Hyaluronidase is a genetically designed protein used as an aid in helping your body absorb other injected medications.

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

Hyqvia are given together to treat primary immunodeficiency in adults.

Hyqvia may also be used for purposes not listed in this medication guide.

You should not use Hyqvia if you have ever had a severe allergic reaction to an immune globulin, or if you have immune globulin A (IgA) deficiency with antibody to IgA.

Immune globulin can cause blood clots, especially if you have certain risk factors such as heart disease, circulation problems, a history of blood clots, or if you are 65 or older. Call your doctor at once if you have: sudden numbness or weakness, problems with speech or vision, chest pain, feeling short of breath, pain or swelling and warmth in your arm or leg.

Hyqvia is usually given once every 4 weeks. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take Hyqvia in larger or smaller amounts or for longer than recommended.

Hyqvia is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. A healthcare provider will show you how to use an infusion pump and inject your medicine. Do not give yourself an injection if you do not understand these instructions. Call your doctor, nurse, or pharmacist for help.

If you use this medicine at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Hyqvia comes in a kit that contains a "dual vial" unit. The small vial contains hyaluronidase and the large vial contains immune globulin. Do not mix these two medicines together. They should be given one after the other. You will inject hyaluronidase first, and then inject immune globulin within 10 minutes. Do not mix any other medicines in the same infusion.

The Hyqvia kit comes with patient instructions for preparing and injecting your dose. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not shake the vials or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. The medicines should look clear and have no color, but the immune globulin may appear a pale yellow. Do not use if either medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

Each single-use vial (bottle) of hyaluronidase or immune globulin is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use disposable injection items (syringe, needle, catheter, tubing) only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using Hyqvia, you may need frequent blood tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Hyqvia.

Store the dual vial unit in its original carton in the refrigerator. Do not freeze and protect from light.

Take a vial out of the refrigerator up to 60 minutes before preparing your dose, to allow the medicine to reach room temperature. Once a vial has reached room temperature, do not return it to the refrigerator.

You may also store the medicine at room temperature for up to 3 months, away from moisture, heat, and light. Throw away any Hyqvia not used before the expiration date on the medicine label.

Do not heat the medicine before using.

You should not use this medicine if you have ever had an allergic reaction to an Hyqvia, or if you have:

• immune globulin A (IgA) deficiency with antibody to IgA.

Immune globulin can harm your kidneys or cause blood clots, especially if you have certain risk factors. To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, blood circulation problems or a blood vessel disorder;

• a history of stroke or blood clot;

• diabetes;

• kidney disease;

• if you use estrogens (birth control pills or hormone replacement therapy);

• if you are dehydrated;

• if you are 65 years or older;

• if you have been bed-ridden due to severe illness; or

• if you are using a catheter.

FDA pregnancy category C. It is not known whether Hyqvia will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Call your doctor for instructions if you miss a dose of this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not inject Hyqvia into any skin that is red or swollen. Injecting Hyqvia into infected skin could cause the infection to spread to other parts of your body.

Do not receive a "live" vaccine while using Hyqvia. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficult breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Hyqvia may cause serious side effects. Call your doctor at once if you have:

• signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your arm or leg--pain, swelling, warmth, and redness or discoloration;

• signs of a kidney problem--swelling, rapid weight gain, and little or no urinating;

• signs of a blood cell disorder--pale or yellowed skin, dark colored urine, feeling light-headed or short of breath, rapid heart rate, or weakness;

• liver problems--fast heart rate, tired feeling, dark urine, jaundice (yellowing of the skin or eyes);

• lung problems--chest pain, trouble breathing, blue lips, pale or blue colored appearance in your fingers or toes; or

• signs of new infection--high fever, flu symptoms, mouth sores, severe headache, neck stiffness, increased sensitivity to light, nausea and vomiting.

Common side effects of Hyqvia may include:

• redness, itching, swelling and mild pain where the medicine was injected;

• nausea, vomiting;

• fever;

• tired feeling; or

• headache.

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.

Immune globulin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with hyaluronidase and immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Not all possible interactions are listed in this medication guide.