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Afinitor Disperz is the brand name for everolimus and is available as tablet for oral suspension.

Afinitor Disperz is available as a 2 mg, 3 mg, and 5 mg tablet for oral suspension.

Afinitor Disperz is a kinase inhibitor that is used to treat:

• Breast cancer (hormone receptor-positive, HER2-negative)
  Neuroendocrine tumors (NET)
• Kidney cancer (renal cell cancer or RCC)
• Tuberous sclerosis complex (TSC)-associated kidney tumor
• Tuberous sclerosis complex (TSC)-associated brain tumor (people age 1 years and older)
• Tuberous sclerosis complex (TSC)-associated seizures (people age 2 years and older)

Afinitor Disperz is kinase inhibitor. It blocks a specific type of protein that’s involved in cell growth and spread. This protein can be more active in cancer cells, leading to tumor growth. When it blocks this protein, cancer cells can’t grow and spread as well.

Afinitor Disperz is dosed as follows:

• Breast cancer, neuroendocrine tumors, kidney cancer, or TSC-associated kidney tumor
• Afinitor and generic everolimus tablet only: The typical dose is 10 mg by mouth once daily

TSC-associated brain tumor

• Afinitor, Afinitor Disperz, and generic everolimus tablet: Your provider will determine your dose base on your body surface area (BSA, in units of m2), which takes into account your body weight and height. The typical starting dose is 4.5 mg/m2 by mouth once daily

TSC-associated seizures

• Afinitor Disperz only: Your provider will determine your dose base on your body surface area (BSA, in units of m2), which takes into account your body weight and height. The typical starting dose is 5 mg/m2 by mouth once daily

Afinitor Disperz is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if you have a clinically significant hypersensitivity to everolimus or to other rapamycin derivatives.

Common side effects of Afinitor Disperz:

• Abnormal blood cell counts
• Higher cholesterol and lipid levels
• Mouth ulcers or inflammation
• Higher blood sugar levels
• Abnormal liver labs
• Rash
• Diarrhea
• Abnormal kidney lab values
• Infections
• Extreme tiredness
• Fluid buildup in the arms or legs
• Stomach pain
• Nausea
• Fever
• Appetite loss
• Headache
• Cough
• Weight loss

Serious side effects are rare with Afinitor Disperz. Contact your healthcare provider immediately if you experience any of the following.

• Serious infections: repeated fevers, chills, cough, trouble breathing, severe diarrhea, vomiting, painful or frequent urination
• Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, throwing up blood, bloody or black and tarry stool
• Lung problems: new or worsening cough, chest pain, difficulty breathing
• Serious allergic reactions: throat tightness, trouble breathing, flushing, swelling, chest pain
  Angioedema: Swelling of the face, lips, throat

The following medications may interact with Afinitor Disperz:

• P-gp and strong CYP3A4 inhibitors: Avoid concomitant use
• P-gp and moderate CYP3A4 inhibitors: Reduce the dose as recommended
• P-gp and strong CYP3A4 inducers: Increase the dose as recommended

Novartis Pharmaceuticals

AFINITOR or Afinitor Disperz can cause harm to your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will give you a pregnancy test before you start treatment with AFINITOR or Afinitor Disperz
• You should use effective birth control during treatment and for 8 weeks after your last dose of AFINITOR or Afinitor Disperz
• Males with a female partner, you should use effective birth control during treatment and for 4 weeks after your last dose of AFINITOR or Afinitor Disperz.
• Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away

• Everolimus