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Gammaplex (Human Immunoglobulin G) - Side Effects and Adverse Reactions



Two serious adverse reactions, thrombosis and chest pain, were observed in a clinical study subject receiving Gammaplex.

The most common adverse reactions to Gammaplex (reported in >5% of clinical trial subjects) were headache, fatigue, nausea, pyrexia, hypertension, myalgia, pain, and vomiting.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In a multicenter, open-label, non-randomized clinical study, 50 subjects with primary humoral immunodeficiency received doses of Gammaplex ranging from 279 to 799 mg/kg every 21days (mean dose 465 mg/kg) or 28 days (mean dose 458 mg/kg), for up to 12 months (see Clinical Studies [14.1] ). Routine premedication was not allowed. Of the 703 infusions administered, 2 (4%) subjects received premedication (antipyretic, antihistamine, or antiemetic agent) prior to 2 courses of treatment, because of experience with consecutive infusion-related adverse reactions.

All 50 subjects had an adverse event at some time during the study. Twenty-four subjects (48.0%) had an adverse reaction at some time during the study that was considered product-related. More subjects with the 21-day infusion cycle had at least one adverse reaction (14 of 22 subjects, 63.6%) than subjects with the 28-day infusion cycle (10 of 28 subjects, 35.7%). Of these 24 subjects who showed adverse reactions, only 3 subjects had adverse reactions that were considered definitely related to Gammaplex: headache, pyrexia, tachycardia, chest discomfort, and hypertension.

The most common adverse reactions observed in this clinical trial were headache (18 subjects, 36.0%), fatigue (6 subjects, 12.0%), nausea (6 subjects, 12.0%), pyrexia (6 subjects, 12.0%), hypertension (3 subjects, 6.0%), myalgia (3 subjects, 6.0%), pain (3 subjects, 6.0%), and vomiting (3 subjects, 6.0%).

Temporally associated adverse events (AEs) are those occurring during or within 72 hours after the end of an infusion, irrespective of causality. In this study, the upper bound of the 1-sided 97.5% confidence interval for the proportion of Gammaplex infusions temporally associated with one or more AEs was 24.2% (actual proportion: 21.2%). This is below the target of 40% for this safety endpoint. The total number of temporally associated AEs was 237 (a rate of 0.34 AEs per infusion), reflecting that some subjects experienced more than one AE during the observation period.

Table 2 lists the temporally associated AEs that occurred in more than 5% of subjects during a Gammaplex infusion or within 72 hours after the end of an infusion, irrespective of causality.

Table 2: Adverse Events Occurring in >5% of Subjects with PI during a Gammaplex Infusion or within 72 Hours after the End of an infusion, Irrespective of Causality
Adverse Event Subjects (%) [n=50] Infusions (%) [n=703]
Headache 18 (36%) 53 (7.5%)
Sinusitis 8 (16%) 9 (1.3%)
Pyrexia 7 (14%) 10 (1.4%)
Nausea 6 (12%) 7 (1.0%)
Pain 5 (10%) 5 (0.7%)
Chills 3 (6%) 5 (0.7%)
Fatigue 3 (6%) 9 (1.3%)
Hypertension 3 (6%) 4 (0.6%)
Insomnia 3 (6%) 3 (0.4%)
Nasal Congestion 3 (6%) 3 (0.4%)
Upper respiratory tract infection 3 (6%) 5 (0.7%)
Vomiting 3 (6%) 3 (0.4%)

Of the 237 temporally associated AEs reported for the 50 subjects, the investigators judged 115 to be related to the infusion of Gammaplex. The most common temporally associated AEs judged to be related to Gammaplex infusion were headache (32% of subjects), pyrexia (8% of subjects), and nausea (8% of subjects).

Five subjects (10%) experienced seven serious AEs. Two of these serious AEs were considered related to Gammaplex treatment (thrombosis and chest pain). Three other subjects withdrew from the study due to the following AEs: paresthesia, bronchospasm, and pregnancy.

Forty-seven of the 50 subjects enrolled in this study had a negative direct antiglobulin test (DAT) at baseline. Of these 47 subjects, 4 (8.5%) developed a positive DAT at some time during the study. However, no subjects showed evidence of hemolytic anemia.

During this study, no subjects tested positive for infection due to human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or B19 virus (B19V).

Postmarketing Experience

Because adverse reactions are voluntarily reported post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse reactions have been identified during post-approval use of intravenous immune globulins10:

  • Infusion reactions: hypersensitivity (e.g., anaphylaxis), headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomfort, nausea, vomiting, rigors, back pain, myalgia, arthralgia, and changes in blood pressure
  • Renal: Acute renal dysfunction/failure, osmotic nephropathy
  • Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm
  • Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension
  • Neurological: Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome
  • Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis)
  • Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test
  • Gastrointestinal: Hepatic dysfunction, abdominal pain
  • General/Body as a Whole: pyrexia, rigors


Below is a sample of reports where side effects / adverse reactions may be related to Gammaplex. The information is not vetted and should not be considered as verified clinical evidence.

Possible Gammaplex side effects / adverse reactions in 69 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-07-05

Patient: 69 year old female weighing 93.1 kg (204.8 pounds)

Reactions: Respiratory Rate Increased, Heart Rate Increased, Chills, Pyrexia

Adverse event resulted in: hospitalization

Suspect drug(s):

Possible Gammaplex side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-07-05

Patient: 56 year old female weighing 84.0 kg (184.8 pounds)

Reactions: Chest Discomfort, Chest Pain, Tachycardia, Headache, Hypertension, Rash Pruritic, Infusion Related Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
    Dosage: 30g
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2010-09-06




Other drugs received by patient: Bendroflumethazide; Metformin HCL; Insulin; Gliclazide

Possible Gammaplex side effects / adverse reactions in 18 year old female

Reported by a physician from India on 2011-07-05

Patient: 18 year old female weighing 50.0 kg (110.0 pounds)

Reactions: Abdominal Pain, Vomiting, Headache, Pyrexia

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
    Dosage: 7.5 mg
    Administration route: Oral

    Dosage: 1000mg/kg
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-05-24

See index of all Gammaplex side effect reports >>

Drug label data at the top of this Page last updated: 2010-06-24

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