Important Risk Information

  1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% for Patients
  2. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% for Healthcare Professionals

GAMMAGARD LIQUID is also used to treat adult patients with Multifocal Motor Neuropathy (MMN), a rare disease that causes muscle weakness that worsens over time.

Stop the infusion immediately and contact your healthcare provider or call emergency services if you have any of the following:

Symptoms of thrombosis (blood clots) that may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration (redness) or lump in an arm or leg, 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.

Symptoms of a kidney problem that may include: reduced urination, sudden weight gain or swelling in your legs.

Symptoms of a serious allergic reaction that may include: hives, skin rash, itching, swelling in the mouth or throat, trouble breathing, wheezing, fainting or dizziness.

Other serious symptoms including: bad headache with nausea, vomiting, stiff neck, drowsiness, fever, sensitivity to light, painful eye movements; blurred vision; brown or red urine, fast heart rate, yellow skin or eyes; trouble breathing, blue lips or extremities; fever over 100°F.

Tell your healthcare provider if you have a history of thrombosis (blood clots), thrombotic events, poor kidney function or kidney failure.

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 deficiency.

GAMMAGARD LIQUID is made from human blood. It may contain infectious agents that can cause disease e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD), and theoretically, the Creutzfeldt-Jakob disease agent. Patients should report any symptoms that concern them which might be caused by virus infections.

GAMMAGARD LIQUID can make vaccines (e.g., measles, mumps, rubella, or chicken pox vaccines) not work as well. It may also affect your blood test results. Before you get any vaccines or have your blood tested, tell your healthcare provider that you take GAMMAGARD LIQUID.

The following is a list of common side effects seen in clinical trials of GAMMAGARD LIQUID:

MMN (IV administration): Headache, chest discomfort, muscle spasms, muscular weakness, nausea, sore throat, ear pain, and pain in extremity.

Although it is possible to receive IV infusions at home, they are more often given in a hospital or infusion center by a nurse. Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help should a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.

Please see the full Prescribing Information, including the Patient Product Information.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may report side effects to Shire Drug Safety at 1-800-999-1785 or drugsafety.us@baxalta.com.

If you have a medical question regarding the use of GAMMAGARD LIQUID, please ask your healthcare provider.

GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin products, including GAMMAGARD LIQUID. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products including GAMMAGARD LIQUID. Renal dysfunction and acute failure occur more commonly with IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
  • For patients at risk of thrombosis, administer GAMMAGARD LIQUID at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
  • GAMMAGARD LIQUID is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
  • HYPERSENSITIVITY: IgA deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. In case of hypersensitivity, discontinue GAMMAGARD LIQUID infusion immediately and institute appropriate treatment.
  • RENAL DYSFUNCTION/FAILURE: Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk for renal dysfunction or thrombotic events, administer GAMMAGARD LIQUID at the minimum infusion rate practicable.
  • Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving GAMMAGARD LIQUID.
  • THROMBOSIS: Thrombosis may occur following treatment with immune globulin products, including GAMMAGARD LIQUID. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
  • Aseptic Meningitis Syndrome (AMS) may occur with IGIV treatment, and has been reported with intravenous (IV) use of GAMMAGARD LIQUID. AMS may occur more frequently with high dose (2 g/kg) IGIV treatment and/or rapid infusion of IGIV.
  • Hemolytic anemia can develop subsequent to GAMMAGARD LIQUID treatment due to enhanced RBC sequestration. Risk factors may include: high doses (e.g., ≥2 g/kg cumulative dose), non-O blood group, and underlying inflammation. Monitor patients for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.
  • Transfusion-Related Acute Lung Injury (TRALI): Non-cardiogenic pulmonary edema has been reported in patients following treatment with IGIV products, including GAMMAGARD LIQUID. Monitor patients for pulmonary adverse reactions.
  • GAMMAGARD LIQUID is made from human blood. It may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease agent. No confirmed cases of viral transmission or vCJD have been associated with GAMMAGARD LIQUID.
  • Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella, varicella, and measles. This passive transfer may also yield false positive serological testing results, with the potential for misleading interpretation.

The serious adverse reactions in the MMN (IV administration) clinical trial were pulmonary embolism and blurred vision. The most common adverse reactions observed in ≥ 5% of patients in the clinical trials were:

MMN (IV administration): Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.

Please see the accompanying full Prescribing Information, including Boxed Warning.

To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report suspected adverse reactions, contact Shire Drug Safety at 1-800-999-1785 or .

If you have a medical or clinical question regarding the use of GAMMAGARD LIQUID, please contact Shire Medical Information at 1-866-424-6724 or