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What is Gamimune N?

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, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). Gamimune N is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

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

Important information about Gamimune N

Gamimune N can be harmful to the kidneys, and these effects are increased when Gamimune N is used together with other medicines that can harm 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 you use 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 this medication is helping your condition and is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be checked. Do not miss any scheduled appointments.

Using Gamimune N can cause you to have 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) and may contain viruses and other infectious agents that can cause disease. Although Gamimune N is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Gamimune:

• 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 is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known if Gamimune N passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Gamimune N given?

Use Gamimune N exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Gamimune N is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

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

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

To be sure this medication is helping your condition and is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be checked. Do not miss any scheduled appointments.

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

Do not use the medication if it has changed colors or has any 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.

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.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

Call your doctor for instructions if you miss a dose of this medication.

What should I avoid while using Gamimune N?

Do not receive live-virus vaccines such as measles, mumps, or rubella. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Gamimune N side effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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, swelling, weight gain, feeling short of breath;

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

• trouble breathing, blue lips;

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

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

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• feeling like you might pass out;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Less serious Gamimune N side effects may include:

• headache;

• dizziness;

• upset stomach, mild nausea, vomiting, diarrhea;

• back pain, joint pain, minor chest pain;

• mild itching or skin rash; or

• runny or stuffy nose, cough, sore throat;

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.

What other drugs will affect Gamimune N?

Gamimune N can be harmful to the kidneys, and these effects are increased when Gamimune N is used together with other medicines that can harm the kidneys. Before taking Gamimune N, tell your doctor if you are also using:

• 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), naproxen (Aleve, Naprosyn), 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), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with Gamimune N. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Gamimune N.