Safety and Tolerability
AFINITOR® is generally well tolerated when a VEGF**-targeted therapy fails
Only 7% of patients discontinued treatment due to adverse reactions1
- Within each frequency grouping for each category, adverse reactions are presented in order of decreasing seriousness1
- The most frequent Grade 3 /4 adverse reactions (those with incidence >2%) were decreased lymphocytes, increased glucose, decreased hemoglobin, decreased phosphate, increased cholesterol, infections, stomatitis, fatigue and pnuemonitis1
Information from further clinical studies
In clinical studies, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome. Reactivation of infection is an expected event during periods of immunosuppression. Pulmonary embolism has been reported in clinical trials.
Laboratory tests and monitoring
Renal Function
Elevations of serum creatinine, usually mild, have been reported. Monitoring of renal function, including measurement of blood urea nitrogen (BUN) or serum creatinine, is recommended prior to the start of AFINITOR therapy and periodically thereafter.
Blood Glucose and Lipids
Hyperglycaemia, hyperlipidaemia and hypertrigylceridaemia have been reported in clinical trials. The majority of cases of hyperglycaemia occurred in patients who had an abnormal fasting glucose level before taking AFINITOR. Monitoring of fasting serum glucose is recommended prior to the start of AFINITOR therapy and periodically thereafter. When possible, optimal glycaemic control should be achieved before starting a patient on AFINITOR.
Hematologic Parameters
Decreased haemoglobin, lymphocytes, neutrophils and platelets have been reported in clinical trials. Monitoring of complete blood count is recommended prior to the start of AFINITOR therapy and periodically thereafter.
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Important Safety information
Afinitor is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives or to any of the excipients.
Cases of non-infectious pneumonitis have been described; some of these have been severe and occasionally fatal. Management of pneumonitis may require dose adjustment and/or interruption, or discontinuation of treatment and/or addition of corticosteroid therapy.
Afinitor is immunosuppressive. Localized and systemic bacterial, fungal, viral or protozoal infections (e.g., pneumonia, aspergillosis, candidiasis, hepatitis B reactivation) have been described; some of these have been severe and occasionally fatal. Pre-existing infections should be treated prior to starting treatment. Patients and physicians should be vigilant for symptoms and signs of infection; in case of emergent infections, appropriate treatment should be instituted promptly and interruption or discontinuation of Afinitor should be considered. Patients with systemic invasive fungal infections should not receive Afinitor.
Hypersensitivity reactions have been observed.
Mouth ulcers, stomatitis and oral mucositis have been seen. Topical treatments are recommended; alcohol- or peroxide-containing mouthwashes should be avoided.
Monitoring of renal function, blood glucose and complete blood counts is recommended prior to initiation and periodically during treatment. Cases of renal failure, some fatal, have been observed.
Afinitor is not recommended in patients with severe hepatic impairment.
Use of live vaccines should be avoided.
Afinitor is not recommended during pregnancy or for women of childbearing potential not using contraception. Afinitor may cause fetal harm in pregnant women. Women taking Afinitor should not breast feed. Male fertility may be compromised by Afinitor.
Avoid concurrent treatment with strong CYP3A4 and PgP inhibitors and use caution with moderate inhibitors. Avoid concurrent treatment with strong CYP3A4 or PgP inducers.
In advanced RCC, the most common adverse reactions (≥10%) include stomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, infections, peripheral edema, dry skin, epistaxis, pneumonitis, pruritus and dyspnea. Common adverse reactions (≥1 to <10%) include headache, dysgeusia, dry mouth, pyrexia, weight loss, hand-foot syndrome, abdominal pain, erythema, insomnia, dyspepsia, dysphagia, hypertension, increased daytime urination, dehydration, chest pain, renal failure, hemoptysis and exacerbation of diabetes mellitus. Uncommon adverse reactions (<1%) include ageusia, congestive cardiac failure, new-onset diabetes mellitus, impaired wound healing, and grade 1 hemorrhage.
Cases of hepatitis B reactivation and pulmonary embolism have been reported.
Full Summary of Product Characteristics for Afinitor.
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