The U.S. Food and Drug Administration (FDA) has approved the use of Cutaquiq [immune globulin, subcutaneous (human)-hipp, 16.5% Solution] to treat children age 2 and older with primary humoral immunodeficiency (PI). The FDA previously approved the medication for adults with PI.
PIs are defects of the immune system that cause increased susceptibility to infections that can be chronic, persistent, recurring, debilitating, and sometimes fatal. There are over 400 different diseases that collectively make up PIs. The conditions are also very underdiagnosed. One study noted that between 70% and 90% of people living with a PI remain undiagnosed.
Treatment for PIs will be dependent on the symptoms and severity but a standard therapy is often immunoglobulin replacement therapy, of which there are numerous options. The pediatric indication for Cutaquiq adds to those options. In a news release, Roger Kobayashi, MD, Clinical Professor at UCLA School of Medicine and National Consultant for the Immune Deficiency Foundation stated, “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,” adding, “The FDA approval also provides more flexible options by permitting more frequent or less frequent infusions, which can be advantageous based on a patient’s pharmacokinetic and clinical response.”
The FDA approval was largely based on the results of two clinical trials, showing the drug to be effective in preventing serious bacterial infections, defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
The medication does come with a Boxed Warning about thrombosis.
- Thrombosis may occur with immune globulin 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 of 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 of hyperviscosity.
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