Immune Globulin, Subcutaneous Infusion

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KEY POINTS

• This medicine is given by infusion pump to treat primary immunodeficiency. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious or life-threatening kidney problems or blood clots, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immune globulin

Generic and brand names: immune globulin, subcutaneous infusion; Cuvitru; Gammagard Liquid; Gammaked; Hizentra; HyQvia (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine is given under the skin by infusion pump to treat primary immunodeficiency, a condition that causes infections that come back frequently or are unusually hard to cure. This medicine may be used to treat other conditions as determined by your healthcare provider. Your healthcare provider will explain why you are receiving this medicine.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have any other medical conditions such as:

• An allergic reaction to any medicine or immunization
• Bleeding disorders, blood clots, or blood vessel disease
• Diabetes
• Heart attack, stroke, atherosclerosis, or other heart disease
• Immunoglobulin A deficiency
• Kidney disease
• Low levels of sodium in your blood
• Problems with dehydration
• Problems with too much protein, or with abnormal proteins, in the blood

If you have had treatment with an immune globulin, tell your healthcare provider if it has been 8 weeks or longer since your last dose.

Tell your healthcare provider if you have recently had an infection, a long period of bed rest or immobilization such as after major surgery or a broken bone in a cast.

Tell your healthcare provider about all the medicines you are taking. While receiving this medicine, some medicines may increase your risk of serious side effects, such blood clots or kidney problems. Tell your healthcare provider if you are taking any hormones, such as estrogen or birth control pills.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving this medicine without your healthcare provider's approval.

How do I use it?

There are several different types of infusion pumps that may be used to deliver this medicine. Your healthcare provider will advise which type of pump is best for you and teach you how to use the pump. The infusions are given just under the skin. Your healthcare provider will determine the exact dosage. Set the rate of infusion on the pump as instructed by your healthcare provider.

Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions included in the medicine package for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children. Some brands should not be used in children under a certain age.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause serious or life-threatening kidney problems. The risk of kidney problems may be higher if you are over age 65, are dehydrated, have diabetes, a history of kidney problems, problems with proteins in your blood, or if you take other medicines that affect your kidneys. Signs of kidney problems include urinating less often, unexplained bloating or swelling, and shortness of breath. If you have these symptoms while being treated with this medicine, contact your healthcare provider right away.

This medicine may cause serious or life-threatening blood clots. The risk of blood clots may be higher in older people, if you have been immobile for a long time, if you take hormones, use a catheter, or have heart or blood vessel problems, or a history of blood clots. Call your healthcare provider right away if you have chest pain, shortness of breath, numbness or weakness (especially on one side of your body), or pain, swelling, warmth, redness, or a lump in your legs or arms.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine is made from human tissue. It is tested for viruses such as hepatitis and HIV. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; fever; chills; nausea; vomiting; chest tightness; trouble breathing; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Severe nausea or vomiting; unexplained fever; unexplained stiff neck; confusion; unusual tiredness or weakness; unusual bruising or bleeding; pinpoint red spots on the skin; sensitivity to light; painful eye movements; dark urine; light-colored bowel movements; fast or irregular heartbeat; yellowing of your skin or eyes; lower back, side, or stomach pain; pain, swelling, warmth, redness, or a lump in your legs or arms; problems urinating or reduced urination; sudden weight gain; swelling in hands, ankles, or feet, or other unexplained swelling; blue lips, fingers, or feet; chest pain or trouble breathing; severe dizziness or fainting.

Other: Mild tenderness, pain, swelling, itching, or redness where the shot was given; headache; diarrhea; nausea; joint or muscle pain; stuffy nose.

What products might interact with this medicine?

Check with your healthcare provider before having any live-virus vaccinations (such as shots for chicken pox, measles, mumps, and rubella). This medicine may interfere with your response to live vaccines for up to 6 months or longer after receiving this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Follow your healthcare provider’s instructions for proper storage, or read the storage instructions included in the medicine package. Do not let the medicine freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Ask your healthcare provider or pharmacist if you have any questions about how to store your medicine.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.