HyQvia

HyQvia is a prescription immune globulin (IgG) therapy used for primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP), given once a month as an infusion under the skin (subcutaneous ).

HyQvia contains both Immune Globulin Infusion (Human) and Recombinant Human Hyaluronidase.

HyQvia’s therapeutic effect is from its Immune Globulin Infusion (Human), which provides antibodies to help fight infections in PI and improve CIDP symptoms. The other component, Recombinant Human Hyaluronidase infusion, helps the immune globulin spread and absorb more effectively under the skin so that it can be administered as a subcutaneous infusion once a month.

Primary Immunodeficiency (PI)

• In adults and pediatric patients two years of age and older
• Including variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies, and may include other primary immunodeficiencies

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• In adults
• For maintenance therapy to prevent relapse of neuromuscular disability and impairment.

HyQvia boxed warning

HyQvia has a boxed warning for thrombosis. A boxed warning is the strongest safety-related warning that the FDA can assign. Thrombosis is the formation of a blood clot inside a blood vessel that blocks blood flow, and can lead to serious issues like stroke, heart attack if it pulmonary embolism (PE). Thrombosis may occur following treatment with immune globulin products, including this medicine.

Other warnings

IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions.

Antibodies to Recombinant Human Hyaluronidase can develop. The potential exists for such antibodies to cross-react with endogenous Hyaluronidase (PH20), which is known to be expressed in the adult male testes, epididymis, and sperm. It is unknown whether these antibodies may interfere with fertilization in humans. The clinical significance of these antibodies is not known.

Renal injury, including acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis, may occur after treatment with immune globulin products, including HyQvia.

Aseptic Meningitis Syndrome (AMS) may occur. Discontinue treatment if AMS symptoms appear.

Acute intravascular hemolysis may occur. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia

Infusion into or around an infected area can spread a localized infection.

Monitor for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

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.

HyQvia should not be administered to patients:

• History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human).
• IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
• Known systemic hypersensitivity to hyaluronidase, including Recombinant Human Hyaluronidase of HyQvia.
• Known systemic hypersensitivity to human albumin (in the hyaluronidase solution).

You should not use this medicine if you have ever had an allergic reaction to 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 bedridden due to severe illness, or
• if you are using a catheter.

Pregnancy

It is not known whether HyQvia can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. HyQvia should be given to a pregnant woman only if clearly needed.

Breastfeeding

It is not known whether this medicine can cause harm to the breastfed infant when administered to a lactating woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this medicine and any potential adverse effects on the breastfed infant from HyQvia or from the underlying maternal condition. Data from the HyQvia Pregnancy Registry are insufficient to predict effects on the breastfed child from exposure to this medicine through human milk.

Common Hyqvia side effects

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.

Serious 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.

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.

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 the FDA at 1-800-FDA-1088.

HyQvia is given as a subcutaneous infusion, meaning it is delivered under the skin (not into a vein). It is infused using an infusion pump and a small needle placed into the fatty tissue, most commonly in the abdomen or thigh. Your healthcare team will advise the best sites for you.

Because HyQviq has two components, the infusions are given in sequence:

• Recombinant Human Hyaluronidase is infused first to help the tissue allow the medicine to spread and absorb more effectively
• Immune Globulin Infusion (Human), 10% is infused next into the same site.

Many people first receive treatments in a clinic or infusion center so the healthcare team can monitor for side effects, teach infusion steps, and confirm the dose and infusion rate are right for you. If appropriate, you may transition to home infusions after training, either by self-infusion or with help from a caregiver or home infusion nurse.

HyQvia is often given on a monthly schedule, but your exact dose, ramp-up plan, and infusion timing will be tailored to your condition and how you respond to treatment. Always follow the instructions provided by your prescribing team. 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.

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.

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.

• Do not freeze.
• Keep the vials in the carton to protect from light.
• Refrigeration: 2° to 8°C [36° to 46°F] for up to 36 months.
• Room Temperature: up to 25°C [77°F] for up to 3 months during the first 24 months from the date of manufacturing (Mfg date) printed on the carton.
• HyQvia must be used within 3 months after removal to room temperature, but within the expiration date on the carton and vial label.
• Do not return this medicine to the refrigerator after it has been stored at room temperature

Takeda Pharmaceuticals U.S.A., Inc. Cambridge, MA 02142