Parenteral Manual

Hu 14.18-IL2 Fusion Protein (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): 
EMD 273063, BB-IND -9798
Classification: 
Immunocytokine, Monoclonal antibody-cytokine fusion protein
Original Date: 
December 2005
Revised Date: 
Indications: 
  • Investigational (Phase II) immunotherapy for recurrent or refractory neuroblastoma (COG Protocol ANBL0322)

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 2mg/2mL frozen clear solution (final concentration 1 mg/mL)
  • Store in the freezer (-10 to -30 oC) until required for use
  • PHARMACY; please use compounding worksheet to prepare dose
  • Thaw at room temperature, which may take up to an hour. After thawing, mix gently by inverting the vial 10 times. DO NOT shake or handle roughly
  • Remove 2.5 mL plus the equivalent volume of Hu 14.18-IL2 from an exact volume 250 mL NS bag. Add 2.5 mL (0.625 g) of 25 % albumin to the bag of NS. Mix gently. Use a 18 gauge needle to transfer drug to 250 mL of NS containing 0.625 g of albumin. Administer as soon as possible after dilution. This solution is stable up to 12 hours at room temperature (including infusion time)
  • Remove headspace air from infusion bag for transport
  • DO NOT use a filter in dose preparation or an in-line filter during administration
  • Do not use if product has aggregated or precipitated
  • Protect from light and heat
  • Do not mix in glass infusion bottles
Compatibility: 

- Solutions Compatible: NS and albumin ONLY

- No other compatibility known. Run in dedicated line

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

For COG protocol ANBL0322;

Infusion rate: 62.5 mL/hour

Infusion time: 4 hours
IV Continuous Infusion NO

 

Dosage: 

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

  • For COG Protocol ANBL0322, 12 mg/m2/day for 3 days every 4 weeks for a maximum of 10 courses
Potential hazards of parenteral administration: 

- More Common: fever, chills/rigors, nausea, vomiting, diarrhea, hypotension, urticaria, pruritus, erythema, muscle and/or  joint pain, headache, tachycardia, fluid retention, hypoalbuminemia, anemia, nephrotoxicity, fatigue, cough, diaphoresis, flushing

- Occasional: confusion, anorexia, dyspnea, urine retention, hyperglycemia, hypomagnesia, hypocalcemia, hypophosphatemia, hyponatremia, serum sickness, thrombocytopenia

- Rare: anaphylaxis, cardiopulmonary arrest, proteinuria, severe hypo/hypertension, hypoglycemia, paresthesia, blurred vision, capillary leak syndrome

- Treatment for unusual side effects are available through the study chair identified on the front page of the protocol and/or pharmacy

Notes: 
  • Study recommends premedication with indomethacin as long as platelet count is >50 and serum creatinine has not increased >50% above baseline
  • If previous reaction,  premedicate with acetaminophen, diphenhydramine (Benadryl) and ranitidine
  • Anaphylactic precautions (monitoring) must be followed as outlined in pre-printed orders and medication available at bedside
  • Cardiac monitoring required during infusion and for approximately 4-5 hour post infusion
References: 

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