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Important Safety Information for ASCENIV™

What is ASCENIV (immune globulin intravenous, human-slra)?

ASCENIV (immune globulin intravenous, human-slra) is a prescription medicine to help adults and adolescents (12 to 17 years old) with primary immunodeficiency fight and prevent infections.

ASCENIV is for intravenous administration only. ASCENIV is made from healthy human blood/plasma.

Who should not use ASCENIV?

ASCENIV should not be used if you had a severe allergic reaction to human immune globulin or if you have been told by a doctor that you are immunoglobulin A (IgA)-deficient and have developed antibodies to IgA and hypersensitivity after exposure to a previous plasma product.

What are possible warnings and precautions with taking ASCENIV?

Hypersensitivity. Severe allergic reactions may occur with immune globulin products, including ASCENIV. If you have a severe allergic reaction, stop the infusion immediately and get medical attention. ASCENIV contains IgA. If you have known antibodies to IgA, you may have a greater risk of developing potentially severe allergic reactions.

If you take ASCENIV or a similar immune globulin product, you could experience a serious and life-threatening blood clot (thromboembolism). This may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness, or weakness on one side of the body. If you are at risk, your doctor may decide to adjust the dose of ASCENIV. Your doctor will monitor you for any signs or symptoms of blood clots or poor blood flow in your arteries.

Always tell your doctor immediately if your medical history is similar to what is described here, and especially if you experience any of these symptoms while taking ASCENIV.

Kidney problems or failure. Kidney problems, kidney failure, and death may occur with use of human immune globulin products, especially those containing sucrose (sugar). ASCENIV does not contain sucrose.

If you have kidney disease or diseases with kidney involvement, your doctor should perform a blood test to assess your hydration level and kidney function before beginning immune globulin treatment and at appropriate intervals thereafter. If your doctor determines that kidney function is worsening, they may discontinue treatment. If your doctor determines you be at risk, they may start your dose of ASCENIV at a safe level.

People taking human immune globulin products, including ASCENIV, may experience hyperproteinemia (high levels of protein in the blood), hyponatremia (low levels of sodium in the blood), and hyperviscosity (poor blood flow). Your doctor may perform certain blood tests and monitor you to minimize any of the above risks.

Aseptic meningitis syndrome (AMS). Aseptic meningitis is a non-infectious inflammation of the membranes that cover the brain. It causes a severe headache, which may occur with human immune globulin treatment, including ASCENIV. AMS usually happens within a few hours to 2 days after treatment. AMS is more commonly associated with higher doses of treatment and/or after rapid infusion. Your doctor may perform a neurological exam, including spinal tap (sampling fluid which surrounds the spinal cord) to evaluate your condition and to rule out other causes of meningitis.

Hemolysis. Hemolysis refers to the destruction of red blood cells. Immune globulin products, including ASCENIV, may contain certain antibodies that can result in the rupturing of red blood cells. Your doctor should monitor you for signs and symptoms of hemolysis, which may include additional confirmation tests.

Taking intravenous human immune globulin products may cause a build up of fluid in the lungs (pulmonary edema) that is unrelated to heart problems. Your doctor should monitor you for lung-related side effects and may conduct appropriate tests that can detect the presence of certain white blood cells (anti-neutrophils) in the drug or your blood. If needed, your doctor may decide to use oxygen or other respiratory methods to help your breathing.

Transmissible infectious agents. Because ASCENIV is made from human blood, it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Your doctor will report to the manufacturer any cases of suspected infections spread by the product.

Interference with lab tests. Because ASCENIV contains a variety of antibodies that are infused into your body, blood tests to determine antibody levels may provide misleading interpretations. Be sure to always tell your doctor, nurse, or lab technician of any medicines you are taking and that you are using ASCENIV.

Interactions with medicines. ASCENIV can make vaccines (like measles, mumps, rubella, and chicken pox vaccines) less effective in your body. Before you get any vaccines, tell your healthcare provider that you take ASCENIV.

What are other possible side effects of ASCENIV?

In clinical studies of ASCENIV, some patients experienced the following:

• Headache
• Sinus inflammation (sinusitis)
• Diarrhea
• Intestinal lining inflammation caused by virus (gastroenteritis)
• Common cold (nasopharyngitis)
• Upper respiratory tract infection
• Bronchitis
• Nausea

These are not all the possible side effects of ASCENIV.
Talk to your healthcare provider about any side effect that bothers you or that does not go away.
You are encouraged to report side effects of prescription drugs to the FDA.Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
Please Click here for full Prescribing Information for ASCENIV.