Applies to tafasitamab: intravenous powder for solution.
Serious side effects of Tafasitamab
Along with its needed effects, tafasitamab 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 Tafasitamab
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]
