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GAMMAKED (immune globulin- human injection


  1. Patient Information
  2. Instruct Patients To Immediately Report The Following Signs And Symptoms To Their Healthcare Provider:
  3. What Is The Most Important Information I Should Know About Gammaked?
  4. What Is Gammaked?
  5. How Should I Take Gammaked?
  6. What Should I Avoid While Taking Gammaked?
  7. The Most Common Side Effects With Gammaked When Given Under The Skin (subcutaneously) Are:
  8. Step 10:
  9. Step 11:
  10. Step 12:
  11. Step 13:

Patient Information 

[seeBoxed WarningandWarnings 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[seeWarnings and Precautions (5.2)]
  • 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[seeWarnings and Precautions (5.4)]
  • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting[seeWarnings and Precautions (5.5)]
  • Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine[seeWarnings and Precautions (5.6)]
  • Trouble breathing, chest pain, blue lips or extremities, and fever[seeWarnings and Precautions (5.7)]

Inform patients that GAMMAKED is made from human plasma and may contain infectious agents that can cause disease. While the risk GAMMAKED can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, patients should report any symptoms that concern them.[seeWarnings and Precautions (5.9)]

Inform patients that GAMMAKED can interfere with their immune response to live virus vaccines such as measles, mumps and rubella. Inform patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations.[seeDrug Interactions (7)]

PI: Self-Administration: Subcutaneous Administration Only

Advise the patient to read the FDA-approved patient labeling (Instructions for Use: Subcutaneous Infusion for Primary Humoral Immunodeficiency).

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, and
  • measures to be taken in case of adverse reactions in the patient instructions.

Distributed by:
Kedrion Biopharma Inc.
400 Kelby Street
Fort Lee, NJ 07024

Manufactured by:
Grifols Therapeutics LLC
Research Triangle Park, NC 27709 USA
U.S. License No. 1871

Revised 6/2018

3052575/3052576

GAMMAKED

Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified

Instructions for Use:Subcutaneous Infusionfor Primary Humoral Immunodeficiency

Information for Patients

Please read this information about GAMMAKED 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 GAMMAKED. If you have any questions after reading this, contact your healthcare professional.

What Is The Most Important Information I Should Know About Gammaked? 


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

What Is Gammaked? 


GAMMAKED (g m - -k d) 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. GAMMAKED provides those healthy antibodies and will help lower the number and severity of infections you could get.

Who shouldNOTtake GAMMAKED?

Do not take GAMMAKED 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 Gammaked? 


You will take GAMMAKED 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, adults may use 1 to 4 needles in different locations at one time. You may use up to 8 needles as directed by your doctor. For children, use up to 6 infusion sites simultaneously. For patients of all ages ensure that the infusion sites are at least 2 inches (5 cm) apart. The needles are attached with a tube to the pump. You will need to have infusions once a week.

Instructions for administering GAMMAKED are at the end of this patient Instructions for Use[see"Steps for Administration"].Only use GAMMAKED by yourself after you have been instructed by your doctor or healthcare professional.

What Should I Avoid While Taking Gammaked? 


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

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

The Most Common Side Effects With Gammaked When Given Under The Skin (subcutaneously) Are: 

  • Redness, swelling, and itching at the injection site
  • Fatigue
  • Headache
  • Pain (including pain in the joints, arms, legs)
  • Diarrhea
  • Nausea
  • Migraine
  • 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.
  • 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. These could be signs of a blood clot in your body (thrombosis). Immediately report symptoms of thrombosis.
  • 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 (37.8oC). 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 GAMMAKED 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 GAMMAKED. Ask your doctor or healthcare professional about any instructions you do not understand.

Before Using GAMMAKED

  • GAMMAKED comes in single-use vials. Do not let it freeze. Keep it refrigerated. If needed, GAMMAKED 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 to opalescent, and colorless to pale yellow.
    • the protective cap or plastic shrink band around the cap is missing, or there is any evidence of tampering. Tell your healthcare provider immediately.
    • 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 GAMMAKED

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

Step 1

Step 2:
Remove the protective cap and sanitize the stopper

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

Step 2

Step 3:
Use aseptic technique when preparing and administering GAMMAKED

  • 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 GAMMAKED 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 3

Step 4:
Prepare the syringe and draw GAMMAKED solution into syringe

  • Remove cap from needle.
  • Pull the syringe plunger back to the level matching the amount of GAMMAKED to be withdrawn from the vial.
  • Place the GAMMAKED 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 GAMMAKED to be withdrawn.
  • Turn the vial upside down and withdraw the correct amount of GAMMAKED. If multiple vials are required to achieve the correct dose, repeat Step 4.

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 GAMMAKED. 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 GAMMAKED exit from the needle.

Example Equipment

Step 5

Step 6:
Select the number and location of infusion sites

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

Step 6

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 7

Step 8:
Insert the needle

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

Step 8

Step 9:
Do not inject GAMMAKED 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.

Step 9a

  • 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 9b

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 GAMMAKED following the pump manufacturer s instructions for the infusion pump

Step 11

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 GAMMAKED 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.

Distributed by:
Kedrion Biopharma, Inc.
400 Kelby Street
Fort Lee, NJ 07024

Manufactured by:
Grifols Therapeutics LLC
Research Triangle Park, NC 27709 USA
U.S. License No. 1871

Revised 6/2018

3052575/3052576



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