"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with ADCETRIS.
ADCETRIS (brentuximab vedotin) is indicated for treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.
Systemic Anaplastic Large Cell Lymphoma
ADCETRIS is indicated for treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
DOSAGE AND ADMINISTRATION
General Dosing Information
The recommended dose is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every 3 weeks. The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg.
Do not administer as an intravenous push or bolus.
Continue treatment until disease progression or unacceptable toxicity.
For new or worsening Grade 2 or 3 neuropathy, dosing should be held until neuropathy improves to Grade 1 or baseline and then restarted at 1.2 mg/kg. For Grade 4 peripheral neuropathy, ADCETRIS should be discontinued.
The dose of ADCETRIS should be held for Grade 3 or 4 neutropenia until resolution to baseline or Grade 2 or lower. G-CSF support should be considered for subsequent cycles in patients who experience Grade 3 or 4 neutropenia. In patients with recurrent Grade 4 neutropenia despite the use of G-CSF support, discontinuation or dose reduction of ADCETRIS to 1.2 mg/kg may be considered.
Instructions for Preparation and Administration
Procedures for proper handling and disposal of anticancer drugs should be considered [see REFERENCES].
Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
Calculate the dose (mg) and number of vials of ADCETRIS required. The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg. Reconstitute each 50 mg vial of ADCETRIS with 10.5 mL of Sterile Water for Injection, USP, to yield a single-use solution containing 5 mg/mL brentuximab vedotin. Direct the stream toward wall of vial and not directly at the cake or powder. Gently swirl the vial to aid dissolution. DO NOT SHAKE. Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution should be clear to slightly opalescent, colorless, and free of visible particulates. Following reconstitution, dilute immediately into an infusion bag, or store the solution at 2-8°C (36-46°F) and use within 24 hours of reconstitution. DO NOT FREEZE. Discard any unused portion left in the vial.
Calculate the required volume of 5 mg/mL reconstituted ADCETRIS solution needed and withdraw this amount from the vials. The dose for patients weighing greater than 100 kg should be calculated based on a weight of 100 kg. Immediately add the reconstituted solution to an infusion bag containing a minimum volume of 100 mL to achieve a final concentration of 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin. ADCETRIS can be diluted into 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection. Gently invert the bag to mix the solution. ADCETRIS contains no bacteriostatic preservatives. Following dilution, infuse the ADCETRIS solution immediately, or store the solution at 2-8°C (36-46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.
Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.
Dosage Forms And Strengths
ADCETRIS (brentuximab vedotin) for Injection single-use vial containing 50 mg of brentuximab vedotin as a sterile, white to off-white lyophilized, preservative-free cake or powder.
Storage And Handling
ADCETRIS (brentuximab vedotin) for Injection is supplied as a sterile, white to off-white preservative-free lyophilized cake or powder in individually-boxed single-use vials:
NDC (51144-050-01), 50 mg brentuximab vedotin.
Store vial at 2-8°C (36-46°F) in the original carton to protect from light.
ADCETRIS is an antineoplastic product. Follow special handling and disposal procedures1.
1. OSHA Hazardous Drugs. OSHA. [Accessed on 30 July 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
Manufactured by: Seattle Genetics, Inc. Bothell, WA 98021 1-855-473-2436. Revised: 8/2013
Last reviewed on RxList: 9/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Adcetris Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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