Hyqvia

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.

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.

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.

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.

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.

HYQVIA
Immune Globulin Infusion 10% (Human) Recombinant Human Hyaluronidase for Subcutaneous Administration

The following summarizes important information about HYQVIA (pronounced Hi-Q-via). Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare professional, and it does not include all of the important information about HYQVIA. If you have any questions after reading this, ask your healthcare professional.

What is the most important information that I should know about HYQVIA?

• HYQVIA can cause blood clots.
• Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
• Your healthcare professional may perform blood tests regularly to check your IgG level.
• With your consent, your healthcare professional may provide blood samples to Baxalta US Inc. to test for antibodies that may form against the hyaluronidase part of HYQVIA.
• Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.
• Talk to your healthcare professional if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling 1-866-424-6724.

What should I tell my healthcare professional before I start using HYQVIA?

Before starting HYQVIA, tell your healthcare professional if you:

• Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
• Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products
• Are pregnant, trying to become pregnant or are breast feeding.

What is HYQVIA?

HYQVIA is a liquid medicine containing immune globulin and recombinant human hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection.

Who should not take HYQVIA?

• Do not take HYQVIA if you: Are allergic to IgG, hyaluronidase, or other blood products
• Have IgA deficiency with antibodies to IgA

How should I take HYQVIA?

• HYQVIA is infused under the skin (subcutaneously) up to once every 4 weeks.
• You can get HYQVIA at your healthcare professional's office, clinic, or hospital.
• You can use HYQVIA at home. You and your healthcare professional will decide if home self-infusion is right for you.

What are the possible or reasonably likely side effects of HYQVIA?

After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused.

The following local reactions may occur at the site of infusion and generally go away in a few hours. Local reactions are less likely after the first few infusions.

Mild or moderate pain
Redness
Swelling
Itching

The most common side effects of HYQVIA are:

Headache
VomitingFatigue
Nausea
Fever

Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any long term effect. In theory, these antibodies could react with your body's own PH20. PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side-effects.

Call your healthcare professional or go to your emergency department right away if you get:

• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of swelling in your brain.
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
• Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
• Chest pain or trouble breathing, blue lips or extremities. These could be signs of a lung problem.

These are not all of the possible side effects for HYQVIA. You can ask your healthcare professional for information that is provided to healthcare professionals. Talk to your healthcare professional about any side effects that bother you or that don't go away.

How do I store HYQVIA?

Store HYQVIA refrigerated or at room temperature.

• You can store HYQVIA in the refrigerator (36° to 46°F [2° to 8°C]) for up to 36 months.
• You can store HYQVIA at room temperature (up to 77°F [25°C]) for up to 3 months during the first 24 months from the date of manufacturing (Mfg Date) printed on the carton.
• Do not return HYQVIA to the refrigerator if you take it out to room temperature.

Check the expiration date on the carton and vial label. Do not use HYQVIA after the expiration date.

Do not freeze.

Protect from light. You can use the original HYQVIA containers to protect it from light.

Recredits at Baxalta Available to the Patients

Detailed Instructions for Administration

Do not use HYQVIA at home until you get instructions and training from your healthcare professional.

Your healthcare professional will decide which administration system that is right for you. You will take the hyaluronidase first. Then, within 10 minutes, you will take the immune globulin through an infusion pump.

Prepare HYQVIA vial(s):

• Remove HYQVIA from the box. Allow vials to reach room temperature. This may take up to 60 minutes.
• Do not apply heat or place in microwave.
• Do not shake the vials.

1. Check the vials:

• Do not use after expiration date.
• Do not use if the protective cap is missing or broken.
• Look at the color:
  • The Recombinant Human Hyaluronidase (HY) should be clear and colorless.
  • The Immune Globulin Infusion 10% (Human) (IG) should be clear and colorless or pale yellow.
  • If either liquid is cloudy or has particles, do not use.

2. Prepare for Infusion:

• Gather all supplies:
• Items include: dual vial unit(s) of HYQVIA, infusion supplies: subcutaneous needle set, solution container (bag or syringe), sterile clear bandage and tape, pump tubing, transfer devices, syringe(s), gauze, tape, sharps container, infusion pump, infusion log and other supplies as needed.
• Clean work area
• Program the infusion pump according to prescribed infusion rates and manufacturer's instructions.
• Wash hands thoroughly.
• Open supplies as shown by your healthcare professional.
• If your HYQVIA vials are pooled together by your pharmacist; skip to step 5.

3. Prepare the Hyaluronidase (Labeled as “HY”):

• Prior to use, take off the protective caps and wipe each of the HY vials (top of vial) with an alcohol wipe and allow to dry
• Remove sterile syringe from package and attach to a sterile needle/needle-less transfer device. Due to the small stopper diameter; use an 18 – 22 gauge sterile needle for the HY 1.25 vial. A sterile needle or needle-less transfer device may be used for all other vial sizes.
• Pull back on plunger of the syringe to fill the syringe with air equal to the amount in the HY vial.
• Position the sharp tip of the needle/needle-less transfer device over the center of the vial stopper and insert it at a 90-degree angle.
• Inject air into the vial and withdraw the full contents of the HY vial(s) into a syringe.
• Repeat the above steps for each additional HY vial using the same syringe, if possible.
• Remove the syringe from the needle/needle-less transfer device.
• Attach the syringe filled with HY to the needle set.
• Point the syringe tip up and push the plunger of the syringe to remove the air and fill the needle set up to the needle hub with the HY.

4. Prepare the immune globulin (Labeled as “IG”):

• Wipe each stopper with a sterile alcohol wipe and allow to dry.
• Transfer the vial(s) labeled IG into either syringe(s) or an infusion bag or as shown by your healthcare professional:
• If using syringe(s)
  • Attach a sterile syringe to a vented spike.
  • Insert the vented spike into the center of the IG vials.
  • Turn the vial upside down and pull back on the plunger to pull the IG into the syringe(s).
  • Repeat these steps, if using multiple vials to achieve the desired dose.
  • If using a sterile needle, attach a sterile syringe to the sterile needle and pull back the plunger of syringe to fill with air which should equal amount of the liquid you will be taking from the vial. Insert the needle into the center of the stopper, and inject air in. Pull back on the plunger to withdraw the desired volume.
• If using an infusion bag:
  • Insert the vented spike into the center of each IG vial. Open the vent.
  • Turn the vial upside down and fill the bag with the IG. Repeat this step, if using multiple vials to achieve the desired dose.
  • Remove the filling tube(s) of the bag and place a sterile cap over the open end of the bag and close the clamp on bag.
  • Insert the spike of the administration pump tubing into the bag and fill as directed by your healthcare professional.

5. Prepare the infusion site:

• Choose an infusion site(s) in either the middle or upper abdomen or thigh. Avoid: bony areas, visible blood vessels, scars and any areas of inflammation (irritation) or infection.
• Select sites on the opposite sides of the body if instructed to infuse in two sites.
• Rotate sites by choosing opposite sides of the body between future infusions.
• Wipe the infusion site(s) with a sterile alcohol wipe beginning at the center of each infusion site and moving outward in a circular motion. Allow the infusion site(s) to dry (at least 30 seconds).

6. Insert and secure the 24 gauge subcutaneous needle:

• Remove the needle cover. Firmly grasp and pinch at least 1 inch of skin between two fingers.
• Insert needle with a rapid motion straight into the skin at a 90 degree angle. Tape needle in place with sterile tape.
• Repeat this step if you have a second infusion site.
• Check for proper needle placement by pulling back on the syringe plunger to check for blood return in the tubing of the needle set.
• If blood is seen in the tubing, remove and discard the subcutaneous needle and repeat steps 3, 5 and 6 with a new subcutaneous needle and infusion site.
• Secure the needle set in place by applying a sterile protective dressing over the site. If more than one site is used, repeat the steps

7. Administer the hyaluronidase (Labeled as “HY”):

• Administer the HY at an initial rate per infusion site of approximately 1 to 2 mL per minute and increase as tolerated. Divide the contents equally between sites, if more than one site is used.
• Remove the syringe from the needle set, after infusing all of the content of the syringe.
• Attach the pump tubing or syringe filled with the IG to the same needle set.

8. Administer the immune globulin (Labeled as “IG”:

Within 10 minutes of completing the infusion of the HY, start the pump to administer the IG.

• Flush infusion tubing up to the needle hub with normal saline or Dextrose 5% in water (D5W) at the end of infusion, if directed by your healthcare professional.

9. Remove subcutaneous needle(s) from the infusion site(s):

• Remove the needle set by loosening the tape on all edges.
• Pull the needle wings straight up and out.
• Gently press a small piece of gauze over the needle site and cover with a dressing.
• Throw away the needle(s) into the sharps container.

10. Record the infusion:

• Remove the peel-off label from HYQVIA vial(s), which has the product lot number and expiration date, and place the label in your treatment record/ infusion log
• Write down the date, time, dose, site(s) of infusion (to assist in rotating sites) and any reactions after each infusion.
• Throw away the disposable supplies, vials, and unused product as recommended by your healthcare professional.

Appropriate studies have not been performed on the relationship of age to the effects of HyQvia in the pediatric population. Safety has not been established.

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Fever

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• nausea
• red streaks on the skin
• swelling, tenderness, or pain at the injection site
• unusual tiredness or weakness
• vomiting

• Itching, redness, swelling, discomfort, or pain at the infusion site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to immune globulin or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have IgA deficiency.

This is not a list of all drugs or health problems that interact with HyQvia.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If you have too much proline in your blood (hyperprolinemia).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where this medicine is given.
• Headache.
• Upset stomach or throwing up.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take HyQvia or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to HyQvia. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

More frequent side effects include: fever, nausea, and vomiting. See below for a comprehensive list of adverse effects.