Gamimune N is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Gamimune N is used to treat primary immune deficiency conditions in which severe impairment of antibody forming capacity has been shown. Gamimune N is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP).

Gamimune N may also be used for purposes not listed in this medication guide.

Gamimune N can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using Gamimune N, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before using Gamimune N, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure Gamimune N is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

Gamimune N can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using Gamimune N.

Gamimune N 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 Gamimune N.

Before using Gamimune N

You should not use Gamimune N 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.

To make sure you can safely use Gamimune N, tell your doctor if you have any of these other conditions:

• kidney disease;

• diabetes (especially if you use insulin);

• a history of stroke or blood clot;

• heart disease or high blood pressure;

• a condition called paraproteinemia; or

• if you are over 65 years old.

FDA pregnancy category C. It is not known whether Gamimune N will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Gamimune N. It is not known if immune globulin passes into breast milk or if it could harm a nursing baby. Do not use Gamimune N without telling your doctor if you are breast-feeding a baby.

Gamimune N 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 Gamimune N.

Gamimune N is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Gamimune N should not be injected into a muscle or under the skin.

Do not use Gamimune N if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Gamimune N is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

Gamimune N can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using Gamimune N.

Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

You should not use Gamimune N 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.

To make sure you can safely use Gamimune N, tell your doctor if you have any of these other conditions:

• kidney disease;

• diabetes (especially if you use insulin);

• a history of stroke or blood clot;

• heart disease or high blood pressure;

• a condition called paraproteinemia; or

• if you are over 65 years old.

FDA pregnancy category C. It is not known whether Gamimune N will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Gamimune N. It is not known if immune globulin passes into breast milk or if it could harm a nursing baby. Do not use Gamimune N without telling your doctor if you are breast-feeding a baby.

Gamimune N 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 Gamimune N.

Call your doctor for instructions if you miss a dose of Gamimune N.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Gamimune N. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Get emergency medical help if you have any of these signs of an allergic reaction to Gamimune N: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• swelling, weight gain, feeling short of breath;

• wheezing, chest tightness;

• feeling like you might pass out;

• fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

• pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious Gamimune N side effects may include:

• mild headache;

• dizziness;

• tired feeling;

• back pain, muscle cramps;

• minor chest pain; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gamimune N can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• lithium (Lithobid);

• methotrexate (Rheumatrex, Trexall);

• pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;

• medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

• medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

• IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

• antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

• cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and other drugs may interact with Gamimune N. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.