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)
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 (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)
There is limited information regarding Inavolisib 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 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
None.
Warnings
Hyperglycemia
Severe hyperglycemia can occur in patients treated with Inavolisib. Increased fasting glucose occurred in 85% of patients treated with Inavolisib, including 22% of patients with Grade 2 (FPG > 160 to 250 mg/dL), 12% with Grade 3 (FPG > 250 to 500 mg/dL), and 0.6% with Grade 4 (FPG > 500 mg/dL) events. Among patients with hyperglycemia, the median time to first onset was 7 days (range: 2 to 955 days). Hyperglycemia led to dose interruption in 28%, to dose reduction in 2.5%, and to discontinuation of Inavolisib in 1.2% of patients. The safety of ITOVEBI in patients with Type 1 diabetes mellitus, or Type 2 diabetes mellitus requiring ongoing anti-hyperglycemic treatment have not been studied. Before initiating treatment with Inavolisib, test fasting glucose levels (FPG or FBG), HbA1C levels, and optimize fasting glucose. After initiating treatment with Inavolisib, or in patients who experience hyperglycemia after initiating treatment with Inavolisib, monitor or self-monitor fasting glucose levels once every 3 days for the first week (Day 1 to 7), then once every week for the next 3 weeks (Day 8 to 28), then once every 2 weeks for the next 8 weeks, then once every 4 weeks thereafter, and as clinically indicated. Monitor HbA1C every 3 months and as clinically indicated. Manage hyperglycemia with anti-hyperglycemic medications as clinically indicated. During treatment with anti-hyperglycemic medication, continue monitoring fasting glucose levels. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of fasting glucose levels. Based on the severity of the hyperglycemia, ITOVEBI may require dose interruption, reduction, or discontinuation.
•Stomatitis
•Severe stomatitis can occur in patients treated with INAVOLISIB. Stomatitis occurred in 51% of patients treated with INAVOLISIB in combination with palbociclib and fulvestrant, including Grade 3 events in 6% of patients. The median time to first onset was 13 days (range: 1 to 610 days). Stomatitis led to interruption of INAVOLISIB in 10%, to dose reduction in 3.7%, and to discontinuation of INAVOLISIB in 0.6% of patients. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue INAVOLISIB based on severity.
•Diarrhea
•Severe diarrhea, including dehydration and acute kidney injury, can occur in patients treated with Inavolisib. Diarrhea occurred in 48% of patients treated with Inavolisib in combination with palbociclib and fulvestrant, including Grade 3 events in 3.7% of patients. The median time to first onset was 15 days (range: 2 to 602 days). Anti-diarrheal medicines were used in 28% (46/162) of patients who received ITOVEBI in combination with palbociclib and fulvestrant to manage symptoms. Dose interruptions were required in 7% of patients, and dose reductions occurred in 1.2% of patients. Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start anti-diarrheal treatment at the first sign of diarrhea while taking ITOVEBI. Withhold, reduce dose, or permanently discontinue ITOVEBI based on severity
•Embryo-Fetal Toxicity
•Based on findings in animals and its mechanism of action, INAVOLISIB can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of inavolisib to pregnant rats during the period of organogenesis caused adverse developmental outcomes, including embryo-fetal mortality, structural abnormalities, and alterations to growth at maternal exposures approximately equivalent to the human exposure at the recommended dose of 9 mg/day based on area under the curve (AUC). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with INAVOLISIB and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with INAVOLISIB and for 1 week after the last dose.
Adverse Reactions
Clinical Trials Experience
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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.