Dosing and Administration
What is the recommended starting dose of Parsabiv?
5mg administered IV Bolus 3x a week at the end of hemodialysis
What is the effective half life?
3-4 days
What is the primary endpoint of each placebo controlled study?
Proportion of patients with a greater than 30% reduction in PTH levels from baseline
In the combined placebo controlled trials, how long were reductions in PTH, corrected calcium and phosphorus maintained with the Parsabiv treated group?
78 weeks
What is the contraindication?
Patients with known sensitivity to etelcalcetide or any of its excipients
What is the lowest maintenance dose used to treat secondary hyperparathyroidism in adults with CKD on dialysis?
2.5mg 3 x a week
When is the steady state reached after 3 days a week IV dosing at the end of each 3 to 6 hour Hemodialysis session in CKD patients on Parsabiv?
7-8 weeks
What was the average dose of Parsabiv in the combined placebo controlled studies?
7.5mg 3 x a week
What was the PTH target in the Placebo controlled trials?
300 or less
What is the highest temperature Parsabiv should be exposed?
77F 25C
What is the Parsabiv dosing recommendation when corrected calcium levels decrease below the lower limit of normal and greater than or equal to 7.5mg with or without symptoms of hypocalcemia?
Discontinue or decrease the dose of Parsabiv
What is the MOA?
Calcimimetic agent modulator of the calcium sensing receptor. Etelcalcetide binds to the calcium sensing receptor and enhances activation of the receptor by extracellular calcium. Activation decreases PTH
What was the total numbers of patients enrolled in studies 1 and 2?
1023
508
515
What was the average duration patients were on hemodialysis prior to study entry in each of the placebo controlled trials 1 and 2?
1-5.5 yrs
2-5.4 yrs
Has the safety and efficacy of Parsabiv been established in pediatric patients?
No
How is Parsabiv supplied?
2.5mg
5mg
10mg
single dose vial clear and colorless
How is Parsabiv metabolized?
Not by CYP450 enzymes. Etelcalcetide is biotransformed in blood by reversible disulfide exchange with endogenous thiols to predominantly form conjugates with serum albumin.
What is the % change from baseline in corrected calcium in the Parsabiv group of each of the placebo controlled study 1 and 2?
1-9.6
2-9.7
What are the mean baseline PTH levels in the Parsabiv group in each of the placebo controlled study 1 and 2?
1-834.2
2-848.4
What % of Parsabiv treated and placebo treated patients required hospitalization for heart failure?
2% Parsabiv vs 1% Placebo
How much saline should be administered if giving Parsabiv during rinse back?
150ml
What is the hemp clearance value of Parsabiv?
7.66
What percentage of Parsabiv treated study subjects tested positive for the binding antibody?
7%
What Adverse Events have been reported in less than 5% of patients in the Parsabiv group in the placebo controlled trials?
Hyperkalemia, hospitalization for heart failure, myalagia, hypophophatemias
For patients with a history of QT prolongation, what action should be taken regarding Parsabiv?
Closely monitor corrected calcium and QT interval in patients at risk receiving Parsabiv