Parenteral Manual

Brentuximab vedotin (SGN35) (NON-FORMULARY or INVESTIGATIONAL)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
ADCETRIS
Classification: 
Anti-CD30 antibody-drug conjugate - CYTOTOXIC
Original Date: 
May 2015
Indications: 
  • Hodgkin's Lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates
  • Systemic anaplastic large cell lymphoma after failure of at least one multi-agent chemotherapy regimen
  • For investigational use in combination with gemcitabine in pediatrics and young adults with relapsed or refractory Hodgkin's Lymphoma

    THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 
  • available as a sterile, white to off-white preservative-free lyophilized cake or powder in single-use vials containing 50 mg of brentuximab vedotin per vial
  • Store unreconstituted vial in refrigerator. Do not freeze. Protect from light. Do not shake
  • Reconstitute vial with 10.5 mL of Sterile water for Injection. Swirl vial gently; do not shake. Final concentration is 5 mg/mL
  • Allow reconstituted vials to settle for one minute to eliminate bubbles. Solution should be colourless, clear or slightly opalescent and particle-free. Store reconstituted vial in the refrigerator and protect from light if not used immediately.  Discard reconstituted vial after 8 hours.
  • The prepared IV bag must be used within 24 hours of initial product reconstitution and stored in the refrigerator. Protect from light. Gently invert IV bag to mix.
Compatibility: 

-Solution Compatible: 0.9% NaCl, D5W, Lactated Ringer's

-Additives/Above Cassette Compatible:  Do not mix with other drugs or IV solutions

-Y-site Compatible: Do not run with other drugs

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Direct NO
IV Intermittent Infusion YES, over 30 minutes
Usual Dilution: Dilute in 100 mL 0.9% NaCl (usual concentration: 0.4 - 1.8 mg/mL)
Do not administer with in-line filters
IV Continuous Infusion NO

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • 1.8 mg/kg/dose (Maximum 180 mg/dose) every 21 days
Potential hazards of parenteral administration: 
  • Common (greater than 20%): diarrhea, nausea, fatigue, fever, neutropenia, peripheral sensory neuropathy
  • Occasional (less than or equal to 20%): anemia, constipation, vomiting, chills, periperal edema, infusion related reaction, thrombocytopenia, arthralgia, myalgia, headache, dizziness, periperal motor neuropathy, cough, dyspnea, alopcia, pruritus, maculo-papular rash, febrile neutropenia
  • Rare, but serious (less than 3%): pancreatitis, anaphylaxis, tumour lysis syndrome, progressive multifocal leukoencephalopathy, pneumonitis (when administered with bleomycin), Stevens-Johnson syndrome
  • Extravasation potential: none
Notes: 
  • Brentuximab vedotin is a substrate of CYP 3A4 with potential for drug interactions. Please consult oncology pharmacy for concerns with drug interactions
  • Premedication is generally not requied unless patient has previously experienced an infusion-related reaction to brentuximab vedotin
  • Infusion reactions can be immediate or delayed up to 2 days following the infusion.  Subsequent infusions should be discontinued or given with premedication dependant on the severity of the reaction
  • Brentuximab vedotin is both renally and hepatically eliminated

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