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

Treats problems with your immune system.

Brand Name(s):

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 as an infusion under the skin of your stomach, upper arm, upper leg or hip area, or thigh.
• 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.
• 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. Do not inject into skin areas that are bony, red, or swelling, or areas that have scars, an infection, or blood vessels.
• The infusion sites should be at least 2 inches apart. Do not use more than 6 infusion sites at the same time. Use this medicine as within 2 hours.
• Check the liquid in the vial. It should be clear and colorless to slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it. Do not shake.
• Allow the medicine to warm to room temperature for at least 60 minutes before you use it. Do not warm it in any other way.
• Carefully follow the manufacturer's instructions for preparing the infusion.
• You might not use all of the medicine in each vial or infusion. Use each vial or infusion only one time. Do not save an open vial.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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. Do not use this medicine if it has been frozen. You may also keep it at room temperature for up to 6 months. Throw away any unused liquid.
• 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.

• 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, diabetes, any type of infection, other immune problems, or a history of blood clots. Tell your doctor if you are having a surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk for blood clots
  • Aseptic meningitis syndrome (AMS)
  • Kidney problems
  • Bleeding problems (including hemolysis or hemolytic anemia)
  • Lung problems
• 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
• Blue lips or fingernails, trouble breathing
• Change in how much or how often you urinate
• 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), chills, cough, sore throat, body aches
• Lightheadedness, dizziness
• 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, 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:

• Diarrhea
• Pain, itching, burning, swelling, or a lump under your skin where the infusion was 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