Note: This document contains side effect information about brentuximab. Some dosage forms listed on this page may not apply to the brand name Adcetris.
Summary
More frequent side effects include: peripheral motor neuropathy. Continue reading for a comprehensive list of adverse effects.
Applies to brentuximab: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
John Cunningham (JC) virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving brentuximab vedotin.
Serious side effects of Adcetris
Along with its needed effects, brentuximab (the active ingredient contained in Adcetris) 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 brentuximab:
More common
- Abdominal or stomach pain
- back pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- body aches or pain
- bone pain
- burning, numbness, tingling, or painful sensations
- chills
- cough
- difficult or labored breathing
- dry mouth
- ear congestion
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- loss of voice
- lower back or side pain
- nausea
- pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- troubled breathing with exertion
- unexplained weight loss
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weakness in the arms, hands, legs, or feet
Less common
- Anxiety
- bladder pain
- blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain
- cloudy urine
- confusion
- diarrhea
- dizziness or lightheadedness
- drowsiness
- fainting
- fast heartbeat
- frequent urge to urinate
- general feeling of discomfort or illness
- irregular heartbeat
- itching
- joint pain, stiffness, or swelling
- muscle pain
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- severe pain in the chest
- sudden onset of severe breathing difficulty
- thickening of bronchial secretions
- unusual weight gain or loss
Incidence not known
- Clay-colored stools
- dark urine
- heartburn
- indigestion
- severe abdominal pain, cramping, or burning
- severe constipation
- severe vomiting
- vomiting of material that looks like coffee grounds
- yellow eyes or skin
Other side effects of Adcetris
Some side effects of brentuximab 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
- Decreased appetite or weight
- difficulty having a bowel movement
- difficulty with moving
- hair loss or thinning of the hair
- muscle spasm or stiffness
- night sweats
- pain in the arms or legs
- rash
- trouble sleeping
Less common
- Dry skin
For Healthcare Professionals
Applies to brentuximab: intravenous powder for injection.
Dermatologic
Very common (10% or more): Rash (up to 31%), pruritus (up to 19%), alopecia (up to 14), night sweats (up to 12%), dry skin (up to 10%)
Rare (less than 0.1%): : Stevens-Johnson syndrome (SJS) (including fatal outcomes), toxic epidermal necrolysis (including fatal outcomes)[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 42%), diarrhea (up to 36%), abdominal pain (up to 25%), vomiting (up to 22%), constipation (up to 19%)
Postmarketing reports: Pancreatitis (including fatal outcomes)[Ref]
Hematologic
Very common (10% or more): Neutropenia (any grade) (up to 78%), anemia (up to 52%), thrombocytopenia (up to 41%), lymphadenopathy (up to 11%)
Postmarketing reports: Febrile neutropenia[Ref]
Hypersensitivity
Frequency not reported: Anaphylactic reaction[Ref]
Metabolic
Very common (10% or more): Weight decreased (up to 19%), decreased appetite (up to 11%)
Common (1% to 10%): Hyperglycemia[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (up to 19%), myalgia (up to 17%), back pain (up to 14%), pain in extremity (up to 10%)
Common (1% to 10%): Muscle spasms[Ref]
Nervous system
Very common (10% or more): Peripheral sensory neuropathy (up to 56%), peripheral motor neuropathy (up to 23%), headache (up to 19%), dizziness (up to 16%)
Common (1% to 10%): Demyelinating polyneuropathy
Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]
Other
Other side effects have included infusion related reactions (12%) including chills, nausea, dyspnea, pruritus, pyrexia and cough.[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 16%), anxiety (up to 11%)[Ref]
Respiratory
Very common (10% or more): Upper respiratory infection (up to 47%), cough (up to 25%), dyspnea (up to 17%), oropharyngeal pain (up to 11%)
Postmarketing reports: Noninfectious pulmonary toxicity (including fatal outcomes)[Ref]
Hepatic
Common (1% to 10%): Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Postmarketing reports: Hepatotoxicity[Ref]
Immunologic
Very common (10% or more): Infection
Common (1% to 10%): Sepsis/septic shock, pneumonia, herpes zoster
Uncommon (0.1% to 1%): Oral candidiasis, pneumocystis jiroveci pneumonia, staphylococcal bacteremia
Postmarketing reports: Serious opportunistic infections[Ref]
Oncologic
Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]
