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Vivaglobin (Immune Globulin Subcutaneous Human) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most common adverse reactions (those AEs considered by the investigator to be at least possibly related to Vivaglobin administration) observed in ≥5% of study subjects receiving Vivaglobin were local injection-site reactions (swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal disorder.

Clinical Studies Experience

Because clinical studies 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 practice.

US-Canada Study

The safety of Vivaglobin was evaluated in a clinical study in the US and Canada for 12 months in 65 subjects with PI who had been previously treated with IGIV every 3 or 4 weeks (see Clinical Studies [14.1] ). After 3 months, subjects were switched from IGIV to weekly subcutaneous administration of Vivaglobin for 12 months. Subjects were treated weekly with Vivaglobin at a mean dose of 158 mg/kg body weight (range: 34 to 352 mg/kg). The 65 subjects received a total of 3,656 infusions of Vivaglobin.

Table 2 shows the number of subjects who withdrew from the US-Canada study due to adverse events (AEs) and the AEs leading to discontinuation.

Table 2: Subjects with Adverse Events (AEs) Leading to Discontinuation, US-Canada Study
AEs Subjects with AEs At Least Possibly Related Subjects with AEs Irrespective of Causality Total Number (%) of Subjects
Subjects with at least 1 AE leading to discontinuation 4 1 5 (8%)
Injection-site reaction 3 3 (5%)
Intestinal obstruction 1 1 (2%)
Hyperventilation 1 1 1 (2%)
Tachycardia 1 1 (2%)

1 One subject experienced hyperventilation and tachycardia.

Table 3 summarizes the most frequent AEs (experienced by more than 5% of subjects), irrespective of causality. It includes all AEs and those considered temporally associated with the Vivaglobin infusion, i.e., occurring during the infusion or within 72 hours after the end of the infusion.

Table 3: Incidence of Subjects With Adverse Events (AEs) 1 (Experienced by >5% of Subjects) and Rate 2 per Infusion, Irrespective of Causality, in the US-Canada Study
All AEs AEs Occurring During or Within 72 Hours of Infusion
AEs
(>5% of Subjects)
Number (%) of Subjects
(n=65)
Number (Rate) of AEs per Infusion
(n=3656)
Number (%) of Subjects
(n=65)
Number (Rate) of AEs per Infusion
(n=3656)
AEs at the injection site Includes injection-site inflammation. 60 (92%) 1789 (0.49) 60 (92%) 1767 (0.4848)
Other AEs
  Headache 31 (48%) 159 (0.04) 30 (46%) 104 (0.033)
  Gastrointestinal disorder 24 (37%) 35 (0.01) 18 (28%) 24 (0.007)
  Fever 16 (25%) 28 (0.008) 12 (8%) 20 (0.005)
  Nausea 12 (18%) 18 (0.005) 11 (17%) 15 (0.004)
  Rash 11 (17%) 22 (0.006) 10 (15%) 16 (0.004)
  Sore throat 10 (15%) 17 (0.005) 8 (12%) 11 (0.003)
  Allergic reaction 7 (11%) 8 (0.002) 5 (8%) 5 (0.001)
  Pain 6 (9%) 8 (0.002) 4 (6%) 4 (0.001)
  Diarrhea 6 (9%) 6 (0.002) 5 (8%) 5 (0.001)
  Cough increased 6 (9%) 6 (0.002) 5 (8%) 5 (0.001)
  Gastrointestinal pain 5 (8%) 6 (0.002) 4 (6%) 5 (0.001)
  Migraine 5 (8%) 5 (0.001) 2 (3%) 2 (0.001)
  Skin disorder 5 (8%) 7 (0.002) 3 (5%) 5 (0.001)
  Asthma 5 (8%) 8 (0.002) 3 (5%) 4 (0.001)
  Arthralgia 4 (6%) 4 (0.001) 3 (5%) 3 (0.001)
  Asthenia 4 (6%) 4 (0.001) 2 (3%) 2 (0.001)
  Malaise 4 (6%) 5 (0.001) 2 (3%) 2 (0.001)

1 Excluding infections.
2 Rate, number of AEs per infusion.

The total number of AEs, irrespective of causality, including injection-site reactions, that began during or within 72 hours after the end of an infusion was 2262 (a rate of 0.62 AEs per infusion); excluding injection-site reactions, the rate of AEs per infusion was 0.14.

Table 4 summarizes the severity of local AEs by infusion, irrespective of causality.

Table 4: Severity of Local Adverse Events (AEs) by Infusion, Irrespective of Causality, in the US-Canada Study
AEs
Number (Rate 1) of AEs Number (Rate) of AEs Occurring During or Within 72 Hours of Infusion
(Number of infusions: 3656)

AEs at the injection site 1789 (0.49) 1767 (0.48)
  MildDefined as those reactions that did not interfere with routine activities. 1112 (0.30) 1100 (0.30)
  ModerateDefined as those reactions that interfered with routine activities. 601 (0.16) 593 (0.16)
  SevereDefined as those reactions that made it impossible to perform routine activities. 65 (0.02) 64 (0.02)
  Unknown severity 11 (<0.01) 10 (<0.01)
Discontinuations due to AEs at the injection site 3 subjects

1 Rate, number of AEs per infusion.

Of the three subjects who discontinued the study due to injection-site reactions, one withdrew on Day 1 (Infusion 1) of the wash-in/wash-out period after a moderate injection-site reaction and a mild headache; one withdrew on Day 22 (Infusion 4) of the wash-in/wash-out period following severe injection-site reactions for two weeks; and one withdrew on Day 78 following a mild injection-site reaction.

Local reactions decreased substantially after repeated use.

Table 5 summarizes the most frequent adverse reactions (experienced by at least 3% of subjects) and considered by the investigator to be at least possibly related to Vivaglobin administration.

Table 5: Incidence of Subjects With Adverse Reactions (Experienced in ≥3% of Subjects) and Rate 1 per Infusion in the US-Canada Study
Related Adverse Reactions
(≥3% Subjects)
Number (%) of Subjects
(n=65)
Number (Rate) of Adverse Reactions per Infusion
(n=3656)
Adverse reactions at the injection siteIncludes injection-site inflammation. 60 (92%) 1787 (0.49)
Other Adverse reactions
  Headache 21 (32%) 59 (0.016)
  Nausea 7 (11%) 9 (0.002)
  Rash 4 (6%) 9 (0.002)
  Asthenia 3 (5%) 3 (0.001)
  Gastrointestinal disorder 3 (5%) 3 (0.001)
  Fever 2 (3%) 2 (0.001)
  Skin disorder 2 (3%) 3 (0.001)
  Tachycardia 2 (3%) 2 (0.001)
  Urine abnormality 2 (3%) 3 (0.001)

1 Rate, number of adverse reactions per infusion.

Europe-Brazil Study

In a clinical study conducted in Europe and Brazil, the efficacy and safety of Vivaglobin were evaluated for 10 months in 60 subjects with PI. Subjects were treated weekly with Vivaglobin at a mean dose of 89 mg/kg body weight (range: 51 to 147 mg/kg), which was 101% of their previous weekly IGIV or IGSC dose (see Clinical Studies [14.2] ). Study subjects received a total of 2,297 infusions of Vivaglobin.

The AEs and their rates reported in this study were similar to those reported in the US-Canada study, with two exceptions: no episodes of headache were reported; and 18 (a rate of 0.008 per infusion) episodes of fever were judged to be related to the administration of Vivaglobin. One subject discontinued due to repeated local reactions of moderate severity.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Vivaglobin

Adverse reactions identified during worldwide postmarketing use of Vivaglobin for treatment of PI are allergic-anaphylactic reactions (including dyspnea, pruritus, urticaria, rash, edema and other cutaneous reactions, wheezing, syncope, hypotension, and throat swelling), generalized reactions (including flu-like symptoms, myalgia, chills, fever, tachycardia, arthralgia, nausea and vomiting, diarrhea, gastrointestinal cramping, stomach pain, back pain, headache, headache possibly caused by increased blood pressure, and chest tightness), migraine, and injection-site reactions.

General

The following adverse reactions have been identified and reported during the postmarketing use of IGIV products11:

  • 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, bullous dermatitis
  • Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs') test
  • General/Body as a Whole: Pyrexia, rigors
  • Musculoskeletal: Back pain
  • Gastrointestinal: Hepatic dysfunction, abdominal pain


REPORTS OF SUSPECTED VIVAGLOBIN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Vivaglobin side effects / adverse reactions in 36 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-01-27

Patient: 36 year old female

Reactions: Malaise, Palpitations, Vision Blurred

Adverse event resulted in: hospitalization

Suspect drug(s):
Vivaglobin



Possible Vivaglobin side effects / adverse reactions in 61 year old female

Reported by a pharmacist from United States on 2012-02-07

Patient: 61 year old female weighing 104.3 kg (229.5 pounds)

Reactions: Thrombosis, Infusion Site Swelling, Infusion Site Erythema

Suspect drug(s):
Vivaglobin
    Dosage: see image
    Indication: Immunodeficiency Common Variable
    Start date: 2009-05-01

Vivaglobin

Vivaglobin

Vivaglobin

Other drugs received by patient: Nexium; Ambien; Coumadin; Crestor; Ipratropium Bromide; Albuterol; Lexapro; Tricor; Xanax; Theocap (Theophylline); Coreg; Reglan; Singulair; Prednisone TAB; Advair Diskus 100/50



Possible Vivaglobin side effects / adverse reactions in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-02-07

Patient: 57 year old female

Reactions: Migraine, Urticaria, Musculoskeletal Stiffness, Meningitis Aseptic

Suspect drug(s):
Vivaglobin



See index of all Vivaglobin side effect reports >>

Drug label data at the top of this Page last updated: 2010-07-15

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