NG INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
Non-infectious Pneumonitis
Warn patients of the possibility of developing non-infectious pneumonitis. In clinical studies, some non-infectious pneumonitis cases have been severe and occasionally fatal. Advise patients to report promptly any new or worsening respiratory symptoms [see Warnings and Precautions (5.1)].
Infections
Inform patients that they are more susceptible to infections while being treated with AFINITOR and that cases of hepatitis B reactivation have been associated with AFINITOR treatment. In clinical studies, some of these infections have been severe (e.g., leading to sepsis, respiratory or hepatic failure) and occasionally fatal. Patients should be aware of the signs and symptoms of infection and should report any such signs or symptoms promptly to their physician [see Warnings and Precautions (5.2)].
Angioedema with Concomitant use of Angiotensin-Converting Enzyme (ACE) Inhibitors
Inform patients that they are more susceptible to angioedema if concomitantly taking angiotensin-converting enzyme (ACE) inhibitors. Patients should be aware of any signs or symptoms of angioedema and seek prompt medical attention [see Warnings and Precautions (5.3)].
Oral Ulceration
Inform patients of the possibility of developing mouth ulcers, stomatitis, and oral mucositis. In such cases, mouthwashes and/or topical treatments are recommended, but these should not contain alcohol, peroxide, iodine, or thyme [see Warnings and Precautions (5.4)].
Renal Failure
Inform patients of the possibility of developing kidney failure. In some cases kidney failure has been severe and occasionally fatal. Inform patients of the need for the healthcare provider to monitor kidney function, especially in patients with risk factors that may impair kidney function [see Warnings and Precautions (5.5)].
Impaired Wound Healing
Inform patients of the possibility of impaired wound healing or dehiscence while being treated with AFINITOR [see Warnings and Prec
Laboratory Tests and Monitoring
Inform patients of the need to monitor blood chemistry and hematology prior to the start of AFINITOR therapy and periodically thereafter [see Warnings and Precautions (5.8)].
Drug-drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications and dietary supplements. Inform the patients to avoid concomitant administration of strong CYP3A4/PgP inhibitors or inducers while on AFINITOR treatment [see Dosage and Administration (2.2, 2.5), Warnings and Precautions (5.9), and Drug Interactions (7.1, 7.2)].
Vaccinations
Advise patients to avoid the use of live vaccines and close contact with those who have received live vaccines [see Warnings and Precautions (5.11)].
Embryo-fetal Toxicity
Advise female patients of childbearing potential that AFINITOR may cause fetal harm and that a highly effective method of contraception should be used during therapy with AFINITOR and for up to 8 weeks after ending treatment [see Warnings and Precautions (5.12)].
Safe Handling Practices for AFINITOR DISPERZ
Advise patients and their caregivers to read and carefully follow the FDA approved AFINITOR DISPERZ “Instructions for Use”.
Dosing Instructions
Inform patients to take AFINITOR Tablets ora |
