AFINITOR Side Effect Management

What are the common side effects patients may experience while taking AFINITOR^® (everolimus) tablets?

• Mouth sores or ulcers (stomatitis)
• Stomach upsets, like nausea, vomiting and diarrhea
• Loss of appetite
• Fatigue; feeling weak or tired
• Rash
• Dry skin
• Cough
• Infections

What can be done if patients experience stomatitis while taking AFINITOR?

Stomatitis is an oral complication of cancer treatment (chemotherapy and targeted biological therapy) which may lead to inflammation of the mucous lining of the mouth and may involve mouth ulcers. In the RECORD-1 trial experience, stomatitis included adverse reactions identified as aphthous stomatitis, mouth ulceration and tongue ulceration. Early intervention may help avoid dose alteration or interruption.

What can be done if patients experience noninfectious pneumonitis while taking AFINITOR?

Noninfectious pneumonitis, a class effect of rapamycin derivatives including AFINITOR, was reported in 12% of AFINITOR treated patients in the RECORD-1 trial experience. The majority of the cases were medically manageable and reversible with dose adjustment or interruption and in some cases, the addition of corticosteroids. A fatal outcome was observed on rare occasions.

Patients should be advised to promptly report any new or worsening respiratory symptoms such as fever, cough, difficulty breathing or shortness of breath. AFINITOR treatment may need to be stopped until symptoms improve. AFINITOR treatment may be restarted, perhaps with a lower dose, once symptoms improve.

What can be done if patients experience infections while taking AFINITOR?

AFINITOR has immunosuppressive properties and may predispose patients to infections, especially infections with opportunistic pathogens. In the RECORD-1 trial experience infections include adverse reactions identified as local and systemic infections such as pneumonia, other bacterial infections and invasive fungal infections (e.g., aspergillosis, candidiasis, sepsis). Some of these infections have been severe (e.g. leading to failure) and occasionally have had a fatal outcome.

• AFINITOR should not be given to patients with
• Invasive fungal disease
• Intercurrent infection
• Physicians should inform patients to be aware of increased risk of infection with AFINITOR and to report symptoms and signs of infection immediately
• If infection is suspected, it should be treated promptly with a normal course of therapy
• Pre-existing infections should be treated appropriately and have resolved fully before starting treatment with AFINITOR
• If a diagnosis of systemic fungal infection is made, AFINITOR should be promptly discontinued and the patient treated with appropriate antifungal therapy

What can you recommend your patients do to help manage potential side effects?

• Avoid large crowds and people who are ill
• Wash hands often, especially after being in public places
• Do not take any live vaccinations or come in close contact with people who have had a live vaccine recently, including vaccines for measles, mumps, rubella, oral polio, BCG, typhoid and intranasal influenza
• Keep the mouth clean using a soft toothbrush at least three times each day. If they can't brush after meals, they should rinse their mouth with water
• Consider using a special mouth rinse or other product to prevent or treat mouth sores. (Note: Many mouthwashes contain peroxide or alcohol that can make mouth sores worse. Patients should check with a doctor about which products to use.)
• If nausea is a problem for your patient, consider recommending a medication that helps with nausea or vomiting
• Try to avoid strong odors
• Eat small meals and healthy snacks often during the day
• Plan rest periods during the day, and try to sleep eight hours every night
• Use creams and moisturizers for dry skin
• Avoid heavy makeup, perfumes, dyes, or other chemicals that may cause itching

Learn more about dosing & administration. Ease your patients' transition after initial VEGF^**-targeted therapy — keep them on a daily oral therapy.

Find out more about setting patient expectations. Find tips and information to help optimize patient starts, compliance and persistency.

In order to help set patient expectations, learn more about how to start your patients on AFINITOR.

Next: Patient Support Tools

^**VEGF: vascular endothelial growth factor