Gamimune-N

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.