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Monjuvi

tafasitamab
CD19-Directed AntibodyFDA Approved 2020MorphoSys / Incyte
Route
IV
Half-Life
~19 days
FDA Approved
2020
Manufacturer
MorphoSys / Incyte
1. Indications and Usage

In combination with lenalidomide for R/R DLBCL, and with lenalidomide and rituximab for R/R follicular lymphoma.

2. Dosage and Administration

12 mg/kg IV on Days 1,4,8,15,22 of Cycle 1; Days 1,8,15,22 of Cycles 2-3; then Days 1,15 of subsequent 28-day cycles.

3. Dosage Forms and Strengths

Injection: 200 mg lyophilized powder in single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Infusion-Related Reactions: Premedicate. Permanently discontinue for Grade 4.
  • Myelosuppression: Monitor CBCs.
  • Infections: Serious and fatal infections reported.
  • Embryo-Fetal Toxicity: Can cause fetal harm when used with lenalidomide.
6. Adverse Reactions
Most Common Adverse Reactions

Neutropenia (51%), Fatigue (38%), Anemia (36%), Diarrhea (34%), Thrombocytopenia (31%), Cough (26%), Pyrexia (24%), Peripheral Edema (22%)

Neutropenia
51%
Fatigue
38%
Anemia
36%
Diarrhea
34%
Thrombocytopenia
31%
Cough
26%
Pyrexia
24%
Peripheral Edema
22%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies conducted. Monitor for additive myelosuppressive effects with lenalidomide.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Tafasitamab is an Fc-modified humanized CD19-targeting monoclonal antibody with enhanced ADCC and ADCP, leading to direct lysis of CD19-expressing malignant B cells.

Pharmacokinetics

Half-life: ~17 days at steady state. Clearance: 0.014 L/hr. Volume of distribution: 9.3 L.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Tafasitamab Trials on ClinicalTrials.gov ↗ 📚 PubMed: Tafasitamab Clinical Trials ↗
FDA-Approved Tumor Types

Monjuvi has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Hodgkin Lymphoma Follicular Lymphoma
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Monjuvi. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Monjuvi (tafasitamab) approved for?

Monjuvi (tafasitamab) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Monjuvi (tafasitamab) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Monjuvi (tafasitamab) work?

Tafasitamab is an Fc-modified humanized CD19-targeting monoclonal antibody with enhanced ADCC and ADCP, leading to direct lysis of CD19-expressing malignant B cells.

What are the most common side effects?

Neutropenia (51%), Fatigue (38%), Anemia (36%), Diarrhea (34%), Thrombocytopenia (31%), Cough (26%), Pyrexia (24%), Peripheral Edema (22%) Neutropenia 51% Fatigue 38% Anemia 36% Diarrhea 34% Thrombocytopenia 31% Cough 26% Pyrexia 24% Peripheral Edema 22%

← All TherapiesFull Prescribing Information ↗