Adults with
Previously untreated
Stage III/IV cHL
Safety
Amina, treated with ADCETRIS+AVD.
Available on this page:
Most Common Adverse Events
ADCETRIS+AVD has a well-established safety profile
Adverse reactions reported in ≥10% of ECHELON-1 patients treated with A+AVD at primary analysis1
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 | - |
SARs, Discontinuations, Deaths
Serious adverse reactions, dose discontinuations, and on-study deaths
Febrile neutropenia and pyrexia were the most common
serious adverse reactions in both arms1,8
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%) |
Neutropenia was the most common reason for dose delay in both arms1,8
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%) |
Rates of dose discontinuation1,8
Dose discontinuation (≥1 drug) | A+AVD (n = 662) | ABVD (n = 659) |
|---|---|---|
Overall rate | 13% | 16% |
Rate due to PN | 7% | 2% |
On-study deaths§1,8
- A+AVD: 9 on-study deaths (7 due to neutropenia; none of these patients had received G-CSF prior to developing neutropenia)¶
- ABVD: 13 on-study deaths (11 due to pulmonary-related toxicity)**
Peripheral Neuropathy (PN) Resolution Rates
Peripheral neuropathy was identifiable, manageable, and resolved in most cases within 6 years1
The 3-, 4-, and 5-year data provided are not contained in the approved product labeling.
Data are provided as supportive clinical information.
PN in patients treated with A+AVD in ECHELON-1 at 2 years1,3
-
67% (442/662) experienced PN
- Grade 1 or 2: 56% (372/662)
- ≥Grade 3: 11% (70/662)
-
Median time to onset (range)
- Any grade: 2 months (0-7)
- Grade 2: 3 months (0-6)
- Grade 3: 4 months (<1-7)
- 7% (44/662) discontinued due to PN
PN in patients treated with A+AVD in ECHELON-1 at 6 years1
-
Median time to partial improvement (range)
- 2.9 months (<1-50)
-
Median time to complete improvement (range)
- <6.6 months (<1-67)
‡PN is recorded as last observation carried forward.
Address PN as early as possible with dose modifications
Recommended dose: 1.2 mg/kg up to a maximum of 120 mg§ in combination with AVD every 2 weeks until a maximum of 12 doses, disease progression, or unacceptable toxicity1
Please see all additional dosing modifications
Patients who develop PN may be able to receive 6 full cycles of treatment with dose modifications1
1
Identify Symptoms
- Early identification and patient education of PN signs and symptoms is important. PN may be cumulative1
- Proactively monitor for signs and symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness at every appointment1
2
Communicate Early
- Ask patients to inform their healthcare team as soon as they experience symptoms of PN
- PN was manageable and resolved for the majority of patients who experienced it with A+AVD1
3
Act With Dose Modifications
- Through appropriate dose reduction and/or holding, some patients who develop PN may still receive all 6 cycles of ADCETRIS1
- Grades 2 and 3 PN should be managed with dose modification, and Grade 4 PN should be managed with dose discontinuation1
Early detection and intervention of PN is critical if PN is present
Peer perspective on long-term safety
“Clear communication is key to detecting peripheral neuropathy early.”
Dr. Adam Foreman, hematologist-oncologist
G-CSF Primary Prophylaxis
Starting G-CSF primary prophylaxis beginning with Cycle 1 of A+AVD may reduce risk of neutropenia1,3,8
- After 75% of patients had started treatment, G-CSF primary prophylaxis was recommended with A+AVD, as observed rates of neutropenia and febrile neutropenia were higher than anticipated1
Start primary prophylaxis with G-CSF beginning with Cycle 1.1
G-PP = G-CSF primary prophylaxis.
View monitoring and dose modifications for neutropenia1
- 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
- Monitor complete blood counts prior to each dose of ADCETRIS
- Monitor more frequently for patients with Grade 3 or 4 neutropenia
- Monitor patients for fever
- Neutropenia led to dose delays of ≥1 drug in 21% of patients; febrile neutropenia led to dose delays in 8% of patients
Please refer to recommended dosing information
Secondary Malignancies
Secondary malignancies among patients treated with A+AVD vs ABVD
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
Additional Data
Pregnancies among patients treated with A+AVD vs ABVD, or their partners§§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.
Live births among patients treated with A+AVD vs ABVD, or their partners¶¶
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
- Per the ECHELON-1 study protocol, female patients who were both lactating and breastfeeding or who had a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before the first dose of study drug were excluded from the study9
- In summary, female patients were advised to avoid pregnancy, and male patients were advised to use effective methods of contraception.9 It is unknown how many study participants intended to or tried to have children. It is also unknown whether all pregnancies/births were reported
- ADCETRIS can cause fetal harm based on findings from animal studies and the drug’s mechanism of action1
- Verify the pregnancy status of females of reproductive potential prior to initiating ADCETRIS therapy1
- 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 ADCETRIS1
- Advise females to immediately report pregnancy1
- ADCETRIS may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities1
- Advise male patients with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS1
AYA Subgroup Analysis
PN incidence and resolution over 6 years (AYA population)***10
Additional safety data for AYA patients at 6 years
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.
Female patients or partners of male patients reported pregnancies at 6 years†††2,10
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
- Fertility was not formally assessed1
- Per the ECHELON-1 study protocol, female patients who were both lactating and breastfeeding or who had a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before the first dose of study drug were excluded from the study9
- In summary, female patients were advised to avoid pregnancy, and male patients were advised to use effective methods of contraception.9 It is unknown how many study participants intended to or tried to have children. It is also unknown whether all pregnancies/births were reported
- ADCETRIS can cause fetal harm based on findings from animal studies and the drug’s mechanism of action1
- Verify the pregnancy status of females of reproductive potential prior to initiating ADCETRIS therapy1
- 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 ADCETRIS1
- Advise females to immediately report pregnancy1
- ADCETRIS may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities1
- Advise male patients with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS1
Important Safety Information
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.
Please see full Prescribing Information, including BOXED WARNING, for ADCETRIS.
Indications
ADCETRIS® (brentuximab vedotin) is indicated for the treatment of:
Previously untreated Stage III/IV cHL
- Adult patients with previously untreated Stage III/IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.
Previously untreated high risk cHL
- Pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.
cHL post-auto-HSCT consolidation
- Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Relapsed cHL
- Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
Previously untreated sALCL or other CD30-expressing PTCL
- Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
Relapsed sALCL
- Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
Relapsed pcALCL or CD30-expressing MF
- Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Please see full Prescribing Information, including BOXED WARNING, for ADCETRIS.
- References:
- 1. ADCETRIS Prescribing Information. Bothell, WA: Seagen Inc.
- 2. Ansell SM, Radford J, Connors JM, et al. Overall survival with brentuximab vedotin in Stage III or IV Hodgkin’s lymphoma. N Engl J Med. 2022;387:310-320.
- 3. Connors JM, Jurczak W, Straus DJ, et al. Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin’s lymphoma. N Engl J Med. 2018;378:331-344.
- 4. Straus DJ, Długosz-Danecka M, Connors JM, et al. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021;8:e410-e421.
- 5. Bartlett NL, Straus DJ, Długosz-Danecka M, et al. Brentuximab vedotin with chemotherapy for Stage III/IV classical Hodgkin lymphoma (cHL): 4-year update of the ECHELON-1 Study. Poster presented at: 61st Annual Meeting of the American Society of Hematology; December 7-10, 2019; Orlando, FL.
- 6. Straus DJ, Długosz-Danecka M, Alekseev S, et al. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020;135:735-742.
- 7. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). v5.0. Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf. Accessed July 14, 2023.
- 8. Data on file. Seagen Inc.
- 9. Connors JM, Jurczak W, Straus DJ, et al. Protocol for: Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin’s lymphoma. N Engl J Med. 2018;378:331-344.
- 10. Crosswell HE, LaCasce AS, Bartlett NL, et al. Brentuximab vedotin with chemotherapy in adolescents and young adults with stage III or IV classical Hodgkin lymphoma in ECHELON-1. Haematologica. 2023;10.3324. doi: 10.3324/haematol.2023.283303
Important Safety Information
Indications
Indications and Important Safety Information
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.
Please see full Prescribing Information, including BOXED WARNING, for ADCETRIS.
Indications
ADCETRIS® (brentuximab vedotin) is indicated for the treatment of:
Previously untreated Stage III/IV cHL
- Adult patients with previously untreated Stage III/IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.
Previously untreated high risk cHL
- Pediatric patients 2 years and older with previously untreated high risk cHL, in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.
cHL post-auto-HSCT consolidation
- Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Relapsed cHL
- Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
Previously untreated sALCL or other CD30-expressing PTCL
- Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
Relapsed sALCL
- Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
Relapsed pcALCL or CD30-expressing MF
- Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Please see full Prescribing Information, including BOXED WARNING, for ADCETRIS.
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