QIVIGY

What is QIVIGY®?

QIVIGY (immune globulin intravenous, human-kthm) is an immune globulin (Ig) liquid used to treat adults with primary humoral immunodeficiency.

Important safety information

QIVIGY may cause:

• Blood clots (thrombosis). Blood clots may occur in people taking Ig intravenous (IGIV) products, including QIVIGY. You may be at greater risk for blood clots if you are older, sit or lie for long periods, have a clotting problem or history of blood clots, take estrogen, 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 risk factors. Your healthcare provider will monitor you for signs and symptoms of blood clotting.
• Impaired kidney function or kidney failure. IGIV products have been associated with kidney dysfunction and damage, kidney failure, and death. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over 65, are seriously dehydrated, overweight, have certain infections like sepsis, have a condition that causes abnormal proteins in your blood, or take drugs that may damage your kidneys. Your healthcare provider will monitor your kidney function before and periodically after your first infusion.

Do NOT use QIVIGY if:

• You have a history of severe hypersensitivity or a history of allergic reactions to human Ig. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human Ig or ask if you are not sure.
• You have an immunoglobulin A (IgA) deficiency, have antibodies to IgA, and have a hypersensitivity or 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. People with IgA deficiency who have antibodies against IgA may be at greater risk of these reactions.
• 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 swelling called aseptic meningitis syndrome may occur with IGIV products, especially if you receive a high dose or a rapid infusion.
• Blood damage called hemolysis and hemolytic anemia can develop after treatment with QIVIGY. Your healthcare provider will monitor you for signs and symptoms.
• Swelling of the lungs may occur following treatment. Your healthcare provider will monitor you for signs of lung damage.
• QIVIGY is made from human blood and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
• 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 while receiving QIVIGY. Tell your healthcare provider that you are taking QIVIGY before you receive any vaccination.

ADVERSE REACTIONS

The most common side effects of QIVIGY were headache, fatigue, infusion-related reaction, positive direct Coombs test result suggesting the immune system is attacking the body's red blood cells, nausea, sinus inflammation, dizziness, and diarrhea. During treatment with QIVIGY, be sure to tell your healthcare provider about any unusual symptoms you experience, as they may indicate a possible side effect.

To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION (1-855-353-7466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for complete prescribing details, including Boxed Warning.