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Gammagard PI
Privigen PI
Safety and Tolerability
Grifols Products
Clinical Trials
100
What are Gammagard Liquid's FDA approved Indication(s) and route administration(s)?
- Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. - Subcutaneous Administration or IV Administration
100
What is Privigen's Active Stabilizer?
Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline (a nonessential amino acid) as a stabilizer
100
43.8% of subject reporting temporally associated Adverse events of Headache in an ITP trial
What is Privigen in the Primary Immunodeficiency study?
100
Name 7 brands that Grifols markets in the USA (irrespective of volume load or vial sizes)?
1- Gamunex-C, 2-Flebogamma DIF, 3- Plasbumin, 4- Albutein, 5- Prolastin-C, 6- Thrombate III, 7- Profilnine S/D, 8- Alphanate, 9- Alphanine, 10- Hyperimmunes,
100
How Many patients were in Gammagard Liquids IV Primary Immunodeficiency trial?
61 patients
200
What are Gammagard's approved infusion rates (Initial and Maximum) for IV Administration?
IV- Intial- .008 mL/kg/min (or .5mL/kg/Hr) IV- Maximum- .08mL/kg/min (or 5mL/kg/Hr)
200
What is Privigen's shelf life and storage requirement?
24-month shelf life at room temperature and must be stored in the dark
200
3 (2.7%) patients discontinued due to the Adverse Events of Urticaria, Dyspnea, Bronchopneumonia
What is Gamunex-C in the CIDP study?
200
How many total patient lives are in Gamunex-C (non Pharmacokinetic or Subcutaneous Studies)?
Total 414 (PI- 172; ITP- 125; CIDP- 117)
200
How many patients in Privigen's ITP trial, reported a positive DAT (Direct Antiglobulin test), that did not have a positive DAT at baseline?
12 patients The direct antiglobulin test (DAT) is used primarily to help determine if the cause of hemolytic anemia, a condition in which red blood cells (RBCs) are being destroyed more quickly than they can be replaced, is due to antibodies attached to RBCs. If the DAT is positive, then there are antibodies attached to the RBCs. A small percentage of the normal population will be DAT positive and not experience hemolytic anemia.
300
What is Gammagard Liquid's shelf life?
36-month shelf life; up to 9 months at room temperature (only within first 24 months)
300
What are the sizes that Privigen comes in?
Privigen comes in a 5g (50mL), 10g (100mL), and 20g (200mL) vial.
300
Of all adverse experiences, 15 events in 8 subjects were serious with two episodes of aseptic meningitis in one patient, deemed to be possibly related to the infusion of this drug in this trial
What is Gammagard Liquid IV, in PI?
300
How many donor centers and how many manufacturing facilities does Grifols have?
147 & 3 (Barcelona, N.C., L.A.)
300
How many patients in Privigen's ITP trial? And how many patients expereinces a serious Adverse event?
57 patients in the trial; 3 patients experienced 3 different serious Adverse Events.
400
What is Gammagard's effective viral inactivation/removal processes?
solvent/detergent (S/D) treatment 35 nm nanofiltration, and a low pH incubation at elevated temperature 30°C to 32°C. (50 Extra Points if the contestant knows the amount of nanofiltration and the temperature of the pH incubation)
400
What is Privigen's infusion rate per indication and risk factor?
Initial infusion rate -.005 mL/kg/min PrimaryImmunodeficiency: Maximum- .08 mL/kg/min ITP: Maximum-.04mL/kg/min Geriatric patients at increased risk of renal insufficiency- Maximum- .02 mL/kg/min
400
Hemolysis, possibly intravascular, occurred in two subjects treated with this drug in this study. These cases resolved uneventfully. Six other subjects experienced hemolysis in this study as documented from clinical laboratory data.
What is Privigen in the ITP study?
400
In all past Grifols marketing pieces, what one thing is indicated as the most important to us?
People
400
How many infusions of Flebogamma 5% DIF in the PI trial had a sever treatment related Adverse Event?
One Infusion
500
what is Gammagard's Subcutaneous approved dosing and infusion rate (Initial and Maintenance)?
Initial Dose is 1.37 x previous intravenous dose divided by # of weeks between intravenous doses - Below 40 KG Body Weight- Total 20 mL site, 15 mL/hr/site - 40 KG Body Weight and above- 30 mL site, 20 mL/hr/site (200 points)- Maintenance Infusion Rate - Below 40 KG Body Weight- Total 20 mL site, 20mL/hr/site 40 KG Body Weight and above- 30 mL site, 30 mL/hr/site
500
What are Privigen's viral inactivation/viral removal steps
The manufacturing process for Privigen includes three steps to reduce the risk of virus transmission. (1) pH 4 incubation (to inactivate enveloped viruses) (2) virus filtration (to remove both enveloped and nonenveloped viruses) (3) depth filtration step (which contributes to the virus reduction capacity)
500
96% of infusions in these trials were headache free
What is Gamunex-C in the CIDP study? (100 extra points, if someone also says Flebogamma 5% DIF in the Primary Immunodeficiency trial )
500
What is Grifols PediGri?
Provides very specific information on each donation and each product lot. Offers full traceability from donation to the final product.
500
Objection
To be judged by Don