Mosunetuzumab-axgb
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Black Box Warning
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Cytokine Release Syndrome (CRS)
See full prescribing information for complete Boxed Warning.
Cytokine Release Syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Clinical signs and symptoms of CRS includes fever, chills, hypotension, tachycardia, hypoxia, and headache along with neurologic adverse reactions such as confusional state, and anxiety. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. Patients who experience CRS should be evaluated and advised not to drive and refrain from operating heavy machinery.
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Overview
Mosunetuzumab-axgb is a humanized monoclonal antibody that is FDA approved for the treatment of relapsing or refractory follicular lymphoma in adults after 2 or more lines of systemic therapy.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cytokine release syndrome, fatigue, rash, pyrexia, and headache..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Treatment of relapsing or refractory follicular lymphoma
- dosing information
- always administered via intravenous infusion-1 mg/mL solution in a single-dose vial.
- administer for 8 cycles, unless the patient experiences drug toxcity or unacceptable disease progression. Recommended dosage are:
- Cycle 1 Day 1 – 1 mg
- Cycle 1 Day 8 – 2 mg
- Cycle 1 Day 15 – 60 mg
- Cycle 2 Day 1 – 60 mg
- Cycle 3+ Day 1 – 30 mg
- always premedicate with antihistamines, corticosteroids, and antipyretics prior to cycle 1 and cycle 2 to reduce the risk of CRS.
- always administer LANSUMIO to well hydrated patients.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
has no off-label use
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and efficacy of LUNSUMIO have not been established in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
has no off label use
Contraindications
none
Warnings
|
Cytokine Release Syndrome (CRS)
See full prescribing information for complete Boxed Warning.
Cytokine Release Syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Clinical signs and symptoms of CRS includes fever, chills, hypotension, tachycardia, hypoxia, and headache along with neurologic adverse reactions such as confusional state, and anxiety. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. Patients who experience CRS should be evaluated and advised not to drive and refrain from operating heavy machinery.
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- Cytokine Release Syndrome
- neurological toxicity
- infection
- cytopenias
- tumor flare
- embryo-fetal toxicity
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Mosunetuzumab-axgb Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Mosunetuzumab-axgb Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Mosunetuzumab-axgb Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Mosunetuzumab-axgb in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mosunetuzumab-axgb in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Mosunetuzumab-axgb during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Mosunetuzumab-axgb in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Mosunetuzumab-axgb in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Mosunetuzumab-axgb in geriatric settings.
Gender
There is no FDA guidance on the use of Mosunetuzumab-axgb with respect to specific gender populations.
Race
There is no FDA guidance on the use of Mosunetuzumab-axgb with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Mosunetuzumab-axgb in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Mosunetuzumab-axgb in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Mosunetuzumab-axgb in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Mosunetuzumab-axgb in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Mosunetuzumab-axgb Administration in the drug label.
Monitoring
There is limited information regarding Mosunetuzumab-axgb Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Mosunetuzumab-axgb and IV administrations.
Overdosage
There is limited information regarding Mosunetuzumab-axgb 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 Mosunetuzumab-axgb Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Mosunetuzumab-axgb Mechanism of Action in the drug label.
Structure
There is limited information regarding Mosunetuzumab-axgb Structure in the drug label.
Pharmacodynamics
There is limited information regarding Mosunetuzumab-axgb Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Mosunetuzumab-axgb Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Mosunetuzumab-axgb Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Mosunetuzumab-axgb Clinical Studies in the drug label.
How Supplied
There is limited information regarding Mosunetuzumab-axgb How Supplied in the drug label.
Storage
There is limited information regarding Mosunetuzumab-axgb 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 Mosunetuzumab-axgb Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Mosunetuzumab-axgb 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 Mosunetuzumab-axgb Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Mosunetuzumab-axgb 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.