Immune globulin subcutaneous (Injection)

How to Use This Medicine

Injectable

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• 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.
• Use a new needle and syringe each time you inject your medicine.
• Allow the Gammagard Liquid, Gamunex®-C, and Vivaglobin® brand to reach room temperature before using it.
• Do not use the medicine if it has changed color or has flecks (particles) floating in it. Do not heat up or shake the medicine.
• Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself or your child an injection.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• If you store Gamunex®-C and Vivaglobin® at home, keep it in the refrigerator, but do not freeze the medicine. Store it in the original container.
• If you store Hizentra® at home, keep it at room temperature, away from heat and direct light. Store it in the original container.
• You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Talk to your doctor before getting any vaccines while you or your child are receiving immune globulin. Some vaccines may not work as well while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have kidney problems, anemia, blood clotting problems, diabetes, heart or blood vessel problems (such as atherosclerosis), low blood volume, serious infection in the body, or a history of heart attack or stroke.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, hives, itching, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after receiving this medicine.
• Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with the subcutaneous (needle under the skin) route of Gamunex®-C. This may result in a buildup of blood under the skin (hematoma).
• Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).
• This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.
• Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after you have received this medicine. These may be symptoms of a serious lung problem.
• This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.
• Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.
• This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Change in how much or how often you urinate.
• Chest pain, blue lips or fingernails, shortness of breath, or coughing up blood.
• Fast or pounding heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Nosebleeds.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Pain your upper stomach.
• Rapid weight gain.
• Red or dark brown urine.
• Stiff neck, painful eye movements, and sensitive to light.
• Sudden or severe headache, or problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Trouble breathing.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

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

• Back pain.
• Diarrhea, constipation, heartburn, upset stomach, or stomach pain.
• Ear pain.
• Mild headache.
• Muscle or joint pain.
• Nausea or vomiting.
• Nervousness.
• Pain, itching, burning, redness, swelling, or a lump under your skin where the shot is given.
• Skin rash.
• 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

Introduction

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

Treats problems with your immune system. Helps prevent infections or makes the infection less severe. Increases the amount of immune globulin in people who do not have enough in their bodies.

Brand Name(s)

Hizentra, Vivaglobin

When This Medicine Should Not Be Used