What is Gamunex?

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

Gamunex 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). Gamunex 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.

Gamunex is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

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

Important information about Gamunex

Gamunex can be harmful to the kidneys, and these effects are increased when Gamunex is used together with other medicines that can harm the kidneys. Before using Gamunex, 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 Gamunex, 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 Gamunex 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 Gamunex can cause you to have unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using Gamunex.

Gamunex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although Gamunex 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 Gamunex.

What should I discuss with my health care provider before using Gamunex?

You should not use Gamunex 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 certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use Gamunex, tell your doctor if you have:

• 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 Gamunex 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 Gamunex passes into breast milk or if it could harm a nursing baby. Do not use Gamunex without telling your doctor if you are breast-feeding a baby.

How is Gamunex given?

Use Gamunex 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.

Gamunex 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 Gamunex 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.

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

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

To be sure Gamunex 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 Gamunex can cause you to have unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using Gamunex.

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.

Gamunex can be stored at room temperature, not exceeding 77° F (25° C), for up to 6 months anytime during the 36-month shelf life. Gamunex can be stored in a refrigerator (36° F-46° F / 2° C to 8° C) for 36 months.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much Gamunex.

What should I avoid while using Gamunex?

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.

Gamunex 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 Gamunex 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 Gamunex?

Gamunex can be harmful to the kidneys, and these effects are increased when Gamunex is used together with other medicines that can harm the kidneys. Before taking Gamunex, 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 Gamunex. 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 Gamunex.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Gamunex only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (’Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.