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.
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What to expect with
IV or subQ infusions
Getting started with intravenous (IV) infusions for PI
Here are a few key things you should know, but you and your doctor should talk through specific details.
- GAMMAGARD LIQUID IV infusions are given into a vein by a healthcare professional
- Infusions can be given at a hospital, an infusion clinic, or by a healthcare professional at home, every 3 or 4 weeks
- Your dose and how often you receive infusions will be prescribed based on how you respond to and tolerate the treatment
Know what to expect with your IV infusions
- Your nurse will prepare the necessary supplies (If you’re in a hospital, you may be asked to sign a consent form for potential risks.)
- Be sure to gather what you want to help pass the time (book, magazine, remote, etc) and grab a glass of water
- Once supplies are prepared, the nurse will put the IV in place to get started
- Let the nurse know if you are uncomfortable at any time
- Try your best to relax
- Put whatever you brought to pass the time to good use
- Drink fluids to stay hydrated
- If anything feels off, let the nurse know
- Write down details of your infusion and any questions for your doctor in a notebook or journal
Looking for safety information?
Getting started with subcutaneous, or subQ, infusions
Here are a few key things you should know, but you and your doctor should talk through specific details.
- GAMMAGARD LIQUID subQ infusions are given under your skin through 1 or more needles. The number of sites depends on your dose
- Infusions can be done at home after training with a nurse, but make sure you read and follow the Detailed Instructions for Administration before getting started
- In the clinical study, weekly infusion times ranged from 0.8 to 2.3 hours (the median time was 1.2 hours)
Know what to expect with your subQ infusions
- Allow vials to reach room temperature naturally (no applied heat). This could take up to 60 minutes
- Find a distraction-free spot and a clean, open workspace that’s been sanitized. Wash hands with antibacterial soap
- Gather supplies from the specialty pharmacy and have the manufacturer’s instructions for your pump handy
- Grab a book, magazine, etc, a glass of water, and notebook or journal to write down any questions you may have during or after your infusion
- Try your best to relax and stay comfy, and put whatever you brought to pass the time to good use
- Care for any side effects based on instructions from your care team
- If you have any side effects, let your doctor or nurse know right away
- Write down details of your infusion in your notebook or journal
Understanding the insurance process can
make a difference
When you are prescribed a specialty medicine like GAMMAGARD LIQUID, your doctor may be required to reach out to your health plan to get preapproval for your treatment. Work with your doctor’s office to ensure you know what your insurance covers and how much GAMMAGARD LIQUID will cost.
First step: Benefits verification
Your doctor’s office will complete a benefits verification on your behalf. They will work with your insurance company to determine if:
- GAMMAGARD LIQUID is covered under your health plan
- How much insurance will pay
- What your deductible will be
- How much you will pay out of pocket
Once the office receives this information, ask the office manager to review your benefits verification results with you. This will help you understand what you are responsible for.
Next step: Prior authorization
Your doctor may need to show your health plan that GAMMAGARD LIQUID is the appropriate treatment for you based on your medical profile. This is called a prior authorization.
- Your doctor’s office will send the necessary forms and documents to your insurance company
- Once your insurance company reviews the prior authorization, you and your doctor’s office will be notified if you are approved for therapy
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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.