• What is GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%?

GAMMAGARD LIQUID is the first and only FDA-approved treatment for adult patients with Multifocal Motor Neuropathy (MMN).1,2 In randomized, withdrawal, double-blind, placebo-controlled clinical study in 44 adult patients with MMN, GAMMAGARD LIQUID was shown to improve muscle strength and reduce disability in adult patients with MMN.1

GAMMAGARD LIQUID is made from human plasma that is donated by healthy people. It may carry a risk of transmitting viruses and, theoretically, the vCJD agent. Patients should report to their healthcare provider any symptoms that concern them that might be caused by virus infections.

  • How is GAMMAGARD LIQUID administered?

GAMMAGARD LIQUID is administered into a vein, also called intravenously (IV). Most often, IVIG infusions are given every 2 to 4 weeks for MMN. Infusion time will vary depending on infusion rate, dose administered, and patient tolerability. GAMMAGARD LIQUID infusions can be administered at a hospital, physician office, infusion center, or at home by a healthcare professional.1

  • What are the risks associated with infusions of GAMMAGARD LIQUID?

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

If any of the following problems occur after starting treatment with GAMMAGARD LIQUID, stop the infusion immediately and contact your healthcare provider or call emergency services.

These could be signs of a serious problem.

  • 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 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, 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.

These are not all of the possible side effects with GAMMAGARD LIQUID. You can ask your healthcare provider for the physician's information leaflet. Tell your healthcare provider about any side effect that bothers you or that does not go away.

  • Who should not be treated with GAMMAGARD LIQUID?

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.

  • Are there any resources available for patients receiving IgG infusions?

Shire offers a number of educational resources and services that may be helpful to adults living with MMN and their caregivers.

References:

  1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.
  2. The Marketing Research Bureau. The Plasma Proteins Market in the United States 2015. Orange, CT: Marketing Research Bureau, Inc; 2016.

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Please expand for Indication and Detailed Important Safety Information.

Selected Important Safety Information about 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.