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Frequently Asked Questions

AFINITOR Tablets and AFINITOR DISPERZ 

Important Safety Information:

Patients should not take AFINITOR® (everolimus) Tablets or AFINITOR DISPERZ™ (everolimus tablets for oral suspension) if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients.

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Approved Use:

AFINITOR and AFINITOR DISPERZ are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.

Important Safety Information:

Patients should not take AFINITOR® (everolimus) Tablets or AFINITOR DISPERZ™ (everolimus tablets for oral suspension) if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR or AFINITOR DISPERZ if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR or AFINITOR DISPERZ can cause serious side effects that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their health care provider’s instructions. Serious side effects include:

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR or AFINITOR DISPERZ may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR or AFINITOR DISPERZ.

Kidney Failure: Patients taking AFINITOR or AFINITOR DISPERZ may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR or AFINITOR DISPERZ.

Delayed Wound Healing: AFINITOR or AFINITOR DISPERZ can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR or AFINITOR DISPERZ, tell your health care provider about all your medical conditions, including if you:

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR or AFINITOR DISPERZ. If you are not sure about the type of vaccine, ask your health care provider
  • Have other medical conditions
  • Are pregnant or could become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby. If you are able to become pregnant, you should use effective birth control while using AFINITOR or AFINITOR DISPERZ and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR or AFINITOR DISPERZ
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR or AFINITOR DISPERZ with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John’s wort (Hypericum perforatum), medicines that weaken your immune system (your body’s ability to fight infections and other problems), or medicines for:

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR or AFINITOR DISPERZ may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects: Common side effects include mouth ulcers. AFINITOR or AFINITOR DISPERZ can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

  • Infections
  • Nausea and vomiting
  • Diarrhea and constipation
  • Swelling of your hands, arms, legs, and feet
  • Joint pain
  • Cough
  • Skin problems (such as rash, acne, or dry skin)
  • Fever
  • Feeling tired
  • Anxiety,aggression, and other abnormal behaviors
  • Low red blood cells, white blood cells, or platelets
  • Increased blood cholesterol level and certain other blood tests
  • Increased blood sugar levels
  • Decreased blood phosphate level

Other side effects that may occur with AFINITOR:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens 
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR or AFINITOR DISPERZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for AFINITOR, including Patient Information.

The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.

Approved Use:

AFINITOR and AFINITOR DISPERZ are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.

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Q: How will I know if AFINITOR® (everolimus) is shrinking my SEGA tumors?

A: The only way to know if your SEGA tumors are shrinking is to get regular scans of your brain per your doctor's treatment plan. Learn the results of studies of AFINITOR in patients with TSC-related brain tumors (SEGAs).


Q: How many people with TSC-related SEGA have been treated with AFINITOR?

A: AFINITOR has been prescribed to more than 1200 patients with TSC-related SEGA since 2010.

Q: How many medications are available to treat TSC-related brain tumors?
A: AFINITOR is the only FDA-approved medication to treat people with TSC who have brain tumors called SEGA. AFINITOR can be prescribed for SEGAs that cannot be removed completely by surgery (for use in adults and children).

Q: Why are there 2 different ways to take AFINITOR, as tablets and as DISPERZ?
A: AFINITOR DISPERZ is a tablet that dissolves in water. It is available as an option for patients who are not able to swallow pills.

Q: How should I take AFINITOR or AFINITOR DISPERZ? 
A: Your health care provider will prescribe the dose of AFINITOR or AFINITOR DISPERZ that is right for you.
Take AFINITOR or AFINITOR DISPERZ exactly as your health care provider tells you to. See How to Take Treatment for more information.

  • Take AFINITOR or AFINITOR DISPERZ one time each day at about the same time
  • Take AFINITOR or AFINITOR DISPERZ the same way each time, either with food or without food
  • If you take too much AFINITOR or AFINITOR DISPERZ, contact your health care provider or go to the nearest hospital emergency department right away. Take the pack of AFINITOR or AFINITOR DISPERZ with you
  • 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 it. If it is more than 6 hours after you normally take your AFINITOR or AFINITOR DISPERZ, skip the dose for that day. The next day, take AFINITOR or AFINITOR DISPERZ at your usual time. Do not take 2 doses to make up for a missed dose. If you are not sure about what to do, call your health care provider

 

AFINITOR tablets:

  • Swallow AFINITOR tablets whole with a glass of water. Do not take any tablet that is broken or crushed

 

AFINITOR DISPERZ:

  • If your health care provider prescribes AFINITOR DISPERZ for you, see the “Instructions for Use” that come with your medicine for instructions on how to prepare and take your dose. You can also watch a video on how to prepare AFINITOR DISPERZ 
  • Each dose of AFINITOR DISPERZ must be prepared as a suspension before it is given
  • AFINITOR DISPERZ can cause harm to an unborn baby. When possible, the suspension should be prepared by an adult who is not pregnant or planning to become pregnant
  • Wear gloves to avoid possible contact with everolimus when preparing suspensions of AFINITOR DISPERZ for another person

 

Q: What are other important things I should know while taking AFINITOR?

A: You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR or AFINITOR DISPERZ. It may make the amount of AFINITOR in your blood increase to a harmful level. Avoid the use of live vaccinations and contact with individuals who have received live vaccinations. If you are not sure about the type of vaccine, ask your health care professional. Click here for additional information on what to avoid.

Q: How does AFINITOR work?

A: Tuberous sclerosis cells typically have changes in their TSC1 or TSC2 genes that make them different from normal cells. These gene changes might cause the cell to make too much of a protein called mammalian target of rapamycin (mTOR). This, in turn, might make the cell grow and divide too quickly, causing a tumor to form. AFINITOR targets mTOR, blocking its effects and thereby reducing the growth of tumor cells. The blocking of mTOR by AFINITOR has been shown to slow the increase in the number of tumor cells and decrease the creation of new blood vessels within the tumor. This was based on data obtained in a laboratory environment as well as studies in living cells.

Important Safety Information

Patients should not take AFINITOR® (everolimus) Tablets or AFINITOR DISPERZ™ (everolimus tablets for oral suspension) if they are allergic to AFINITOR or AFINITOR DISPERZ or to any of its ingredients. Patients should tell their health care provider before taking AFINITOR or AFINITOR DISPERZ if they are allergic to sirolimus (Rapamune®) or temsirolimus (Torisel®).

AFINITOR or AFINITOR DISPERZ can cause serious side effects that can even lead to death. If patients experience these side effects, they may need to stop taking AFINITOR or AFINITOR DISPERZ for a while or use a lower dose. Patients should follow their health care provider’s instructions. Serious side effects include:

Lung or Breathing Problems: In some patients, lung or breathing problems may be severe and can even lead to death. Patients should tell their health care provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR or AFINITOR DISPERZ may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their health care provider right away if they have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, chills, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.

Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your health care provider before taking AFINITOR or AFINITOR DISPERZ if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR or AFINITOR DISPERZ.

Kidney Failure: Patients taking AFINITOR or AFINITOR DISPERZ may develop kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with AFINITOR or AFINITOR DISPERZ.

Delayed Wound Healing: AFINITOR or AFINITOR DISPERZ can cause incisions to heal slowly or not heal well. Call your health care provider right away if your incision is red, warm, or painful; if you have blood, fluid, or pus in your incision; if your incision opens up; or if your incision swells.

Before taking AFINITOR or AFINITOR DISPERZ, tell your health care provider about all your medical conditions, including if you:

  • Have or have had kidney problems
  • Have or have had liver problems
  • Have diabetes or high blood sugar
  • Have high blood cholesterol levels
  • Have any infections
  • Previously had hepatitis B
  • Are scheduled to receive any vaccinations. You should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with AFINITOR or AFINITOR DISPERZ. If you are not sure about the type of vaccine, ask your health care provider
  • Have other medical conditions
  • Are pregnant or could become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby. If you are able to become pregnant, you should use effective birth control while using AFINITOR or AFINITOR DISPERZ and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR or AFINITOR DISPERZ
  • Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose

Tell your health care provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using AFINITOR or AFINITOR DISPERZ with certain other medicines can cause serious side effects. Keep a list of medicines you take and show it to your health care provider when you get a new medicine. Especially tell your health care provider if you take St John’s wort (Hypericum perforatum), medicines that weaken your immune system (your body’s ability to fight infections and other problems), or medicines for:

  • Fungal infections
  • Bacterial infections
  • Tuberculosis
  • Seizures
  • HIV-AIDS
  • Heart conditions or high blood pressure

If you are taking any medicines for the conditions listed above, your health care provider might need to prescribe a different medicine or your dose of AFINITOR or AFINITOR DISPERZ may need to be changed. Tell your health care provider before you start taking any new medicine.

Common Side Effects: Common side effects include mouth ulcers. AFINITOR or AFINITOR DISPERZ can cause mouth ulcers and sores. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

  • Infections
  • Nausea and vomiting
  • Diarrhea and constipation
  • Swelling of your hands, arms, legs, and feet
  • Joint pain
  • Cough
  • Skin problems (such as rash, acne, or dry skin)
  • Fever
  • Feeling tired
  • Anxiety,aggression, and other abnormal behaviors
  • Low red blood cells, white blood cells, or platelets
  • Increased blood cholesterol level and certain other blood tests
  • Increased blood sugar levels
  • Decreased blood phosphate level

Other side effects that may occur with AFINITOR:

  • Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
  • AFINITOR may affect fertility in females and males, and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your health care provider if this is a concern for you

Tell your health care provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of AFINITOR or AFINITOR DISPERZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for AFINITOR, including Patient Information.

The brands listed are the trademarks or register marks of their respective owners and are not trademarks or register marks of Novartis.

Approved Use

AFINITOR and AFINITOR DISPERZ are prescription medicines used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.