Glofitamab-gxbm
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Muhammad Waleed, M.B.B.S. [2]
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Black Box Warning
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CYTOKINE RELEASE SYNDROME
See full prescribing information for complete Boxed Warning.
Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity.
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Overview
Glofitamab-gxbm is a bispecific antibodies that is FDA approved for the treatment of COLUMVI (glofitamab) has been approved by the FDA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or large B-cell lymphoma arising from follicular lymphoma after at least two prior lines of systemic therapy. This approval is granted under the FDA’s accelerated approval program based on the tumor response rate and durability of the response observed in clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include 1. Cytokine Release Syndrome (CRS): Occurs in the majority of patients, with symptoms that can range from mild to severe, including fever, chills, hypotension, and hypoxia. 2. Musculoskeletal Pain: Includes pain in muscles, bones, back, neck, and extremities. 3. Rash: Various types of skin reactions, which can include general rashes, dermatitis, and erythema. 4. Fatigue: A significant number of patients report feeling unusually tired or weak..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
COLUMVI (glofitamab) is administered intravenously and requires careful dosage and administration protocols. It begins with pretreatment using a single 1,000 mg dose of obinutuzumab administered intravenously 7 days before initiating COLUMVI. The administration of COLUMVI itself follows a step-up dosing schedule to mitigate the risk of Cytokine Release Syndrome (CRS). The initial step-up dose on Cycle 1 Day 8 is 2.5 mg, followed by a 10 mg dose on Day 15. From Cycle 2 to Cycle 12, a 30 mg dose is administered on Day 1 of each 21-day cycle. Due to the risk of CRS, patients must be hospitalized for the 2.5 mg step-up dose and closely monitored for subsequent doses, especially after experiencing any grade of CRS during prior administrations. Each infusion should only be conducted in a facility equipped to manage severe adverse reactions, ensuring the safety and well-being of the patient.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Glofitamab-gxbm FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Glofitamab-gxbm Contraindications in the drug label.
Warnings
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CYTOKINE RELEASE SYNDROME
See full prescribing information for complete Boxed Warning.
Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity.
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There is limited information regarding Glofitamab-gxbm Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Glofitamab-gxbm Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Glofitamab-gxbm Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Glofitamab-gxbm Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Glofitamab-gxbm in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glofitamab-gxbm in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Glofitamab-gxbm during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Glofitamab-gxbm in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Glofitamab-gxbm in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Glofitamab-gxbm in geriatric settings.
Gender
There is no FDA guidance on the use of Glofitamab-gxbm with respect to specific gender populations.
Race
There is no FDA guidance on the use of Glofitamab-gxbm with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Glofitamab-gxbm in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Glofitamab-gxbm in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Glofitamab-gxbm in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Glofitamab-gxbm in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Glofitamab-gxbm Administration in the drug label.
Monitoring
There is limited information regarding Glofitamab-gxbm Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Glofitamab-gxbm and IV administrations.
Overdosage
There is limited information regarding Glofitamab-gxbm 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 Glofitamab-gxbm Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Glofitamab-gxbm Mechanism of Action in the drug label.
Structure
There is limited information regarding Glofitamab-gxbm Structure in the drug label.
Pharmacodynamics
There is limited information regarding Glofitamab-gxbm Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Glofitamab-gxbm Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Glofitamab-gxbm Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Glofitamab-gxbm Clinical Studies in the drug label.
How Supplied
There is limited information regarding Glofitamab-gxbm How Supplied in the drug label.
Storage
There is limited information regarding Glofitamab-gxbm 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 Glofitamab-gxbm Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Glofitamab-gxbm 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 Glofitamab-gxbm Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Glofitamab-gxbm 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.