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VIGIV

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VIGIV

Side Effects
Interactions

SIDE EFFECTS

Overview

No serious adverse drug reactions have been reported following the administration of Vaccinia Immune Globulin Intravenous (Human) (VIGIV (vaccinia immune globulin intravenous) ). However, drug exposure to date has been in healthy volunteers. The majority of adverse events reported in a clinical trial evaluating the pharmacokinetics of VIGIV (vaccinia immune globulin intravenous) in healthy volunteers were mild and were similar to those regarded as causally related to infusion of other protein products, such as headache, nausea, dizziness, feeling hot, feeling cold and rigors (see ADVERSE REACTIONS - General).

General Adverse Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

In a clinical study, 60 healthy male and female volunteers received a single intravenous dose of either 6000 U/kg or 9000 U/kg VIGIV (vaccinia immune globulin intravenous) in a pharmacokinetics trial. 4 The population consisted of vaccinia vaccination-naïve subjects, ages 18 to 32, with both males and females enrolled in an approximate 50:50 ratio.

In another clinical study, 32 healthy male and female volunteers were randomized to receive vaccinia vaccination (n=10), VIGIV (vaccinia immune globulin intravenous) (9000 u/kg) four days prior to vaccinia vaccination (n=10), or VIGIV (vaccinia immune globulin intravenous) (9000 U/kg) concurrent with vaccinia vaccination (n=12). 28 The population consisted of vaccinia vaccination-naïve subjects, ages 18 to 32, with both male and female enrolled in a 75:25 ratio. The ethnic background of patients included those of Caucasian, African American, Asian and Hispanic descent, with the majority of them being Caucasian.

The most frequently reported adverse events related to VIGIV (vaccinia immune globulin intravenous) administration in both studies were headache, rigors, nausea, dizziness, feeling cold, sweating increased and feeling hot. Table 3 describes all adverse events that were temporally related (overall and related) to VIGIV (vaccinia immune globulin intravenous) or placebo administration (within 3 days).

Table 3: Adverse events that occurred temporally following VIGIV (vaccinia immune globulin intravenous) administration ( ≥ 5%)

  VIGIV
6000 U/kg[1]
(N=31)
9000 U/kg[1]
(N=29)
9000 U/kg[2]
(N=10)
PLACEBO[3]
(N=22)
Body System
Preferred Term
All
(%)
Rel.
(%)
All
(%)
Rel.
(%)
All
(%)
Rel.
(%)
All
(%)
Rel.
(%)
All body systems 21 (67.7) 19 (61.3) 25 (86.2) 24 (82.8) 6 (60) 6 (60) 7 (31.8) 4 (18.2)
Eye disorders 2 (6.5) 2 (6.5) 1 (3.4) 1 (3.4) 0 (0) 0 (0) 0 (0) 0 (0)
Gastrointestinal disorders 5 (16.1) 5 (16.1) 8 (27.6) 8 (27.6) 5 (50) 3 (30) 1 (4.5) 1 (4.5)
Nausea 4 (12.9) 4 (12.9) 8 (27.6) 8 (27.6) 4 (40) 3 (30) 1 (4.5) 1 (4.5)
Vomiting NOS 1 (3.2) 1 (3.2) 2 (6.9) 2 (6.9) 2 (20) 1 (10) 0 (0) 0 (0)
Lip dry 0 (0) 0 (0) 0 (0) 0 (0) 1 (10) 0 (0) 0 (0) 0 (0)
General disorders and administration site conditions 10 (32.3) 10 (32.3) 16 (55.2) 15 (51.7) 4 (40) 4 (40) 2 (9.1) 1 (4.5)
Rigors 7 (22.6) 7 (22.6) 6 (20.7) 6 (20.7) 3 (30) 1 (10) 0 (0) 0 (0)
Feeling cold 4 (12.9) 4 (12.9) 7 (24.1) 6 (20.7) 0 (0) 0 (0) 0 (0) 0 (0)
Pain NOS 1 (3.2) 1 (3.2) 2 (6.9) 2 (6.9) 3 (30) 3 (30) 0 (0) 0 (0)
Asthenia 2 (6.5) 2 (6.5) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 1 (4.5) 1 (4.5)
Feeling hot 3 (9.7) 3 (9.7) 1 (3.4) 1 (3.4) 0 (0) 0 (0) 0 (0) 0 (0)
Pyrexia 2 (6.5) 2 (6.5) 0 (0) 0 (0) 1 (10) 1 (10) 0 (0) 0 (0)
Fatigue 0 (0) 0 (0) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 1 (4.5) 1 (4.5)
Energy increased 0 (0) 0 (0) 0 (0) 0 (0) 1 (10) 1 (10) 1 (4.5) 0 (0)
Metabolism and nutrition disorders 2 (6.5) 2 (6.5) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Appetite decreased NOS 2 (6.5) 2 (6.5) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Musculoskeletal and connective tissue disorders 6 (19.4) 5 (16.1) 7 (24.1) 7 (24.1) 0 (0) 0 (0) 0 (0) 0 (0)
Back pain 2 (6.5) 2 (6.5) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Muscle cramp 2 (6.5) 2 (6.5) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Nervous system disorders 19 (61.3) 18 (58.1) 21 (72.4) 20 (69) 6 (60) 6 (60) 5 (22.7) 4 (18.2)
Headache 17 (54.8) 17 (54.8) 19 (65.5) 18 (62.1) 5 (50) 5 (50) 4 (18.2) 3 (13.6)
Dizziness 5 (16.1) 5 (16.1) 6 (20.7) 6 (20.7) 1 (10) 1 (10) 1 (4.5) 1 (4.5)
Paraesthesia 2 (6.5) 2 (6.5) 1 (3.4) 1 (3.4) 0 (0) 0 (0) 0 (0) 0 (0)
Tremor 1 (3.2) 1 (3.2) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Respiratory, thoracic and mediastinal disorders 2 (6.5) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Skin and subcutaneous tissue disorders 3 (9.7) 3 (9.7) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Sweating increased 3 (9.7) 3 (9.7) 2 (6.9) 2 (6.9) 0 (0) 0 (0) 0 (0) 0 (0)
Vascular disorders 2 (6.5) 1 (3.2) 2 (6.9) 2 (6.9) 3 (30) 1 (10) 1 (4.5) 1 (4.5)
Pallor 1 (3.2) 1 (3.2) 2 (6.9) 2 (6.9) 3 (30) 1 (10) 0 (0) 0 (0)
[1] Infusion rate: 4 mL/min.
[2] Infusion rate: 2 mL/min.
[3] 0.9% NaCl infused at 2 mL/min.
Adverse events that occurred within 3 days of VIGIV (vaccinia immune globulin intravenous) administration.

These adverse events were mostly mild and expected, and are related to intravenous infusion of immune globulins. VIGIV (vaccinia immune globulin intravenous) had no effect on blood pressure or heart rate during a clinical trial of 90 days duration. Other less frequently reported adverse events related to VIGIV (vaccinia immune globulin intravenous) included back pain, nonspecific pain, pyrexia, vomiting, muscle cramps, muscle tightness and muscle spasms. One subject in the 9000 U/kg dosage group experienced syncope. These less frequently reported adverse events are also expected with intravenous infusion of immune globulins. There was a lower incidence of adverse events when VIGIV (vaccinia immune globulin intravenous) (9000 U/kg) was infused at 2 mL/min (60%) than 4 mL/min (86%). It is important to note that all subjects were fasted overnight prior to infusion of VIGIV (vaccinia immune globulin intravenous) or placebo.

There were no serious adverse events or adverse events of severe intensity in this clinical trial. There were no instances where VIGIV (vaccinia immune globulin intravenous) was either discontinued due to an adverse event, or where a reduction in either the dose administered or the infusion rate was required.

Increases in serum creatinine and blood urea nitrogen have been observed as soon as 1 to 2 days after treatment with other IGIVs. Other severe renal adverse events seen after IGIV therapy include acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis.10, 11, 12, 29

Post-marketing Experience with Other IGIV Products

The following is a list of adverse reactions that have been identified and reported during the post-approval use of IGIV: 17, 18, 19, 20, 21, 22, 23, 24, 30

Because post-marketing reporting of these reactions is voluntary and the at-risk populations are uncertain size, it is not always possible to reliably estimate the frequency of a reaction or establish a causal relationship to exposure to the product. This is also the case with literature reports authored independently.

Read the VIGIV (vaccinia immune globulin intravenous) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Immune globulin administration may impair the efficacy of live attenuated vaccines such as measles, rubella, mumps and varicella.25, 26 Vaccination with live virus vaccines should be deferred until approximately three months after administration of VIGIV (vaccinia immune globulin intravenous) . People who received VIGIV (vaccinia immune globulin intravenous) shortly after live virus vaccination, should be revaccinated 3 months after the administration of the immune globulin.

There are no available data on concomitant use of Vaccinia Immune Globulin Intravenous (Human) (VIGIV (vaccinia immune globulin intravenous) ) and other medications. Admixtures of VIGIV (vaccinia immune globulin intravenous) with other drugs have not been evaluated. It is recommended that VIGIV (vaccinia immune globulin intravenous) be administered separately from other drugs or medications that the patient may be receiving (see DOSAGE AND ADMINISTRATION section). If a pre-existing catheter must be used, the line should be flushed with 0.9% Sodium Chloride for injection USP before administering the product. Compatibility of VIGIV (vaccinia immune globulin intravenous) was only assessed with 0.9% Sodium Chloride USP and not with other solutions such as dextrose in water.

Drug/Laboratory Test Interactions

After administration of VIGIV (vaccinia immune globulin intravenous) , a transitory increase of passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing (e.g. anti-HBs).

REFERENCES

4. Unpublished data on file, VA-002 Final Study Report, Cangene Corporation.

10. Perazella MA, Cayco AV. Acute renal failure and intravenous immune globulin: sucrose nephropathy in disguise? Am J Ther 1998; 5:399-403.

11. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997; 8:1788-1793.

12. Important Drug Warning ("Dear Doctor") letter. Center for Biologics Evaluation and Research, Food and Drug Administration; 1998.

17. Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986; 26:410-412.

18. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J Hemolysis after high-dose intravenous Ig. Blood 1993; 82:3789.

19. Reinhart WH, Berchtold PE. Effect of high-dose intravenous immunoglobulin therapy on blood rheology. Lancet 1992; 339:662-664.

20. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmunity 1999; 13:129-135.

21. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001; 4:264-268.

22. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994; 44:223-226.

23. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986; 2:217-218.

24. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000; 65:30-34.

25. Miura M, Katada Y, Ishihara J. Time interval of measles vaccination in patients with Kawasaki disease treated with additional intravenous immune globulin. Eur J Pediatr 2004; 163:25-9.

26. Ruderman JW, Barka N, Peter JB, Stiehm ER. Antibody response to MMR vaccination in children who received IVIG as neonates. Am J Dis Child 1991; 145:425-6.

27. Bowman, JM. Antenatal suppression of Rh alloimmunization. Clin Obst & Gynec 1991; 34:296-303.

28. Unpublished data on file, VA-003A Final Study Report, Cangene Corporation.

29. Snydman DR, Werner BG, Tilney NL, et al. Final analysis of primary cytomegalovirus disease prevention in renal transplant recipients with cytomegalovirus immune globulin: comparison of the randomized and open-label trials. Transplant Proc 1991; 23:1357-1360.

30. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev 2003; 17:241-251.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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