Immune Globulin, Subcutaneous Infusion ih-MYOON GLOB-yoo-lin, sub-kyoo-TAY-nee-us

What are other names for this medicine?

Type of medicine: immune globulin

Generic and brand names: immune globulin, subcutaneous; Vivaglobin

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.

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 or blood clots
• heart or blood vessel disease
• selective immunoglobulin A deficiency

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.

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?

Carefully read and follow the directions that come in the package of medicine for preparing the shots. Before using, let the medicine warm to room temperature.

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. The infusions are given just under the skin. Check the label on the medicine for directions about your specific dose. Your healthcare provider will determine the exact dosage. Set the rate of infusion on the pump as instructed by your healthcare provider.

Follow these steps to give yourself the infusions:

1. Wash your hands before using this medicine.
2. Before each infusion, gently swirl each vial. Do not shake the vial. Check to make sure that the medicine looks clear. Do not use it if it is cloudy or has particles in it. Remove the protective cap from each vial of this medicine. Clean the top of each vial stopper with an alcohol wipe, and let it dry.
3. Attach a needle to the syringe tip. Pulling back on the syringe plunger, draw as much air into the syringe as the amount of medicine that will be withdrawn. Insert the needle into the center of the vial stopper. Inject the air into the vial. Withdraw the medicine into the syringe and remove the filled syringe from the vial. Remove the needle from the syringe and discard the needle.
4. Follow manufacturer's instructions for filling the infusion pump and removing the air from the tubing and catheter that will be used to infuse this medicine.
5. Your healthcare provider will tell you where you can give yourself the shots (abdomen, thigh, upper arm, or hip). If you are giving the shot in your abdomen, choose a site around the belly button but not in the belly button. If you need to give this medicine in more than one site, make sure that each site is at least 2 inches apart. The maximum amount of medicine to use per infusion site is 15 mL.
6. Use an alcohol swab to clean the skin where you will give the infusion and then let it dry.
7. Gently pinch up the skin and insert the needle into the skin at a 45° angle. Test to make sure that a blood vessel has not been accidentally entered by gently pulling back on the plunger. If blood appears when you pull back on the plunger, withdraw the needle and gently press the alcohol swab on the injection site. Start over with a fresh needle.
8. Use gauze or another dressing and tape to secure the needle in place.
9. Attach the tubing to the infusion pump following the manufacturer's instructions and turn on the pump.
10. Once the infusion is done, turn off the infusion pump and remove the needle from the infusion site.
11. Discard the needle and drug vial. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.
12. Remove the peel-off label on the drug vial. This label contains the product lot number and expiration date. Record the time, date, and exact dose of your infusion on the label and place the label in your treatment diary. Take the treatment diary with you when your visit your healthcare provider.

Ask your healthcare provider about anything you do not understand.

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?

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.

If you need emergency care, surgery, 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 are unable to 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).

Serious (report these to your healthcare provider right away): Nausea; vomiting; fever; unexplained stiff neck; severe headache; unusual tiredness or weakness; sensitivity to light; painful eye movements; brown or red urine; fast heartbeat; yellow skin or eyes; lower back or side pain; pain, swelling, warmth, redness, or a lump in your legs or arms; reduced urination; sudden weight gain; chest pain or trouble breathing.

Other: Mild tenderness, pain, swelling, itching, or redness where the shot was given; headache; sore throat; diarrhea; cough.

What products might interact with this medicine?

Check with your healthcare provider before having any live-virus vaccinations (such as shots for measles, mumps, and rubella) within 3 months of this immunization. This medicine may interfere with your response to other vaccines.

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?

Store this medicine in the refrigerator. Do not let it freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Keep the medicine in the original box until ready for use.

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.