Gamunex

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:

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

(See Boxed Warning and WARNINGS and PRECAUTIONS Sections)

Inform patients to immediately report the following to their physician:

• signs and symptoms of renal failures, such as decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath
• signs and symptoms of aseptic meningitis, such as headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting
• signs and symptoms of hemolysis, such as fatigue, increased heart rate, yellowing of the skin or eyes, and dark-colored urine
• signs and symptoms of TRALI, such as severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. TRALI typically occurs within 1 to 6 hours following transfusion

Inform patients that GAMUNEX is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses, and, theoretically, the CJD agent). Inform patients that the risk GAMUNEX (immune globulin intravenous (human) 10%) may transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing the donated plasma for certain virus infections and by inactivating and/or removing certain viruses during manufacturing..

Inform patients that administration of IgG may interfere with the response to live viral vaccines such as measles, mumps and rubella. Inform patients to notify their immunizing physician of therapy with GAMUNEX (immune globulin intravenous (human) 10%) .

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Gamunex. Please read with care.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gammaked™, Gamunex®-C, and Hizentra® products may be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. The Hizentra® product may also be given once every 2 weeks. If you are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. You will be shown the body areas where the medicine can be given. Use a different body area for each infusion. Keep track of where you give an infusion to make sure you rotate sites. This will help prevent skin problems.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you must change the brand of medicine, talk to your doctor before giving yourself an infusion. Make sure you understand the instructions on how to use the new brand.

Allow the Gammagard Liquid, Gammaked™, or Gamunex®-C brand to reach room temperature before using it.

To use Gammagard Liquid, Gammaked™, Gamunex®-C, or Hizentra®:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
• Wash your hands with soap and water before and after using this medicine.
• If you have been told to wear gloves when preparing your infusion, put the gloves on.
• Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.
• If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.
• Follow your doctor's instructions on how to prepare the correct amount of medicine.
• Choose an injection site on your body (eg, abdomen or stomach area, thigh, upper arm, upper leg, hip). Clean the injection site with a fresh alcohol wipe, and let it dry.
• With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.
• Put sterile gauze and tape over the injection site to keep the needle from coming out.
• Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.
• Follow your doctor's instructions on how to use the infusion pump.
• Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.
• It usually takes about 60 minutes for each infusion.
• When all of the medicine has been infused, turn off the pump.
• Take the gauze off and remove the needle and tube from your skin.
• Clean and store the infusion pump.
• Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture, for up to 30 months. Keep from freezing. Protect the product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C product in the original container and in the refrigerator, but do not freeze it.

You may store the Gammagard Liquid or Gammaked™ product in the refrigerator or at room temperature. Check the box or label of the vials for expiration dates. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

You should not use Gamunex-C if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

Gamunex-C can harm your kidneys or cause blood clots. To make sure Gamunex-C is safe for you, tell your doctor if you have:

• heart disease, blood circulation problems or a blood vessel disorder;

• a history of stroke or blood clot;

• if you use estrogens (birth control pills or hormone replacement therapy);

• kidney disease;

• diabetes;

• a serious infection called sepsis;

• hyperproteinemia (too much protein in the blood);

• paraproteinemia (abnormal proteins in the blood);

• if you are dehydrated;

• if you are 65 years or older;

• if you have been bed-ridden due to severe illness; or

• if you are using a catheter.

FDA pregnancy category C. It is not known whether Gamunex-C will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Gamunex-C is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.