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Adcetris Side Effects

Generic name: brentuximab

Medically reviewed by Drugs.com. Last updated on Nov 16, 2023.

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

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

Less common

Incidence not known

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

Less common

For Healthcare Professionals

Applies to brentuximab: intravenous powder for injection.

General

The most common adverse reactions when used as monotherapy in adult patients were peripheral neuropathy (sensory and motor), fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, infections, arthralgia, rash, cough, vomiting, pruritus, infusion-related reactions, constipation, dyspnea, myalgia, decreased weight, and abdominal pain.

The most common adverse reactions when used in combination with doxorubicin, vinblastine, and dacarbazine (AVD) or cyclophosphamide, doxorubicin, and prednisone (CHP) in adult patients were peripheral neuropathy (sensory and motor), neutropenia, nausea, constipation, vomiting, fatigue, asthenia, diarrhea, pyrexia, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, infections, febrile neutropenia, decreased appetite, insomnia, bone pain, rash, cough, dyspnea, arthralgia, myalgia, back pain, upper respiratory tract infection, and dizziness.

The most common grade 3 or higher adverse reactions in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) in pediatric patients were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection.[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, supraventricular arrhythmia

Dermatologic

Fatal and serious cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Very common (10% or more): Rash (up to 31%), alopecia (up to 26%), pruritus (up to 19%), rashes/eruptions/exanthems (includes maculopapular rash, macular rash, rash, papular rash, generalized rash, vesicular rash; up to 13%), night sweats (up to 12%), maculopapular rash (up to 11%), generalized pruritus (up to 11%), dry skin (10%)

Common (1% to 10%): Cellulitis, herpes simplex

Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic epidermal necrolysis

Frequency not reported: Severe cutaneous adverse reactions (including Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS]), DRESS

Postmarketing reports: Toxic epidermal necrolysis

Gastrointestinal

Very common (10% or more): Nausea (up to 46%), constipation (up to 42%), diarrhea (up to 38%), vomiting (up to 33%), abdominal pain (up to 25%), stomatitis (up to 21%)

Common (1% to 10%): Colitis, oral candidiasis

Uncommon (0.1% to 1%): Acute pancreatitis

Postmarketing reports: Acute pancreatitis, gastrointestinal complications (including perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, ileus)

Fatal and serious events of acute pancreatitis have been reported. Other fatal and serious gastrointestinal complications included perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus.

Genitourinary

Common (1% to 10%): Pyelonephritis, urinary tract infection

Hematologic

Very common (10% or more): Anemia (up to 98%), neutropenia (up to 96%), lymphopenia (up to 51%), thrombocytopenia (includes decreased platelet count; up to 41%), febrile neutropenia (up to 28%), lymphadenopathy (up to 11%)

Common (1% to 10%): Neutropenic sepsis

Postmarketing reports: Febrile neutropenia

Fatal and serious cases of febrile neutropenia have been reported with this drug.

Hepatic

Fatal and serious cases of hepatotoxicity have occurred in patients receiving this drug. Cases were consistent with hepatocellular injury (including elevated transaminases and/or bilirubin). Cases have occurred after the first dose of this drug or after drug rechallenge.

Very common (10% or more): Increased ALT (10%)

Common (1% to 10%): Hepatotoxicity, increased AST

Postmarketing reports: Hepatotoxicity

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction (includes, but not limited to, urticaria, angioedema, hypotension, bronchospasm)

Immunologic

Common (1% to 10%): Persistently positive antidrug antibodies

Local

Rare (0.01% to 0.1%): Infusion site extravasation (resulting in related reactions including skin redness, pain, swelling, blistering, exfoliation, cellulitis at/surrounding the infusion site)

Metabolic

Serious events of hyperglycemia (such as new-onset hyperglycemia, exacerbation of preexisting diabetes mellitus, and ketoacidosis [including fatal outcomes]) have been reported in patients treated with this drug. In studies of this drug as monotherapy, hyperglycemia (any grade) occurred in 8% of patients, with 6% having grade 3 or 4 hyperglycemia. The median time to onset for any grade or grade 3 or 4 was 1 month (range: 0 to 10 months). Hyperglycemia occurred more frequently in patients with high body mass index or diabetes.

Very common (10% or more): Decreased appetite (up to 18%), hypokalemia (up to 12%)

Common (1% to 10%): Hyperglycemia (including new-onset hyperglycemia, exacerbation of preexisting diabetes mellitus, ketoacidosis), hyponatremia, dehydration

Uncommon (0.1% to 1%): Tumor lysis syndrome

Postmarketing reports: Hyperglycemia

Musculoskeletal

Very common (10% or more): Bone pain (up to 19%), arthralgia (up to 19%), myalgia (up to 17%), back pain (up to 14%), muscle spasms (up to 11%), pain in extremity (10%)

Nervous system

In studies of this drug as monotherapy, peripheral neuropathy (any grade) was reported in 62% of patients; the median time to onset was 3 months (range: 0 to 12 months). Of the patients who had neuropathy, 62% had complete resolution, 24% had partial improvement, and 14% had no improvement at their last evaluation; the median time from onset to resolution/improvement was 5 months (range: 0 to 45 months). Of the patients with ongoing neuropathy (38%), 71% had grade 1, 24% had grade 2, and 4% had grade 3.

In a study of this drug in combination with AVD, peripheral neuropathy was reported in 67% of patients. The median time to onset of any grade was 2 months (range: 0 to 7 months), of grade 2 was 3 months (range: 0 to 6 months), and of grade 3 was 4 months (range: less than 1 to 7 months). By the time of the primary analysis, 43% of affected patients had complete resolution, 24% had partial improvement, and 33% had no improvement at their last evaluation. The median time from onset to resolution or improvement of any grade was 2 months (range: 0 to 32 months). At the updated analysis of this study, 72% of the patients who reported peripheral neuropathy had complete resolution, 14% had partial improvement, and 14% had no improvement. The median time to partial improvement was 2.9 months (range: less than 1 to 50 months), and the median time to complete resolution was 6.6 months (range: less than 1 to 67 months). Of the patients with ongoing neuropathy (28%), 57% had grade 1, 30% had grade 2, 12% had grade 3, and less than 1% had grade 4.

In a study of this drug in combination with CHP, new/worsening peripheral neuropathy was reported in 52% of patients; by maximum grade, 34% had grade 1, 15% had grade 2, 3% had grade 3, and less than 1% had grade 4. The peripheral neuropathy was primarily sensory (94% sensory, 16% motor) and had a median onset time of 2 months (range: less than 1 to 5 months). At last evaluation, 50% had complete resolution of neuropathy, 12% had partial improvement, and 38% had no improvement. The median time to resolution or improvement overall was 4 months (range: 0 to 45 months). Of patients with ongoing neuropathy (50%), 72% had grade 1, 25% had grade 2, and 3% had grade 3.

In a study of this drug in combination with AVEPC, peripheral neuropathy (any grade) was reported in 20% of pediatric patients; 7% had grade 3 and less than 1% had grade 4. The peripheral neuropathy was primarily sensory (81% sensory, 29% motor).

Fatal cases of John Cunningham virus (JC virus) infection resulting in PML have been reported in patients treated with this drug. First onset of symptoms occurred at various times from the start of therapy, with some cases occurring within 3 months of initial exposure.

Very common (10% or more): Peripheral neuropathy (up to 67%), peripheral sensory neuropathy (up to 65%), peripheral motor neuropathy (up to 23%), headache (up to 19%), dizziness (up to 16%)

Common (1% to 10%): Paresthesia

Uncommon (0.1% to 1%): Demyelinating polyneuropathy

Postmarketing reports: Progressive multifocal leukoencephalopathy (PML)

Other

The most common adverse reactions in clinical studies associated with infusion-related reactions were chills (4%), nausea (up to 4%), dyspnea (up to 3%), pruritus (up to 5%), pyrexia (2%), and cough (2%). Overall, a higher incidence of infusion-related reactions was observed in patients who developed persistently positive antidrug antibodies relative to patients who were transiently positive or negative.

Serious infections and opportunistic infections (such as pneumonia, bacteremia, sepsis/septic shock [including fatal outcomes]) have been reported in patients treated with this drug. The most commonly reported opportunistic infections were herpes zoster and herpes simplex.

Very common (10% or more): Fatigue (up to 49%), pyrexia (up to 38%), asthenia (up to 35%), mucositis (up to 30%), pain (up to 28%), decreased weight (up to 22%), peripheral edema (up to 16%), edema (up to 15%), serious infections (including opportunistic infections; up to 15%), infusion-related reactions (includes anaphylactic reaction, hypersensitivity, drug hypersensitivity, bronchospasm, headache, rash, back pain, vomiting, chills, nausea, dyspnea, pruritus, cough, infusion-site pain, pyrexia, dizziness, extravasation, hypoesthesia, hypoxia; up to 13%), chills (up to 13%), infections (includes sepsis, device-related infection, skin infection, infectious enterocolitis, pneumonia, appendicitis, cellulitis, urinary tract infection, candida infection, mucosal infection, vaginal infection, wound infection, anorectal infection, infective arteritis, bacteremia, catheter site infection, Clostridioides difficile colitis, norovirus gastroenteritis, gingivitis, H1N1 influenza, herpes simplex reactivation, infective myositis, Klebsiella bacteremia, Klebsiella sepsis, meningitis, esophageal infection, oral candidiasis, osteomyelitis, otitis media, septic shock, Serratia infection, sinusitis, soft tissue infection, staphylococcal infection, vulvitis)

Common (1% to 10%): Sepsis, septic shock, herpes zoster

Uncommon (0.1% to 1%): Staphylococcal bacteremia, CMV infection/reactivation

Postmarketing reports: Serious infections, opportunistic infections

Psychiatric

Very common (10% or more): Insomnia (up to 19%), anxiety (up to 11%)

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 47%), cough (up to 25%), dyspnea (up to 19%), oropharyngeal pain (up to 11%)

Common (1% to 10%): Pneumonia, acute respiratory distress syndrome (ARDS), pulmonary embolism, pneumonitis, pneumothorax, noninfectious pulmonary toxicity events (including lung infiltration, pneumonitis, interstitial lung disease), pulmonary toxicity

Uncommon (0.1% to 1%): Pneumocystis jirovecii pneumonia

Postmarketing reports: Noninfectious pulmonary toxicity (including pneumonitis, interstitial lung disease, ARDS)

Fatal and serious events of noninfectious pulmonary toxicity (including pneumonitis, interstitial lung disease, ARDS) have been reported.

Frequently asked questions

References

1. Product Information. Adcetris (brentuximab vedotin). Seagen Inc. 2023;SUPPL-107.

2. Product Information. Adcetris (brentuximab vedotin). Takeda Pharmaceuticals Australia Pty Ltd. 2023;ADCETRIS V11 (CCDS V.

3. Product Information. Adcetris (brentuximab vedotin). Takeda UK Ltd. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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