Osimertinib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]Associate Editor(s)-in-Chief: Vishal Devarkonda, M.B.B.S[3]
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Overview
Osimertinib is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Osimertinib FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Osimertinib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Osimertinib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Osimertinib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Osimertinib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Osimertinib in pediatric patients.
Contraindications
There is limited information regarding Osimertinib Contraindications in the drug label.
Warnings
There is limited information regarding Osimertinib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Osimertinib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Osimertinib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Osimertinib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Osimertinib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Osimertinib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Osimertinib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Osimertinib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Osimertinib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Osimertinib in geriatric settings.
Gender
There is no FDA guidance on the use of Osimertinib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Osimertinib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Osimertinib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Osimertinib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Osimertinib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Osimertinib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Osimertinib Administration in the drug label.
Monitoring
There is limited information regarding Osimertinib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Osimertinib and IV administrations.
Overdosage
There is limited information regarding Osimertinib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Osimertinib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Osimertinib Mechanism of Action in the drug label.
Structure
There is limited information regarding Osimertinib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Osimertinib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Osimertinib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Osimertinib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Osimertinib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Osimertinib How Supplied in the drug label.
Storage
There is limited information regarding Osimertinib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Osimertinib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Osimertinib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Osimertinib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Osimertinib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.