Standard therapy in adults and children. 0.4g per kg per day for 5 days. 1g per kg per day for 2 days high dose.
Mode of Action
"IVIG has been reported to have a wide variety of effects on the immune system, for example, including diminished macrophage FcR number and binding affinity, altered platelet antibody binding, suppression of T cell and B cell function, and changes in cytokine production". Ref. Seminars in Hematology, Vol 35, No 1, Suppl 1, 1998 pp 19: "Anti-D: Mechanisms of Action; Russell E. Ware and Sherri A Zimmerman
Side Effects
Reference: This section has been copied from the Compendium of Pharmaceuticals and Specialties, 2005 pp 871, Adverse Effects of Gamunex10% in ITP patients.
This section reports the adverse effects observed in two studies.
In the first study (randomized and double-blind), 97 ITP patients were randomized to a single dose of 2000 mg/kg of GAMUNEX10% or GAMIMUNE N, 10%. The total dose was divided into two 1000 mg/kg doses given on two consecutive days at a maximum infusion rate of 0.08 mLkg/min.
As expected, the adverse event rate for Immune Globulin Intravenous (Human), 10% in this ITP trial was higher than observed in the replacement therapy for Primary Humoral Immunodeficiencies (PID), but was within the range reported earlier for Immune Globulin Intravenous (Human). It should be noted that the dose is 4-5 fold higher than in PID and that the total dose was given on two consecutive days rather than on five consecutive days, which is associated with a higher adverse event rate. Finally, no pre-medication with corticosteroids was permitted in the study protocol. More than 90% of the observed drug related adverse events were of mild to moderate severity and of transient nature.
The most frequently recorded drug related adverse events (> 2.0%)
| Incidence
of drug related adverse event |
Gamunex (n=48) |
Gamimune N 10% (n=49) |
| Headache | 24 (50%) | 24 (49%) |
| Mild | 25% | 18% |
| Moderate | 21% | 20% |
| Severe | 4% | 12% |
| ‹Day 3 | 46% | 49% |
| >Day 3 | 4% | 0% |
| Vomiting | 6 (13%) | 8 (16%) |
| Mild | 10% | 10% |
| Moderate | 2% | 6% |
| Severe | 0% | 0% |
| ‹Day 3 | 10% | 16% |
| >Day 3 | 2% | 0% |
| Fever | 5 (10%) | 5 (10%) |
| Nausea | 5 (10%) | 5 (10%) |
| Rash | 3 (6%) | 0 (0%) |
| Back Pain | 3 (6%) | 2 (4%) |
| Asthenia | 2 (4%) | 3 (6%) |
| Arthralgia | 2 (4%) | 0 (0%) |
| Pruritis | 2 (4%) | 0 (0%) |
| Dizziness | 1 (2%) | 3 (6%) |
| Neck Pain | 0 (0%) | 2 (4%) |
The infusion rate was reduced for only 4 of the 97 treated patients (1 GAMUNES, 3 GAMIMUNE N, 10%) on 4 occasions. Mild to moderate headache, nausea, and fever were the reported reasons. There were no anaphylactic or anaphylactoid reactions.
At various time points after the infusion of Immune Globulin Intravenous (Human) 10%, serum samples were drawn to monitor the viral safety of the ITP patients. Viral markers of hepatitis C, hepatitis B, HIV-1, and parvovirus B19 were monitored bynucleic acid testing (NAT, PCR), and serological testing. There were no treatment related emergent findings of viral transmission.
A second trial was carried out in 28 chronic ITP patients who received 1000 mg/kg GAMUNEX on three occasions for treatment of relapses to determine tolerability of various infusion rates. The maximum infusion rate of the three occasions was randomly assigned to 0.08, 0.11, or 0.14 mL/kg/min (8, 11 or 14 mg/kg/min) in which each patient was to receive Immune Globulin Intravenous (Human), 10%, at all 3 rates. No pre-medication with corticosteroids to alleviate infusion related intolerability was permitted. Seven patients did not complete the study for the following reasons: one adverse event (hives) at the 0.08 mL/kg/min level, one patient withdrew because he refused to participate without a forbidden concomitant medication (prednisone) and five patients did not require additional treatment.
The number of patients who experienced at least one adverse event for the 0.08, 0.11, and 0.14 mL/kg/min infusion rates was 12 (46%), 13 (59%), and 11 (46%), respectively. The most commonly reported adverse event was headache, which occurred more frequently during the higher infusion rates (4% in 0.08 mL/kg/min patients vs. 23% in 0.11 mL/kg/min patients vs. 13% in 0.14 mL/kg/min patients). Importantly, all of the headaches were mild except for one severe headache at the 0.08 mL/kg/min rate. Otherwise, the incidence rates of adverse events and drug-related adverse events generally appeared to be similar among the three infusion groups. No patients experienced a drug related serious adverse event. There were no other abnormal safety results except for slightly decreased heart rates following all infusion rates.
RESPONSE RATES :
Based on our clinical trials, the response rate of children with Acute ITP for High dose IVIG and Low dose IVIG are 93% and 90% respectively. Please see the Safety and Efficacy Section of this website for more information (AITP Efficacy Results).
