Inavolisib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh
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Overview
Inavolisib is a phosphoinositide 3-kinase inhibitors that is FDA approved for the treatment of Inavolisib is a phosphoinositide 3-kinase inhibitor that is FDA approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.. Common adverse reactions include Common adverse reactions include decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased ALT, nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Inavolisib 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 Inavolisib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Inavolisib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
HR-positive, HER2-negative, locally advanced or metastatic breast cancer with the presence of one or more PIK3CA mutations in plasma specimens Recommended dosage of Inavolisib is 9 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Inavolisib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Inavolisib in pediatric patients.
Contraindications
There is limited information regarding Inavolisib Contraindications in the drug label.
Warnings
There is limited information regarding Inavolisib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Inavolisib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Inavolisib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Inavolisib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Inavolisib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Inavolisib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Inavolisib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Inavolisib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Inavolisib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Inavolisib in geriatric settings.
Gender
There is no FDA guidance on the use of Inavolisib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Inavolisib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Inavolisib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Inavolisib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Inavolisib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Inavolisib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Inavolisib Administration in the drug label.
Monitoring
There is limited information regarding Inavolisib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Inavolisib and IV administrations.
Overdosage
There is limited information regarding Inavolisib 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 Inavolisib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Inavolisib Mechanism of Action in the drug label.
Structure
There is limited information regarding Inavolisib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Inavolisib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Inavolisib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Inavolisib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Inavolisib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Inavolisib How Supplied in the drug label.
Storage
There is limited information regarding Inavolisib 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 Inavolisib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Inavolisib 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 Inavolisib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Inavolisib 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.