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 a {{{drugClass}}} that is FDA approved for the treatment of Osimertinib is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Osimertinib Patient Selection Confirm the presence of a T790M EGFR mutation in tumor or, in the absence of tumor, plasma specimens prior to initiation of treatment with Osimertinib. Testing for the presence of the mutation in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. If this mutation is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing. Information on FDA-approved tests for the detection of T790M mutations is available at HTTP://WWW.FDA.GOV/COMPANIONDIAGNOSTICS. Recommended Dosage Regimen The recommended dose of Osimertinib is 80 mg tablet once a day until disease progression or unacceptable toxicity. Osimertinib can be taken with or without food.
If a dose of Osimertinib is missed, do not make up the missed dose and take the next dose as scheduled.
Administration to Patients Who Have Difficulty Swallowing Solids Disperse tablet in 60 mL (2 ounces) of non-carbonated water only. Stir until tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 mL to 240 mL (4 to 8 ounces) of water and immediately drink.
If administration via naso-gastric tube is required, disperse the tablet as above in 15 mL of non-carbonated water, and then use an additional 15 mL of water to transfer any residues to the syringe. The resulting 30 mL liquid should be administered as per the nasogastric tube instructions with appropriate water flushes (approximately 30 mL).
- Dosage Modification
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.