Uses For Afinitor

Everolimus is used to treat advanced (late-stage) cancers or noncancerous tumors, such as kidney and breast cancer, subependymal giant cell astrocytoma (SEGA, a brain tumor), renal angiomyolipoma (kidney tumor), tuberous sclerosis complex, and neuroendocrine tumors of the pancreas, intestines, and lungs. It is used for patients who have already received other medicines that did not work well or those who will not be treated with surgery.

Everolimus works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. It belongs to the group of medicines known as antineoplastics (cancer medicines).

Everolimus is also used together with other medicines to lower the body's natural immunity in patients who receive kidney or liver transplants. When a patient receives an organ transplant, the body's white blood cells try to get rid of (reject) the transplanted organ. Everolimus works to suppress the immune system and prevents the white blood cells from getting rid of the transplanted organ.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, everolimus is used in certain patients with the following medical conditions:

  • Hodgkin lymphoma, relapsed or refractory, in patients who had failed or were not eligible for autologous hematopoietic stem cell transplant or had treatment with a gemcitabine-, vinorelbine-, or vinblastine-containing regimen but did not work well.
  • Waldenstrom's macroglobulinemia (rare type of slow growing non-Hodgkin lymphoma).

Before Using Afinitor

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of everolimus when used for SEGA brain tumors in children. However, use is not recommended in children younger than 1 year.

Appropriate studies have not been performed on the relationship of age to the effects of everolimus when used for kidney cancer, neuroendocrine tumors, and kidney or liver transplants in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of everolimus in the elderly. However, elderly patients are more likely to have unwanted side effects, which may require caution and an adjustment in the dose for patients receiving everolimus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Benazepril
  • Boceprevir
  • Captopril
  • Carbamazepine
  • Ceritinib
  • Cholera Vaccine, Live
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Dronedarone
  • Eliglustat
  • Enalapril
  • Enalaprilat
  • Enzalutamide
  • Fosinopril
  • Fosphenytoin
  • Idelalisib
  • Indinavir
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Lisinopril
  • Lopinavir
  • Lumacaftor
  • Measles Virus Vaccine, Live
  • Mitotane
  • Moexipril
  • Mumps Virus Vaccine, Live
  • Nefazodone
  • Nelfinavir
  • Perindopril
  • Phenytoin
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Quinapril
  • Ramipril
  • Rifampin
  • Ritonavir
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Saquinavir
  • Smallpox Vaccine
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Trandolapril
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Venetoclax
  • Verapamil
  • Voriconazole
  • Yellow Fever Vaccine
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clotting problems or
  • Diabetes or
  • Hepatitis B infection, history of or
  • Hyperglycemia (high sugar in the blood) or
  • Hyperlipidemia (high cholesterol in the blood) or
  • Hypertriglyceridemia (high fat in the blood) or
  • Hypoxia (low oxygen in the blood) or
  • Infection (eg, bacteria, fungus, virus) or
  • Lung or breathing problems or
  • Lymphoma (cancer of the lymph glands) or
  • Proteinuria (protein in the urine) or
  • Skin cancer—Use with caution. May make these conditions worse.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of everolimus

This section provides information on the proper use of a number of products that contain everolimus. It may not be specific to Afinitor. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you have a kidney or liver transplant, you might have to take this medicine for the rest of your life to prevent rejection of the organ. Do not change your dose or stop taking this medicine without checking first with your doctor.

This medicine comes with a patient information leaflet. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, talk to your doctor.

Take this medicine the same way every day. Take it at the same time and take it consistently either with or without food.

Swallow the regular tablet whole with a glass of water. Do not crush, break, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.

Do not swallow the tablet for suspension. It must be dissolved in water before you take the medicine. If you are preparing the oral suspension for another person, wear disposable gloves.

  • To dissolve the tablet for suspension in a small glass:
    • Use a medicine cup to measure 25 milliliters (mL) of water. Pour the water into a small glass and put the tablet in the water without breaking or crushing it. Wait 3 minutes then gently stir the mixture to break up the tablets. Drink the mixture right away. After drinking, rinse the glass with the same amount of water and drink the liquid.
  • To dissolve the tablet for suspension in an oral syringe:
    • Use a syringe that measures 10 milliliters (mL). Pull out the plunger and put the tablet in the barrel of the syringe. Replace the plunger and push it until it touches the tablet. Fill a small glass with 30 mL (2 tablespoons) of water. Place the syringe tip in the water and draw up enough water to cover the tablet and to fill half of the syringe. Hold the syringe with the tip up and draw in 4 mL of air. Place the syringe in an empty glass with the tip up and wait 3 minutes. Slowly turn the syringe up and down 5 times but do not shake it. Hold the syringe with the tip up and push the plunger to remove most of the air. Place the syringe in the mouth and slowly give the dose. Fill the syringe with 5 mL of water from the small glass. Hold the tip up and add 4 mL of air. Swirl the water in the syringe to rinse any extra medicine from the sides. Hold the syringe with the tip up and push the plunger to remove most of the air. Place the syringe in the mouth and slowly give the liquid. Use a new syringe for each dose.

Do not use the regular tablet and the tablet for suspension together. Use only one dosage form of this medicine.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit and grapefruit juice may cause higher levels of everolimus in the body. This could result in more unwanted effects.

If you have a kidney transplant, everolimus will be given together with another medicine called cyclosporine. Take both medicines at the same time.

If you have a liver transplant, everolimus will be given together with another medicine called tacrolimus. Take both medicines at the same time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For advanced breast cancer:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For advanced kidney cancer:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For advanced neuroendocrine tumors:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For angiomyolipomas:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For brain tumors (SEGA):
      • Adults and children 1 year and older—Dose is based on body size and must be determined by your doctor. The starting dose is 4.5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose if needed.
      • Children younger than 1 year—Use is not recommended.
    • For kidney transplant rejection:
      • Adults—At first, 0.75 milligram (mg) two times per day, taken 12 hours apart. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For liver transplant rejection:
      • Adults—At first, 1 milligram (mg) two times per day, taken 12 hours apart. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets for suspension):
    • For brain tumors (SEGA):
      • Adults and children 1 year and older—Dose is based on body size and must be determined by your doctor. The starting dose is 4.5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose if needed.
      • Children younger than 1 year—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Afinitor® or Afinitor® Disperz, you may still take it up to 6 hours after the time you normally take the dose. But if more than 6 hours have passed, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the original package until you are ready to use it. The oral suspension must be used within 60 minutes after mixing. If it is not used during this time, throw it away and prepare another dose.

Precautions While Using Afinitor

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are using this medicine and for at least 8 weeks after stopping treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you are planning to have children, talk with your doctor before using this medicine. This medicine may decrease fertility in men and women.

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, shortness of breath, or trouble breathing.

Check with your doctor right away if you have agitation, confusion, decreased urine amount, dizziness, headache, irritability, muscle twitching, nausea, rapid weight gain, swelling of the face, ankles, or hands, or unusual tiredness or weakness. These may be symptoms of a serious kidney problem.

While you are being treated with everolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Everolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live virus vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Everolimus can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk for getting skin cancer. When you begin taking this medicine:

  • Stay out of direct sunlight, especially between the hours of 10:00 AM and 3:00 PM, if possible.
  • Wear protective clothing, including a hat and sunglasses.
  • Apply a sunblock product that has a sun protection factor (SPF) of at least 15, or higher if you have a fair complexion.
  • Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
  • Do not use sunlamps, tanning beds, or tanning booths.
  • If you have any questions about this, check with your doctor.

Everolimus may cause a serious type of allergic reaction called angioedema. This may occur more often when it is used with certain heart and blood pressure medicines called ACE inhibitors (eg, captopril [Capoten®], enalapril [Vasotec®], fosinopril [Monopril®], quinapril [Accupril®], ramipril [Altace®]). Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness while you are using this medicine.

If you have a kidney transplant, this medicine may increase your risk for having a blood clot in the new kidney. This usually occurs within the first 30 days after the kidney transplant. Check with your doctor right away if you are making less urine, or if you have pain in your groin, lower back, side, or stomach, dark-colored urine, a fever, or nausea or vomiting.

This medicine may also prevent you from healing correctly after an injury. Call your doctor right away if you have blood, fluid, or pus in your incision, your incision opens up, or it is red, warm, painful, or swollen.

If you are taking this medicine after a kidney transplant, it may increase your risk for developing rare and serious virus infections, such as polyoma virus-associated nephropathy (PVAN), progressive multiple leukoencephalopathy (PML), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

Everolimus may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain, discomfort, or open sores in your mouth while you are using this medicine. You may use a special mouthwash or mouth gel to treat these ulcers. Ask your doctor what type of products to use.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor if you notice a change in your blood or urine sugar tests.

Tell your doctor if you are taking a corticosteroid or another medicine that may weaken your immune system. This may increase your risk for developing a serious infection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's Wort) or vitamin supplements.

Afinitor Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • chest pain or tightness
  • cough or hoarseness
  • decreased weight
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • fever or chills
  • general feeling of discomfort or illness
  • lower back or side pain
  • painful or difficult urination
  • rapid weight gain
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • tingling of the hands or feet
Less common
  • Bleeding gums
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing up blood
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst or urination
  • irregular breathing
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • nosebleeds
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow heartbeat
  • stomachache
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Agitation
  • confusion
  • depression
  • dizziness
  • hostility or irritability
  • lethargy
  • muscle twitching
  • seizures
  • stupor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • change in taste
  • dry skin
  • itching skin or rash
  • lack or loss of strength
  • loss of taste
  • pain in the arms or legs
  • unable to sleep
Less common
  • Back pain
  • blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
  • bumps on the skin
  • burning, dry, or itching eyes
  • discoloration of the fingernails or toenails
  • flushing or redness of the skin
  • full feeling
  • jaw pain
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • passing gas
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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