KRN23 (STUDY DRUG)
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Recombinant Human IgG1 Monoclonal Antibody
- 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
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
Maximum Volume: 1.5 mL
|IV Intermittent Infusion
|IV Continuous Infusion
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- 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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