Welcome to our latest edition of the Guidelines+ Monographs Series, where we delve into the medication brentuximab vedotin, marketed under the brand name Adcetris® by Pfizer. Adcetris is a CD30-directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, mycosis fungoides, and large B-cell lymphoma. It was initially approved in 2011.
In the following sections, we will provide a comprehensive overview of faricimab-svoa and analyze its positioning across various guidelines for its approved indications.
Note* - This Guidelines+ Monographs for brentuximab vedotin (Adcetris) is current as of March 2025. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
- Brand name: Adcetris
- Generic name: brentuximab vedotin
- Manufacturer(s): Pfizer
- Initial FDA Approval: August 2011
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age | Date Approved |
|---|---|---|---|
| Hodgkin lymphoma (cHL) | Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine | Adult | March 20, 2018 |
| Hodgkin lymphoma (cHL) | Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide | Pediatric - 2 years of age and older | November 10, 2022 |
| Hodgkin lymphoma (cHL) | Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation | Adult | August 19, 2011 |
| Hodgkin lymphoma (cHL) | Adult patients with classical Hodgkin lymphoma (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 | Adult | August 19, 2011 |
| Systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (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 (NOS), in combination with cyclophosphamide, doxorubicin, and prednisone | Adult | November 16, 2018 |
| Systemic anaplastic large cell lymphoma (sALCL) | Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen | Adult | August 19, 2011 |
| Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) | Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy | Adult | November 9, 2017 |
| Relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL) | Adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for auto-HSCT or CAR T-cell therapy, in combination with lenalidomide and a rituximab product | Adult | February 12, 2025 |
Dosage and Administration
- Administer only as an intravenous infusion over 30 minutes.
- The recommended dosage as monotherapy for adult patients is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks.
- The recommended dosage in combination with chemotherapy for adult patients with previously untreated Stage III or IV cHL is 1.2 mg/kg up to a maximum of 120 mg every 2 weeks for a maximum of 12 doses.
- The recommended dosage in combination with chemotherapy for pediatric patients 2 years and older with previously untreated high risk cHL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for a maximum of 5 doses.
- The recommended dosage in combination with chemotherapy for adult patients with previously untreated PTCL is 1.8 mg/kg up to a maximum of 180 mg every 3 weeks for 6 to 8 doses.
- The recommended dosage in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory LBCL is 1.2 mg/kg up to a maximum of 120 mg every 3 weeks.
- Avoid use in patients with severe renal impairment.
- Reduce dose in patients with mild hepatic impairment; avoid use in patients with moderate or severe hepatic impairment.
Dosage Forms and Strengths
- For injection: 50 mg lyophilized powder in a single-dose vial.
Contraindications
- Concomitant use with bleomycin due to pulmonary toxicity.
Warnings and Precautions
- Peripheral neuropathy: Monitor patients for neuropathy and institute dose modifications accordingly.
- Anaphylaxis and infusion reactions: If an infusion reaction occurs, interrupt the infusion. If anaphylaxis occurs, immediately discontinue the infusion.
- Hematologic toxicities: Monitor complete blood counts. Monitor for signs of infection. Manage using dose delays and growth factor support.
- Serious infections and opportunistic infections: Closely monitor patients for the emergence of bacterial, fungal or viral infections.
- Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor or high tumor burden.
- Hepatotoxicity: Monitor liver enzymes and bilirubin.
- Pulmonary toxicity: Monitor patients for new or worsening symptoms.
- Serious dermatologic reactions: Discontinue if Stevens-Johnson syndrome or toxic epidermal necrolysis occurs.
- Gastrointestinal complications: Monitor patients for new or worsening symptoms.
- Hyperglycemia: Monitor patients for new or worsening hyperglycemia. Manage with anti-hyperglycemic medications as clinically indicated.
- Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Reactions/Side Effects
- The most common adverse reactions (≥20%) are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash.
- The most common laboratory abnormalities (≥20%) are decreased neutrophils, increased creatinine, decreased hemoglobin, decreased lymphocytes, increased glucose, increased alanine aminotransferase (ALT), and increased aspartate aminotransferase (AST).
Drug Interactions
Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use In Specific Populations
- Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased.
- Lactation: Advise women not to breastfeed.
Now that we’ve covered the basic monograph information for Adcetris, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Brentuximab Vedotin in the Guidelines
| Society | Publication Date | Guideline | Recommendation | Strength of Recommendation |
|---|---|---|---|---|
| National Comprehensive Cancer Network (NCCN) | January 30, 2025 | Guidelines for Hodgkin Lymphoma | Brentuximab vedotin is recommended for treatment of relapsed/refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplantation (auto-HSCT) or after failure of two prior chemotherapy regimens in patients who are not candidates for auto-HSCT. | Category 1 (Strong, evidence-based recommendation) |
| American Society of Clinical Oncology (ASCO) | July 13, 2020 | Antiemetics in Cancer Treatment | Recommend the use of antiemetics for patients receiving chemotherapy (e.g., for Hodgkin lymphoma), with a focus on high emetic risk regimens. Specific guidelines for antiemetic regimens are provided based on chemotherapy type. | Level 1A (Strong recommendation based on high-quality evidence) |
| American Society for Transplantation and Cellular Therapy (ASTCT) | February 1, 2019 | Maintenance Therapies for Hodgkin and Non-Hodgkin Lymphomas After Autologous Transplantation | For patients with Hodgkin lymphoma who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT), consider the use of maintenance therapies (e.g., Brentuximab vedotin) as part of the post-transplant management for consolidation in high-risk patients. | Level II (Recommendation based on expert opinion or clinical consensus) |
| American Society for Transplantation and Cellular Therapy (ASTCT) | March 14, 2015 | Role of Cytotoxic Therapy with Hematopoietic Cell Transplantation in the Treatment of Hodgkin Lymphoma | Cytotoxic chemotherapy combined with hematopoietic cell transplantation is a key therapeutic strategy for Hodgkin lymphoma, especially in relapsed/refractory cases. Maintenance with agents like Brentuximab vedotin may be considered based on patient risk profile. | Level II (Recommendation based on expert opinion or clinical consensus) |
This concludes our Guidelines+ Monographs for brentuximab vedotin (Adcetris). This list is current as of March 2025, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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