Immune Globulin (i-MUNE GLOB-ue-lin)

Treats problems with your immune system. Helps prevent infection or make infection less severe.

Brand Name(s):

Cutaquig, Cuvitru, Hizentra, Xembify

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through an IV catheter placed into one of your veins, as a shot into one of your muscles, or as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Keep a treatment diary or logbook to record details about each injection, including time, date, dose, lot number, and any reactions.
• Gammagard Liquid ERC®:
  • Allow the medicine to warm to room temperature for 60 minutes before you use it. Do not warm it in any other way (including microwave).
  • Wash your hands with soap and water before and after using this medicine.
  • Check the liquid in the vial. It should be clear, colorless to slightly yellowish. Do not use it if it looks cloudy, has particles in it, or is dark yellow. Do not shake. Do not use it if the cap is missing or damaged.
  • Pull the plunger back to fill the syringe with air. Inject air into the vial and withdraw the prescribed amount.
  • Remove the needle cover. Pinch the skin. Insert the needle at a 90 degree angle.
  • Before starting the infusion, make sure no blood is flowing into the needle tubing. If blood is present, remove and throw away the used needle and tube.
  • Carefully follow the manufacturer's instructions for preparing the infusion.
  • Remove the peel-off label from the vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, the time of your treatment, and any reactions after each infusion.
• Use a new needle and syringe each time you inject your medicine.
• Do not change the brand or type of your immune globulin unless your doctor tells you to.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
  • Cuvitru® or Gammagard Liquid ERC®: You may store at room temperature, away from heat and moisture, for up to 24 months or in the refrigerator for up to 36 months. Do not freeze. Do not shake. Protect the product from direct light. Keep the medicine in its original package until you are ready to use it.
  • Gammagard Liquid or Gammaked™: You may store in the refrigerator or at room temperature. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.
  • Hizentra®: You may store 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 its original package until you are ready to use it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how immune globulin works. Tell your doctor about any medicine you use that affects your kidneys, or if you are also using heparin or estrogen (including birth control pills).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, heart or blood vessel problems, blood clotting problems, or diabetes. Also tell your doctor if you have IgA deficiency or antibodies, or high levels of proline.
• This medicine may cause the following problems:
  • Increased risk for blood clots
  • Kidney problems
  • Lung or breathing problems
  • Low sodium or high protein levels in your blood
  • Aseptic meningitis syndrome (AMS)
  • Bleeding problems (including hemolysis or hemolytic anemia)
• This medicine is made from donated human blood. All donated blood is tested for certain viruses (including Creutzfeldt-Jakob disease). Although your risk for getting a virus from the medicine is very low, talk with your doctor if you have concerns.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling red skin rash
• Blue lips or fingernails
• Change in how much or how often you urinate, rapid weight gain, swelling in your hands, ankles, or feet
• Chest pain, trouble breathing, coughing up blood
• Fast, slow, pounding, or uneven heartbeat
• Pain in your lower leg, numbness or weakness in your arm or leg or on one side of your body
• Severe back, stomach, chest, or side pain
• Stiff neck, eye pain, sensitivity of the eye to light
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Low fever
• Mild headache or pain
• Pain, itching, burning, redness, swelling, warmth, or a lump under your skin where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088