Atezolizumab

Atezolizumab
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino, M.D. [2]

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Overview

Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody that is FDA approved for the treatment of elected patients (see below) with locally advanced or metastatic urothelial carcinoma. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Atezolizumab is also indicated for the treatment of patients with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Atezolizumab.. Common adverse reactions include fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation (≥20%) in patients with locally advanced or metastatic urothelial carcinoma. Most common adverse reactions (≥ 20%) in patients with metastatic non-small cell lung cancer were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Locally Advanced or Metastatic Urothelial Carcinoma

Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

• Have disease progression during or following platinum-containing chemotherapy
• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Metastatic Non-Small Cell Lung Cancer

Atezolizumab is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Atezolizumab.

Dosage

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Atezolizumab FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Atezolizumab Contraindications in the drug label.

Warnings

There is limited information regarding Atezolizumab Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Atezolizumab Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Atezolizumab Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Atezolizumab Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Atezolizumab in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Atezolizumab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Atezolizumab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Atezolizumab in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Atezolizumab in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Atezolizumab in geriatric settings.

Gender

There is no FDA guidance on the use of Atezolizumab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Atezolizumab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Atezolizumab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Atezolizumab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Atezolizumab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Atezolizumab in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Atezolizumab Administration in the drug label.

Monitoring

There is limited information regarding Atezolizumab Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Atezolizumab and IV administrations.

Overdosage

There is limited information regarding Atezolizumab 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 Atezolizumab Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Atezolizumab Mechanism of Action in the drug label.

Structure

There is limited information regarding Atezolizumab Structure in the drug label.

Pharmacodynamics

There is limited information regarding Atezolizumab Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Atezolizumab Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Atezolizumab Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Atezolizumab Clinical Studies in the drug label.

How Supplied

There is limited information regarding Atezolizumab How Supplied in the drug label.

Storage

There is limited information regarding Atezolizumab 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 Atezolizumab Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Atezolizumab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Atezolizumab Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Atezolizumab 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.