Asceniv

Asceniv (immune globulin intravenous, human – slra) is a prescription medication used to treat primary humoral immunodeficiency (PI) in persons aged 12 and older.

Asceniv belongs to a group of drugs called immunoglobulins. These work by supplementing the body’s natural defenses in individuals who cannot make their own.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Asceniv include headache, sinusitis, and diarrhea.

Asceniv (immune globulin intravenous, human – slra) is a prescription medication used to treat primary humoral immunodeficiency (PI) in persons aged 12 and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Asceniv. See the "Asceniv Precautions" section.

Common side effects of Asceniv include the following:

• headache
• sinusitis
• diarrhea
• stomach upset caused by virus
• stuffy nose with sore throat
• bronchitis
• nausea

This is not a complete list of Asceniv side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

If you are taking Asceniv it may interfere with your body's ability to mount an adequate immune reaction to live vaccines. 

Additionally, persons taking Asceniv are advised that it may interfere with blood testing results.

Serious side effects have been reported with Asceniv including the following:

• severe hypersensitivity reactions.
• thrombotic events in patients at risk of hyperviscosity.
• acute renal failure. monitor renal function
• hyperproteinemia
• aseptic meningitis syndrome (AMS), especially with high doses or rapid infusion
• hemolytic anemia
• pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]).
• because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Do not take Asceniv if you

• have a history of anaphylactic or severe systemic reactions to human immunoglobulin. 
• are IgA-deficient with antibodies to IgA and a history of hypersensitivity.

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

• Thrombosis may occur with immune globulin (IGIV) products, including ASCENIV. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors (see Warnings and Precautions

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients.

• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ASCENIV does not contain sucrose.

• For patients at risk of thrombosis, renal dysfunction or renal failure, administer ASCENIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.