Treats problems with your immune system.

Brand Name(s):

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. It is usually given in the stomach or thighs.
• 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.
• 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 this medicine into skin with bony areas, blood vessels, scars, or areas that are inflamed or infected.
• Use a new needle and syringe each time you inject your medicine.
• Allow the medicine to warm to room temperature for up to 60 minutes before using it. Do not warm it in any other way. Do not shake.
• Check the medicine in the vial. The recombinant human hyaluronidase should be clear and colorless, while the immune globulin should be clear and colorless or pale yellow. Do not use it if it is cloudy, discolored, or has particles in it.
• You will take the hyaluronidase first, then the immune globulin through an infusion pump within 10 minutes. Be sure to follow all instructions and training from your doctor before using this 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: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may keep the medicine in the refrigerator for up to 36 months. You may also store it at room temperature for up to 36 months. Protect it from light. Do not freeze. Do not put it back in the refrigerator once kept in room temperature.
• 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. Do not use mumps, rubella, and varicella vaccine for up to 6 months or measles vaccine for 1 year while using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel problems, any type of infection, diabetes, or a history of bleeding problems or blood clotting problems.
• This medicine may cause the following problems:
  • Increased risk for blood clots
  • Aseptic meningitis syndrome (AMS)
  • Bleeding problems
  • Kidney problems
  • Lung problems
• 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, trouble breathing
• Change in how much or how often you urinate, rapid weight gain, swelling in your hands, ankles, or feet
• Chills, cough, fever, sore throat, nausea, vomiting
• Pain in your lower leg (calf), numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Stiff neck, headache, fever, eye pain, eye sensitivity to light
• Unusual bleeding, bruising, or weakness
• Yellow skin or eyes, urine that is dark, red, or brown

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

• Pain, itching, burning, redness, swelling, or a lump under your skin where the shot was given
• Tiredness

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