Here are frequently asked questions.

About GAMMAGARD LIQUID

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GAMMAGARD LIQUID is a ready-to-use liquid medicine that contains immunoglobulin G, or IgG, antibodies, which protect the body against infection. These antibodies, collected from the plasma of healthy people, replace the missing antibodies in patients with primary immunodeficiency (PI). GAMMAGARD LIQUID is used to treat PI in people 2 years and older.

GAMMAGARD LIQUID temporarily increases the amount of antibodies in your body to fight germs that can make you sick. Learn more about GAMMAGARD LIQUID.

GAMMAGARD LIQUID is prescribed to help your body fight off bacterial and viral infections you are more susceptible to because of primary immunodeficiency (PI). The medicine being infused, either subcutaneously or intravenously, is immune globulin, or IG, which is what your body needs to fight off infections. Learn more.

GAMMAGARD LIQUID contains antibodies from human plasma donated by healthy people. These antibodies help your body fight off bacterial and viral infections. See how GAMMAGARD LIQUID works.

With GAMMAGARD LIQUID, you have a choice of intravenous (IV) infusions or subcutaneous (subQ) infusions. IV infusions are infusions directly into a vein and subQ infusions are infusions just under the skin into the fatty tissue, or subQ layer. Talk with your doctor about which infusion option would work best for you. Learn more about how GAMMAGARD LIQUID works.

If you're infusing at home, you'll receive everything you need to infuse GAMMAGARD LIQUID from a specialty pharmacy. Learn more.

Store vials in their original boxes to protect from light. Do not freeze GAMMAGARD LIQUID.

You can store GAMMAGARD LIQUID in the refrigerator or at room temperature. The maximum storage time for GAMMAGARD LIQUID depends on the storage temperature you choose.

In the Refrigerator: at 2° to 8°C (36° to 46°F) for up to 36 months.

Room Temperature: up to 25°C (77°F) for up to 24 months.

The refrigerator and room temperature expiration dates are printed on the vial labels and the box. Always check the expiration date. You should not use the product after the expiration date.

Note: If you remove GAMMAGARD LIQUID from the refrigerator and store it at room temperature, do not refrigerate again.

Infusing GAMMAGARD LIQUID

GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously). For patients with PI, infusions into the vein are usually given every 3 or 4 weeks whereas infusions under the skin are usually given every week. You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or a family member or friend. Although it is possible to give yourself infusions into the vein at home, they are more often given in a hospital or infusion center by a nurse.

Instructions for giving GAMMAGARD LIQUID under the skin (subcutaneously) are provided in the Instructions for Use. Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider and have received training. Learn more about the administration of GAMMAGARD LIQUID.

Infusions into the vein are usually given every 3 or 4 weeks whereas infusions under the skin are usually given every week. You and your healthcare provider will decide which way is best for you. Learn more about GAMMAGARD LIQUID infusions.

Infusion schedule/dosing

Once you and your doctor talk about and decide whether infusing intravenously or subcutaneously is right for you, you can determine your infusion schedule. If you infuse subcutaneously, you’ll usually infuse every week. If you infuse intravenously, you’ll infuse every 3 to 4 weeks. 

Safety considerations 

GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider that you take GAMMAGARD LIQUID.

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

Do not use GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if GAMMAGARD LIQUID can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours and are less likely after the first few infusions.

  • Mild or moderate pain
  • Swelling
  • Itching
  • Redness
  • Bruising
  • Warmth

During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects:

  • Headache
  • Migraine
  • Fever
  • Fatigue
  • Itching
  • Rash/Hives
  • Cough
  • Chest pain/tightness
  • Chills/shaking chills
  • Dizziness
  • Nausea/vomiting
  • Faster heart rate
  • Upper abdominal pain
  • Increased blood pressure
  • Muscle cramps
  • Sore throat
  • Anemia
  • Illness
  • Somnolence
  • Tremor
  • Nasal dryness
  • Nasopharyngitis
  • Pain in extremity

Learn more about possible side effects of GAMMAGARD LIQUID.

GAMMAGARD LIQUID support + resources

Several organizations have started offering co-pay assistance programs. To learn more about them in detail, you can visit their specific websites. Additionally, the following websites offer co-pay assistance or guidance from time to time:

  • Takeda Patient Support
  • Accessia Health (formerly Patient Services, Inc.)
  • National Organization for Rare Disorders (NORD®)*
*NORD and the NORD logo are registered trademarks of the National Organization for Rare Disorders. NORD is a registered 501(c)(3) charity.

The Immune Deficiency Foundation and the Jeffrey Modell Foundation are both dedicated to providing resources for people with primary immunodeficiency (PI).

My Life, My Story events are led by nurses and patient ambassadors living with primary immunodeficiency (PI). Find out more and register to attend an event at mylifemystory.com.

The Immune Deficiency Foundation also has a number of resources that are available for people living with primary immunodeficiency (PI). They have local events and every other year in June hold a national conference. In the off years, they hold family retreat weekends. The Immune Deficiency Foundation is available to help in many ways—register with them at primaryimmune.org.

The Jeffrey Modell Foundation also has a number of resources that are available to people living with PI. Additionally, they are committed to empowering the community with “Calls to Action,” which are meant to bring the global medical community together to help enhance early diagnosis with access to equal and appropriate treatments for all patients around the world.

Learn more about primary immunodeficiency (PI) and connect with someone who is living with PI or has a loved one with PI. Go to MyIgSource.com or call 1-855-250-5111. MyIgSource is open to PI patients and their caregivers regardless of therapy.

  1. The Immune Deficiency Foundation’s discussion boards. More information can be found at idffriends.org.
  2. The Jeffrey Modell Foundation website, jmfworld.com, which can also be found on Facebook, YouTube, Instagram, and Flickr.

World PI Week aims to raise awareness and diagnosis of primary immunodeficiency (PI) on a global level. On their website, you can learn all about PI and the events that occur all across the world during World PI Week. World PI Week was founded by a variety of organizations including the Immune Deficiency Foundation and Jeffrey Modell Foundation.

Additionally, the Jeffrey Modell Foundation is dedicated to global awareness of PI, physician education, research, patient support, and advocacy. In 2004, they created the first-ever public service advertising (PSA) campaign for primary immunodeficiency, to coincide with their focus on public awareness and physician education. Since then, they have continued to expand the reach of the campaign to help bring knowledge to members of the PI community and the public. Learn more about the Jeffrey Modell Foundation’s PSA campaign.

Insurance 

GAMMAGARD LIQUID is covered under many commercial health insurance plans. If you have commercial health insurance (like Aetna, BCBS, or UnitedHealthcare) chances are you may be covered, but coverage varies by plan. Ask your doctor’s office staff to help explain out-of-pocket costs. When you’re prescribed GAMMAGARD LIQUID, our specialists can also walk you through the insurance process step by step. They’ll help you understand what’s covered, what’s not, and what to do next—because our goal is to help make your journey a little easier.

The Takeda Patient Support Co-Pay Assistance Program may help you save on GAMMAGARD LIQUID.*

The program can cover up to 100% of your out-of-pocket co-pay costs, if you’re eligible. To be eligible for this program, you must: 

  1. Be prescribed a Takeda treatment for a condition it’s approved by the Food and Drug Administration (FDA) to treat.   
    This is called an “approved indication.” Ask your doctor if you’re not sure.
  2. Have commercial insurance. This includes Health Insurance Marketplace plans. Commercial insurance does not include 
    
    Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans.
  3. Be enrolled in Takeda Patient Support.

If you have government insurance, we are here to help answer questions about your prescribed Takeda treatment coverage. This includes federal or state insurance such as Medicare, Medicare Advantage, or Medicaid. If you can’t afford your treatment, we may be able to connect you to programs that may help.

Not enrolled? You can join Takeda Patient Support in a few simple steps at TakedaPatientSupport.com. If English is not your preferred language, let us know. We can assist you in a language of your choosing.

WANT TO CONNECT?

Our support specialists are never more than a tap or a call away—1-866-861-1750, Monday through Friday, 8 AM to 8 PM ET.

*IMPORTANT NOTICE: The Takeda Patient Support Co-Pay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-866-861-1750. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

When you’re prescribed a Takeda treatment, our specialists are here for you. They’ll review your coverage and help you understand what financial options may be available. Our specialists can walk you through the insurance process step by step. They’ll help you understand what’s covered, what’s not, and what to do next—because our goal is to help make your journey a little easier.

WANT TO CONNECT?

Our support specialists are never more than a tap or a call away—1-866-861-1750, Monday through Friday, 8 AM to 8 PM ET. 

Additionally, the Immune Deficiency Foundation (IDF) has a great handbook on how to handle insurance issues and questions. Search for the IDF Health Insurance Toolkit at their website, primaryimmune.org.

As always, your insurer and your insurance policy can affect coverage for any drugs your doctor prescribes, including treatments that you receive on a regular basis like immune globulin (Ig). Many insurance companies have a list of prescription medications that they will cover under the benefit plan. This list is called a formulary. 

It’s important to know if the drugs you take are on your insurance carrier’s formulary. You can check the formulary by visiting your insurance company’s web page and see if the drug your doctor prescribes is listed. Also look to see if the list includes the type of drug you receive, as well as the specific brand your doctor recommends. Sometimes, insurance formularies will only list some of the brands that are available for a medication.

If your brand of medication is—or is not—on the formulary, it can affect how much money you will have to pay for the drug as out-of-pocket costs or co-pays.

When you’re prescribed GAMMAGARD LIQUID, our specialists are here for you. They’ll help you understand what’s covered, what’s not, and what to do next—because our goal is to help make your journey a little easier.

When it comes to immune globulin (Ig) treatment, each brand of Ig is considered to be a different treatment because there are important differences in how each brand of these plasma-derived products is made. As a result, different brands of Ig treatment are not considered to be interchangeable (or identical) according to medical experts and the Immune Deficiency Foundation (IDF).

Some insurance carriers have begun limiting access to specific brands of Ig, but many of these insurers also have exception policies in place that may allow for continued access to the Ig brand your physician recommends.

When you’re prescribed GAMMAGARD LIQUID, our specialists are here for you. They’ll help you understand what’s covered, what’s not, and what to do next—because our goal is to help make your journey a little easier. Visit TakedaPatientSupport.com for details.

If your insurance plan has special rules for brand name drugs, you or your caregiver should make sure your doctor is aware of them. For example, tell your doctor if your prescription for immune globulin (Ig) needs to be worded in a special way to make sure you get the exact brand your doctor wants you to receive. Depending on the state you live in, the doctor may need to write “Dispense as written (DAW),” “Brand necessary,” or other statements on the prescription to ensure that the pharmacy dispenses the exact brand of Ig that was prescribed.

The Patient & Family Handbook for Primary Immunodeficiency Disease, developed by the Immune Deficiency Foundation (IDF), devotes an entire chapter to health insurance. A copy of the sixth edition of the handbook can be downloaded here.

If you're interested in becoming part of a community for those living with PI, you can visit MyIgSource.com.

Additional questions 

GAMMAGARD LIQUID was originally approved by the U.S. Food and Drug Administration (FDA) in September 2005.

GAMMAGARD LIQUID is used to treat primary immunodeficiency (PI) in people 2 years and older.

Primary immunodeficiency is considered a complex and rare disease and the treatments are considered specialty drugs. GAMMAGARD LIQUID is a specialty drug, and only select specialty pharmacy providers (SPPs) have this medication in stock. So your doctor’s office will order GAMMAGARD LIQUID through an SPP. Rather than pick up your prescription at a retail pharmacy in your neighborhood, specialty drugs are mailed to your home or your doctor’s office. You may be contacted by the SPP to coordinate the delivery.

IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots, decreased kidney function or kidney failure

What is the most important information that I should know about GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause the following serious reactions: severe allergic reactions causing difficulty in breathing or skin rashes; decreased kidney function or kidney failure; blood clots in the heart, brain, lungs or elsewhere in the body; severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting; dark colored urine, swelling, fatigue, or difficulty breathing.

INDICATION

What is GAMMAGARD LIQUID?

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) or under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

Important Safety Information

What is the most important information that I should know about GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause the following serious reactions:

  • Severe allergic reactions causing difficulty in breathing or skin rashes
  • Decreased kidney function or kidney failure
  • Blood clots in the heart, brain, lungs or elsewhere in the body
  • Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
  • Dark colored urine, swelling, fatigue, or difficulty breathing

Who should not use GAMMAGARD LIQUID?

Do not use GAMMAGARD LIQUID if you:

  • Have had a severe allergic reaction to immune globulin or other blood products.
  • Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking GAMMAGARD LIQUID?

  • GAMMAGARD LIQUID can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take GAMMAGARD LIQUID.
  • Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of GAMMAGARD LIQUID?

GAMMAGARD LIQUID can cause serious side effects. If any of the following problems occur after starting GAMMAGARD LIQUID, stop the infusion immediately and contact your HCP or call emergency services:

  • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
  • Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
  • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
  • Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
  • Fever over 100°F. This could be a sign of an infection.

The following one or more possible reactions may occur at the site of infusion of GAMMAGARD LIQUID for PI, generally go away within a few hours, and are less likely after the first few infusions:

  • Mild or moderate pain
  • Swelling
  • Itching
  • Redness
  • Bruising
  • Warmth

During the infusion of GAMMAGARD LIQUID for PI, look out for the first signs of the following common side effects:

  • Headache
  • Migraine
  • Fever
  • Fatigue
  • Itching
  • Rashes/hives
  • Cough
  • Chest pain/tightness
  • Chills/shaking chills
  • Dizziness
  • Nausea/vomiting
  • Faster heart rate
  • Upper abdominal pain
  • Increased blood pressure
  • Muscle cramps
  • Sore throat

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.

For additional safety information including Warning about Blood Clots, Decreased Kidney Function, and Kidney Failure, click for Information for Patients and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.