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GAMMAGARD LIQUID SubQ Administration Side Effects1

Side effects may occur with SubQ treatment.

The most common side effects with SubQ infusions of GAMMAGARD LIQUID, observed in ≥5% of the study subjects in the clinical trial, are shown below.

Most Common Side Effects1

  • infusion site reactions (i.e., mild or moderate pain, swelling, itching, redness, bruising, and/or warmth)
  • headache
  • fatigue
  • increased heart rate
  • fever
  • upper abdominal pain
  • nausea
  • vomiting
  • asthma
  • increased blood pressure
  • diarrhea
  • ear pain
  • canker sores
  • migraine
  • sore throat
  • pain in hands or feet

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 healthcare provider 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.

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications available, such as antihistamines or epinephrine.

It's important to talk to your healthcare provider about what to expect with SubQ administration of GAMMAGARD LIQUID treatment. Your doctor, nurse, or other healthcare professional can help you prepare for treatment and tell you what can be done to manage possible side effects. Also, resources and support are available to help you understand your treatment.

Reference: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.


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Gammagard Liquid MyIgCoPayCard Program Terms and Conditions

This manufacturer's coupon program is not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE, or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law

Shire's MyIgCoPayCard program provides a maximum total benefit of $5,000 for eligible out-of-pocket costs and expires 12 months from date of activation. Eligible costs include deductible, copayment, and co-insurance costs for eligible Shire IG (Immunoglobulin) products. Non-medication expenses, such as ancillary supplies or administration-related costs, are not eligible.

To be eligible, patients must: 1. be starting or receiving treatment with (and have current prescription for) an eligible Shire IG product with an ICD-10 for a diagnosis of Primary Immunodeficiency; and 2. have commercial insurance that covers medication costs for prescribed Shire IG product and allows for CoPay assistance; and 3. be two (2) years old or older.

Acceptance of this offer must be consistent with the terms of benefits provided by patient's health insurance provider.

Offer limited to one card per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, or other offer.

This program is only valid for residents of the United States.

Shire reserves the right to change or discontinue this program at any time without notice.

This is not health insurance.

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Add to patient instructions:

If your insurance situation changes, it is your responsibility to notify MyIgSource's CoPay assistance program.


© 2017 Shire. All rights reserved.

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. Gammagard Liquid is a trademark or registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.

S30515 04/17

Please expand for Indication and Important Safety Information.

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.