Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Infections [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥ 20%) in patients with relapsed or refractory DLBCL are neutropenia, respiratory tract infection, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, and decreased appetite.
( 6.1 ) The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, in patients with relapsed or refractory FL are respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) are decreased neutrophils and decreased lymphocytes.
To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory Diffuse Large B-cell Lymphoma The safety of MONJUVI in patients with relapsed or refractory DLBCL was evaluated in L-MIND [see Clinical Studies ( 14 .1 )].
Patients (N = 81) received MONJUVI 12 mg/kg intravenously in combination with lenalidomide for a maximum of 12 cycles, followed by MONJUVI as monotherapy until disease progression or unacceptable toxicity as follows: Cycle 1: Days 1, 4, 8, 15, and 22 of the 28-day cycle;
Cycles 2 and 3: Days 1, 8, 15, and 22 of each 28-day cycle;
Cycles 4 and beyond: Days 1 and 15 of each 28-day cycle.
Among patients who received MONJUVI, 57% were exposed for 6 months or longer, 42% were exposed for greater than one year, and 24% were exposed for greater than two years.
5 WARNINGS AND PRECAUTIONS Infusion-Related Reactions : Monitor patients frequently during infusion.
Interrupt or discontinue infusion based on severity.
( 2.5 , 5.1 ) Myelosuppression : Monitor complete blood counts.
Manage using dose modifications and growth factor support.
Interrupt or discontinue MONJUVI based on severity.
Like all medications, Monjuvi can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: