Afinitor Side Effect Management

What are the common side effects while taking Afinitor®?

  • Mouth ulcers
  • Infections
  • Feeling weak or tired
  • Cough, shortness of breath, and lung or breathing problems
  • Diarrhea
  • Rash, dry skin, and itching
  • Nausea and vomiting
  • Fever
  • Loss of appetite
  • Swelling of arms, hands, feet, ankles, face, or other parts of the body
  • Abnormal taste
  • Inflammation of lining of the digestive system
  • Headache
  • Nose bleeds
  • Pain in arms and legs

What if patients experience lung or breathing problems (pneumonitis), or infections?

If your patients experience new or worsening lung/breathing symptoms like cough, difficulty breathing, or wheezing, tell them to notify you right away. You might need to stop Afinitor treatment until symptoms improve and may restart treatment, perhaps with a lower dose, once symptoms improve. You might also add other medicine to help with this side effect.

Afinitor can make your patients more likely to get an infection (like pneumonia or a bacterial or fungal infection). In some patients infections have been severe and even fatal. Encourage your patients to tell you right away if they have a temperature, chills, or other signs of an infection. Your patients might need treatment for the infection, and the dose of their Afinitor may be changed or stopped for a short while.

In what event should patients notify the doctor immediately?

Patients should contact their doctor immediately if they experience new or worsening cough, shortness of breath, difficulty breathing or wheezing, have a fever of 100.5 or above, chills, or do not feel well.

Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

Important Safety Information

Afinitor is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.

Non-infectious pneumonitis is a class effect of rapamycin derivatives, including Afinitor. Fatal outcomes have been observed. If symptoms are moderate or severe, patients should be managed with dose interruption until symptoms improve or discontinuation, respectively. Corticosteroids may be indicated. Afinitor may be reintroduced at 5 mg daily depending on the individual clinical circumstances.

Afinitor has immunosuppressive properties and may predispose patients to infections. Localized and systemic infections (bacterial and invasive fungal infections) have occurred. Some of these infections have been severe or fatal. Complete treatment of pre-existing invasive fungal infections prior to starting treatment. If a diagnosis of invasive systemic fungal infection is made, discontinue Afinitor and treat with appropriate antifungal therapy.

Oral ulcerations have occurred in patients treated with Afinitor. In such cases, topical treatments are recommended, but alcohol- or peroxide-containing mouthwashes should be avoided. Antifungal agents should not be used unless fungal infection has been diagnosed.

Elevations of serum creatinine, glucose, lipids, and triglycerides and reductions of hemoglobin, lymphocytes, neutrophils and platelets have been reported in clinical trials. Renal function, hematological parameters, blood glucose, and lipids should be evaluated prior to treatment and periodically thereafter. When possible, optimal glucose and lipid control should be achieved before starting a patient on Afinitor.

Co-administration with strong or moderate inhibitors of CYP3A4 or PgP should be avoided. Increase in the Afinitor dose is recommended when co-administered with a strong CYP3A4 inducer.

Afinitor should not be used in patients with severe hepatic impairment.

The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with Afinitor.

Fetal harm can occur if Afinitor is administered to a pregnant woman.

The most common adverse reactions (incidence ≥30%) were stomatitis (44%), infections (37%), asthenia (33%), fatigue (31%), cough (30%), and diarrhea (30%). The most common grade 3/4 adverse reactions (incidence ≥3%) were infections (9%), dyspnea (8%), fatigue (5%), stomatitis (4%), dehydration (4%), pneumonitis (4%), abdominal pain (3%), and asthenia (3%). The most common laboratory abnormalities (incidence ≥50%) were anemia (92%), hypercholesterolemia (77%), hypertriglyceridemia (73%), hyperglycemia (57%), lymphopenia (51%), and increased creatinine (50%). The most common grade 3/4 laboratory abnormalities (incidence ≥3%) were lymphopenia (18%), hyperglycemia (16%), anemia (13%), hypophosphatemia (6%), and hypercholesterolemia (4%). Deaths due to acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were observed on the Afinitor arm.

Full Prescribing Information about Afinitor.

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References
  • Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009.