Amina, treated with ADCETRIS+AVD.
A+AVD (total n = 662), % of patients | ABVD (total n = 659), % of patients | |||||
---|---|---|---|---|---|---|
Adverse reaction | Any Grade | Grade 3 | Grade 4 | Any Grade | Grade 3 | Grade 4 |
Adverse reaction | Grade | Grade | ||||
Any | 3 | 4 | Any | 3 | 4 | |
Blood and lymphatic system disorders | ||||||
Anemia* | 98 | 11 | <1 | 92 | 6 | <1 |
Neutropenia* | 91 | 20 | 62 | 89 | 31 | 42 |
Febrile neutropenia | 19 | 13 | 6 | 8 | 6 | 2 |
Gastrointestinal disorders | ||||||
Constipation | 42 | 2 | - | 37 | <1 | <1 |
Vomiting | 33 | 3 | - | 28 | 1 | - |
Diarrhea | 27 | 3 | <1 | 18 | <1 | - |
Stomatitis | 21 | 2 | - | 16 | <1 | - |
Abdominal Pain | 21 | 3 | - | 10 | <1 | - |
Nervous system disorders | ||||||
Peripheral sensory neuropathy | 65 | 10 | <1 | 41 | 2 | - |
Peripheral motor neuropathy | 11 | 2 | - | 4 | <1 | - |
General disorders and administration site conditions | ||||||
Pyrexia | 27 | 3 | <1 | 22 | 2 | - |
Musculoskeletal and connective tissue disorders | ||||||
Bone pain | 19 | <1 | - | 10 | <1 | - |
Back pain | 13 | <1 | - | 7 | - | - |
Skin and subcutaneous tissue disorders | ||||||
Rashes, eruptions, and exanthems† | 13 | <1 | <1 | 8 | <1 | - |
Respiratory, thoracic, and mediastinal disorders | ||||||
Dyspnea | 12 | 1 | - | 19 | 2 | - |
Investigations | ||||||
Decreased weight | 22 | <1 | - | 6 | <1 | - |
Increased alanine aminotransferase | 10 | 3 | - | 4 | <1 | - |
Metabolism and nutrition disorders | ||||||
Decreased appetite | 18 | <1 | - | 12 | <1 | - |
Psychiatric disorders | ||||||
Insomnia | 19 | <1 | - | 12 | <1 | - |
Serious adverse reactions | A+AVD (n = 662) | ABVD (n = 659) |
---|---|---|
Overall rate | 43% | 27% |
Most common | Febrile neutropenia (17%), pyrexia (7%), neutropenia and pneumonia (3% each) | Febrile neutropenia (7%), pyrexia (4%) |
Dose delays (≥1 drug in 5% of patients) | A+AVD (n = 662) | ABVD (n = 659) |
---|---|---|
Rate due to adverse reaction | Neutropenia (21%), febrile neutropenia (8%) | Neutropenia (15%) |
Dose discontinuation (≥1 drug) | A+AVD (n = 662) | ABVD (n = 659) |
---|---|---|
Overall rate | 13% | 16% |
Rate due to PN | 7% | 2% |
The 3-, 4-, and 5-year data provided are not contained in the approved product labeling.
Data are provided as supportive clinical information.
‡PN is recorded as last observation carried forward.
1
2
3
Early detection and intervention of PN is critical if PN is present
“I find that PN generally resolves over time.”
Dr Andrew Ip, hematologist-oncologist
Start primary prophylaxis with G-CSF beginning with Cycle 1.1
G-PP = G-CSF primary prophylaxis.
This exploratory 6-year analysis was not specified in the protocol, is descriptive in nature, and offers supportive, but not conclusive, results about secondary malignancies reported in ECHELON-1 participants. This analysis was not powered to determine differences between treatment arms.
There was 1 unknown secondary malignancy in the ABVD arm.2
This exploratory 6-year analysis was not specified in the protocol, is descriptive in nature, and offers supportive, but not conclusive, results about pregnancies reported by ECHELON-1 participants or their partners. This analysis was not powered to determine differences between treatment arms. Fertility was not formally assessed.1
Individual female patients or partners of male patients may have recorded multiple pregnancies and multiple pregnancy outcomes.
This exploratory 6-year analysis was not specified in the protocol, is descriptive in nature, and offers supportive, but not conclusive, results about pregnancies reported by ECHELON-1 participants or their partners. This analysis was not powered to determine differences between treatment arms. Fertility was not formally assessed.1
Multiple patients or partners of male patients recorded more than 1 live birth.2
***PN is recorded as last observation carried forward.
This exploratory 6-year analysis was not specified in the protocol, is descriptive in nature, and offers supportive, but not conclusive, clinical information only. This analysis was not powered to determine differences between treatment arms.
This exploratory 6-year analysis was not specified in the protocol, is descriptive in nature, and offers supportive, but not conclusive, results about pregnancies reported by ECHELON-1 participants or their partners. This analysis was not powered to determine differences between treatment arms.
Multiple patients or partners of male patients recorded more than one live birth.2
A+AVEPC: Approved for pediatric patients 2 years and older
Explore Pediatric Safety
BOXED WARNING
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
CONTRAINDICATION
Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
WARNINGS AND PRECAUTIONS
Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS.
Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.
Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.
Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL.
Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.
Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections.
Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures.
Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment.
Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment.
Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.
PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.
Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.
Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.
Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of preexisting diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.
Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS. Advise male patients with female partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS.
ADVERSE REACTIONS
The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.
DRUG INTERACTIONS
Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.
USE IN SPECIAL POPULATIONS
Lactation: Breastfeeding is not recommended during ADCETRIS treatment.
ADCETRIS® (brentuximab vedotin) is indicated for the treatment of:
Previously untreated Stage III/IV cHL
Previously untreated high risk cHL
cHL post-auto-HSCT consolidation
Relapsed cHL
Previously untreated sALCL or other CD30-expressing PTCL
Relapsed sALCL
Relapsed pcALCL or CD30-expressing MF
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