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August '23 Infectious Diseases Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD on Aug 8th 2023

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board and our AMS Program Manager. Links marked with a * are available to Sanford Guide Web Edition and All Access clients. All other links are available without a Sanford Guide subscription. To receive monthly updates via email, sign up now. 

AUGUST 2023

SARS-CoV-2 / COVID-19

US Approval of Nirsevimab-alip

  • The US FDA has approved nirsevimab-alip* (brand name Beyfortus), a monoclonal antibody that provides passive immunization against respiratory syncytial virus* (RSV) by targeting the prefusion conformation of the fusion (F) glycoprotein. It is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Safety and efficacy are supported by three clinical trials. Nirsevimab has been available in the European Union since October 31, 2022. It will be available in the US ahead of the upcoming 2023-2024 RSV season.
  • Dosage for neonates and infants born during or entering their first RSV season:
    • Body weight at time of dosing <5 kg: 50 mg IM x1
    • Body weight at time of dosing ≥5 kg: 100 mg IM x1
  • Dosage for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season:
    • 200 mg IM x1, administered as two 100 mg injections
  • Product availability: Prefilled syringes, 50 mg/0.5 mL and 100 mg/mL
  • See FDA news release here.

New Product for Molluscum Contagiosum

  • THe US FDA has approved cantharidin 0.7% topical solution (brand name Ycanth) for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. It is the first FDA-approved treatment for molluscum. Health care providers are to apply a single application to each lesion every three weeks as needed. See FDA news release here.

US Approval of Anthrax Vaccine Adsorbed, Adjuvante

  • Cyfendus, an adjuvanted formulation of Biothrax, has been FDA approved for PEP only (not PrEP).
  • Cyfendus eliminates the need for a third dose at 4 weeks for PEP.  Concomitant antibiotics are still necessary.
  • This vaccine simplifies the response to a large-scale public health emergency involving anthrax.
  • 3 million doses of Cyfendus (labelled AV7909) are already in US government stockpiles.
  • Detailed guidelines for use are pending ACIP recommendations, but dose and timing will be per FDA labeling.
  • See Anthrax, Vaccine page for more information.

AMS Pearl - Improving Efficiency in Patient-Level Stewardship Activities

  • The Centers for Disease Control and Prevention Core Elements of Hospital Antibiotic Stewardship Programs recommends priority actions for antimicrobial stewardship (AMS) programs. However, many of these require significant time and resources for implementation.
  • A recent paper explores strategies to improve efficiency in preauthorization and prospective audit and feedback, two patient-level priority interventions. The authors propose the following process to optimize AMS workflow: identify resources, prioritize initiatives, develop alerts to operationalize the initiatives, and prioritize daily tasks and actions.
  • AMS teams can use the tools and resources suggested in this paper to optimize their daily tasks. Open Forum Infectious Diseases, 2023; ofad412.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 6, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since July 10, 2023:
      • Tedizolid injection
    • Shortage recently resolved:
      • Azithromycin injection
      • Clotrimazole 10 mg oral troches
      • Rifampin injection
      • Rifapentine 150 mg tablets
      • Rifaximin tablets (200 mg, 550 mg)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefdinir (all oral formulations)
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
      • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
      • Sulfanilamide 15% vaginal cream (unavailable)
      • Tedizolid 200 mg tablets
    • Antifungal drugs: 
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
    • Antimycobacterial drugs: 
      • Isoniazid injection (100 mg/mL)
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules, powder for oral suspension
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)
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