Demonstrated Effectiveness

GAMMAKED HAS BEEN PROVEN EFFECTIVE FOR THE
TREATMENT OF CIDP, PI AND ITP¹

Patients with CIDP show significant improvement when treated with GAMMAKED

In a clinical study with 117 subjects with CIDP, those treated with GAMMAKED showed significantly improved disability scores compared to those given an inactive substance (placebo).

Also, more than 87% of patients given GAMMAKED every 3 weeks maintained these improvements and did not relapse during the extension phase, compared to 55% patients given placebo.²

GAMMAKED is proven to protect against infections in patients with PI as demonstrated in a 9-month study

Most people with a primary immunodeficiency disorder suffer from frequent, and often severe, sinus infections.³ That's why a reduced number of sinus infections can be a great indication that your therapy is working effectively.

In a clinical study with 172 patients with primary humoral immunodeficiency, GAMMAKED demonstrated protection from severe infections and acute sinusitis.⁴

GAMMAKED doubled the platelet count in chronic ITP

Patients with chronic ITP have low blood platelet counts.⁵

In a clinical study with 97 adults and children with ITP, GAMMAKED treatment resulted in a doubling of platelet counts in 90% of subjects by the 7th day after completing treatment compared to 83% of patients receiving another ITP treatment.⁶

ASK YOUR HEALTHCARE PROFESSIONAL IF GAMMAKED IS RIGHT FOR YOU

References: 1. GAMMAKED [prescribing information]. Fort Lee, NJ: Kedrion Biopharma; 2018. 2. Hughes RAC, Donofrio P, Bril V, et al. Intravenous immune globulin (10% caprylate/chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008;7:136-44. 3. Ten warning signs of primary immunodeficiency. The Jeffrey Modell Foundation Website. http://www.info4pi.org/library/educational-materials/10-warning-signs. Accessed July 27, 2021. 4. Roifman CM, Schroeder H, Berger M., et al. Comparison of the efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency: A randomized double-blind trial. Int Immunopharmacol. 2003;3:1325-33. 5. Provan D, Stasi R, Newland AC, et al. International consensus report on investigation and management of immune thrombocytopenia. Blood. 2010;115:168-86. 6. Bussell JB, Eldor A, Kelton JG, et al. IGIV-C, a novel intravenous immunoglobulin: evaluation of safety, efficacy, mechanisms of action and impact on quality of life. Thromb Haemost. 2004;91:771-8.

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.