Parenteral Manual

KRN23 (STUDY DRUG)

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.

Classification: 
Recombinant Human IgG1 Monoclonal Antibody
Original Date: 
April 2017
Indications: 
  • Treatment of X-linked Hypophosphatemia (XLH)
  • Treatment of osteomalacia associated with Tumor Induced Osteomalacia (TIO) / Expidermal Nevus Syndrome (ENS)
Reconstitution and Stability: 
  • Available as 10 mg/ml (1 mL vial) and 30 mg/mL (1 mL vial)
  • Store vials in refrigerator between 2˚ - 8˚C, DO NOT FREEZE
  • Warm vials to room temperature ( about 30 minutes)
  • Avoid foaming.  Do not shake
  • Use same date as prepared
  • Sterile, clear, colorless, and preservative free solution
  • Protect from light
Compatibility: 

Not applicable

Administration: 

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

SC YES
Maximum Volume: 1.5 mL
IM NO
IV Direct NO
IV Intermittent Infusion NO
IV Continuous Infusion NO

 

Dosage: 

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

Pediatric:

  • 0.8 mg/kg subcutaneously every 2 weeks x 64 weeks (study duration)
  • Dose may be increased to 1.2 mg/kg at any time during study if subject meets the following dose-adjustment criteria;
    -  Two consecutive serum phosphorus measurements are below the normal range
    -  Serum phosphorus has increased by less than 0.5 mg/dL from baseline; and
    -  Subject has not missed a dose of study drug that would account for the decrease in serum phosphorus
Potential hazards of parenteral administration: 
  • Gastrointestinal Disorders:  vomiting (33%), upper abdominal pain (19%), diarrhea (11%)
  • Injection site reaction (36%)
  • Arthralgia (19%)
  • Headache (39%)
  • Rash (11%)

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