CIDP Symptoms May Interfere with Daily Activities

What is CIDP?¹

Chronic inflammatory demyelinating polyneuropathy (CIDP) is an autoimmune disorder that attacks the protective covering of the nerves. In an autoimmune disorder, the body attacks its own cells and tissues by mistake.
- The nerve damage from CIDP can make the arms and legs weak and cause numbness or tingling. Patients may notice their symptoms changing over weeks or months.
CIDP can worsen very quickly, so diagnosis and fast treatment are important.
A visit to a neurologist is usually needed to diagnose CIDP.

Diagram showing human nerve system and myelin, outer cover of a nerve — In CIDP, damage to the myelin cover causes nerves to lose their ability to send signals. This can make muscles weak and hard to move.¹

What are the signs and symptoms of CIDP?¹

Numbness and tingling in fingers and toes
Weakness of arms and legs
Loss of tendon reflexes in arms and legs
Fatigue

Diagram showing a silhouette of a human with the nerve system

CIDP May Not Affect Everyone the Same. People with CIDP May Notice¹:

Trouble when walking
Tripping, shuffling, or falls
Difficulty using the stairs
Feeling tired
Having a hard time lifting objects
Finding it hard to use fingers, like with buttons

What causes CIDP?¹

The exact cause of CIDP is unknown.
CIDP causes damage to myelin, the outer cover that protects the nerves in the body.
Damage to myelin causes nerve signals to slow down or get lost. This affects the nerves in the arms and legs. As a result, the muscles get weak and do not move the way they should.

Who gets CIDP?^2,3

CIDP affects about 2 out of every 100,000 people worldwide and 9 per 100,000 people in the US.
CIDP can start at any point in life, but it is often first noticed in people around the age of 50.
CIDP occurs twice as often in males as in females.

How is CIDP treated?^1-3

Many patients with CIDP respond well when treated early.
Your doctor may recommend physical therapy along with medicine to improve movement, reduce symptoms, and potentially maintain long-term remission. A patient in remission no longer has CIDP symptoms.
Intravenous immune globulin (IVIG) is one of the commonly used treatments for CIDP.
- IVIG contains naturally occurring antibodies that help to make the immune system stronger.
- IVIG is given through a vein over several hours per infusion.
- GAMMAKED is an IVIG medicine used to treat CIDP.
If you have CIDP—Talk with your doctor about IVIG and other available treatments to find out what is best for you.

Learn more about GAMMAKED for CIDP

References: 1. GBS-CIDP International. What is chronic inflammatory demyelinating polyneuropathy? Accessed May 19, 2025. https://www.gbs-cidp.org/cidp/. 2. Bright RJ, Wilkinson J, Coventry BJ. Therapeutic options for chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review. BMC Neurol. 2014;14:26. 3. Steinberg JS, Koski CL. Guillain-Barré syndrome, CIDP and variants. An overview for the layperson 10th ed. Accessed May 19, 2025. https://www.gbs-cidp.org/wp-content/uploads/2014/09/Overview-for-the-Layperson-ENGLISH.pdf.

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

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.

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.