Immune globulin and hyaluronidase (Subcutaneous)

Immune globulin and recombinant human hyaluronidase injection contains antibodies that help boost your immune system. It is used for patients with primary immunodeficiency (PI), including congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and other serious combined immune system disorders.

Immune globulin injection is part of a group of medicines called immunizing agents. It is used to prevent or treat diseases that happen when your immune system is weak. Immune globulin has antibodies that strengthen your immune system. Hyaluronidase injection is a substance that helps the body absorb immune globulin better.

This medicine is available only with a doctor's prescription.

It is very important for your doctor to check your progress during regular visits for any issues that may arise from this medicine. Blood and urine tests may be necessary to look for unwanted effects.

While you are being treated with this medicine, do not get any immunizations (vaccines) without your doctor's approval. Do not use mumps, rubella, and varicella vaccine for up to 6 months or the measles vaccine for 1 year while using this medicine.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you develop a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain individuals, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin or hyaluronidase products should not use this medicine.

This medicine may lead to blood clots. This is more likely if you have a history of blood clotting issues, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, taking medicines containing estrogen, or need to stay in bed for a long time due to surgery or illness. Contact your doctor immediately if you suddenly experience chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

Contact your doctor right away if you begin to have a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or sensitivity to light. These could be signs of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis). Inform your doctor immediately if you have stomach or back pain, dark urine, decreased urination, trouble breathing, an increased heart rate, tiredness, or yellowing of your eyes or skin after receiving the medicine.

Contact your doctor right away if you notice red or dark brown urine, lower back or side pain, sudden weight gain, swelling in your face, arms, or legs, decreased urine output, or any problems with urination after you receive this medicine. These may indicate a serious kidney issue.

Contact your doctor immediately if you experience chest pain, difficulty breathing, rapid or noisy breathing, sometimes with wheezing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces pink frothy sputum, shortness of breath, or swelling of the legs and ankles after receiving this medicine. These may be signs of a serious lung problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (e.g., Creutzfeldt-Jakob disease) to people who received them, although the risk is low. Both human donors and donated blood are tested for viruses to minimize this risk. Discuss this risk with your doctor if you have concerns.

Make sure any doctor or dentist treating you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless you have talked about them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be weighed against the benefits. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how immune globulin and recombinant human hyaluronidase injection affects children younger than 2 years old. Safety has not been established for this age group.

Geriatric

Appropriate studies on how immune globulin and recombinant human hyaluronidase injection affects older adults have not been performed. Geriatric-specific problems are not expected to limit the usefulness of this medicine in elderly patients. However, older patients are more likely to have age-related blood clotting issues, kidney, or heart problems, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Benzocaine
• Bupivacaine
• Bupivacaine Liposome
• Butacaine
• Chloroprocaine
• Cholera Vaccine, Live
• Cocaine
• Dengue Tetravalent Vaccine, Live
• Dibucaine
• Ebola Zaire Vaccine, Live
• Etidocaine
• Influenza Virus Vaccine, Live
• Lidocaine
• Measles Virus Vaccine, Live
• Mepivacaine
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Prilocaine
• Procaine
• Proparacaine
• Propoxycaine
• Ravulizumab-cwvz
• Ropivacaine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tetracaine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Bleeding problems, history of or
• Kidney problems—Use with caution. May worsen these conditions.
• Blood clotting problems, history of or
• Diabetes or
• Recent heart attack or stroke, or
• Heart or blood vessel disease or
• Hyperviscosity (thick blood), known or suspected or
• Hypovolemia (low blood volume or major loss of body fluids) or
• Paraproteinemia (paraproteins in the blood) or
• Sepsis (serious infection in the body)—Use with caution. May worsen side effects.
• IgA (immunoglobulin A) deficiency with antibodies against IgA—Should not be used in patients with this condition.

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

Check with your doctor right away if any of the following side effects occur:

More common

• Fever

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

More common

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

Less common

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

Other side effects not listed may also happen 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.

In the U.S.

• HyQvia

Available Dosage Forms:

• Solution

A doctor or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach or thigh. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using this medicine at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems. Do not inject this medicine into skin with bony areas, blood vessels, scars, or areas that are inflamed or infected.

Allow the medicine to warm to room temperature for up to 60 minutes before using it. Do not warm it in any other way. Do not shake.

To use immune globulin and recombinant human hyaluronidase injection:

• Gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
• Wash your hands with soap and water before and after using this medicine.
• Check the liquid in the vials (glass container). The immune globulin solution should be clear and colorless or pale yellow. The hyaluronidase solution should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.
• Follow your doctor's instructions on how to prepare the correct amount of medicine.
• With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.
• Put sterile gauze and tape over the injection site to keep the needle from coming out.
• Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.
• Follow your doctor's instructions on how to use the infusion pump.
• Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.
• When all of the medicine has been infused, turn off the pump.
• Take the gauze off and remove the needle and tube from your skin.
• Clean and store the infusion pump.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):For primary immunodeficiency: Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 300 to 600 milligrams (mg) per kilograms (kg) at 3 to 4 week intervals, after an initial ramp-up. Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in its original container in the refrigerator for up to 36 months. You may also store it at room temperature for up to 3 months during the first 24 months from the manufacturing date printed on the carton. Do not freeze. Do not put it back in the refrigerator once kept in room temperature.

Throw away used needles and tubes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.