Erzofri Approved for Schizophrenia

On July 26, 2024, the U.S. Food and Drug Administration (FDA) approved Luye Pharma’s Erzofri^® (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia in adults and schizoaffective disorder in adults as a monotherapy and as an adjunct to mood stabilizers or antidepressants. It is a long-acting version of the atypical antipsychotic and is administered by a healthcare professional as a once-monthly intramuscular (IM) injection. It will be available in doses of 39mg, 78mg, 117mg, 156mg, 234mg, and 351mg strengths of paliperidone. The labeling includes a boxed warning that atypical antipsychotics should not be used to manage psychosis related to dementia in elderly patients due to an increased risk of death. Erzofri contains the same active ingredient found in Janssen’s injectable long-acting Invega^® products Invega Sustenna^®, Trinza^™ and Hafyera^™, which are administered as IM injections monthly, every three months, and every six months, respectively. Invega tablets are also available generically. The cost and launch date for Erzofri are not yet known. Look here for current prescribing information.

Zunveyl Approved for Alzheimer’s disease

Alpha Cognition received FDA approval for Zunveyl^® (benzgalantamine – Alpha Cognition) on July 26, 2024, for treating mild to moderate dementia of the Alzheimer’s type in adults. It’s an acetylcholinesterase inhibitor that prevents acetylcholine breakdown, enhancing cognitive functions. As a prodrug, it is designed to pass through the gastrointestinal (GI) tract in this form to help minimize GI side effects commonly associated with this class of Alzheimer’s disease medications, such as nausea, vomiting and diarrhea. Once absorbed into the body, however, it is metabolized in the liver to the active form of the drug, galantamine (Razadyne^®/generics). The initial recommended dose of Zunveyl is 5mg twice daily, which can be increased to 10mg twice a day after at least four weeks if tolerated. The maximum dose should not exceed 15mg twice daily. Launch is expected in the first quarter of 2025, but pricing is not yet known. AD is the most common form of dementia, affecting nearly seven million people in the U.S. Other treatments in the same class of drugs for treating AD include donepezil (Aricept^®, generics) and rivastigmine (Exelon^®, generics). Check here for its complete prescribing information.

Palforzia Gets Age Expansion

The FDA has approved an expanded age indication for Stallergenes Greer’s Palforzia^® [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. The approval now includes toddlers one year to three years of age with a confirmed diagnosis of peanut allergies. Palforzia is an oral immunotherapy designed to prevent severe allergic reactions (anaphylaxis) to peanuts. Previously, Palforzia was only approved for children ages four years to 17 years old. Patients still will have to avoid eating or being around products that contain peanuts and keep emergency treatments at hand, but using Palforzia may help prevent or decrease reactions if peanuts are encountered accidentally. Treatment for the new indication is in three stages; initial dosing, updosing, which is administered in progressively larger doses over several months and maintenance dosing of 300mg per day. The first doses at each increasing dose level will be given in a healthcare facility staffed and equipped to manage severe allergic reactions. A boxed warning on the labeling cautions that Palforzia, itself, could trigger anaphylaxis. Since the drug has a risk for anaphylaxis it is available through a restricted program under Palforzia Risk Evaluation and Mitigation Strategy (REMS). Approval was based on a phase III study where 73.5% of patients ages one year to four years old tolerated a single dose of ≥600mg peanut protein at the 12 month mark with only mild allergy symptoms. For full prescribing details, click here.

Xembify Label Expanded

On July 18, 2024, the labeling for Grisfols’ Xembify^® (immune globulin subcutaneous, human- klhw) was expanded by the FDA to include treatment-naïve patients with primary humoral immunodeficiencies (PI). PI disorders include common variable immunodeficiency, congenital agammaglobulinemia, severe combined immunodeficiencies, Wiskott-Aldrich syndrome and several others. Patients who have a PI usually are at risk for repeated, serious infections. Xembify is a 20% immune globulin that is infused subcutaneously (SC) through an infusion pump. Previously, it was only approved for use in patients after initial intravenous immune globulin (IVIG) therapy. The FDA also approved a new bi-weekly (every two weeks) dosing regimen for Xembify. The original approval was for dosing one weekly or more frequently. Labeling for all immune globulin products includes warnings that they may cause blood clots and kidney damage that could lead to kidney failure. Updated prescribing information can be found here.

Recall

Sodium Chloride Recalled

On July 24, 2024, B. Braun Medical Inc. recalled two lots of sodium chloride (NaCl) injection 0.9% 1000mL – E8000. The affected lots were recalled because they were released with particulate matter inside the bags, which could potentially cause harm or permanent impairment. The presence of particulate matter could increase the risk of fluid leakage from the bags, leading to contamination with microorganisms and potential bloodstream infections. Furthermore, if hazardous medication is added to the bags, a leak could lead to exposure and harm to those who come in contact with the contents. Sodium chloride 0.9% injection solution is used to replenish lost salt and water due to certain conditions. It is also a sterile solution used to dissolve or dilute medications before giving them intravenously. For more information contact B. Braun Medical Inc. at 833.425.1464 or email recalls@bbraunusa.com.