Your source for the latest industry trends and drug information news.
Volume 6 | Issue 22
November 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On October 25, 2024, the U.S. Food and Drug Administration (FDA) approved Orlynvah™ (sulopenem etzadroxil and probenecid) tablets for the treatment of uncomplicated urinary tract infections (UTIs) caused by the microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. An uncomplicated UTI is a bacterial infection of the bladder in women with no structural abnormalities of the urinary tract. Up to half of women will experience an uncomplicated UTI in their lifetime. Orlynvah™ is a combination product that contains sulopenem etzadroxil, the antibacterial used to treat the infection, and probenecid, an ingredient that helps keep the antibiotic in the body longer. Orlynvah™ possesses potent activity against bacteria species that are often resistant to other antibiotic treatments. The recommended dosing of Orlynvah™ is one tablet twice daily for five days, taken with food.
The approval of Orlynvah™ for the treatment of uncomplicated UTIs was based on the results of two clinical trials that evaluated the safety and efficacy of ORLYNVAH™ compared to ciprofloxacin (SURE 1 trial) and amoxicillin/clavulanate (REASSURE trial) in the treatment of adult women with uncomplicated UTIs. In both studies, Orlynvah™ was well tolerated and resulted in a higher response rate. Orlynvah™ should not be prescribed to patients with gout, kidney stones, blood disorders or a known history of allergy to penicillin or cephalosporin antibiotics. The most common side effects are diarrhea, nausea, yeast infection, headache and vomiting.
On November 1, 2024, the FDA issued a safety warning to patients and health care professionals not to use drugs compounded and distributed by California-based Fullerton Wellness LLC. Fullerton Wellness is a facility that compounds drugs intended to be sterile, including semaglutide and tirzepatide injections. The FDA received a complaint from a patient who noticed a black particulate in a vial of semaglutide distributed by Fullerton Wellness. After a state inspection that noted deficiencies in the production facility, the FDA observed the facility used non-sterile ingredients to produce the injectable products and took no steps to sterilize them, which could introduce health risks. Fullerton Wellness voluntarily ceased operations due to these findings. The Agency is urging patients who have received drugs from Fullerton Wellness to stop using them and contact their health care provider. Health care professionals should immediately check their medical supplies, quarantine any drug products from Fullerton Wellness and not administer them. At this time, the FDA is not aware of any reports of adverse events associated with the use of compounded drugs from this facility. If any adverse effects are experienced, consumers should contact their health care provider and report it to the FDA’s MedWatch Adverse Event Reporting program.
On October 23, 2024, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) released their updated fall vaccine recommendations. ACIP recommended lowering the age for routine pneumococcal vaccination from 65 to 50 years. Pneumococcal bacteria can cause serious illnesses, including pneumonia, meningitis and bloodstream infections. Older adults are at increased risk for pneumococcal disease, and vaccination with the pneumococcal conjugate vaccine (PCV) is the best way to prevent it. Lowering the age for PCV vaccination gives more adults the opportunity to protect themselves from pneumococcal disease at the age when risk of infection substantially increases. Adults 50 years or older should talk with a health care provider regarding this new recommendation.
New Drug: Vyloy® (zolbetuximab-clzb)
Intravenous injection approved, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with a rare type of cancer that can develop in the stomach or stomach-esophagus junction area. [10/18/24 – Astellas]
Abraxane® (paclitaxel)
Indication: Injectable intravenous suspension used to treat patients with metastatic breast cancer, metastatic pancreatic cancer and locally advanced or metastatic non-small cell lung cancer.
Dosage Form/Strength: 100mg vial for injection.
Average Wholesale Price (AWP): Generic = $1,778 | Brand = $1,896
