HIZENTRA ( Immune Globulin)

What is this medication?

Hizentra is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Hizentra subcutaneous injection(for injection under the skin) is used to treat primary immunodeficiency diseases. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra is also used to treat chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder in which the immune system attacks the nerves, causing muscle weakness and numbness).

How should I use this medication?

Hizentra is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin. A healthcare provider may teach you how to properly use the medication by yourself.

Hizentra is sometimes given daily, and sometimes once every 1 to 2 weeks. Use this medicine at regular intervals to keep a steady amount of the drug in your body at all times. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Hizentra must be given slowly, and you may need to use up to 8 different catheters to infuse this medicine into different body areas at the same time. Your healthcare provider will show you where to on your body to inject Hizentra. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has is cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not shake the medication bottle or you may ruin the medicine.

Do not inject Hizentra into a vein.

You will need frequent blood tests. This medicine can affect the results of certain other medical tests you may need. Tell any doctor who treats you that you are using Hizentra.

You will need to use your medicine within a certain number months. This will depend on the how you store the medicine (at room temperature, or in a refrigerator). Carefully follow the storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Throw away any unused medication after the expiration date on the label has passed.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use disposable injection items (needle, catheter, tubing) only once only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What if I miss a dose?

Call your doctor for instructions if you miss a dose.

How should I store this medication?

Store Hizentra in the original carton at room temperature. Protect from heat and light.

You may also store this medicine in its original carton in the refrigerator. Do not freeze Hizentra, and throw the medicine away if it has frozen.

What are the possible side effects of using this medication?

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction to Hizentra:

• hives;
• wheezing,
• chest tightness,
• difficult breathing;
• dizziness,
• feeling like you might pass out;
• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a blood cell disorder - pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• kidney problems - little or no urination, swelling, rapid weight gain, feeling short of breath;
• lung problems - chest pain, trouble breathing, blue colored lips, fingers, or toes;
• signs of a new infection - fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
• signs of a blood clot - shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common Hizentra side effects may include:

• wheezing, trouble breathing;
• pain, redness, bruising, itching, swelling, or a hard lump where the medicine was injected;
• fever, tiredness, dizziness;
• nausea, vomiting, diarrhea, bloating, stomach pain;
• itching, rash, or other skin problems;
• cold or flu symptoms such as stuffy nose, sneezing, sore throat, cough;
• headache, migraine; or
• pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hizentra?

Immune globulin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.