Obinutuzumab

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Obinutuzumab
Black Box Warning
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: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete Boxed Warning.
* Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation.
  • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA.

Overview

Obinutuzumab is an antineoplastic agent that is FDA approved for the treatment of chronic lymphoid leukemia,previously untreated. There is a Black Box Warning for this drug as shown here. Common adverse reactions include anemia, neutropenia,thrombocytopenia,disorder of musculoskeletal system,cough, fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Obinutuzumab in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Obinutuzumab in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Obinutuzumab in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Obinutuzumab in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Obinutuzumab in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete Boxed Warning.
* Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation.
  • Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Obinutuzumab in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Obinutuzumab in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Obinutuzumab with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Obinutuzumab with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Obinutuzumab with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Obinutuzumab in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Obinutuzumab in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Obinutuzumab in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Obinutuzumab01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Obinutuzumab in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Obinutuzumab in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

  • GAZYVA

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "http://www.ismp.org". External link in |title= (help)

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