Hizentra is a 20% liquid preparation of Immune Globulin Subcutaneous (Human) intended for subcutaneous administration. It contains polyvalent human immunoglobulin G (IgG) and is not subjected to heating, chemical, or enzymatic modification, thus maintaining its IgG molecule functions. The formulation includes L-proline as a stabilizer and small amounts of polysorbate 80 and sodium. It is designed to be free of carbohydrate stabilizers and preservatives, and undergoes multiple steps to reduce the risk of virus transmission.

How should I use this medication?

This medication is infused into a vein or under the skin. It may also be injected into a muscle. It is usually given by your care team in a hospital or clinic setting. It may also be given at home. If you get this medication at home, you will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop. It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one. Talk to your care team about the use of this medication in children. While it may be given to children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment. If you give yourself this medication at home: If you miss a dose, take it as soon as you can. Then continue your normal schedule. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

Where should I keep my medication?

Keep out of the reach of children and pets. You will be instructed on how to store this medication. Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis -Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion -Shortness of breath or trouble breathing, cough, unusual weakness or fatigue, blue skin or lips Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Chills -Diarrhea -Fever -Headache -Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Blood clotting disorder -Condition where you have excess fluid in your body, such as heart failure or edema -Dehydration -Diabetes -Have had blood clots -Heart disease -Immune system conditions -Kidney disease -Low levels of IgA -Recent or upcoming vaccine -An unusual or allergic reaction to immune globulin, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication. This medication increases the risk of blood clots. People with heart, blood vessel, or blood clotting conditions are more likely to develop a blood clot. Other risk factors include advanced age, estrogen use, tobacco use, lack of movement, and being overweight. This medication can decrease the response to a vaccine. If you need to get vaccinated, tell your care team if you have received this medication within the last year. Extra booster doses may be needed. Talk to your care team to see if a different vaccination schedule is needed. This medication is made from donated human blood. There is a small risk it may contain bacteria or viruses, such as hepatitis or HIV. All products are processed to kill most bacteria and viruses. Talk to your care team if you have questions about the risk of infection. If you have diabetes, talk to your care team about which device you should use to check your blood sugar. This medication may cause some devices to report falsely high blood sugar levels. This may cause you to react by not treating a low blood sugar level or by giving an insulin dose that was not needed. This can cause severe low blood sugar levels.

What are the most serious risks of this medication?

This medication may cause kidney injury. Your care team will monitor your kidney function closely. Tell your care team right away if you have a decrease in the amount of urine or swelling of the ankles, hands, or feet. This medication increases the risk of blood clots. People with heart, blood vessel, or blood clotting conditions are more likely to develop a blood clot. Other risk factors include advanced age, estrogen use, tobacco use, lack of movement, and being overweight.