ADCETRIS Brentuximab Vedotin Application Scope

An antibody-drug conjugate (ADC) targeting CD30, used for treating various types of lymphomas. Its approved indications include:

Classical Hodgkin Lymphoma (cHL): Previously untreated Stage III/IV cHL in adults (in combination with chemotherapy); cHL in adults post-autologous hematopoietic stem cell transplantation (ASCT) consolidation or after failure of ASCT or multi-agent chemotherapy; high-risk cHL in children ≥2 years old (in combination with chemotherapy).
Systemic Anaplastic Large Cell Lymphoma (sALCL): Previously untreated sALCL or other CD30-positive Peripheral T-Cell Lymphoma (PTCL) in adults (in combination with chemotherapy); Relapsed or refractory sALCL in adults.
Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) or CD30-expressing Mycosis Fungoides (MF): In adults who have received prior systemic therapy.
Relapsed or Refractory Large B-Cell Lymphoma (LBCL): In adults who have received at least two prior lines of systemic therapy and are not candidates for autologous HSCT or CAR-T cell therapy (in combination with lenalidomide and rituximab)

brentuximab vedotin

ADCETRIS Brentuximab Vedotin Characteristics

Ingredients: Brentuximab Vedotin
Properties: Targets CD30-positive tumor cells, internalized and releases MMAE inside the cell to induce apoptosis
Packaging Specification:Supplied as single-dose vials:50 mg lyophilized powder
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). Keep the vial in the original outer carton to protect from light. Do not freeze. Do not shake the reconstituted or diluted solution
Expiry Date: Refer to the expiration date on the vial and packaging.
Executive Standard: Manufactured according to applicable Good Manufacturing Practice (GMP) standards and approved biologics regulations.
Approval Number: Vary by country/region
Date of Revision: Please refer to the latest official prescribing information for the most recent revision date.
Manufacturer: Pfizer (for US HCP materials); co-marketed by Seattle Genetics / Millennium outside the US

Guidelines for the Use of ADCETRIS Brentuximab Vedotin

Dosage and Administration:
- Recommended Dose:
  - For most indications: 1.8 mg/kg (maximum 180 mg per dose) administered intravenously every 3 weeks.
  - For previously untreated Stage III/IV cHL (with AVD): 1.2 mg/kg (maximum 120 mg per dose) administered intravenously every 2 weeks.
  - Dosing continues until disease progression, unacceptable toxicity, or for a maximum number of cycles (e.g., up to 16 cycles for consolidation therapy post-ASCT in cHL). Dose adjustments are required for hepatic impairment, neutropenia, or peripheral neuropathy.
- Administration: IV infusion over 30 minutes. Use dedicated line; do not use as a push or bolus; do not mix with other drugs
- Missed Dose: Management of a missed dose should be discussed with a healthcare provider. Do not administer two doses simultaneously to make up for a missed dose.
Adverse Reactions:
- Common Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory infection, fever, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, febrile neutropenia.
- Serious Adverse Reactions:Peripheral motor neuropathy, pulmonary toxicity, pulmonary embolism, septic shock, arrhythmias, serious infections, PML, Stevens-Johnson syndrome, tumor lysis syndrome
Contraindications:Co-administration with bleomycin due to risk of pulmonary toxicity
Precautions:
- Monitor for peripheral neuropathy; dose adjustments recommended.
- Monitor CBC, infection signs, liver enzymes, pulmonary signs, dermatological reactions, tumor lysis, hyperglycemia.
- Warning for PML (black-box)—pts may develop serious brain infection; discontinue if symptoms occur.
- Not recommended during breastfeeding. Contraception advised (females: during + 2 months after; males: during + 4 months after).

ADCETRIS Interactions

Strong CYP3A4 Inhibitors (e.g., ketoconazole): May increase the exposure and toxicity of MMAE (the cytotoxic component). Monitor closely for adverse reactions.
Strong CYP3A4 Inducers (e.g., rifampin): May decrease the exposure and efficacy of MMAE. Consider alternative medications.
Bleomycin: Concomitant use is contraindicated due to increased risk of pulmonary toxicity.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.