adcetris brentuximab vedotin for injection 50mg per vial package

Description

Indication & Scope

Brentuximab Vedotin for Injection (Adcetris®) is a CD30-targeted antibody-drug conjugate (ADC). It consists of chimeric anti-CD30 IgG1 antibody linked to MMAE (microtubule inhibitor). The antibody binds selectively to CD30 on lymphoma cells, delivers MMAE intracellularly to block microtubule assembly and trigger tumor cell apoptosis.

Mechanism
CD30 targeted antibody-drug conjugate (ADC)
Drug class
Prescription ADC Anti-Lymphoma Biotherapy
Clinical use
CD30-positive relapsed/refractory lymphoma

Specification

Generic Name	Brentuximab Vedotin for Injection
Brand Name	Adcetris®
Ingredient	Brentuximab Vedotin
Dosage Form	Injection
Package	50mg/vial
Conditions Treated	Relapsed/refractory systemic anaplastic large cell lymphoma (sALCL); Relapsed/refractory classical Hodgkin lymphoma (cHL); Primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF) after prior systemic therapy
Taboos	Hypersensitivity to brentuximab vedotin or any excipients
Place of origin	Latina Scalo, Italy
Priscription Type	Prescription Drug
Storage Conditions	Store at 2°C–8°C, protected from light. Do not freeze or shake vigorously.
Manufacturer	BSP Pharmaceuticals S.p.A.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	SJ20200008
Approval Date	February 07, 2025
Shelf Life	36 months

How to use ?

Recommended Dose: Monotherapy standard dose: 1.8 mg/kg every 3 weeks. Max calculated dose capped at 180 mg for patients over 100kg. Treatment cycle: Minimum 8 cycles, maximum 16 cycles (around 1 year) for stable/improved relapsed/refractory cHL/sALCL patients; continue until disease progression or intolerable toxicity. Dose adjustment: Dose interruption, reduction or permanent discontinuation based on peripheral neuropathy, hepatotoxicity, neutropenia and pulmonary adverse reactions.

Time: Intravenous infusion over no less than 30 minutes for each administration.

Interaction: No formal drug-drug interaction studies. Avoid concurrent use of strong CYP3A4 inhibitors, which may elevate MMAE exposure. Do not co-infuse with other chemotherapeutics in the same pipeline.

Side effects: Peripheral neuropathy, fatigue, nausea, musculoskeletal pain, constipation, diarrhea, pyrexia, neutropenia, elevated liver transaminases, upper respiratory tract infection, rash, pulmonary toxicity, gastrointestinal complications.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is brentuximab vedotin used for?

Brentuximab vedotin (BV), a potent antibody-drug conjugate, targets the CD30 antigen. Owing to the remarkable efficacy shown in CD30-positive lymphomas.

Does brentuximab cause hair loss?

Hair loss or thinning is another side effect associated with Brentuximab Vedotin.

What should I avoid while on brentuximab?

Grapefruit or grapefruit juice may interact with brentuximab vedotin.

What is the success rate of brentuximab vedotin?

Independent review showed single-agent brentuximab vedotin yielded an ORR of 86% and CR rate of 57% in pivotal trial patients with relapsed/refractory systemic ALCL.