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AFINITOR- everolimus tabletAFINITOR DISPERZ- everolimus tablet, for suspension


Patient Information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Non-infectious Pneumonitis

Advise patients of the risk of developing non-infectious pneumonitis and to immediately report any new or worsening respiratory symptoms to their healthcare provider[see Warnings and Precautions (5.1)].

Infections

Advise patients that they are more susceptible to infections and that they should immediately report any signs or symptoms of infections to their healthcare provider[see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Advise patients of the risk of clinically significant hypersensitivity reactions and to promptly contact their healthcare provider or seek emergency care for signs of hypersensitivity reaction including rash, itching, hives, difficulty breathing or swallowing, flushing, chest pain, or dizziness[see Contraindications (4), Warnings and Precautions (5.3)].

Angioedema with Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors

Advise patients to avoid angiotensin-converting enzyme (ACE) inhibitors and to promptly contact their healthcare provider or seek emergency care for signs or symptoms of angioedema[see Warnings and Precautions (5.4)].

Stomatitis

Advise patients of the risk of stomatitis and to use alcohol-free mouthwashes during treatment[see Warnings and Precautions (5.5)].

Renal Impairment

Advise patients of the risk of developing kidney failure and the need to monitor their kidney function periodically during treatment[see Warnings and Precautions (5.6)].

Impaired Wound Healing

Advise patients of the risk of impaired wound healing or dehiscence during treatment[see Warnings and Precautions (5.7)].

Geriatric Patients

Inform patients that in a study conducted in patients with breast cancer, the incidence of deaths and adverse reactions leading to permanent discontinuation was higher in patients 65 years compared to patients < 65 years[see Warnings and Precautions (5.8), Use in Specific Populations (8.5)].

Metabolic Disorders

Advise patients of the risk of metabolic disorders and the need to monitor glucose and lipids periodically during therapy[see Warnings and Precautions (5.9)].

Myelosuppression

Advise patients of the risk of myelosuppression and the need to monitor complete blood counts periodically during therapy[see Warnings and Precautions (5.10)].

Risk of Infection or Reduced Immune Response with Vaccination

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 females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 8 weeks after the last dose. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 weeks after the last dose[see Warnings and Precautions (5.12) and Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with AFINITOR/AFINITOR DISPERZ and for 2 weeks after the last dose[see Use in Specific Populations (8.2)].

Infertility

Advise males and females of reproductive potential of the potential risk for impaired fertility[see Use in Specific Populations (8.3)].

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

T2018-50



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