Afinitor is used to treat late-stage kidney cancer in patients who have already received other medications that did not work well. It is also used to treat subependymal giant cell atrocytoma (SEGA; brain tumors), renal angiomyolipoma (non-cancerous kidney tumor), and late-stage pancreatic neuroendocrine tumors (PNET; a pancreas tumor that spreads to the nervous system).
This medication is used with Exemestane to treat late-stage hormone receptor-positive, HER-2 negative breast cancer in post-menopausal women who have already received other medications that did not work well.
This medication belongs to a group of medications called antineoplastics. It works by interrupting the growth of cancer cells, which are eventually destroyed by the body. Because the growth of normal body cells may also be affected, other unwanted side effects will also occur.
This medication is also used with other medications 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 (WBCs) try to reject the transplanted organ. Everolimus works to suppress the immune system and prevents the WBCs from rejecting the transplanted organ.
Before you begin treatment with this medication, you should talk with your doctor about the risks and benefits of this medication.
This medication is only available with your doctor’s prescription.
This product is available in the following forms:
- Tablet for suspension
- Tablet
Only take Afinitor as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.
This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.
If you have a kidney or liver transplant, you may need to take this medication for the rest of your life to prevent rejection of the organ. Do not change your dose or stop taking this medication without first checking with your doctor.
Take this medication the same way every day. This means take it at the same time, consistently, either with or without food.
Swallow the regular tablet whole with a glass of water. Do not crush, break or chew the tablet. If you accidentally break or crush the tablet, wash your hands with water immediately.
Do not swallow the tablet for suspension. It must be dissolved in water before you take the medication. If you are preparing the oral suspension for another person, wear disposable gloves.
To dissolve the tablet in a small glass:
Measure 25ml of water into a small glass and put the tablet in the water without breaking or crushing it. Wait 3 minutes, then stir the mixture to break up the tablets. Drink the mixture immediately. After you drink the mixture, rinse the glass with another 25mL of water and drink the liquid.
To dissolve the tablet in an oral syringe:
- Use a syringe that measures 10ml. Pull out the plunger and put the tablet in the barrel of the syringe. Replace the plunger and push it in until it touches the tablet.
- Fill a small glass with 30ml (2 tbsp) of water. Place the syringe tip into the water and draw up enough water to cover the tablet and fill half of the syringe.
- Hold the syringe with the tip up and draw in 4mL of air.
- Place the syringe in an empty glass with the tip up and wait 3 minutes.
- Turn the syringe up and push the plunger until most of the air is removed. Slowly turn the syringe up and down 5 times, but do not shake.
- 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 5mL of water from a small glass.
- Hold the tip up and add 4mL of air.
- Swirl the water in the syringe to rinse any extra medication 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. Only use one form of this medication.
Do not eat grapefruit or drink grapefruit juice while taking this medication. Grapefruit and grapefruit juice may cause higher levels of Everolimus in the body, which may result in more unwanted effects.
If you have a kidney transplant, Everolimus will be given with another medication called Cyclosporine. These two medications should be taken at the same time.
If you have a liver transplant, Everolimus will be given with another medication called Tacrolimus. These two medications should be taken at the same time. Everolimus should not be started until at least 30 days after your liver transplant.
Dosing
Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.
The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.
For tablet dosage forms:- For advanced breast cancer:
- Adults - 10 mg once a day. Your doctor may adjust the dose as needed
- Children - Use and dose must be determined by your doctor
- For advanced kidney cancer:
- Adults - 10 mg once a day. Your doctor may adjust the dose as needed
- Children - Use and dose must be determined by your doctor
- For advanced pancreatic neuroendocrine tumors (PNET):
- Adults - 10mg once a day. Your doctor may adjust the dose as needed
- Children - Use and dose must be determined by your doctor
- For angiomyolipomas (kidney tumors):
- Adults - 10mg once a day. Your doctor may adjust the dose as needed
- Children - Use and dose must be determined by your doctor
- For brain tumors (SEGA):
- Adults and children 1 year of age or older - Dose is based on body size and must be determined by your doctor. Start at 4.5 mg per square meter (mg/m(2)) of body size once a day. Your doctor may adjust your dose as needed.
- Children younger than 1 year of age - Use is not recommended
- For kidney transplant rejection:
- Adults - Start at 0.75 mg twice a day, taken 12 hours apart. Your doctor may adjust the dose as needed.
- Children - Use and dose must be determined by your doctor
For tablets for suspension:- For brain tumors (SEGA):
- Adults and children 1 year of age or older - Dose is based on body size and must be determined by your doctor. Start at 4.5 mg per square meter (mg/m(2)) of body size once a day. Your doctor may adjust your dose as needed.
- Children younger than 1 year of age - Use is not recommended
Missed Dose
If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.
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. If more than 6 hours have passed, skip the missed dose and resume your normal dosing schedule.
Storage
Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze.
Keep out of the reach of children. Keep 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 within this time frame, throw it away and prepare another dose.
Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.
It is very important that your doctor checks in with you often while you are receiving Afinitor to make sure that it is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medication while pregnant may harm your unborn child. Use an effective form of birth control while you use this medication and for at least 8 weeks after stopping treatment. If you think you have become pregnant while on this medication, inform your doctor immediately.
If you plan to have children, talk with your doctor before starting this medication. This medication may decrease fertility in men and women.
This medication may cause a serious lung problem called noninfectious pneumonitis. Inform your doctor immediately if you have chest pain, chills, cough, fever, shortness of breath or difficulty breathing.
Inform your doctor immediately if you have more than one of these symptoms while using this medication:
Agitation, confusion, decreased urination, dizziness, headache, irritability, muscle twitching, nausea, rapid weight gain, swelling in the face, ankles or hands, or unusual fatigue or weakness. These may be symptoms of a serious kidney problem.
While being treated with this medication, and after you stop treatment, do not have any vaccinations without your doctor’s approval. Everolimus may lower your body’s resistance and the vaccine may not work as well, or you may get the infection the vaccine is meant to prevent.
You should not be around other people 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 vaccines include measles, mumps, influenza, polio virus, rotavirus and rubella. Do not get close to them and do not stay in the same room with them for very long. Ask your doctor about any questions.
This medication may temporarily lower the number of WBCs in your blood, which increases your risk of infection. It can also lower the number of platelets, which are necessary for proper blood clotting.
If this occurs, there are precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- Avoid people with infections, if you are able to. Tell 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 difficult or painful urination.
- Tell your doctor immediately if you notice unusual bleeding or bruising, black stool, blood in the urine or stool, or red spots on the skin.
- Be careful when using a toothbrush, dental floss or toothpick. Your doctor or dentist can recommend other ways to clean your teeth or gums. Talk with your doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have washed your hands and have not touched anything else in the meantime.
- Take care not to cut yourself when using sharp objects, such as a razor, knife or nail clippers.
- Avoid contact sports or situations where injury and bruising could occur.
This medication may increase your risk of getting skin cancer.
When you begin taking this medication:
- Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if you are able.
- Wear protective clothing, including hat and sunglasses.
- Apply a sunscreen product that has a high SPF of 15 or more.
- Apply sunscreen lipstick that has an SPF of 15 or more.
- Do not use sunlamps, tanning beds or tanning booths.
Zortress may cause a serious allergic reaction called angioedema. This may occur more often when used with certain heart and blood pressure medications called ACE inhibitors (Ex. captopril, enalapril, fosinopril, quinapril, ramipril). Tell your doctor immediately if you have a rash, itching, large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genital area, difficulty breathing or chest tightness while using this medication.
If you have a kidney transplant, this medication may increase your risk for blood clots in the new kidney. This usually occurs within the first 30 days after the transplant. Tell your doctor immediately if you have reduced urination, pain in your groin, lower back, side or stomach, dark-colored urine, nausea or vomiting.
This medication may prevent you from healing properly after an injury. Call your doctor immediately if you have any of these symptoms: blood, fluid, or pus in your incision, your incision opens and it is red, warm, painful or swollen.
If you are taking this medication after a kidney transplant, it may increase your risk of developing rare and serious viral 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.
Tell your doctor immediately if you experience more than one of these symptoms: blood in the urine, decreased urination, increased thirst (polydipsia), loss of appetite, lower back or side pain, nausea, swelling of the face, fingers or lower legs, difficulty breathing, unusual fatigue or weakness, vomiting or weight gain.
Everolimus may cause mouth ulcers and sores in some patients. Tell your doctor immediately if you have pain, discomfort or open sores in your mouth while using this medication. Your doctor may give you a special mouthwash or oral gel to treat the ulcers.
This medication may affect your blood sugar levels. Tell your doctor if you notice a change in your blood or urine sugar tests.
Tell your doctor if you are taking a corticosteroid or other medication that may weaken the immune system. This may increase your risk for developing a serious infection.
Do not take other prescription or over-the-counter medications without asking your doctor.
