OCTAGAM 5%
What is Octagam 5% indicated for?
PI
What is Octagam 10% indicated for?
Octagam 10% is indicated for adult patients with chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to control or prevent bleeding.
What is the boxed warning for Octagam 10%?
THROMBOSIS
RENAL DYSFUNCTION
ACUTE RENAL FAILURE
What are the indications for Panzyga?
Treatment of PI in patients 2 years of age & older:
Includes CVID, Congenital Agammaglobulinemia, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiences
Treatment of ITP in adults to raise platelet counts to control or prevent bleeding
What is the stabilizer for Panzyga?
Glycine
What is the stabilizer in Octagam 5%?
Maltose
What are the 4 vial size options for Octagam 10%?
2g 20mL
5g 50mL
10g 100mL
20g 200mL
How is Ocatgam 10% (ITP) dosed?
Octagam 10% (ITP) is dosed at a total of 2g/kg body weight divided into 2 doses of 1g/kg body weight given on 2 consecutive days
What is the boxed warning for Panzyga?
THROMBIOSIS
RENAL DYSFUNCTION
ACUTE RENAL FAILURE
In patients with PI, the overall annual rate was _____ SBIs per patient per year (____ infections over 50.2 patient - years)
0.08
4
What is the boxed warning for Octagam 5%?
THROMBOSIS
RENAL DYSFUNCTION
ACUTE RENAL FAILURE
What is the J Code for Octagam 10%?
J 1568
What was the number of patients that were pre-medicated in the clinical study?
0
What is the half-life of Panzyga?
The mean half-life of about 25-40 days was established for Panzyga when measured in PI patients.
What is the Panzyga dose for PI patients?
Panzyga 10% for PI is dosed at 300-600mg/kg body weight every 3-4 weeks.
What is the rate of administration for infusing Octagam 5%?
First 30 minutes = ____________
Next 30 minutes = ____________
Next 30 minutes = ____________
Maximum = ________________
First 30 minutes = 0.5 mg/kg/min
Next 30 minutes = 1 mg/kg/min
Next 30 minutes = 2 mg/kg/min
Maximum = < 3.33 mg/kg/min
The most common ARs reported in >5% of subjects during a clinical trial were (include rates):
Headache 25%
Fever 15%
Increased Heart Rate 11%
In the clinical study (ITP):
_____% responded with a rise to 5o x 10/L within 7 days of first infusion
Regarding resolution of bleeding at baseline, _____% of subjects had completely resolved by day 7.
82%
78%
What is the 4 letter FDA assigned code that is attached to the Panzyga label?
-ifas
What is Panzyga dose for patients with ITP?
Panzyga 10% for patients with ITP is dosed at a total of 2g/kg divided into 2 doses of 1g/kg given on 2 consecutive days
What are the vial sizes for Octagam 5%?
1g
2.5g
5g
10g
25g
Explain the Octagam 10% Clinical Study:
# of Patients __________
Platelet count was _______/L or less
Dose utilized was _________
Primary Endpoint: _______________________
Secondary Endpoint: _____________________
116 patients with newly diagnosed ITP or chronic ITP
Platelet count was 20 X 109/L or less
Dose utilized: 2g/kg administered as 2 1g/kg doses given on 2 consecutive days
Primary Endpoint: 54 of 66 (82%) responded with a rise to 50 X 109/L within 7 days of infusion
Secondary Endpoint: 35 of 45 (78%) of subjects had bleeding completely resolved by day 7
What are the infusion rates of administration for Octagam10%?
First 30 minutes = ____________
Next 30 minutes = ____________
Next 30 minutes = ____________
Next 30 minutes = ____________
Maximum = _____________
Octagam 10% infusion rates:
First 30 minutes = 1 mg/kg/min
Next 30 minutes = 2 mg/kg/min
Next 30 minutes = 4 mg/kg/min
Next 30 minutes = 8 mg/kg/min
Maximum = < or = 12 mg/kg/min
What is the maximum infusion rate for PI patients on Panzyga (as tolerated):
NEW: __________ mg/kg/min
EXPERIENCED: __________mg/kg/min
NEW: 8 mg/kg/min
EXPERIENCED: 12 or 14 mg/kg/min
In the ITP clinical trial, of the 36 subjects in the full analysis set, ____% responded to PANZYGA with a rise in platelet count to at least 50 x 10/L within 7 days after the first infusion.
81%