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Afinitor (everolimus) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with advanced renal cell carcinoma (RCC) after treatment with sunitinib or sorafenib did not work.

How Afinitor Works and How It’s Taken

Afinitor is a type of medicine called a kinase inhibitor. It works by blocking mechanistic target of rapamycin (mTOR), a protein involved in cell growth and blood vessel formation. In advanced renal cell carcinoma, this helps reduce abnormal cell growth and the blood supply tumors need.

Doctors use Afinitor as a kidney cancer treatment for adults with advanced renal cell carcinoma after treatment with sunitinib or sorafenib has not worked.

Afinitor is given as a tablet taken by mouth, usually once a day at the same time each day. It should be taken the same way each time, either with food or without food.

Typical Dosing for Kidney Cancer

The recommended dose of Afinitor for kidney cancer is 10 milligrams by mouth once daily until the disease gets worse or side effects become unacceptable. Doctors may lower the dose, pause treatment, or stop treatment because of side effects.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

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Afinitor Side Effects

In clinical trials of adults taking Afinitor for advanced renal cell carcinoma (kidney cancer) after failure of treatment with sunitinib or sorafenib, the most common side effects occurred in 10 percent to 44 percent of people. These include:

  • Mouth sores or mouth ulcers (stomatitis)
  • Infections
  • Rash
  • Asthenia (weakness or low energy)
  • Tiredness (fatigue)
  • Cough
  • Diarrhea
  • Edema (swelling)
  • Headache
  • Low appetite
  • Nausea
  • Fever
  • Vomiting
  • Mucosal inflammation
  • Dyspnea (shortness of breath)
  • Epistaxis (nosebleed)
  • Pneumonitis (lung inflammation)
  • Pruritus (itching)
  • Dry skin
  • Dysgeusia (changes in taste)
  • Pain in extremity

Serious Side Effects and Warnings

Afinitor can cause serious side effects that require immediate medical attention. These include:

  • Noninfectious pneumonitis — Lung inflammation that is not caused by an infection can cause cough or trouble breathing.
  • Serious infections — These can include bacterial, fungal, viral, or protozoal infections.
  • Severe hypersensitivity reactions — Allergic reactions, including anaphylaxis, can cause trouble breathing, chest pain, flushing, or swelling.
  • Angioedema — Swelling under the skin, including swelling of the tongue, mouth, or throat, can affect breathing.
  • Stomatitis — This can include mouth ulcers and oral mucositis.
  • Renal failure — Sudden or worsening kidney problems can be life-threatening.
  • Impaired wound healing — Cuts or surgical wounds may heal more slowly or poorly.
  • Metabolic disorders — These can include high blood sugar, high cholesterol, or high triglycerides.
  • Myelosuppression — Low blood cell counts can raise the risk of infection, bleeding, or severe fatigue.
  • Increased risk of infection or reduced immune response with live vaccines — Live vaccines may increase infection risk or may not work as well during treatment.
  • Radiation sensitization or radiation recall — Severe skin or organ reactions can occur during or after radiation therapy.
  • Embryo-fetal toxicity — Afinitor may harm your baby if you are pregnant.

Get medical help right away if you think you are having a serious reaction.

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How To Save on Afinitor

Novartis, the manufacturer of Afinitor, offers the Novartis Oncology Universal Co-Pay Program. Eligible people with private insurance may pay as little as $0 per month.

Novartis Patient Support also offers insurance assistance, including benefits investigations and help with prior authorizations and appeals, as well as live one-on-one educational support from Patient Navigators. To learn more, visit the Novartis Oncology Universal Co-Pay Program or call 877-577-7756.

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What To Know Before Taking Afinitor

Before starting Afinitor, your doctor will test or check your kidney and liver function, fasting blood sugar, cholesterol and triglycerides, and complete blood count (CBC).

Avoid live vaccines and close contact with anyone who has recently received a live vaccine.

Tell your doctor if you have any allergies to everolimus or any ingredients in Afinitor. Do not take Afinitor if you have had a clinically significant allergic reaction to everolimus or to other rapamycin derivatives.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Also tell your doctor if you have or have had an infection, kidney or liver problems, diabetes, or hepatitis B.

Afinitor is also FDA-approved to treat certain types of breast cancer, certain neuroendocrine tumors, and certain conditions linked to tuberous sclerosis complex.

If you miss a dose, you can take it up to six hours after your usual time. If it is more than six hours late, skip that dose. Take your next dose at the regular time.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Afinitor, talk with your doctor about the risks and benefits. Afinitor can harm your baby if you are pregnant. Your doctor should check your pregnancy status before treatment.

Females who can become pregnant should use effective birth control during treatment and for eight weeks after the last dose. Males with female partners who can become pregnant should use effective birth control during treatment and for four weeks after the last dose.

Do not breastfeed during treatment and for two weeks after the last dose.

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Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Afinitor?

In a study of adults with advanced renal cell carcinoma after treatment with sunitinib or sorafenib failed, people taking Afinitor lived a median of 4.9 months without their cancer getting worse, compared with 1.9 months for people taking placebo (an inactive treatment). The study included 277 people who took Afinitor and 139 people who took placebo. In the final overall survival analysis, there was no statistically significant difference between the two groups.

Should I take Afinitor for kidney cancer if I have an infection?

Afinitor can increase the risk of infections because it affects the immune system. Serious bacterial, fungal, viral, and other infections can happen during treatment. Before starting Afinitor, invasive fungal infections should be completely treated.

During treatment, your doctor should monitor you for signs and symptoms of infection. Depending on how serious the infection is, Afinitor treatment may need to be paused or permanently stopped.

What tests or monitoring are needed with Afinitor for kidney cancer?

Your doctor should check your kidney function before you start treatment and at least once a year after that. If you have extra risk factors for kidney problems, kidney function should be checked at least every six months. Blood sugar, cholesterol, and triglycerides should be checked before treatment and at least once a year during treatment.

A complete blood count (CBC) should be checked before treatment, every six months during the first year, and then once a year after that.

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