Label: EVEROLIMUS tablet

  • NDC Code(s): 72603-254-01, 72603-255-01, 72603-256-01, 72603-257-01
  • Packager: NorthStar RxLLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 30, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use EVEROLIMUS safely and effectively. See full prescribing information for EVEROLIMUS. EVEROLIMUS tablets, for oral use - Initial ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer - Everolimus tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Dosage Information - Everolimus tablets and AFINITOR DISPERZ are two different dosage forms. Select the recommended dosage form based on the indication [see Indications and Usage ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Everolimus tablets - Tablets, white to off white, capsule shaped, flat faced bevelled edge: • 2.5 mg: debossed with B 2.5 on one side and plain on other side. • 5 mg: debossed with B 5 on one side ...
  • 4 CONTRAINDICATIONS
    Everolimus tablets are contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see Warnings and Precautions (5.3)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Non-infectious Pneumonitis - Non-infectious pneumonitis is a class effect of rapamycin derivatives. Non-infectious pneumonitis was reported in up to 19% of patients treated with everolimus in ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the labeling: Non-Infectious Pneumonitis [see Warnings and Precautions (5.1)]. Infections [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs on Everolimus - Inhibitors - Avoid the concomitant use of P-gp and strong CYP3A4 inhibitors [see Dosage and Administration (2.11), Clinical Pharmacology (12.3)]. Reduce ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on animal studies and the mechanism of action [see Clinical Pharmacology (12.1)], everolimus can cause fetal harm when administered to a pregnant woman. There ...
  • 11 DESCRIPTION
    Everolimus tablets (everolimus) are kinase inhibitors. The chemical name of everolimus, USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Administration of everolimus for up to 2 years did not indicate oncogenic potential in mice and rats up to the highest doses tested ...
  • 14 CLINICAL STUDIES
    14.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer - A randomized, double-blind, multicenter study (BOLERO-2, NCT00863655) of everolimus tablets in combination with exemestane vs ...
  • 15 REFERENCES
    OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Everolimus tablets - 2.5 mg tablets: White to off white, capsule shaped, flat faced bevelled edge tablet debossed with B 2.5 on one side and plain on other side; available in: Bottle of 30 tablets ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Non-infectious Pneumonitis - Advise patients of the risk of developing non-infectious pneumonitis and to ...
  • PATIENT INFORMATION
    This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 08/2024 - Everolimus - (e” ver oh’ li mus) Tablets - Read this Patient Information ...
  • Package/Label Display Panel – 2.5-mg-bottle
    PRINCIPAL DISPLAY PANEL - Package Label –2.5 mg - NDC 70377-010-11 - Everolimus Tablets - 2.5 mg - Rx Only 30 Tablets
  • Package/Label Display Panel – 5-mg-bottle
    PRINCIPAL DISPLAY PANEL - Package Label – 5 mg - NDC 70377-011-11 - Everolimus Tablets - 5 mg - Rx Only             30 Tablets
  • Package/Label Display Panel – 7.5-mg-bottle
    PRINCIPAL DISPLAY PANEL - Package Label –7.5 mg - NDC 70377-012-11 - Everolimus Tablets - 7.5 mg - Rx Only             30 Tablets
  • Package/Label Display Panel – 10-mg-bottle
    PRINCIPAL DISPLAY PANEL - Package Label – 10 mg - NDC 70377-013-11 - Everolimus Tablets - 10 mg - Rx Only             30 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information