September 2, 2015
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Adcetris

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Adcetris




Indications
Dosage
How Supplied

INDICATIONS

Classical Hodgkin Lymphoma (HL)

ADCETRIS (brentuximab vedotin) is indicated for treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.

Classical Hodgkin Lymphoma (HL) Post-auto-HSCT Consolidation

ADCETRIS is indicated for the treatment of patients with classical HL at high risk of relapse or progression as post-auto-HSCT consolidation [see Clinical Studies].

Systemic Anaplastic Large Cell Lymphoma (sALCL)

ADCETRIS is indicated for treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.

The sALCL indication is approved under accelerated approval based on overall response rate [see Clinical Studies]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE AND ADMINISTRATION

Dosage Recommendations

Administer ADCETRIS as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. See Table 1 for the recommended starting dosage.

For classical HL post-auto-HSCT consolidation treatment, initiate ADCETRIS treatment within 4–6 weeks post-auto-HSCT or upon recovery from auto-HSCT. These patients should continue treatment until a maximum of 16 cycles, disease progression, or unacceptable toxicity.

Table 1: Recommended ADCETRIS Dosage

  Recommended Starting Dosage
Normal renal and hepatic function 1.8 mg/kg up to 180 mg
Renal impairment
  Mild (creatinine clearance > 50-80 mL/min) or moderate (creatinine clearance 30-50 mL/min) 1.8 mg/kg up to 180 mg
  Severe (creatinine clearance less than 30 mL/min) Avoid use [see WARNINGS AND PRECAUTIONS]
Hepatic impairment
  Mild (Child-Pugh A) 1.2 mg/kg up to 120 mg
  Moderate (Child-Pugh B) or severe (Child-Pugh C) Avoid use [see WARNINGS AND PRECAUTIONS]

Dose Modification

Peripheral Neuropathy

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.

Neutropenia

The dose of ADCETRIS should be held for Grade 3 or 4 neutropenia until resolution to baseline or Grade 2 or lower. Consider G-CSF prophylaxis for subsequent cycles in patients who experience Grade 3 or 4 neutropenia in the previous cycle. In patients with recurrent Grade 4 neutropenia despite the use of G-CSF prophylaxis, consider discontinuation or dose reduction of ADCETRIS to 1.2 mg/kg.

Instructions For Preparation And Administration

Administration
  • Administer ADCETRIS as an intravenous infusion only.
  • Do not mix ADCETRIS with, or administer as an infusion with, other medicinal products.
Reconstitution
  • Follow procedures for proper handling and disposal of anticancer drugs [see REFERENCES].
  • Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.
  • Determine the number of 50 mg vials needed based on the patient's weight and the prescribed dose [see Dosage Recommendations].
  • 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 the 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. If not diluted immediately, 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.
Dilution
  • Calculate the required volume of 5 mg/mL reconstituted ADCETRIS solution needed.
  • Withdraw this amount from the vial and immediately add it to an infusion bag containing a minimum volume of 100 mL of 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection to achieve a final concentration of 0.4 mg/mL to 1.8 mg/mL brentuximab vedotin.
  • Gently invert the bag to mix the solution.
  • Following dilution, infuse the ADCETRIS solution immediately. If not used immediately, store the solution at 2–8°C (36–46°F) and use within 24 hours of reconstitution. DO NOT FREEZE.

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 50 mg of brentuximab vedotin as a sterile, white to off-white lyophilized, preservative-free cake or powder in a single-use vial for reconstitution.

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.

Storage

Store vial at 2–8°C (36–46°F) in the original carton to protect from light.

Special Handling

ADCETRIS is an antineoplastic product. Follow special handling and disposal procedures1.

REFERENCES

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: Aug 2015

Last reviewed on RxList: 8/31/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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