GAMMAKED
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GAMMAKED

What is GAMMAKED?

GAMMAKED is an immune globulin (IG) infusion medication used to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) and adults and children with idiopathic thrombocytopenic purpura (ITP). It raises platelet counts and prevents bleeding in patients with ITP who are scheduled to undergo surgery. It is also designed to improve neuromuscular disability, as well as to prevent relapse of primary humoral immunodeficiency (PI) in patients who are two years of age or older.

Important Safety Information

GAMMAKED may increase the risk of blood clots in patients who are of advanced age, lead a sedentary lifestyle, or have a medical history of blood clots or any condition that could lead to cardiovascular disease. It could also result in blood clots in individuals who take estrogen hormones, have thick blood, or have a central catheter.

GAMMAKED could also increase the risk of kidney failure in patients with kidney disease, diabetes, dehydration, sepsis, paraproteinemia, or are 65 and older. The risk of kidney failure also increases if the patient is already taking other medications that could have an adverse effect on the kidneys.

GAMMAKED may interact with other medications. Tell your doctor about all drugs you’re currently taking — whether they’re prescription, over-the-counter, vitamins, or herbal supplements.

What is the most important information I should know about GAMMAKED?

GAMMAKED is made from human blood. Therefore, it carries a risk of transmitting viruses and other infectious agents. Do not use this medication if you have a history of severe allergic reactions to human immune globulin or other medications that contain human immune globulin.

Do not use GAMMAKED if you have an immunoglobulin A (IgA) deficiency and have antibodies to IgA and a history of allergic reactions. GAMMAKED could also cause higher than normal levels of protein in the blood, thick blood, and/or low sodium levels in the blood. As a result, this may restrict your blood from flowing freely and increase the risk of blood clots.

Patients who receive a high dose of GAMMAKED or a rapid infusion rate could develop aseptic meningitis (brain inflammation). The medication could also increase the risk of swelling of the lungs, hemolysis, and hemolytic anemia following treatment.

Also, tell your doctor about any recent vaccinations you’ve received. Certain live vaccinations — such as those for rubella, varicella, measles, and mumps — may not work well while undergoing treatment with GAMMAKED.

GAMMAKED Side Effects

As with any prescription medication, GAMMAKED carries the risk of side effects. These may vary depending on the patient’s medical history and the condition being treated. The most common ones include:

  • Fever
  • Sore throat
  • Coughing
  • Stuffy nose
  • Nausea
  • Diarrhea
  • Sinus infection
  • Headaches
  • Bruising
  • Vomiting
  • Abdominal pain
  • Back pain
  • Indigestion
  • Increased blood pressure
  • Chills
  • Joint pain
  • Weakness

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

GAMMAKED is an immune globulin (IG) infusion medication used to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), adults and children with idiopathic thrombocytopenic purpura (ITP), and to prevent bleeding in patients who are about to undergo ITP surgery. The dosage amount and infusion rate will vary depending on the age of the patient, their medical history, and the condition being treated.

Please refer to the full prescribing information.