Monjuvi Side Effects Center

Last updated on RxList: 1/22/2021
Monjuvi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Monjuvi?

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody indicated in combination with lenalidomide to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

What Are Side Effects of Monjuvi?

Side effects of Monjuvi include:

Dosage for Monjuvi

The recommended dosage of Monjuvi is 12 mg/kg as an intravenous infusion according to the following dosing schedule: 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. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle. Monjuvi is administered in combination with lenalidomide for a maximum of 12 cycles and then Monjuvi is continued as monotherapy until disease progression or unacceptable toxicity.

Monjuvi In Children

The safety and effectiveness of Monjuvi in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Monjuvi?

Monjuvi may interact with other medicines.

Tell your doctor all medications and supplements you use.

Monjuvi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Monjuvi; it may cause fetal B-cell depletion when administered to a pregnant woman. Females of reproductive potential are advised to use effective contraception during treatment with Monjuvi and for at least 3 months after the last dose. It is unknown if Monjuvi passes into breast milk. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended while using Monjuvi and for at least 3 months after the last dose. Refer to lenalidomide prescribing information for additional information.

Additional Information

Our Monjuvi (tafasitamab-cxix) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Monjuvi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel chilled, warm, sweaty, anxious, or have a headache, trouble breathing, or pounding in your neck or ears.

Call your doctor at once if you have:

  • cough with mucus, chest tightness, shortness of breath;
  • fever above 100.4 degrees F (38 degrees C);
  • pain or burning when you urinate;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • low blood cell counts;
  • fever;
  • feeling weak or tired;
  • cough;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • loss of appetite, diarrhea; or
  • swelling in your hands or lower legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Monjuvi (Tafasitamab-cxix Injection )

Monjuvi Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Infusion-related reactions [see WARNINGS AND PRECAUTIONS]
  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]

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 was evaluated in L-MIND [see Clinical Studies]. 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.

Serious adverse reactions occurred in 52% of patients who received MONJUVI. Serious adverse reactions in ≥6% of patients included infections (26%), including pneumonia (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 5% of patients who received MONJUVI, including cerebrovascular accident (1.2%), respiratory failure (1.2%), progressive multifocal leukoencephalopathy (1.2%) and sudden death (1.2%).

Permanent discontinuation of MONJUVI or lenalidomide due to an adverse reaction occurred in 25% of patients and permanent discontinuation of MONJUVI due to an adverse reaction occurred in 15%. The most frequent adverse reactions which resulted in permanent discontinuation of MONJUVI were infections (5%), nervous system disorders (2.5%), respiratory, thoracic and mediastinal disorders (2.5%).

Dosage interruptions of MONJUVI or lenalidomide due to an adverse reaction occurred in 69% of patients and dosage interruption of MONJUVI due to an adverse reaction occurred in 65%. The most frequent adverse reactions which required a dosage interruption of MONJUVI were blood and lymphatic system disorders (41%), and infections (27%).

The most common adverse reactions (≥ 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

Table 3 summarizes the adverse reactions in L-MIND.

Table 3: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Received MONJUVI in L-MIND

Adverse Reaction MONJUVI
(N=81)
All Grades (%) Grade 3 or 4 (%)
Blood and lymphatic system disorders
Neutropenia 51 49
Anemia 36 7
Thrombocytopenia 31 17
Febrile neutropenia 12 12
General disorders and administration site conditions
Fatigue* 38 3.7
Pyrexia 24 1.2
Peripheral edema 24 0
Gastrointestinal disorders
Diarrhea 36 1.2
Constipation 17 0
Abdominal pain^ 15 1.2
Nausea 15 0
Vomiting 15 0
Respiratory, thoracic and mediastinal disorders
Cough 26 1.2
Dyspnea 12 1.2
Infections
Respiratory tract infection+ 24 4.9
Urinary tract infection† 17 4.9
Bronchitis 16 1.2
Metabolism and nutrition disorders
Decreased appetite 22 0
Hypokalemia 19 6
Musculoskeletal and connective tissue disorders
Back pain 19 2.5
Muscle spasms 15 0
Skin and subcutaneous tissue disorders
Rash‡ 15 2.5
Pruritus 10 1.2
* Fatigue includes asthenia and fatigue
+ Respiratory tract infection includes: lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection
† Urinary tract infection includes: urinary tract infection, Escherichia urinary tract infection, urinary tract infection bacterial, urinary tract infection enterococcal ^ Abdominal pain includes abdominal pain, abdominal pain lower, and abdominal pain upper
‡ Rash includes rash, rash maculo-papular, rash pruritic, rash erythematous, rash pustular

Clinically relevant adverse reactions in <10% of patients who received MONJUVI were:

  • Blood and lymphatic system disorders: lymphopenia (6%)
  • General disorders and administration site conditions: infusion-related reaction (6%)
  • Infections: sepsis (4.9%)
  • Investigations: weight decreased (4.9%)
  • Musculoskeletal and connective tissue disorders: arthralgia (9%), pain in extremity (9%), musculoskeletal pain (2.5%)
  • Neoplasms benign, malignant and unspecified: basal cell carcinoma (1.2%)
  • Nervous system disorders: headache (9%), paresthesia (7%), dysgeusia (6%)
  • Respiratory, thoracic and mediastinal disorders: nasal congestion (4.9%), exacerbation of chronic obstructive pulmonary disease (1.2%)
  • Skin and subcutaneous tissue disorders: erythema (4.9%), alopecia (2.5%), hyperhidrosis (2.5%)

Table 4 summarizes the laboratory abnormalities in L-MIND.

Table 4: Select Laboratory Abnormalities (>20%) Worsening from Baseline in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Received MONJUVI in L-MIND

Laboratory Abnormality MONJUVI1
All Grades (%) Grade 3 or 4 (%)
Chemistry
Glucose increased 49 5
Calcium decreased 47 1.4
Gamma glutamyl transferase increased 34 5
Albumin decreased 26 0
Magnesium decreased 22 0
Urate increased 20 7
Phosphate decreased 20 5
Creatinine increased 20 1.4
Aspartate aminotransferase increased 20 0
Coagulation
Activated partial thromboplastin time increased 46 4.1
1 The denominator used to calculate the rate was 74 based on the number of patients with a baseline value and at least one post-treatment value.

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assays. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other tafasitamab products may be misleading.

Overall, no treatment-emergent or treatment-boosted anti-tafasitamab antibodies were observed. No clinically meaningful differences in the pharmacokinetics, efficacy, or safety profile of tafasitamab-cxix were observed in 2.5% of 81 patients with relapsed or refractory DLBCL with pre-existing anti­tafasitamab antibodies in L-MIND.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Monjuvi (Tafasitamab-cxix Injection )

© Monjuvi Patient Information is supplied by Cerner Multum, Inc. and Monjuvi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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