Gamunex-C

PATIENT INFORMATION

GAMUNEX®-C
Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified

Subcutaneous Infusion for Primary Humoral Immunodeficiency

Information for Patients

Please read this information about GAMUNEX-C carefully before using this medicine. This information does not take the place of talking with your healthcare professional, and it does not include all of the important information about GAMUNEX-C. If you have any questions after reading this, contact your healthcare professional.

What is the most important information I should know about GAMUNEX-C?

GAMUNEX-C should be infused under your skin (in the subcutaneous tissue). DO NOT inject GAMUNEX-C into a blood vessel or directly into a muscle.

What is GAMUNEX-C?

GAMUNEX-C (Gam-y–oo-nex) is an immunoglobulin used to treat primary immune deficiency (PI). Immunoglobulin is another name for the purified antibodies from human plasma that defend the body against infections such as viruses and bacteria. People with PI lack the healthy antibodies needed to fight off these infections. GAMUNEX-C provides those healthy antibodies and will help lower the number and severity of infections you could get.

Who should NOT take GAMUNEX-C?

Do not take GAMUNEX-C if you have known severe allergic reactions or a severe response to Immune Globulin (Human). Tell your doctor if you have had a serious reaction to other medicines that contain immune globulin. Also tell your doctor if you have an immunoglobulin A (IgA) deficiency.

How should I take GAMUNEX-C?

You will take GAMUNEX-C through infusions given just below the skin (in the subcutaneous tissue). As directed by your physician, one or more injection sites on your body will be selected. The number and location of the injection sites depends on the amount you need to receive. Typically, people use 1 to 4 needles in different locations on your body at one time. You may use up to 8 needles as directed by your doctor. The needles are attached with a tube to the pump. You will need to have infusions once a week.

Instructions for administering GAMUNEX-C are at the end of this patient package insert (see “Steps for Administration”). Only use GAMUNEX-C by yourself after you have been instructed by your doctor or healthcare professional.

What should I avoid while taking GAMUNEX-C?

Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immunoglobulin products like GAMUNEX-C. The antibodies in GAMUNEX-C may prevent the vaccine from working. Before you get a vaccine, tell the doctor or nurse that you are taking GAMUNEX-C.

Tell your doctor or healthcare professional if you are pregnant or plan to become pregnant, or if you are nursing.

What are possible side effects of GAMUNEX-C?

The most common side effects with GAMUNEX-C when given under the skin (subcutaneously) are:

  • Redness, swelling, and itching at the injection site
  • Headache
  • Fatigue
  • Pain (including pain in the back, joints, arms, legs)
  • Fever

Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.

Tell your doctor right away if you have any of the following symptoms. They could be signs of a rare, but serious problem.

  • Decreased urination, sudden weight gain, fluid retention/swelling in your legs, and/or shortness of breath. They could be signs of a serious kidney problem called renal failure.
  • Chest pain, shortness of breath, leg pain, and swelling of the legs/feet. These could be signs of a blood clot in your body (thromboembolism).
  • Severe headache, stiff neck, fatigue, fever, sensitivity to light, painful eye movements, nausea and vomiting. These could be signs of a type of brain inflammation called aseptic meningitis.
  • Increased heart rate, fatigue, yellow skin or eyes, and dark colored urine. These could be signs of a type of blood problem called hemolytic anemia.
  • Chest pains, trouble breathing, blue lips or extremities, and fever. These could be signs of a lung problem called TRALI (transfusion-related acute lung injury).
  • Fever over 100° F. This could be a sign of an infection.

Tell your doctor about any side effects that concern you. You can ask your doctor to give you the full prescribing information available to healthcare professionals.

Steps for Administration

Infuse GAMUNEX-C only after you have been trained by your doctor or healthcare professional. Below are step-by-step instructions to help you remember how to use GAMUNEX-C. Ask your doctor or healthcare professional about any instructions you do not understand.

Before Using GAMUNEX-C

  • GAMUNEX-C comes in single-use vials. Do not let it freeze. Keep it refrigerated. If needed, GAMUNEX-C can be stored at room temperature for up to 6 months but you must use it within that time or you must throw it away.
  • Do not shake the vials.
  • Prior to use, allow the solution to come to room temperature (68-77°F or 20-25°C). This can take 60 minutes or longer.
  • Do not use the vial if:
    • the solution is cloudy, discolored or contains particles. The solution should be clear and colorless to pale yellow.
    • the protective cap or plastic shrink band around the cap is missing.
    • the expiration date has passed.
  • Sanitize your infusion set-up area by preparing a clean, flat, non-porous surface such as a kitchen counter. Avoid using porous surfaces such as wood. Clean the surface with an alcohol wipe using a circular motion from the center outward.

Step 1:

Wash and dry your hands thoroughly before administering GAMUNEX-C

  • Your healthcare provider may recommend that you use anti bacterial soap or that you wear gloves.

Wash and dry your hands - Illustration

Step 2:

Remove the protective cap and sanitize the rubber stopper

  • Remove the protective cap from the vial to expose the central portion of the rubber stopper.
  • Wipe the rubber stopper with alcohol and allow to dry.

Remove the protective cap and sanitize the rubber stopper - Illustration

Step 3:

Use aseptic technique when preparing and administering GAMUNEX-C

  • Do not allow your fingers or other objects to touch the inner stem of the plunger, the syringe tip, or other areas that will come in contact with your GAMUNEX-C solution. This is called aseptic technique and is designed to prevent transmission of germs.
  • Using aseptic technique, attach each needle to the syringe tip.

Attach each needle to the syringe - Illustration

Step 4: Prepare the syringe and draw GAMUNEX-C solution into syringe

  • Remove cap from needle.
  • Pull the syringe plunger back to the level matching the amount of GAMUNEX-C to be withdrawn from the vial.
  • Place the GAMUNEX-C bottle on a clean flat surface and insert the needle into the center of the vial stopper.
  • Inject air into the vial. The amount of air should match the amount of GAMUNEX-C to be withdrawn.
  • Turn the vial upside down and withdraw the correct amount of GAMUNEX-C. If multiple vials are required to achieve the correct dose, repeat Step 4.

Draw GAMUNEX-C solution into syringe - Illustration

Step 5:

Fill the pump reservoir and prepare the infusion pump

  • Follow the pump manufacturer's instructions for filling the pump reservoir and preparing the infusion pump, administration tubing and Y-site connection tubing, if needed.
  • Be sure to prime the administration tubing to ensure that no air is left in the tubing or needle by filling the tubing/needle with GAMUNEX-C. To prime, hold the syringe in one hand and the administration tubing's capped needle in the other. Gently squeeze on the plunger until you see a drop of GAMUNEX-C exit from the needle.

Example Equipment

Example Equipment - Illustration

Step 6:

Select the number and location of infusion sites

  • Select one or more infusion sites as directed by your health care provider.
  • The number and location of injection sites depends on the volume of the total dose.

Location of infusion sites - Illustration

Step 7:

Prepare the infusion site

  • Cleanse the infusion site(s) with antiseptic solution using a circular motion working from the center of the site and moving to the outside.
  • Sites should be clean, dry, and at least 2 inches apart.

Prepare the infusion site - Illustration

Step 8:

Insert the needle

  • Grasp the skin between two fingers and insert the needle into the subcutaneous tissue.

Insert the needle into the subcutaneous tissue - Illustration

Step 9:

Do not inject GAMUNEX-C into a blood vessel

  • After inserting each needle into tissue (and before your infusion), make sure that a blood vessel has not been accidentally entered. To do this, attach a sterile syringe to the end of the primed administration tubing. Pull back on the syringe plunger and watch for any blood flowing back into administration tubing.
  • If you see any blood, remove and discard the needle and administration tubing.

Check for presence of blood - Illustration

  • Repeat priming and needle insertion steps using a new needle, administration tubing and a new infusion site.
  • Secure the needle in place by applying sterile gauze or transparent dressing over the site.

Repeat priming and needle insertion steps - Illustration

Step 10:

Repeat for other sites, as needed

  • If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.

Step 11:

Infuse GAMUNEX-C following the pump manufacturer's instructions for the infusion pump

Infuse GAMUNEX-C - Illustration

Step 12:

After infusion, turn off pump and dispose of used supplies

  • Follow manufacturer's instructions to turn off pump.
  • Undo and discard any dressing or tape.
  • Gently remove the inserted needle(s) or catheter(s).
  • Discard any unused solution in an appropriate waste container as instructed.
  • Discard any used administration equipment in an appropriate waste container.
  • Store your supplies in a safe place.
  • Follow manufacturer's instructions to care for the infusion pump.

Step 13:

Record each infusion

  • Remove the peel-off label with the product lot number from the GAMUNEX-C vial and use this to complete the patient record.
  • Remember to bring your journal with you when you visit your physician or healthcare provider.

Be sure to tell your doctor about any problems you have doing your infusions. Your doctor may ask to see your journal, so be sure to take it with you each time you visit the doctor's office.

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

Last reviewed on RxList: 1/14/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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