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hyaluronidase and immune globulin

Generic Name: hyaluronidase and immune globulin (HYE al ure ON i dase and i MUNE GLOB ue lin)
Brand Name: Hyqvia

What is hyaluronidase and immune globulin?

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.

Hyaluronidase and immune globulin are given together to treat primary immunodeficiency in adults.

Hyaluronidase and immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hyaluronidase and immune globulin?

You should not use this medicine 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.

What should I discuss with my healthcare provider before using hyaluronidase and immune globulin?

You should not use this medicine if you have ever had an allergic reaction to an hyaluronidase and immune globulin, 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 hyaluronidase and immune globulin 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.

How is hyaluronidase and immune globulin given?

Hyaluronidase and immune globulin 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 this medicine in larger or smaller amounts or for longer than recommended.

Hyaluronidase and immune globulin 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.

Hyaluronidase and immune globulin 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 hyaluronidase and immune globulin 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 hyaluronidase and immune globulin, 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 hyaluronidase and immune globulin.

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 hyaluronidase and immune globulin not used before the expiration date on the medicine label.

Do not heat the medicine before using.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while using hyaluronidase and immune globulin?

Do not inject this medicine into any skin that is red or swollen. Injecting hyaluronidase and immune globulin into infected skin could cause the infection to spread to other parts of your body.

Do not receive a "live" vaccine while using hyaluronidase and immune globulin. 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.

Hyaluronidase and immune globulin side effects

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.

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 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.

See also: Side effects (in more detail)

Hyaluronidase and immune globulin dosing information

Usual Adult Dose for Primary Immunodeficiency Syndrome:

Ramp up dosing:

First infusion/week 1: One quarter of full maintenance dose, subcutaneously
Second infusion/week 2: One half of full maintenance dose, subcutaneously

Infusion rates for first 2 infusions:
-Administer the hyaluronidase at an initial rate per site of approximately 1 to 2 mL/min, or as tolerated.
-Administer immune globulin at the following rates:
-5 mL/hr (<88 lbs) or 10 mL/hr (88 lbs or higher) over the first 5 to 15 minutes
-Increase rate to 10 mL/hr (<88 lbs) or 30 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
-Increase rate to 20 mL/hr (<88 lbs) or 60 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
-Increase rate to 40 mL/hr (<88 lbs) or 120 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
-Infuse at 80 mL/hr (<88 lbs) or 240 mL/hr (88 lbs or higher) for the remainder of the infusion

Third infusion/week 4: Three quarters of full maintenance dose, subcutaneously
Fourth infusion/week 7/maintenance dose: Full maintenance dose, subcutaneously

Infusion rates for third to fifth infusions:
-Administer the hyaluronidase at an initial rate per site of approximately 1 to 2 mL/min, or as tolerated.
-Administer immune globulin at the following rates:
-10 mL/hr (all weights) over the first 5 to 15 minutes
-Increase rate to 20 mL/hr (<88 lbs) or 30 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
-Increase rate to 40 mL/hr (<88 lbs) or 120 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
-Increase rate to 80 mL/hr (<88 lbs) or 240 mL/hr (88 lbs or higher) for the next 5 to 15 minutes
-Infuse at 160 mL/hr (<88 lbs) or 300 mL/hr (88 lbs or higher) for the remainder of the infusion

Maintenance dose:

Naive to IgG treatment or switching from Immune Globulin Subcutaneous (Human) [IGSC]:
-300 to 600 mg/kg subcutaneously at 3 to 4 week intervals, after initial ramp-up.

Switching from Immune Globulin Intravenous (Human) [IGIV] treatment:
-Use same dose and frequency as previous intravenous treatment after the initial ramp-up

Infusion rate:
-Administer the hyaluronidase at an initial rate per site of approximately 1 to 2 mL/min, or as tolerated.
-If the patient tolerated the ramp up infusions at the full dose and maximum rate, adjust both the time intervals and number of rate changes of the ramp-up used for successive infusions at the discretion of the physician and patient.

Site selection:
-The suggested site(s) for the infusion are the abdomen and thighs.
-If two sites are used, they should be on opposite sides of the body.
-Avoid bony prominences, or areas that are scarred, inflamed, or infected.

Volume per site:
-Administer up to 300 mL (<88 lbs) or 600 mL (88 lbs or higher) per site.
-Use a second site, at physician and patient discretion, based on tolerability and total volume.
-If using a second site, administer half of total volume in each site.

Comments:
-Safety and efficacy have not been established in conditions other than primary immunodeficiency.
-For patients previously on another IgG treatment, administer the first dose approximately one week after the last infusion of their previous treatment.
-Increase the dose and frequency from a 1 week dose to a 3 or 4 week dose (see ramp-up dose).
-Initiating treatment at a full monthly dose was not evaluated in the clinical trial.

Use: Treatment of Primary Immunodeficiency (PI) in adults.

What other drugs will affect hyaluronidase and immune globulin?

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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about hyaluronidase and immune globulin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01.

Date modified: November 30, 2016
Last reviewed: December 01, 2014

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