Gammagard S / D (Immune Globulin Intravenous) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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.²⁶

Types of severe renal adverse reactions that have been seen following IGIV therapy include:

• acute renal failure
• acute tubular necrosis²⁷
• proximal tubular nephropathy
• osmotic nephrosis^{18 (see also 28-30)}

In general, reported adverse reactions to GAMMAGARD, in patients with either congenital or acquired immunodeficiencies are similar in kind and frequency. Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine should be available for treatment of any acute anaphylactoid reaction. (See WARNINGS).

PRIMARY IMMUNODEFICIENCY DISEASES

Twenty-one adverse reactions occurred in 341 infusions (6%), when using GAMMAGARD (5% solution), in a clinical trial of 17 patients with primary immunodeficiency.³¹ Of the 17 patients, 12 (71%) were adults, and 5 (29%) were children (16 years or younger).

In a cross-over study comparing GAMMAGARD and GAMMAGARD S/D (5% solutions) conducted in a small number (n=10) of primary immunodeficient patients, no unusual or unexpected adverse reactions were observed in the GAMMAGARD S/D group. The adverse reactions experienced in the GAMMAGARD S/D group were similar in frequency and nature to those observed in the control group consisting of patients receiving GAMMAGARD.

GAMMAGARD, reconstituted to a concentration of 10%, was administered intravenously at rates varying from 2-11 mL/kg/Hr. Systemic reactions occurred in 23 (10.5%) of 219 infusions. This compares with an adverse reaction incidence of 6% (only systemic reactions reported) for primary immunodeficient patients previously treated with a 5% solution at infusion rates varying between 2 and 8 mL/kg/Hr, as described above (also, see reference 31). Local pain or irritation was experienced during 35 (16%) of 219 infusions. Application of a warm compress to the infusion site alleviated local symptoms. These local reactions tended to be associated with hand vein infusions and their incidence may be reduced by infusions via the antecubital vein.

B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

In the study of patients with B-cell Chronic Lymphocytic Leukemia, the incidence of adverse reactions associated with GAMMAGARD infusions was approximately 1.3% while that associated with placebo (normal saline) infusions was 0.6%. ⁹

IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)

During the clinical study of GAMMAGARD for the treatment of Idiopathic Thrombocytopenic Purpura, the only adverse reaction reported was headache which occurred in 12 of 16 patients (75%). Of these 12 patients, 11 had chronic ITP (9 adults, 2 children), and one child had acute ITP. Oral antihistamines and analgesics alleviated the symptoms and were used as pretreatment for those patients requiring additional IGIV therapy. The remaining 4 patients did not report any side effects and did not require pretreatment.

KAWASAKI SYNDROME

In a study of patients (n=51) with Kawasaki syndrome, no hypersensitivity-type reactions (urticaria, bronchospasm or generalized anaphylaxis) were reported in patients receiving either a single 1g/kg dose of IGIV, GAMMAGARD, or 400 mg/kg of IGIV, GAMMAGARD, for four consecutive days. ²⁰ Mild adverse reactions, including chills, flushing, cramping, headache, hypotension, nausea, rash and wheezing, were reported with both dose regimens. These adverse reactions occurred in 7/51 (13.7%) patients and in association with 7/129 (5.4%) infusions. Of the 25 patients who received a single 1 g/kg dose, 4 patients experienced adverse reactions for an incidence of 16%. Of the 26 patients who received 400 mg/kg/day over 4 days, 3 experienced a single adverse reaction for an incidence of 11.5%. ³

REPORTS OF SUSPECTED GAMMAGARD S/D SIDE EFFECTS / ADVERSE REACTIONS

Possible Gammagard S/D side effects / adverse reactions in 85 year old male

Reported by a physician from Germany on 2011-10-03

Patient: 85 year old male weighing 70.0 kg (154.0 pounds)

Reactions: Chills, Headache, Loss of Consciousness, Malaise, Chest Pain, Dizziness, Vision Blurred, Ventricular Fibrillation

Adverse event resulted in: death

Suspect drug(s):
Octagam
    Indication: Immunoglobulin Therapy
    Start date: 2011-09-22

Gammagard S/D
    Indication: Immunoglobulin Therapy
    Start date: 2011-09-22

Gammagard Liquid
    Indication: Immunoglobulin Therapy
    Start date: 2011-08-01
    End date: 2011-09-22

Other drugs received by patient: Methylprednisolone

Possible Gammagard S/D side effects / adverse reactions in 50 year old female

Reported by a pharmacist from United States on 2011-10-14

Patient: 50 year old female weighing 66.0 kg (145.2 pounds)

Reactions: Malaise, Pain in Extremity, Bone Pain, Chills, Pain, Musculoskeletal Stiffness, Meningitis Aseptic

Suspect drug(s):
Gammagard S/D

Other drugs received by patient: Multi-Vitamins; Zithromax

Possible Gammagard S/D side effects / adverse reactions in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2011-10-20

Patient: 68 year old female

Reactions: Weight Increased, Malaise, Nausea, Cardiac Failure, Hypotension, Dizziness, Cough

Adverse event resulted in: hospitalization

Suspect drug(s):
Gammagard S/D
    Dosage: 1 x per 21 dagen
    Start date: 2011-08-29
    End date: 2011-09-19

Gammagard S/D
    Dosage: 1 x per 21 dagen
    Start date: 2011-08-29
    End date: 2011-09-19

Gammagard S/D
    Dosage: 1 x per 21 dagen
    Indication: Myositis
    Start date: 2009-03-06
    End date: 2009-03-06

Gammagard S/D
    Dosage: 1 x per 21 dagen
    Indication: OFF Label USE
    Start date: 2009-03-06
    End date: 2009-03-06

Other drugs received by patient: Lasix