Takeda CIDP

What is HYQVIA?

HYQVIA is a liquid medicine that is given under the skin (subcutaneously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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

• HYQVIA can cause blood clots.
• Call your healthcare professional (HCP) if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), 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.
• Your HCP may perform blood tests regularly to check your IgG level.
• Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.

Who should not take HYQVIA?

Do not take HYQVIA if you:

• Are allergic to IgG, hyaluronidase, other blood products, or any ingredient in HYQVIA.

What should I avoid while taking HYQVIA?

• HYQVIA can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your HCP that you take HYQVIA.

What should I tell my HCP before I start using or while using HYQVIA?

Tell your HCP if you:

• Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
• Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products.
• Are pregnant, trying to become pregnant or are breast feeding. It is not known whether HYQVIA can harm the unborn baby or breastfed infant.

What are the possible or reasonably likely side effects of HYQVIA?

HYQVIA can cause serious side effects. If any of the following problems occur after starting HYQVIA, 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, other than at the infusion site(s). 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, 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.

After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. The following possible side effects may occur at the site of infusion and generally go away within a few hours, and are less likely after the first few infusions.

• Mild or moderate pain
• Redness
• Swelling
• Itching

The most common side effects of HYQVIA are:

• Headache
• Fatigue
• Nausea
• Fever
• Itching
• Redness
• Abdominal pain
• Back pain
• Pain in extremity

Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any long-term effect. In theory, these antibodies could react with your body’s own hyaluronidase (PH20). PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side-effects.

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, 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.

HyQvia is the unique combination of IG + Hy. HyQvia can meet you where you are* as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

HyQvia is not indicated as a treatment for Guillain-Barré syndrome (GBS).

*HyQvia can be administered across multiple sites of care, including hospital, infusion centers, offices, or at home with the support of a healthcare professional. Appropriate training is required prior to self infusion.

HyQvia is an IG + Hy CIDP maintenance therapy that is given subcutaneously. But it’s different from traditional IVIG and other SCIG therapies because it’s made with a unique component: hyaluronidase, or Hy.

HyQvia is the only IG therapy that combines IG with Hy.

• IG is thought to reduce damage to the nerves and assist in defending the nerves from harm. HyQvia is similar to the IG in IVIG therapies.
• Hy helps your body take in and disperse a larger amount of IG, which is why HyQvia can be infused up to monthly.***

You’ve got options

You and your doctor can find the right combination to create an infusion experience that’s best for you.

• Flexible site of care options: Gives you the choice to receive infusions at a center or at home after appropriate training*
• Up to 2-hour** monthly infusions: Up to 4-week*** dosing intervals means you may get time back between infusions
• Proven relapse prevention: HyQvia may help you as a maintenance therapy for your CIDP

Hy=hyaluronidase; IG=immune globulin; IVIG=intravenous immune globulin; SCIG=subcutaneous immune globulin.

*HyQvia can be administered across multiple sites of care,  including hospitals, infusion centers, offices, or at home with the support of a healthcare professional. Appropriate training is required prior to self-infusion.

**Infusion time median (range): 116.5 (65, 259) minutes.

***Every 2, 3, or 4 weeks as prescribed by your doctor.

The Takeda Patient Support Co-Pay Assistance Program may cover 100% of your out-of-pocket costs if you’re eligible.

When prescribed a Takeda treatment—whether it’s new to you, you’ve been on treatment, or you’re taking care of someone else—Takeda Patient Support is here to help.

• A co-pay assistance program
• Help getting your medicine
• Nursing support
• Education about your condition
• Ongoing support

Our support specialists are never more than a tap or a call away. Reach us at 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.

Discover treatment with HyQvia and download resources to get you started.

What is GAMMAGARD LIQUID? 

GAMMAGARD LIQUID is a ready-to-use liquid medicine that is given in a vein (intravenously) to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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 sign of an infection.

The most common side effects of GAMMAGARD LIQUID for CIDP include:

• Headache
• Fever
• Anemia
• Illness
• Dizziness
• Migraine
• Somnolence
• Tremor
• Nasal dryness
• Upper abdominal pain
• Vomiting
• Chills
• Nasopharyngitis
• Pain in extremity

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, 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.

US-XMP-2618v1.0 01/24

Take a step toward putting your treatment plan in motion with GAMMAGARD LIQUID, an immune globulin (IG) therapy that is used to treat chronic inflammatory demyelinating polyneuropathy (CIDP). Talk to your doctor to see if GAMMAGARD LIQUID may be appropriate for you.

GAMMAGARD LIQUID is not indicated as a treatment for Guillain-Barré syndrome (GBS).

GAMMAGARD LIQUID is an intravenous infusion, which means that it’s delivered directly into a vein. At the start of therapy, infusions are given for 2-5 days. After that, infusions are given every 3 weeks, but this may be adjusted according to your response.

Learn More About Takeda Patient Support

When you’re prescribed GAMMAGARD LIQUID, Takeda Patient Support is here for you. The support specialists are ready to answer your questions and help get you the resources and tools you need. They can also:

• Help you receive your treatment when you need it
• Connect you to co-pay or insurance help, and more

Visit TakedaPatientSupport.com to find:

• An easy-to-use online portal to help you join Takeda Patient Support
• Details about Takeda Patient Support services and how the program can assist you
• Answers to frequently asked questions
• Links to informative websites and advocacy organizations
• Downloadable tools, and more

You may be eligible to save on certain out-of-pocket treatment costs. Learn more about Takeda’s product support program by clicking here.

In a clinical trial, 94.4% of people receiving GAMMAGARD LIQUID* (17 out of 18) experienced improvement in arm and leg mobility after six months.

*No comparative placebo arm was used in this phase of the study.

The most common side effects of GAMMAGARD LIQUID in patients with CIDP were headache, fever, anemia, illness, dizziness, migraine, somnolence, tremor, nasal dryness, upper abdominal pain, vomiting, chills, nasopharyngitis, and pain in extremity. 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.

If you’re interested in learning more about the study, the infusion process, working with a specialty pharmacy, and other helpful insights, visit www.gammagard.com.

Intravenous immune globulin (IVIG) is not the only treatment option that allows you to stay on therapy (maintenance). There is another treatment that does not require venous access and provides options regarding when and where to infuse. Click here to learn more.