July 20, 2021

The U.S. FDA has approved a new indication for Octagam® 10% [immune globulin intravenous (human)] to treat adult dermatomyositis, a rare inflammatory disease. Octagam 10% first received FDA approval in 2014 to treat chronic immune thrombocytopenic purpura, an autoimmune disorder that affects blood platelets.

Dermatomyositis is a type of myopathy – a disease that affects muscle tissue – for which the cause is unknown. The condition can present differently depending on the individual, but possible signs and symptoms include muscle aches and weakness, muscle stiffness and atrophy, limited range of motion, problems speaking and swallowing, skin abnormalities such as rashes, and fluid accumulation in the body’s tissues (edema). Individuals diagnosed with dermatomyositis have three times the risk of mortality versus the general population.

In a clinical trial, 78.7% of patients on Octagam 10% had a positive response to treatment compared to 43.8% of patients on placebo. Recommended dosing under the new indication is 2g/kg of the patient’s body weight, divided in equal doses and given by intravenous infusion over the course of 2-5 consecutive days every four weeks. The length of infusion time varies based on how well the treatment is tolerated.

A black box warning cautions that thrombosis (blood clots), kidney dysfunction, and acute kidney failure may occur in individuals who are receiving immune globulin intravenous products like Octagam 10%.

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