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Intravenous Immune Globulins (IVIG) Side-by-Side Comparison
Brand Name
Manufacturer
FDA-Approved Indications
Plasma Source
Specific Viral Inactivation/
Removal Process
Pharmacology
Pharmacokinetics/Stability
Half-life (days)
Storage
Shelf-life (months)
Stability after reconstitution
Contraindications
Precautions/
Warnings
Flebogamma DIF 5%
Flebogamma DIF 10%
Privigen 10%
CSL Behring
PID, Chronic ITP
FDA approved plasmapheresis centers
1.) Fractionation/Depth filtration
2.) pH 4 incubation
3.) Nanofiltration (20 nm)
Grifols
PID
Gamunex 10%
Grifols
ITP, PID, CIDP
1.) Pasteurization
1.) Caprylate precipitation/ Depth
2.) Solvent/Detergent
Filtration; 2.) Caprylate incubation;
3.) Double sequential nanofiltration
3.) Depth Filtration; 4.) Column
(35 nm, 20 nm)
Chromatography; 5.) Low pH
+ 4 non-specific steps
incubation
Intravenous immune globulins are sterile preparations of concentrated antibodies (immune globulins) recovered from pooled
human plasma of healthy donors. These preparations provide replacement therapy for patients with immune deficiencies, as
well as treatment for a variety of immunologically mediated or idiopathic diseases and syndromes.
36.6 days
Up to 25°C
Do not freeze
Protect from light
c
32 ± 5 (5%)
37 ± 13 (10%)
2 to 25°C
Protect from light
Do not freeze
35
2 to 8°C - or Up to 25°C
36 if stored at 2-8°C
6 if stored at 25°C
N/A
N/A
N/A
Ready-to-use liquid
Ready-to-use liquid
Ready-to-use liquid
History of anaphylactic or severe systemic reactions to human immunoglobulin; IgA deficient patients with antibodies against
IgA and a history of hypersensitivity
Hyperprolinemia
------Adverse event profiles are often patient-specific. Brand, concentration, and rate of infusion may have an effect on patient
tolerability. Common side effects include hypotension, hypertension, and headache, which can be diminished by reducing
rate of infusion. Flu-like symptoms may occur several hours or days after infusion and can be managed with non-steroidal
anti-inflammatory agents. Back- and leg-pain syndrome, and fever and shaking can be managed by stopping the infusion,
administering methylprednisolone, diphenhydramine, and a sufficient dose of intravenous narcotic analgesics; once
controlled, infusion may be restarted. Most patients develop tolerance, but if side effects become intolerable, another brand
of IVIG may be administered
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UNC Drug Information Center
August 2014
Brand Name
Adverse Events (Incidence)
Drug Interactions
Administration
Routes
Maximum Infusion Rate
Infusion Rate in Renal Disease
Reconstitution Time
Filter
Content/Characteristics
Flebogamma DIF 5%
Gamunex 10%
Flebogamma DIF 10%
Adverse event profiles are often patient-specific. Brand, concentration, and rate of infusion may have an effect on patient
tolerability. Common side effects include hypotension, hypertension, and headache, which can be diminished by reducing
rate of infusion. Flu-like symptoms may occur several hours or days after infusion and can be managed with non-steroidal
anti-inflammatory agents. Back- and leg-pain syndrome, and fever and shaking can be managed by stopping the infusion,
administering methylprednisolone, diphenhydramine, and a sufficient dose of intravenous narcotic analgesics; once
controlled, infusion may be restarted. Most patients develop tolerance, but if side effects become intolerable, another brand
of IVIG may be administered
PID (≥5%): Headache, pain, nausea, fatigue,
Incidence ≥ 5%: anxiety, back pain,
PID (≥5%): Headache, cough,
chills, vomiting, joint swelling, pyrexia,
abdominal cramps, chest tightness,
injection site reaction, nausea,
urticaria. ITP (≥5%): Headache, pyrexia,
palpitations, tachycardia, nausea,
pharyngitis, urticaria; ITP (≥5%):
anemia, vomiting, nausea,
vomiting, wheezing, rash, arthralgia,
Headache, vomiting, fever, nausea,
hyperbilirubinemia, increased lactate
edema, cutaneous reactions
back pain, rash; CIDP (≥5%):
dehydrogenase, (+) direct antiglobulin
Headache, fever, chills, hypertension,
rash, nausea, asthenia
May interfere with response to live viral vaccines; appropriately delay for 3 or more months from time of IVIG administration.
Do not mix with other drugs and administer via separate infusion line. Due to the maltose component, use of Octagam is
associated with falsely elevated glucose values in glucose meters that use the glucose dehydrogenase
pyrroloquinolinequinone (GDH-PQQ) method for testing.
See individual package inserts for more specific dosing guidelines
IV (PID, ITP, CIDP)
IV
IV
Subcutaneous (PID)
2.4 mL/kg/hr (PID)
6 mL/kg/hr (5%)
4.8 mL/kg/hr
4.8 mL/kg/hr (ITP)
4.8 mL/kg/hr (10%)
Infuse at minimum rate practicable
Infuse at the minimum rate
Infuse at the minimum rate
practicable
practicable
Liquid/ready-to-use
Liquid/ready-to-use
Liquid/ready-to-use
May be diluted with D5W
May be diluted with D5W
No filter required
No filter required
No filter required
Privigen 10%
IgA (mcg/mL)
≤25
IgG (%)
98
Albumin
Trace
Sugar
0 (L-proline stabilized)
< 50 (5%); < 100 (10%)
c
< 3.2
≥97
2 mcg/mL (5%)
5 mcg/mL (10%)
5% D-sorbitol
46
> 98
< 20 mcg/mL
0 (glycine stabilized)
UNC Drug Information Center
August 2014
Brand Name
Sodium
pH when liquid
Osmolality
Available Dosage Forms
Privigen 10%
Trace
4.8 (4.6 – 5)
320 mOsmol/kg
(240 – 440)
Liquid (latex-free): 5 g, 10 g, 20 g, 40 g
Flebogamma DIF 5%
Flebogamma DIF 10%
Trace
c
< 3.2 mmoL/L
5–6
c
327±4.5 mOsm/kg (5%)
c
342±7.2 mOsm/kg (10%)
Liquid (5%): 2.5 g, 5 g,
10 g, 20 g. Liquid (10%):
5 g, 10 g, 20 g
Gamunex 10%
Trace
c
< 7 mEg/L
4 – 4.5
258 mOsm/kg
Liquid (latex-free): 1 g, 2.5 g, 5 g,
10 g, 20 g
UNC Drug Information Center
August 2014