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immune globulin (subcutaneous) (cont.)

What should I discuss with my health care provider before using immune globulin (Hizentra, Vivaglobin)?

You should not use this medication if you have ever had an allergic reaction to an immune globulin, if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • blood circulation problems or a blood vessel disorder;
  • a history of stroke or blood clot; or
  • if you have been bed-ridden due to severe illness.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is immune globulin given (Hizentra, Vivaglobin)?

Immune globulin subcutaneous is given as an injection using an infusion pump. The medicine enters the body through a needle or catheter placed under your skin. The catheter is attached to the pump with an infusion tube.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Immune globulin must be given slowly, and the infusion can take about 1 hour to complete. You may need to use up to 4 catheters to inject this medicine into different body areas at the same time. Your care provider will show you the best places on your body to inject the medication. Follow your doctor's instructions.

Subcutaneous immune globulin is for injection only under the skin. Do not inject this medicine into a vein. Before injecting the medicine, test to make sure the needle is not in a vein. To do this, gently pull back on the plunger of the syringe connected to the infusion tube. If blood flows back into the syringe, remove the catheter and tubing and throw them away. Start over with a new catheter and syringe, insert the needle in a new place on your body, and test for blood flow-back again.

Immune globulin is usually given once every week. Follow your doctor's dosing instructions. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give yourself an injection. Do not mix immune globulin with other medications in the same infusion. Do not use the medication if it has changed colors, looks cloudy, or has particles in it. Call your doctor for a new prescription.

Use disposable injection items (needle, catheter, tubing) only once. Throw away the used items in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using immune globulin.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store Hizentra in the original carton at room temperature, away from moisture, heat, and light. Do not freeze.

Store Vivaglobin in its original carton in the refrigerator. Do not freeze. Take the medicine out and allow it to reach room temperature before preparing your dose.

Throw away any immune globulin that has become frozen. Throw away any unused medication after the expiration date on the label has passed.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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