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Gamunex

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Gamunex

Indications
Dosage
How Supplied

INDICATIONS

Gamunex is an immune globulin intravenous (human) 10% liquid indicated for the treatment of:

Primary Humoral Immunodeficiency (PI)

GAMUNEX (immune globulin intravenous (human) 10%) is indicated as replacement therapy of primary humoral immunodeficiency This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies [16-23].

Idiopathic Thrombocytopenic Purpura (ITP)

GAMUNEX (immune globulin intravenous (human) 10%) is indicated in Idiopathic Thrombocytopenic Purpura to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery [5-10].

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

GAMUNEX (immune globulin intravenous (human) 10%) is indicated for the treatment of CIDP to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.

DOSAGE AND ADMINISTRATION

For intravenous use only

GAMUNEX (immune globulin intravenous (human) 10%) consists of 9%–11% protein in 0.16–0.24 M glycine. The buffering capacity of GAMUNEX (immune globulin intravenous (human) 10%) is 35.0 mEq/L (0.35 mEq/g protein). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight [15]. Thus, the acid load delivered with a dose of 1 g/kg of GAMUNEX (immune globulin intravenous (human) 10%) would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously.

Preparation and Handling

  • GAMUNEX (immune globulin intravenous (human) 10%) should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.
  • Do not freeze. Solutions that have been frozen should not be used.
  • The GAMUNEX (immune globulin intravenous (human) 10%) vial is for single use only. GAMUNEX (immune globulin intravenous (human) 10%) contains no preservative. Any vial that has been entered should be used promptly. Partially used vials should be discarded.
  • GAMUNEX (immune globulin intravenous (human) 10%) should be infused using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving.
  • GAMUNEX (immune globulin intravenous (human) 10%) is not compatible with saline. If dilution is required, GAMUNEX (immune globulin intravenous (human) 10%) may be diluted with 5% dextrose in water (D5/W). No other drug interactions or compatibilities have been evaluated.
  • Content of vials may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling.
  • Do not mix with immune globulin intravenous (IGIV) products from other manufacturers.
  • Do not use after expiration date.

Treatment of Primary Humoral Immunodeficiency

As there are significant differences in the half-life of IgG among patients with primary immunodeficiencies, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.

The dose of GAMUNEX (immune globulin intravenous (human) 10%) for replacement therapy in primary immune deficiency diseases is 300 to 600 mg/kg body weight (3-6 mL/kg) administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical responses.

Treatment of Idiopathic Thrombocytopenic Purpura

GAMUNEX (immune globulin intravenous (human) 10%) may be administered at a total dose of 2 g/kg, divided in two doses of 1 g/kg (10 mL/kg) given on two consecutive days or into five doses of 0.4 g/kg (4 mL/kg) given on five consecutive days. If after administration of the first of two daily 1 g/kg (10 mL/kg) doses, an adequate increase in the platelet count is observed at 24 hours, the second dose of 1g/kg (10 mL/kg) body weight may be withheld.

Forty-eight ITP subjects were treated with 2 g/kg GAMUNEX (immune globulin intravenous (human) 10%) , divided in two 1 g/kg doses (10 mL/kg) given on two successive days. With this dose regimen 35/39 subjects (90%) responded with a platelet count from less than or equal to 20 x109/L to more than or equal to 50 x109/L within 7 days after treatment. [11] The high dose regimen (1 g/kg 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

GAMUNEX (immune globulin intravenous (human) 10%) may be initially administered as a total loading dose of 2 g/kg (20 mL/kg) given in divided doses over two to four consecutive days. GAMUNEX (immune globulin intravenous (human) 10%) may be administered as a maintenance infusion of 1 g/kg (10 mL/kg) administered over 1 day or divided into two doses of 0.5 g/kg (5 mL/kg) given on two consecutive days, every 3 weeks.

Administration

GAMUNEX (immune globulin intravenous (human) 10%) should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or if discoloration is observed.

Only administer intravenously. GAMUNEX (immune globulin intravenous (human) 10%) should be at room temperature during administration.

Only 18 gauge needles should be used to penetrate the stopper for dispensing product from the 10 mL vial; 16 gauge needles or dispensing pins should only be used with 25 mL vial sizes and larger. Needles or dispensing pins should only be inserted once and be within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.

GAMUNEX vial size Gauge of needle to penetrate stopper
10 mL 18 gauge
25, 50, 100, 200 mL 16 gauge

Any vial that has been opened should be used promptly. Partially used vials should be discarded.

If dilution is required, GAMUNEX (immune globulin intravenous (human) 10%) may be diluted with 5% dextrose in water (D5/W).

Rate of Administration

It is recommended that GAMUNEX (immune globulin intravenous (human) 10%) should initially be infused at a rate of 0.01 mL/kg per minute (1 mg/kg per minute) for the first 30 minutes. If well-tolerated, the rate may be gradually increased to a maximum of 0.08 mL/kg per minute (8 mg/kg per minute).

Indication Initial Infusion rate (first 30 minutes) Maximum infusion rate (if tolerated)
PI 1 mg/kg/min 8 mg/kg/min
ITP 1 mg/kg/min 8 mg/kg/min
CIDP 2 mg/kg/min 8 mg/kg/min

Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue GAMUNEX (immune globulin intravenous (human) 10%) if renal function deteriorates.

For patients at risk of renal dysfunction or thromboembolic events, administer GAMUNEX (immune globulin intravenous (human) 10%) at the minimum infusion rate practicable.

Incompatibilities

GAMUNEX (immune globulin intravenous (human) 10%) is not compatible with saline. If dilution is required, GAMUNEX (immune globulin intravenous (human) 10%) may be diluted with 5% dextrose in water (D5/W). No other drug interactions or compatibilities have been evaluated.

Shelf Life

GAMUNEX (immune globulin intravenous (human) 10%) may be stored for 36 months at 2-8C (36-46F) from the date of manufacture AND product may be stored at temperatures not to exceed 25C (77 F) for up to 6 months any time during the 36 month shelf life , after which the product must be immediately discarded.

Special Precautions for Storage

Do not freeze. Frozen product should not be used. Do not use after expiration date

HOW SUPPLIED

Dosage Forms and Strength

GAMUNEX (immune globulin intravenous (human) 10%) is supplied in 1.0 g, 2.5 g, 5 g, 10 g, or 20 g single use bottles.

  • 1 g in 10 mL solution
  • 2.5 g in 25 mL solution
  • 5 g in 50 mL solution
  • 10 g in 100 mL solution
  • 20 g in 200 mL solution

GAMUNEX (immune globulin intravenous (human) 10%) is supplied in single-use, tamper evident vials (shrink band) containing the labeled amount of functionally active IgG. The three larger vial size labels incorporate integrated hangers. The components used in the packaging for GAMUNEX (immune globulin intravenous (human) 10%) are latex-free. GAMUNEX (immune globulin intravenous (human) 10%) is supplied in the following sizes:

NDC Number Size Grams Protein
13533-645-12 10 mL 1.0
13533-645-15 25 mL 2.5
13533-645-20 50 mL 5.0
13533-645-71 100 mL 10.0
13533-645-24 200 mL 20.0

GAMUNEX (immune globulin intravenous (human) 10%) may be stored for 36 months at 2 - 8°C (36 - 46°F), AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded. Do not freeze. Do not use after expiration date.

REFERENCES

5. Blanchette, V.S., M.A. Kirby, and C. Turner, Role of intravenous immunoglobulin G in autoimmune hematologic disorders. Semin Hematol, 1992. 29(3 Suppl 2): p. 72-82.

6. Lazarus, A.H., J. Freedman, and J.W. Semple, Intravenous immunoglobulin and anti-D in idiopathic thrombocytopenic purpura (ITP): mechanisms of action. Transfus Sci, 1998. 19(3): p. 289-94.

7. Semple, J.W., A.H. Lazarus, and J. Freedman, The cellular immunology associated with autoimmune thrombocytopenic purpura: an update. Transfus Sci, 1998. 19(3): p. 245-51.

8. Imbach, P.A., Harmful and beneficial antibodies in immune thrombocytopenic purpura. Clin Exp Immunol, 1994. 97(Suppl 1): p. 25-30.

9. Bussel, J.B., Fc receptor blockade and immune thrombocytopenic purpura. Semin Hematol, 2000. 37(3): p. 261-6.

10. Imbach, P., et al., Immunthrombocytopenic purpura as a model for pathogenesis and treatment of autoimmunity. Eur J Pediatr, 1995. 154(9 Suppl 4): p. S60-4.

11. Cyrus P, F.G., Kelleher J, Schwartz L,, A Randomized, Double-Blind, Multicenter, Parallel Group Trial Comparing the Safety, and Efficacy of IGIV-Chromatography, 10% (Experimental) with IGIV-Solvent Detergent Treated, 10% (Control) in Patients with Idiopathic (Immune) Thrombocytopenic Purpura (ITP), 2000. Report on file.

15. Guyton, A., Textbook of Medical Physiology. 5th Edition. 1976, Philadelphia: W.B. Saunders. 499-500.

16. Ammann, A.J., et al., Use of intravenous gamma-globulin in antibody immunodeficiency: results of a multicenter controlled trial. Clin Immunol Immunopathol, 1982. 22(1): p. 60-7.

17. Buckley, R.H. and R.I. Schiff, The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med, 1991. 325(2): p. 110-7.

18. Cunningham-Rundles, C. and C. Bodian, Common variable immunodeficiency: clinical and immunological features of 248 patients. Clin Immunol, 1999. 92(1): p. 34-48.

19. Nolte, M.T., et al., Intravenous immunoglobulin therapy for antibody deficiency. Clin Exp Immunol, 1979. 36(2): p. 237-43.

20. Pruzanski, W., et al., Relationship of the dose of intravenous gammaglobulin to the prevention of infections in adults with common variable immunodeficiency. Inflammation, 1996. 20(4): p. 353-9.

21. Roifman, C.M., H. Levison, and E.W. Gelfand, High-dose versus low-dose intravenous immunoglobulin in hypogammaglobulinaemia and chronic lung disease. Lancet, 1987. 1(8541): p. 1075-7.

22. Sorensen, R.U. and S.H. Polmar, Efficacy and safety of high-dose intravenous immune globulin therapy for antibody deficiency syndromes. Am J Med, 1984. 76(3A): p. 83-90.

23. Stephan, J.L., et al., Severe combined immunodeficiency: a retrospective single-center study of clinical presentation and outcome in 117 patients. J Pediatr, 1993. 123(4): p. 564-72.

24. Cayco, A.V., M.A. Perazella, and J.P. Hayslett, Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol, 1997. 8(11): p. 1788-94.

Manufactured by: Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA. September 2008. FDA Rev date: 9/12/2008

Last reviewed on RxList: 10/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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