Reid
Once serum phosphorous is below the reference range in an adult, treatment may be restarted at _____ the initial starting does up to a max of 180 mg administered every 2 weeks
Half
What does the term mesenchymal mean?
Tumor occurring in soft tissue
TIO dosing in Adults
.5 mg/kg rounded to the nearest 10 mg, administered every 4-wk up to a max of 2 mg/kg, not to exceed 180 mg every two weeks
Phosphaturic Means:
Excess phosphates in Urine
Reassess fasting serum phosphorus levels ____ weeks after the dose adjustment
four
Two most common adverse reactions
tooth abscess
muscle spasms
seven percent of patients experience______ reaction in the pooled clinical data
Hyperphosphatemia
safety and effectiveness of Crysvita in pediatric patients two years of age and older with TIO is supported by this
Adult TIO patients
Modeling of PK and PD data from adult and pediatric XLH patients
Every 2 weeks post dose for the first three months and thereafter as appropriate. What should be done?
Measure fasting serum phosphorous levels
How many total patients were in study six and seven?
27 patients
Excess FGF 23 suppresses the re-absorption of _____ and the production of _____ in the kidneys?
phosphate
1,25 dihydroxvitamin D
In study six mineralization lag time decreased in 3 patients by ____%
50%
In study 7 the mean serum phosphorous level increased from 1.62 mg/dL to _____ through week 24
2.63 mg/dL
What does an increase in tracer uptake signal?
presumed nontramatic fractures
pseudo fractures
Study six serum phosphorus levels increased from 1.6 mg/dL @ baseline to _____ @ week 24
2.64 mg/dL
Crysvita is indicated for the treatment of FGF-23 related hypophosphatemia in TIO associated with phosphaturic mesenchymal tumors_______ in adults and pediatric patients two years of age and older.
That can not be curatively resected or localized
How is Crysvita dosed for TIO in pediatric patients 2 years of age to 18?
.4 mg/kg rounded to the nearest 10 mg administered every 2 wks up to a max dose of 2 mgkg not to exceed 180 mg.
What is the max dose of Crysvita in TIO patients?
180 mg every two weeks
How often should fasting serum phosphorus be monitored?
monthly every 2 wks post dose, for the first 3 months and thereafter as appropriate
If a patient undergoes treatment of underlying tumor what should happen with Crysvita treatment?
Interrupted
Serum phosphorous re-assessed after the completion of treatment
Percentage of patients that experienced hypersensitivity in the pooled data
22%
In pooled data______% of patients experienced injection site reactions
15%
What does ADA mean in the Crysvita PI?
Anti-Drug Antibodies
In study 6 and 7 how many weeks was the titration period?
16 wks
In study six how many patients achieved mean serum phosphorous levels above the LLN through wk 24?
50%