New Ready-To-Use IVIG Product Approved

Cheryl A. Thompson

BETHESDA, MD 21 September 2009—FDA on September 17 approved the marketing of Gammaplex, a ready-to-use 5% intravenous immune globulin (IVIG) product for the treatment of primary humoral immunodeficiency.

The plasma-derived product is manufactured in England by Bio Products Laboratory, a nonprofit organization owned by the British government.

According to Gammaplex's labeling (PDF), the product is made from plasma obtained from healthy U.S. donors who have passed viral screening tests.

The manufacturer declared it inactivates and removes viruses from the pooled plasma by using solvent, detergent, and a 20-nM filter and incubating the final solution at a low pH and elevated temperature.

As with other IVIG products, the labeling includes a boxed warning about the association between the development of renal dysfunction and acute renal failure and receipt of the products in general. These adverse effects, the boxed warning states, are known to occur more commonly in patients receiving sucrose-containing IVIG products. Gammaplex contains sorbitol but not sucrose.

To treat primary humoral immunodeficiency, the manufacturer recommends infusing 300–800 mg of the IVIG solution per kilogram of body weight every three to four weeks. The i.v. infusion should start at a rate of 0.5 mg/kg/min; after 15 minutes, the rate may be increased but should not exceed 4 mg/kg/min. The infusion set should have a 15–20-μm inline filter.

Patients must not receive Gammaplex if they have a history of anaphylactic or severe systemic reactions to human immune globulin or if they are deficient in immunoglobulin A and have antibodies against it and also have a history of hypersensitivity.

During the Phase III multicenter study, the most common adverse events among the 50 patients were headache, fatigue, nausea, and pyrexia.

The manufacturer will supply Gammaplex in single-use glass bottles containing 50, 100, or 200 mL of 5% IVIG. The product must be stord at 2–25 ºC.

FFF Enterprises Inc. will distribute the new IVIG product in the United States.

Spokeswoman Sheryl Perez said the company is hopeful that it can start distribution in early November.