ANTICANCER PRODUCTS

AFINITOR® (everolimus) Tablets is a prescription medicine used to treat advancedhormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC), along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.

 

Approved Uses:

Advanced Breast Cancer

AFINITOR® (everolimus) Tablets is a prescription medicine used to treat advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC), along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer.

Advanced Kidney Cancer

AFINITOR is a prescription medicine used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked.

Advanced Pancreatic Neuroendocrine Tumor

AFINITOR is a prescription medicine used to treat adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery.

AFINITOR is not for use in people with carcinoid tumors that actively produce hormones.

Advanced GI/Lung NET

AFINITOR is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal) or lung that has progressed and cannot be treated with surgery.

AFINITOR is not for use in people with carcinoid tumors that actively produce hormones.

Renal Angiomyolipoma With Tuberous Sclerosis Complex

AFINITOR is a prescription medicine used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away.

SEGA With Tuberous Sclerosis Complex

AFINITOR and AFINITOR DISPERZ (everolimus tablets for oral suspension) 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 or AFINITOR DISPERZ 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, have 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, could become pregnant, or have a partner who could become pregnant. AFINITOR or AFINITOR DISPERZ can cause harm to your unborn baby. If you are a woman who is able to become pregnant, you should use effective birth control while using AFINITOR or AFINITOR DISPERZ and for 8 weeks after your last dose. If you are a male with a woman partner, you should use effective birth control during treatment and for 4 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
  • Are about to have surgery, if you have had recent surgery, or if you have an unhealed wound

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. When you start treatment with AFINITOR, your health care provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your health care provider’s instructions on how to use this prescription mouthwash. Tell your health care provider if you have pain, discomfort, or open sores in your mouth. Your health care provider may tell you to re-start this mouthwash or to use a special mouthwash or gel that does not contain alcohol, hydrogen peroxide, iodine, or thyme.

Other common side effects include:

  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath
  • Diarrhea and constipation
  • Skin problems (such as rash, acne, dry skin, or itching)
  • Nausea and vomiting


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