Note: This document contains side effect information about tafasitamab. Some dosage forms listed on this page may not apply to the brand name Monjuvi.

Applies to tafasitamab: intravenous powder for solution.

Serious side effects of Monjuvi

Along with its needed effects, tafasitamab (the active ingredient contained in Monjuvi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tafasitamab:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• chest pain
• chills
• confusion
• cough producing mucus
• decreased urine
• diarrhea
• difficult, burning, or painful urination
• dizziness
• dry mouth
• ear congestion or pain
• fainting
• fast or slow heartbeat
• fever
• frequent urge to urinate
• hoarseness or other voice changes
• increased thirst
• lightheadedness
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• pale skin
• persistent non-healing sore on the skin
• pink growth on the skin
• pinpoint red spots on the skin
• rapid, shallow breathing
• reddish patch or irritated area on the skin
• runny nose
• seizures
• shiny bump on the skin
• sneezing
• sore throat
• tightness in the chest
• tingling of the hands or feet
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• white, yellow or waxy scar-like area on the skin

Other side effects of Monjuvi

Some side effects of tafasitamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• constipation
• difficulty in moving
• joint or muscle pain
• loss of taste
• muscle spasm
• redness of the skin
• unusually warm skin

Less common

• Hair loss
• increased sweating

For Healthcare Professionals

Applies to tafasitamab: intravenous powder for injection.

Hematologic

Very common (10% or more): Neutropenia (51%), activated partial thromboplastin time increased (46%), anemia (36%), thrombocytopenia (31%), febrile neutropenia (12%), leukopenia

Common (1% to 10%): Lymphopenia^[Ref]

Immunologic

Very common (10% or more): Infections (73%), Grade 3 or higher infection (30%)

Common (1% to 10%): Sepsis, hypogammaglobulinemia

Frequency not reported: Potential immunogenicity^[Ref]

Local

Common (1% to 10%): Infusion related reactions (IRRs) (e.g., chills, flushing, dyspnea, hypertension)^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (19%), muscle spasms (15%)

Common (1% to 10%): Arthralgia, pain in extremity, musculoskeletal pain^[Ref]

Metabolic

Very common (10% or more): Glucose increased (49%), calcium decreased (47%), gamma glutamyl transferase increased (34%), albumin decreased (26%), magnesium decreased (22%), anorexia (22%), urate increased (20%), phosphate decreased (20%), hypokalemia (19%), decreased appetite

Common (1% to 10%): Weight loss, C-reactive protein increased^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (e.g., urinary tract infection, Escherichia urinary tract infection, urinary tract infection bacterial, urinary tract infection enterococcal) (17%)^[Ref]

Hepatic

Very common (10% or more): Aspartate aminotransferase increased (20%)

Common (1% to 10%): Hyperbilirubinemia, transaminases increased (includes ALT and/or AST increased)^[Ref]

Oncologic

Common (1% to 10%): Basal cell carcinoma^[Ref]

Respiratory

Very common (10% or more): Cough (26%), respiratory tract infection (e.g., lower respiratory tract infection, upper respiratory tract infection, respiratory tract infection) (24%), bronchitis (16%), dyspnea (12%), nasopharyngitis (10%), pneumonia (10%)

Common (1% to 10%): Nasal congestion, exacerbation of obstructive pulmonary disease^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (38%), pyrexia (24%), peripheral edema (24%)^[Ref]

General

The most common adverse reactions (20% or greater) were infections, neutropenia, fatigue, asthenia, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.^[Ref]

Nervous system

Common (1% to 10%): Headache, paresthesia, dysgeusia^[Ref]

Renal

Very common (10% or more): Creatinine increased (20%)^[Ref]

Dermatologic

Common (1% to 10%): Erythema, alopecia, hyperhidrosis, rash (includes different types of rash, e.g. rash, rash maculopapular, rash pruritic, rash erythematous)^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (36%), constipation (17%), nausea (15%), vomiting (15%), abdominal pain

Common (1% to 10%): Mucosal inflammation^[Ref]