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Gamimune N (Immune Globulin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

GENERAL

Increases in creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following infusion. Progression to oliguria and anuria requiring dialysis has been observed, although some patients have improved spontaneously following cessation of treatment.32 Types of severe renal adverse reactions that have been seen following IGIV therapy include: acute renal failure, acute tubular necrosis,33 proximal tubular nephropathy, and osmotic nephrosis.24, see also 34-36

In the studies undertaken to date, other types of reactions have not been reported with Gamimune N, 5% or Gamimune N, 10%. It may be, however, that adverse effects will be similar to those previously reported with intravenous and intramuscular immunoglobulin administration. Potential reactions, therefore, may also include anxiety, flushing, wheezing, abdominal cramps, myalgias, arthralgia, and dizziness; rash has been reported only rarely. Very rarely have there been cases reported of severe injection site reactions. Reactions to intravenous immunoglobulin tend to be related to the rate of infusion.

True anaphylactic reactions to Gamimune N, 10% may occur in recipients with documented prior histories of severe allergic reactions to intramuscular immunoglobulin, but some patients may tolerate cautiously administered intravenous immunoglobulin without adverse effects. 32 Very rarely an anaphylactoid reaction may occur in patients with no prior history of severe allergic reactions to either intramuscular or intravenous immunoglobulin.2

PRIMARY HUMORAL IMMUNODEFICIENCY

A safety study has been conducted in 20 adult and pediatric subjects with primary immunodeficiency syndrome comparing side effects of Gamimune N, 5% with those of Gamimune N, 10%. The incidence, nature, or severity of reactions with Gamimune N, 10% were not different from those observed with Gamimune N, 5%, and were consistent with those observed in previous studies with Gamimune N, 5%. Symptoms related to the infusion of Gamimune N, 10% were observed in 9 (3.5%) of 255 infusions. These symptoms were all mild to moderate in severity and included chills, fever, headache and emesis.

In a study of 37 patients with immunodeficiency syndromes receiving Gamimune N, 5% in a monthly dose of 400 mg/kg body weight, reactions were seen in 5.2% of the infusions. Symptoms reported included malaise, a feeling of faintness, fever, chills, headache, nausea, vomiting, chest tightness, dyspnea and chest, back or hip pain. Mild erythema following infiltration of Gamimune N, 5% at the infusion site was reported in some cases.

A safety study has been conducted in 17 adult and adolescent subjects with primary immunodeficiency syndrome, comparing side effects and bioequivalency of Gamimune N, 10% with those of Gamimune N, 10% treated with solvent/detergent. The incidence, nature and severity of reactions with Gamimune N, 10% treated with solvent/detergent were not different from those observed with Gamimune N, 10%.

IDIOPATHIC THROMBOCYTOPENIC PURPURA

An investigation of Gamimune N, 10% in 31 adult and pediatric subjects with ITP encountered side effects in 17 of 119 (14.3%) infusions. The dosage in these studies was 1,000 mg/kg body weight for 1 day or 2 consecutive days. However, in the adult study, an induction dosage of 500 mg/kg body weight for 1 day or 2 consecutive days was associated with 17 of these infusions. Of those 17 infusions, three had adverse events. Overall, side effects included mild chest pain, mild and moderate emesis, moderate fever, mild or moderate headache (severe on one occasion) and a single incidence of hives, pruritus and rash. At least 17 of the 50 infusions in the pediatric study were given at rates of >/= 0.1 mL/kg body weight per minute as part of a rate escalation investigation. Maximum infusion rates obtained were not limited by or interrupted due to adverse effects.

In studies of Gamimune N, 5% administered at a dose of 400 mg/kg body weight in the treatment of adult and pediatric patients with ITP, systemic reactions were noted in only 4 of 154 (2.6%) infusions, and all but one occurred at rates of infusion greater than 0.04 mL/kg body weight per minute. The symptoms reported included chest tightness, a sense of tachycardia (pulse was 84 beats per minute), and a burning sensation in the head; these symptoms were all mild and transient.

In studies of Gamimune N, 5% administered at a dose of 1,000 mg/kg body weight either as a single dose or as two doses on consecutive days in the treatment of adult and pediatric patients with ITP, adverse reactions were noted in 25 of 251 (10%) infusions. Symptoms reported included headache, nausea, fever, chills, back pain, chest tightness, and shortness of breath. In children, the high dose regimen has been well-tolerated at the highest rates of infusion. In adults, however, the frequency of adverse reactions tended to increase with infusion rates in excess of 0.06 mL/kg body weight per minute. In general, reactions reported with infusion of Gamimune N, 5% in these studies were reported as mild or moderate, and responded to slowing of the infusion rate.

BONE MARROW TRANSPLANTATION

In studies of Gamimune N, 5% administered to 185 bone marrow transplant recipients at doses of 500 mg/kg (10 mL/kg) body weight on day -7 and day -2 pretransplant, then weekly through day 90 posttransplant, adverse reactions were noted in 12 (6.5%) of the 185 patients that received Gamimune N, 5% and in 14 (0.6%) of 2,176 infusions. All reactions reported were rate-related and classified as mild. Chills were the most common symptom reported, occurring in nine patients. The other symptoms reported included headache, flushing, fever, pruritus and slight back discomfort. All reactions resolved satisfactorily, usually without treatment or decreasing the infusion rate.

PEDIATRIC HIV INFECTION

Three hundred seventy-six (376) patients, 187 treated with Gamimune N, 5% and 189 treated with placebo (0.1% Albumin [Human]), were included in the safety analysis. Adverse reactions occurred during or within 24 hours of an infusion in 50 of 3,451 (1.4%) infusions of Gamimune N, 5% and 62 of 3,447 (1.8%) infusions of placebo. Fever was the most common adverse reaction and occurred in 30 of 105 (28.6%) patients receiving placebo and 19 of 78 (24.4%) patients treated with Gamimune N, 5%. Irritability was the second most common symptom reported, with 10 of 105 (9.5%) reports for the placebo group and 9 of 78 (11.5%) for the group treated with Gamimune N, 5%. A large number of diverse adverse reactions accounted for the remaining adverse reactions reported in both study groups. In general, the number of adverse events reported was comparable in both the placebo and Gamimune N, 5% treated groups. Three serious adverse reactions were reported. One patient experienced a hypersensitivity reaction and did not receive further Gamimune N, 5% treatment. A second patient developed tachycardia and was admitted to an intensive care unit, but later continued treatment with Gamimune N, 5%. A third patient had skin infiltration during infusion and developed a full thickness skin slough over the dorsum of the hand that required skin grafting.

Drug label data at the top of this Page last updated: 2006-05-25

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