Parenteral Manual

Nimotuzumab (SPECIAL ACCESS PROGRAM)

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): 
CIMAher, TheraCIM h-R3, Theraloc
Classification: 
Monoclonal antibody targeting human Epidermal Growth Factor Receptor (EGFR)
Original Date: 
January 2016
Indications: 
  • Investigational for Diffuse Intrinsic Pontine Glioma (DIPG) in children
Reconstitution and Stability: 
  • Available as 5 mg/mL preservative-free injectable solution in vial of 10 mL (50 mg/10mL)
  • Store vials in refrigerator (2 - 8C)
  • Dilute in 0.9% NaCl for a final concentration of 1 mg/mL; DO NOT SHAKE, invert gently to mix
  • Diluted solution stable for 6 hours at room temperature or for 12 hours at 2 - 8 C
  • Protect from light
Compatibility: 

- Solutions Compatible: 0.9% NaCl only

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

- Y-site Compatible: Do not run with 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 Direct NO
IV Intermittent Infusion YES - use a 0.22 um low-protein binding filter
Usual dilution: 1 mg/mL diluted in 0.9% NaCl
Infusion time: over 30 - 60 minutes
IV Continuous Infusion NO

 

Dosage: 

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

  • Pediatric DIPG (investigational): 150 mg/m2 IV once weekly x 8 weeks, then every 2 weeks x 10 weeks
Potential hazards of parenteral administration: 
  • More frequent: Erythema, fatique, leukopenia, thrombocytopenia, anemia, nausea, vomiting, headache, elevated ALT & AST, rash, fever
  • Less frequent/rare: Hypo- or hyperkalemia, mucositis, seizures, hypo- or hyperthermia, anaphylaxis, bronchospasm, chills, hyper- or hypotension, hyperpigmentation, sleepiness, disorientation, myalgia, motor dysphasia, incoherent language, buccal dryness, face reddening, weakeneing of lower limbs, phlebitis, increase creatinine, thoracic pain, peribuccal cyanosis
Notes: 
  • Pre-medicate with diphenhydrAMINE (Benadryl)
  • Monitor vital signs pre-infusion, every 30 minutes during infusion and 1 hour post-infusion. Patient should be monitored for a least 1 hour following end of infusion. Have epinephrine, diphenhydramine and hydrocortisone available at bedside
  • Monitor (baseline and every 3 months): CBC with differential, serum creatinine, BUN, LFTs, electrolytes (including Mg, Ca, Phos)
  • Consider cardiac (ECG) and renal function monitoring for patients receiving more than 40 doses) every 3 months
References: 

Saurez-Martinez G et al. Nimotuzumab, effective immunotherapy for the treatment of malignant epithelial tumors. Biotecnología Aplicada 2014;31:159-167

InnoCIMAb PTE LTD. Investigator’s Brochure. Nimotuzumab:
Humanized Monoclonal Antibody Targeting the Epidermal Growth Factor Receptor (EGFR). Edition Number: Version 15. Release Date: May 29th, 2015

Bartels U et al. Phase 2 study of safety and efficacy of nimotuzumab in pediatric patients with progressive diffuse intrinsic pontine glioma Neuro-Oncology. 2014:16(11):1554–1559

Massimino M. et al. Nimotuzumab for pediatric diffuse intrinsic pontine gliomas

Expert Opin. Biol. Ther. 2011:11(2):247-256

Product information. Biomab. Biocon India. (for stability)

The information contained on this website is provided for informational purposes only, as a guide to assist physicians, nurses and other healthcare providers in deciding on the appropriate care required for a particular patient. At all times, physicians, nurses and other healthcare providers must exercise their independent clinical judgment, based on their knowledge, training and experience, taking into account the specific facts and circumstances of each patient, when deciding on the appropriate course of investigation and/or treatment to recommend in a particular clinical situation.

CHEO has made every effort to ensure that the information contained on this website is as current and accurate as possible. However, changes can occur due to ongoing research and the constant influx of new information. Where possible, hospitals and healthcare practitioners should verify the information before acting on it.

Reliance on any information in this website is at the user's own risk. CHEO is not responsible or liable for any harm, loss or other consequences from the use or misuse of the information on this website.