Pediatric Indication Approved for HyQvia

Takeda announced on April 11, 2023, that it has received U.S. Food and Drug Administration (FDA) approval to extend the patient age range for HyQvia^® [immune globulin infusion 10% (human) with recombinant human hyaluronidase]. Available on the U.S. market for treating adults since September 2014, HyQvia contains mostly immunoglobulin G (IgG), the most common natural antibody. Derived from human blood plasma, it is infused subcutaneously (SC) to restore at least partial immune function for patients who have primary immunodeficiency (PI). Genetic disorders of the immune system, PIs are believed to affect about 1% of the global population to various extents. For most patients who have a PI, the risk of infection is increased because their immune systems do not function properly. HyQvia’s hyaluronidase component makes IgG easier to absorb after SC administration and helps to spread it more evenly throughout the body. The new approval extends its use to children as young as two years old. Doses are based on both patient weight and blood levels of IgG. Although they are packaged in two separate vials, the components of HyQvia can be given sequentially during one SC infusion using an infusion pump. Treatments are needed once every three weeks to four weeks. Labeling carries a boxed warning that using any IG may increase the risk of having blood clots, especially for patients who have additional blood clotting risk factors. Revised prescribing information is here.

MedWatch Updates

FreeStyle Libre Readers

Since February, Abbott has been notifying individuals who use readers (separate cell phone-like devices that are used by patients who do not use cellphone apps) for three of their continuous glucose monitoring devices – FreeStyle Libre (NDC # 57599-0000-21), Freestyle Libre 14-day (NDC # 57599-0002-00) and FreeStyle Libre 2 (NDC # 57599-0803-00) – of possible risks. If the readers are charged with cables and/or power adaptors that were not original equipment, the batteries may overheat, potentially causing fires. Only the readers are affected, not the complete systems or any other parts of the systems. Abbott is not recalling the units. Look here and here for more information from Abbott.

Opioids
In a Safety Communication dated April 13, 2023, the FDA is requiring manufacturers of all medications that contain opioids to revise the prescribing information and patient Medication Guides for the drugs. Both immediate-release and long-acting opioids are included. To encourage safer use of the drugs, extensive changes have been made to the FDA’s mandatory wording for boxed warnings, instructions for use, and dosing recommendations. Furthermore, a new warning about possible increases in pain (hyperalgesia) or pain sensitivity (allodynia) caused by taking opioids now must be included in product prescribing information. Healthcare providers who prescribe opioids are being advised to consider dose size and duration carefully and to reassess opioid treatment frequently for each patient. Additionally, they are reminded to inform patients about the opioid overdose reversal agent, naloxone, which can be prescribed along with opioid prescriptions or purchased over-the-counter (OTC). For patients and caregivers, the FDA suggests using opioids exactly as prescribed, discussing any changes in pain with their doctors, storing the drugs safely, disposing of any excess supplies, and keeping naloxone at hand in case of accidental overdoses. Details about the changes are here.