In People with ITP, the Immune System Mistakenly Destroys Platelets that Are Needed for Blood Clotting

What is ITP?

  • Idiopathic thrombocytopenic purpura (ITP) is a disorder in which blood does not clot properly.
  • This happens because there aren’t enough platelets.
  • Platelets are tiny cells that stick together to help make clots and stop bleeding.
  • Without enough platelets, it takes longer than normal for blood to clot and bleeding to stop.

The Role of Platelets in Normal Blood Clotting

1
Blood vessel injury results in bleeding.
Injured blood vessel
2
Platelets start sticking together to begin a clot.
Platelets starting to stick together to stop the bleeding from the injured blood vessel
3
Platelets work with other proteins to complete a clot.
A strong blood clot stops the bleeding from the injured blood vessel

ITP may be easier to understand if you look at each word by itself:

  • Immune—dealing with the system that protects the body from infection
  • Thrombocytopenic—low numbers of platelets (also called thrombocytes) that are needed for blood clotting
  • Purpura—bruises

Today, ITP is also known as primary immune thrombocytopenia.

What are the signs and symptoms of ITP?

The most common sign of ITP is bleeding. People with ITP may have:

  • Purpura—purple bruises on skin or mucous membranes, like inside the mouth
  • Petechiae—tiny red dots caused by minor bleeding under the skin; often looks like a rash
  • Hematomas—clotted or partly clotted blood in an organ, tissue or body space. Hematomas can occur anywhere in the body, including the brain.
  • Nosebleeds or bleeding from the gums
  • Blood in the urine or stool
  • Heavy menstrual bleeding (heavy periods) in women
  • Any kind of bleeding that is hard to stop
  • Fatigue or feeling of being tired

What causes ITP?

In most cases, ITP is caused by the immune system destroying the body’s platelets by mistake.

  • ITP is a type of autoimmune disorder.
  • An autoimmune disorder occurs when the body attacks itself.
  • The cause of autoimmune disorders is not known.

Who gets ITP?

In children:

  • ITP is usually a temporary condition that occurs rapidly, often after a viral infection.
  • Most children with ITP recover without any treatment within 6 months.

In adults:

  • ITP tends to be chronic (long-term) and is more common in women than in men.
  • About 1 in every 4,000 adults has chronic ITP.

How is ITP treated?

  • ITP cannot be cured, but it can be treated and managed.
  • The goal of treatment is to raise blood platelet counts to a normal range.
  • One option for treatment is IVIg (intravenous immunoglobulin):

    • Immunoglobulins (Ig) are part of the immune system.
    • Treating people with ITP using Ig has been shown to raise platelet counts.
    • Ig products are made by purifying blood plasma donated by people without ITP.
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GAMMAKED™ immune globulin injection (human), 10% caprylate/chromatography purified

Important Safety Information

What is GAMMAKED?

GAMMAKED [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is used to treat primary humoral immunodeficiency (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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

GAMMAKED should be infused under your skin (in the subcutaneous tissue). DO NOT inject GAMMAKED into a blood vessel or directly into a muscle.

GAMMAKED May Cause

  1. Blood Clots (Thrombosis). Blood clots may occur in patients taking immune globulin intravenous (IGIV) products, including GAMMAKED. You may be at greater risk for blood clots if you are of advanced age, sit or lie for long periods, have a clotting condition or a history of blood clots, take estrogen hormones, have a central catheter, have thick blood, and/or if you have other conditions that put you at risk for cardiovascular disease. Blood clots may occur even if you do not have any of these known risk factors.
  2. Impaired kidney function or kidney failure. IGIV products, particularly those that contain sugar (sucrose), have been reported to be associated with kidney dysfunction and damage, kidney failure, and death. Kidney damage and kidney failure happen more often in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over age 65, are seriously dehydrated, have a blood infection (sepsis), have a blood condition called paraproteinemia, or take drugs that can damage your kidneys.

CONTRAINDICATIONS

  • Do not use GAMMAKED if:

    • You have a history of severe allergic reactions to human immune globulin. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human immune globulin. Ask if you are not sure.
    • You have an immunoglobulin A (IgA) deficiency and have antibodies to IgA and have a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.

WARNINGS AND PRECAUTIONS

  • Severe allergic reactions may occur with IGIV products, including GAMMAKED. IgA deficient patients who have antibodies against IgA are at greater risk of developing severe allergic reactions. Your healthcare provider should have medications, such as epinephrine, to immediately treat any sudden severe allergic reactions.
  • If you are receiving GAMMAKED, you could experience higher than normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.
  • Brain inflammation or brain swelling called Aseptic Meningitis Syndrome (AMS) may occur infrequently with IGIV products, including GAMMAKED, especially if you receive a high dose or a rapid infusion.
  • Blood damage called hemolysis and hemolytic anemia can develop after treatment with GAMMAKED. Your healthcare provider will closely monitor you for signs and symptoms of hemolysis and hemolytic anemia.
  • Swelling of the lungs may occur in patients following IGIV treatment, including GAMMAKED. Your healthcare provider will monitor you for signs of lung damage (also known as transfusion-related acute lung injury [TRALI]).
  • GAMMAKED is made from human blood and, therefore, carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.
  • Be sure to tell your healthcare provider about your recent history of vaccinations. Live vaccines for diseases like measles, mumps, rubella and varicella may not work as well for you while you are receiving GAMMAKED. Tell your healthcare provider that you are taking GAMMAKED before you receive any vaccination.

ADVERSE REACTIONS

  • In clinical studies, the most common side effects of GAMMAKED were:

    • Increased cough, stuffy nose, sore throat, headache, asthma, nausea, fever, diarrhea, and sinus infection, when administered intravenously to patients with PI.
    • Swelling and itching at the injection site, fatigue, headache, upper respiratory infection, joint pain, diarrhea, nausea, sinus infection, bronchitis, depression, allergic skin reactions, redness of the skin, migraine, muscle pain, viral infection, and fever, when administered subcutaneously to patients with PI.
    • Headache, bruising, vomiting, fever, nausea, rash, abdominal pain, back pain, and indigestion in patients with ITP.
    • Headache, fever, increased blood pressure, chills, rash, nausea, joint pain, and weakness in patients with CIDP.
  • During treatment with GAMMAKED, be sure to tell your healthcare provider about any unusual symptoms you experience as they may indicate a possible side effect.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088.

Please click here for the Full Prescribing Information for more information including the Boxed Warning, a description of who should not take GAMMAKED, and dosing and administration information.