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GAMMAGARD LIQUID for
Subcutaneous (SubQ) Administration

Sustained Protection Against Infection1

SubQ administration of GAMMAGARD LIQUID treatment has been shown to be effective in a clinical study of 49 adult and pediatric PI subjects. Prior to receiving GAMMAGARD LIQUID SubQ, subjects were treated with IV Ig* every 3 or 4 weeks for 12 weeks.1

  • Annual rate of less than 0.1 validated acute serious bacterial infections per subject-year
  • 3 cases of serious validated bacterial pneumonia; none required hospitalization to treat the infection
  • No hospitalizations secondary to any infections over the course of the clinical study

*Intravenous Immunoglobulin

The upper 99% confidence limit of 0.133 is lower than the minimal goal of achieving a rate of >1 bacterial infection per subject-year.


Demonstrated Tolerability in the Clinical Study1

In the GAMMAGARD LIQUID clinical study for SubQ administration, there was demonstrated tolerability.

Please see below for Detailed Important Risk Information.

of infusions were completed without reducing the infusion rate or stopping the infusion due to
side effects or tolerability issues.

The safety of GAMMAGARD LIQUID in SC infusions was evaluated in 47 subjects during all SC treatment periods.


GAMMAGARD LIQUID treatment is formulated with1:

  • Added Sugars1
  • Added Sodium1
  • Added Preservatives1

  • Stabilized and buffered with glycine1 for those patients in whom additives may be a concern
  • The packaging is not made with natural rubber latex1

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.

Selected Important Safety Information for GAMMAGARD LIQUID
  • GAMMAGARD LIQUID can cause decreased kidney function or kidney failure, blood clots in the heart, brain, lungs or elsewhere in the body. Call your healthcare professional or go to your emergency department right away if you have: 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.
  • Do not take GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to IgG or other blood products.