IgG 20 gram/200 mL (10 %)-hyaluronidase,recomb. subcutaneous solution

Generic name:
Immune globulin/hyaluronidase kit - subcutaneous injection

Pronunciation
(i-MUNE-GLOB-ue-lin/HYE-al-ure-ON-i-dase)

Brand name(s)
Hyqvia

Immune globulin may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist.

The risk of blood clots may be decreased by injecting immune globulin more slowly. Drinking enough water before receiving immune globulin may also help reduce this risk.

Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, or confusion.

This kit contains two medications: immune globulin and hyaluronidase.

Immune globulin is used to boost the body's natural defense system against infection in persons with a weakened immune system (primary immune deficiency). Immune globulin contains natural substances called antibodies (a type called IgG) that come from healthy human blood (plasma). These antibodies help protect your body against infections and help you to fight an infection if you get sick.

Immune globulin is also used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.

Hyaluronidase is used to help the body absorb the immune globulin.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using immune globulin/hyaluronidase and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given slowly by injection (infusion) under the skin in the abdomen or thigh as directed by your doctor, usually every 3 to 4 weeks. Hyaluronidase should be injected first followed by immune globulin. Do not inject this medication into a blood vessel. The dosage is based on your medical condition, weight, and response to treatment.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose and dosing interval. Follow your doctor's instructions carefully.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

Let the medication vials come to room temperature before use. Do not shake the vials. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site(s) each time to lessen injury under the skin. Do not inject into bony areas or into skin that is infected, scarred or swollen. To lessen bruising, do not rub the injection site after each dose. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning section.

Redness, warmth, pain, swelling, or itching at the injection site may occur. Headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fast heartbeat
• unusual tiredness
• yellowing eyes/skin
• dark urine
• signs of kidney problems (such as change in the amount of urine)

Treatment with this medication may rarely cause a serious swelling of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you have severe headache, stiff neck, drowsiness, fever, sensitivity to light, eye pain, or nausea/vomiting.

Lung problems may rarely occur 1 to 6 hours after your treatment. Get medical help right away if you have trouble breathing, chest pain, blue lips/skin, or fever.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using immune globulin/hyaluronidase, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain type of immune system deficiency (selective IgA deficiency with known antibody against IgA)
• kidney disease
• diabetes
• severe loss of body fluids (dehydration)
• a certain blood problem (paraproteinemia)

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response. Also tell your doctor if you plan to travel to areas that have a measles outbreak or if you have been exposed to measles.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as blood type), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab tests (such as IgG levels, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. Depending on the manufacturing date, this medication may also be stored at room temperature for up to 3 months if needed. Refer to the manufacturer's instructions or your pharmacist for other storage details. If the medication is stored at room temperature, do not put it back in the refrigerator. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.