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Afinitor (everolimus) - Drug Description and Patient Information


Updated April 13, 2009

Definition of Afinitor (everolimus):

Afinitor is an mTOR inhibitor, which blocks a specific protein and inhibits tumor growth. Afinitor is a targeted drug therapy.

Uses of Afinitor:

The primary ingredient in Afinitor is everolimus (also sold as Certican), which has been used as an immunosuppressant to prevent tissue rejection of transplanted hearts or kidneys. Everolimus has also been used as a coating on coronary stents to help prevent blockage of the blood vessel. Afinitor has been approved by the FDA as a treatment for advanced kidney cancer that has stopped responding to other therapies.

Future Uses of Afinitor:

Researchers are testing Afinitor on other diseases, which include breast cancer, neuroendrocrine tumors, lymphoma, gastric, lung and other cancers. It may also prove to be effective on tuberous sclerosis, an inherited disease that causes benign tumors to grow in the brain and other vital organs.

Also Known As:

Afinitor (everolimus), Novartis Afinitor

How Afinitor Works:

Afinitor works by blocking a specific protein called mTOR. mTOR is responsible for the central regulation of many normal cell growth processes. This protein blocking action disrupts the growth, division and metabolism of cancer cells.

Potential Use For Breast Cancer Treatment:

Early clinical trials produced data that shows that the addition of Afinitor to chemotherapy and Herceptin appears to overcome resistance to Herceptin. Women who participated in clinical trials had a diagnosis of HER2-positive metastatic breast cancer. A different clinical trial is just getting started for women with triple-negative metastatic breast cancer, using Afinitor "to act directly on the tumor cells by inhibiting tumor cell growth and proliferation," which would extend survival for these patients.

How Afinitor is Given:

This drug is available as a 5 mg or 10 mg tablet and is taken once daily. You can take this tablet with a full glass of water, being careful not to chew or crush the tablet. Do not take this drug with grapefruit juice. Taking Afinitor on an empty or full stomach will not affect the way the drug works. Take this drug at the same time each day. Afinitor is available by prescription only.

Some Possible Side Effects of Afinitor:

In clinical trials, patients' experience with this drug was varied. You might have some, but not all of these side effects if you're taking Afinitor:
  • Mucositis
  • Diarrhea
  • Nausea
  • Vomiting
  • Fatigue
  • Cough
  • Pneumonitis
  • Skin rash or dry skin
  • Loss of appetite
  • Headache
  • Low resistance to infection
  • Low blood counts

Who Should Not Take Afinitor :

Women should not take this drug if they are pregnant. There has not been enough studies done on Afinitor and fetal health, but scientists think it may cause harm to a fetus. Patients who have liver impairment should inform their doctor before starting Afinitor. Do not take Afinitor if you are allergic to everolimus or other rapamycin derivatives.

Recommendations During Treatment:

Be sure to give your doctor a complete list of all the drugs you are taking, including vitamins and herbs, because Afinitor can interact badly with specific substances. Do not take live vaccinations while on Afinitor. Good examples of live vaccines are flu shots, and shots for measles, mumps, rubella and polio. Do not breastfeed while taking Afinitor, because there is a possibility that it could leach into breast milk. Women and men should use contraception during treatment with Afinitor.

Risks of Taking Afinitor:
This drug can lower your resistance to infections. Your immune system will be low; if you develop an infection, you will need immediate treatment. Mouth ulcers and mucositis occurred in about half of all patients in clinical trials. Afinitor can affect your complete blood count, so be sure not to miss any appointments for blood draws and take appropriate treatments to boost your cell counts. Like some types of chemotherapy, Afinitor can reduce fertility in men and women. After treatment ends, fertility might return at reduced levels.

When to Call Your Doctor:
If you are taking Afinitor and experience these symptoms, call your doctor:

  • Allergic reactions: swollen tounge or throat, difficulty breathing, chest pain, anaphylactic shock
  • Pneumonia: fluid in the lungs, coughing, difficulty breathing
  • High Temperature: a temperature of 100.5 or above
Afinitor, Label and Approval History. Approved for treatment of advanced renal cell carcinoma on March 30, 2009. US FDA/Center for Drug Evaluation and Research.

Trial of RAD001 in Triple Negative Metastatic Breast Cancer. Sponsors and Collaborators: Penn State University and Novartis.

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