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

Treats problems with your immune system. Helps prevent infections or makes the infection less severe (including hepatitis A, chickenpox, measles, or rubella). Treats disorders that involve the muscle and nervous systems. Also used to improve muscle strength and disability in certain patients.

Brand Name(s):

Alyglo, Asceniv, Bivigam, Cutaquig, Cuvitru, Flebogamma 10% DIF, Flebogamma 5% DIF, Gamastan, Gammagard S/D (IgA less than 1 mcg/mL), Gammaplex 10%, Gammaplex 5%, Hizentra, Octagam, Octagam 10%, Octagam 5%

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 as a shot under your skin, into a muscle, or into a vein.
• A nurse or other trained health professional 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.
• Use a new needle and syringe each time you inject your medicine.
• Allow Gammagard Liquid, Gammaked™, or Gamunex®-C to reach room temperature before using it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• Store Hizentra® 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
• Store Gamunex®-C in its original container and in the refrigerator, but do not freeze it.
• You may store Gammagard Liquid or Gammaked™ 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.
• Store Cuvitru® 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.
• 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 medicines can affect how immune globulin works. Tell your doctor if you are using estrogen, heparin, or any medicine that may affect your kidneys.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not get a live virus vaccine for 3 to 6 months after receiving this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, heart disease, anemia, blood clotting problems, diabetes, atherosclerosis (hardening of the arteries), idiopathic thrombocytopenic purpura (ITP), protein problems (including paraproteinemia or hyperproteinemia), any type of infection, problems with your immune system, or a history of heart attack or stroke. Tell your doctor if you have an allergy to corn or latex or if you are having a surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Kidney problems
  • Increased risk of blood clots in your heart, lungs, or brain
  • Aseptic meningitis syndrome (AMS)
  • Bleeding problems (including hemolysis or hemolytic anemia)
  • High blood pressure
  • Lung problems, including transfusion-related acute lung injury (TRALI)
• This medicine is made from donated human blood. All donated blood is tested for certain viruses. 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, trouble breathing
• Change in how much or how often you urinate
• Chills, cough, sore throat, nausea, vomiting during the infusion
• Confusion, weakness, muscle twitching
• Dark, red, or brown urine
• Fast, slow, pounding, or uneven heartbeat
• Fever higher than 100 degrees Fahrenheit (37.7 degrees Celsius)
• Lightheadedness, dizziness
• Muscle or bone pain
• Pain in your lower leg (calf), numbness or weakness in your arm or leg or on one side of your body
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe back, stomach, chest, or side pain
• Stiff neck, headache, fever, eye pain, eye sensitivity to light
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes

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

• Diarrhea, stomach pain or upset
• Pain, itching, burning, redness, swelling, warmth, or a lump under your skin where the needle is placed or shot is given
• Stuffy or runny nose

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