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).

Dosage

Recommended Dosage Regimen

  • Premedicate before each infusion.
  • Administer only as an intravenous infusion through a dedicated line.
  • Do not administer as an intravenous push or bolus.
  • Monitor blood counts at regular intervals.
  • GAZYVA should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.

Recommended Dose:

  • Each dose of GAZYVA is 1000 mg, administered intravenously, with the exception of the first infusions in Cycle 1, which are administered on day 1 (100 mg) and day 2 (900 mg).
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This image is provided by the National Library of Medicine.
  • If a planned dose of GAZYVA is missed, administer the missed dose as soon as possible and adjust dosing schedule accordingly. If appropriate, patients who do not complete the Day 1 Cycle 1 dose may proceed to the day 2 Cycle 1 dose.
  • If a patient experiences an infusion reaction of any grade during infusion, adjust the infusion as follows:
  • Grade 4 (life-threatening): Stop infusion immediately and permanently discontinue GAZYVA therapy.
  • Grade 3 (severe): Interrupt infusion and manage symptoms. Upon resolution of symptoms, consider restarting GAZYVA infusion at no more than half the previous rate (the rate being used at the time that the infusion reaction occurred) and, if patient does not experience any further infusion reaction symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose. Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further. Permanently discontinue treatment if patients experience a Grade 3 infusion-related symptom at rechallenge.
  • Grade 1–2 (mild to moderate): Reduce infusion rate or interrupt infusion and treat symptoms. Upon resolution of symptoms, continue or resume infusion and, if patient does not experience any further infusion reaction symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose. Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further.

Recommended Premedication

  • Premedication is recommended to reduce the risk of infusion reactions as outlined in TABLE 2.
  • Hypotension may occur during GAZYVA intravenous infusions. Consider withholding antihypertensive treatments for 12 hours prior to and throughout each GAZYVA infusion and for the first hour after administration [see WARNINGS AND PRECAUTIONS (5.3)].
  • For patients with high tumor burden and/or high circulating absolute lymphocyte counts (greater than 25 × 109/L), premedicate with anti-hyperuricemics (e.g., allopurinol) beginning 12–24 hours prior to start of therapy and ensure adequate hydration for prophylaxis of tumor lysis syndrome.
File:XXXXX.png
This image is provided by the National Library of Medicine.

Premedication for Antimicrobial Prophylaxis

  • Patients with neutropenia are strongly recommended to receive antimicrobial prophylaxis throughout the treatment period. Antiviral and antifungal prophylaxis should be considered.

Treatment Interruption for Toxicity

Consider treatment interruption if patients experience an infection, Grade 3 or 4 cytopenia, or a ≥ Grade 2 non-hematologic toxicity.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

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.

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

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

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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