Parenteral Manual

Epratuzumab (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): 
hLL2IgG1, humanized LL2
Classification: 
Humanized monoclonal antibody
Original Date: 
March 2008
Indications: 
  • Relapsed and refractory B-cell CD-22 positive malignancies
Reconstitution and Stability: 
  •   Available as 10 mg/mL clear and colourless liquid   ( 17.5 mL / vial)     
  •  Preservative-free   - vials should be used only once.      
  •   Refrigerate vials.        
  •  Do NOT shake vial or solution.
  •  Further diluted solution in NS stable 24 hours at room temperature  
Compatibility: 

-Solution Compatible:  NS only

Incompatible:  Dextrose solutions, DO NOT mix with any other drugs or IV solutions

Administration: 

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

 

SC NO
IM NO
IV Push NO
IV Intermittent Infusion

YES Slow infusion through a 0.22 micron in-line filter

 

Usual dilution: Dilute to a final concentration of 1 mg/mL

 

Infusion time:

·   Start initial infusion at 0.5 mg/kg/hr (max 50 mg/hr) for first hour.  If no hypersensitivity or infusion-related events occur, increase rate in increments of 0.5 mg/kg/hr (max 50 mg/hr), every 30 min to a maximum of 400 mg/hr.  If reaction occurs, stop infusion temporarily and notify physician.  Once patient improves and tumor lysis syndrome and pulmonary infiltrate have been ruled out, re-start at 50% of rate at which reaction occurred and increase rate as directed above as tolerated.

  • Subsequent infusions may be started at 1 mg/kg/hr (max 50 mg/hr) for 1 hr, and increased by 1 mg/kg/hr every 30 min (Max 50 mg/hr), up to 400 mg/hr if tolerated well.
IV Continuous Infusion NO
Dosage: 

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

Pediatric:

  • 360 mg/m2 IV weekly x 4 week

Adult:

  • 120-1000mg/m2 weekly x 4 weeks
Potential hazards of parenteral administration: 
  • Occasional: Infusion reaction (usually associated with first infusion), nausea/vomiting, diarrhea, chills/rigors, back pain, fever, fatigue, headache, dizziness, flu-like symptoms, infection, anxiety, thrombocytopenia (delayed)
  • Rare: Severe allergic reaction, bronchospasm, tachycardia, tachypnea, hypotension, hypertension, flushing, chest pain and abdominal pain

  **For any infusion toxicities,refer to protocol for detailed information on management**

Notes: 
  • Pre-medicate with acetaminophen and diphenhydramine
  • Anaphylactic precautions at bedside
  • Ensure no antihypertensive medication has been taken within 12 hours of beginning the infusion as hypotension may occur
  • Monitor vital signs, including BP: immediately prior to infusion, Q 15 minutes during first hour, Q 30 minutes during second hour and hourly during third hour and until completion of the infusion. Also monitor 30 and 60 minutes post infusion.

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