BETHESDA, MD 21 December 2012—Germany-based Biotest AG announced December 20 that its U.S. subsidiary received approval from FDA to market Bivigam 10% intravenous immune globulin (IVIG) liquid for the treatment of primary humoral immunodeficiency.
The product's labeling (PDF) includes the standard boxed warning about IVIG products' link to acute renal dysfunction and failure under certain circumstances.
One of those circumstances is the presence of sucrose in the IVIG product. Bivigam, however, does not contain sucrose.
The labeling recommends a dosage of 300–800 mg/kg every three to four weeks. An infusion should start at a rate of 0.5 mg/kg/min for the first 10 minutes and then, depending on the patient's tolerance, increase by 0.8 mg/kg/min every 20 minutes until the rate is 6 mg/mg/min.
Patients who have had an anaphylactic or severe systemic reaction to a human immunoglobulin product must not receive Bivigam. The product is also contraindicated in patients with selective IgA deficiency who have antibodies to immunoglobulin A.
Headache and fatigue occurred most commonly among the 63 patients with primary humoral immunodeficiency who participated in the multicenter, open-label, nonrandomized study of the IVIG product. The labeling reports that two thirds of the patients received an antipyretic, antihistamine, or antiemetic drug before their IVIG infusion.
Bivigam will be available in single-use latex-free vials containing 50 or 100 mL of ready-to-use 10% IVIG liquid. The vials should be stored at 2–8 °C but allowed to come to room temperature before use.
Biotest said its U.S. subsidiary, Biotest Pharmaceuticals Corporation, plans to start shipping the new product shortly.
The U.S. subsidiary came into existence in 2007, when Biotest AG bought the biologics strategic business unit of Nabi Biopharmaceuticals.