Note: This document contains side effect information about polatuzumab vedotin. Some dosage forms listed on this page may not apply to the brand name Polivy.
Applies to polatuzumab vedotin: intravenous powder for solution.
Serious side effects of Polivy
Along with its needed effects, polatuzumab vedotin (the active ingredient contained in Polivy) 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 polatuzumab vedotin:
More common
- Back pain
- black, tarry stools
- bleeding gums
- blood in urine or stools
- bone pain
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- confusion
- cough or hoarseness
- dry mouth
- fast or irregular heartbeat
- fever or chills
- flushing
- headache
- increased thirst
- lightheadedness or fainting
- loss of appetite
- lower back, side, or stomach pain
- mood or mental changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the mouth, fingers, hands, or feet
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- seizures
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach cramps
- swelling of the feet or lower legs
- swollen glands
- tremor
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
Other side effects of Polivy
Some side effects of polatuzumab vedotin 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
- Body aches or pain
- change in taste
- constipation
- cracked lips
- diarrhea
- difficulty in moving
- difficulty in swallowing
- dizziness
- ear congestion
- hair loss or thinning
- joint pain
- loss of voice
- muscle stiffness
- runny or stuffy nose
- skin rash
- sneezing
- sores, ulcers, or white spots on lips, tongue, or inside mouth
- weight loss
Less common
- Blurred vision
For Healthcare Professionals
Applies to polatuzumab vedotin: intravenous powder for injection.
Hematologic
Very common (10% or more): Neutropenia (49%), thrombocytopenia (49%), anemia (47%), lymphopenia (13%), febrile neutropenia (11%)
Common (1% to 10%): Pancytopenia[Ref]
Immunologic
Very common (10% or more): Infections (32%), herpesvirus infection (12%)
Common (1% to 10%): Cytomegalovirus infection
Uncommon (0.1% to 1%): Progressive multifocal leukoencephalopathy (PML), sepsis
Frequency not reported: Immunogenicity[Ref]
Local
Very common (10% or more): Infusion-related reactions (e.g., fever, chills, flushing, dyspnea, hypotension, urticaria) (67%)
Common (1% to 10%): Infusion-related reactions[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia[Ref]
Ocular
Common (1% to 10%): Blurred vision[Ref]
Metabolic
Very common (10% or more): Anorexia (27%), weight loss (16%), hypokalemia (16%), hypoalbuminemia (13%), hypocalcemia (11%)
Common (1% to 10%): Hypophosphatemia
Frequency not reported: Tumor lysis syndrome (TLS)[Ref]
Hepatic
Common (1% to 10%): Transaminase elevation[Ref]
Respiratory
Very common (10% or more): Dyspnea (19%), upper respiratory tract infection (16%), lower respiratory tract infection (10%)
Common (1% to 10%): Pneumonitis[Ref]
Other
Very common (10% or more): Pyrexia (33%)[Ref]
Nervous system
Very common (10% or more): Peripheral neuropathy (40%), dizziness (13%)[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (38%), vomiting (18%)
Common (1% to 10%): Lipase increased[Ref]
