Sign Out
(see Warnings and Precautions).
Instruct patients to immediately report the following signs and symptoms to their healthcare provider: Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath (see Warnings and Precautions).
Symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body. (See Warnings and Precautions.)
Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye 1047 movements, nausea, and vomiting (see Warnings and Precautions).
Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine (see Warnings and Precautions).
Trouble breathing, chest pain, blue lips or extremities, and fever (see Warnings and Precautions).
Inform patients that GAMUNEX-C is made from human plasma and may contain infectious agents that can cause disease. While the risk GAMUNEX-C can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them. (See Warnings and Precautions.)
Inform patients that GAMUNEX-C can interfere with their immune response to live viral vaccines such as measles, mumps and rubella. Inform patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations. (See Drug Interactions.)
PI: Self-Administration: Subcutaneous Administration Only.
Provide the patient with instructions on subcutaneous infusion for home treatment, if the physician believes that home administration is appropriate for the patient.
The type of equipment to be used along with its maintenance, proper infusion techniques, selection of appropriate infusion sites (e.g., abdomen, thighs, upper arms, and/or lateral hip), maintenance of a treatment diary, measures to be taken in case of adverse reactions in the patient instructions.
Steps for Administration: Infuse GAMUNEX-C only after patient has been trained by the doctor or healthcare professional. Below are step-by-step instructions to help remember how to use GAMUNEX-C. Ask the doctor or healthcare professional about any instructions that the patient does 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 it must be use it within that time or the patient 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 the 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 the hands thoroughly before administering GAMUNEX-C.
The healthcare provider may recommend that the patient use antibacterial soap or that he/she should wear gloves.
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.
Step 3: Use aseptic technique when preparing and administering GAMUNEX-C.
Do not allow the fingers or other objects to touch the inner stem of the plunger, the syringe tip, or other areas that will come in contact with the 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.
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.
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 the patient sees a drop of GAMUNEX-C exit from the needle.
Step 6: Select the number and location of infusion sites: Select one or more infusion sites as directed by the healthcare provider.
The number and location of injection sites depends on the volume of the total dose.
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.
Step 8: Insert the needle: Grasp the skin between two fingers and insert the needle into the subcutaneous tissue.
Step 9: Do not inject GAMUNEX-C into a blood vessel.
After inserting each needle into tissue (and before the 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 the patient sees any blood, remove and discard the needle and administration tubing.
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.
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.
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 the 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.
Remind patient to bring their journal when visiting their physician or healthcare provider.
Be sure to tell the physician about any problems the patient has doing their infusions. The doctor may ask to see the journal, so be sure the patient has it each time they visit the doctor's office.
Call the doctor for medical advice about side effects. The patient can also report side effects to 1269 FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
