By PPN News Staff

The FDA granted a new indication for cutaquig (immune globulin, subcutaneous [Human]-hipp, 16.5% Solution; Octapharma) for the treatment of pediatric patients age 2 years and older with primary humoral immunodeficiency (PI). 

The FDA previously approved cutaquig for adults with PI.

The new indication is based on the results of two clinical trials, which involved 75 PI patients: 37 adults and 38 children between 24 months and 17 years of age. The patients received weekly infusions of the subcutaneously administered immune globulin (IG) during a 12-week wash-in/wash-out period followed by a 12-month efficacy period. 

The primary objective of the research was to assess the efficacy of the IG in preventing serious bacterial infections, defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess. No serious bacterial infections were reported.

“The FDA approval provides physicians and families with more treatment options for patients with primary immune disorders, which weaken the immune system and can allow infections and other health issues to occur more easily,” said Roger H. Kobayashi, MD, a clinical professor at UCLA School of Medicine, in Los Angeles, and a national consultant to the Immune Deficiency Foundation. 

The approval also provides more flexible options by permitting more or less frequent infusions, which can be advantageous based on a patient’s pharmacokinetic and clinical response.

Patients and providers have the flexibility to administer this formula of subcutaneous IG at a lower dose more frequently or at a larger dose less frequently if desired. Patients who prefer less frequent injections may have the option of receiving therapy every other week. Conversely, physicians can prescribe daily dosing if patients respond better to more frequent therapy.

“Cutaquig provides enhanced convenience for a wider group of patients who want to customize therapy with their prescriber to best match patient lifestyle needs,” said Octapharma U.S.A. President Flemming Nielsen. “Octapharma is committed to providing people with immune disorders the lifesaving therapies they need. Both the addition of the pediatric indication and the flexible dosing illustrate our commitment to ensure patients have access to lifesaving products that offer a variety of choices for therapy delivery.”

Globally, millions of people suffer with primary immunodeficiencies, a group of more than 400 different diseases. Roughly, one in every 10,000 people have PI, but the diseases are even more prevalent in children. Between 70% and 90% of people living with a PI remain undiagnosed (Orphanet J Rare Dis 2010;5[suppl 1]:10; 2010 Oct 19. doi:10.1186/1750-1172-5-S1-P10).

Thrombosis may occur with IG products, including cutaquig. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.

For patients at risk for thrombosis, administer cutaquig 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.

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