November '24 Infectious Diseases Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD. on Nov 12th 2024

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 All Access & Sanford Guide for Web clients. All other links are available without a Sanford Guide subscription. To receive monthly updates via email, sign up now.

COVID-19 mRNA Vaccine: Updated Recommendations

Summary of guidelines for persons ≥5 years of age who are not moderately or severely immunocompromised:
- Initial vaccination:
  - 1 dose of 2024–25 Moderna or Pfizer vaccine
- Received previous doses of a COVID-19 vaccine:
  - 1 dose of 2024–25 Moderna or Pfizer vaccine
- No additional doses of 2024–25 vaccine for people <65 years of age who are not moderately or severely immunocompromised are recommended at this time.
- Persons ≥65 years of age should receive 2 doses of 2024–2025 mRNA vaccine separated by 6 months (minimum interval 2 months) regardless of previous vaccination history, October 2024 guidelines for people ≥5 years of age who are not moderately or severely immunocompromised.
Dosing, including additional discretionary doses for the moderately and severely immunocompromised, remains complex.

Pneumococcal Vaccination: Significant Changes

For all PCV-naïve adults >50 years of age, a single dose of either PCV20 (Prevnar 20) or PCV21 (Capvaxive), or a series of PCV15 (Vaxneuvance) followed one year later by PPSV23 (Pneumovax 23), is now recommended.
- An estimated 32–54% of adults age 50-64 years already have a risk-based indication for vaccination.
PCV21 (Capvaxive, Merck) is FDA-approved and now available.
Same regimens for persons 19-49 years of age with underlying conditions.
Standard of care is a conjugated vaccine (PCV21, PCV20, or PCV15)
- PPSV 23 (Pneumovax 23) alone is no longer recommended under any circumstances.
The PCV21 alone regimen appears preferable, despite PCV20 or the PCV15/PPSV23 options considered as equivalent by ACIP guidelines.

Mpox Indication for ACAM2000

ACAM2000 is a live vaccinia virus vaccine previously indicated for the prevention of smallpox disease in individuals determined to be at high risk for infection. In August 2024 the US FDA added prevention of mpox as an indication to the ACAM2000 product labeling based on animal challenge data. Large quantities of ACAM2000 remain in the Strategic National Stockpile, but due to the more favorable tolerability of Jynneos, no doses have been released in recent years.

Sulopenem Etzadroxil-Probenecid Approved

The US FDA has approved sulopenem etzadroxil-probenecid (Orlynvah) for the treatment of uncomplicated UTI caused by E. coli, K. pneumoniae, or P. mirabilis in adult women with limited or no alternative oral treatment options. Sulopenem etzadroxil is a thiopenem prodrug that is hydrolyzed to sulopenem upon oral administration. Systemic exposure is boosted by probenecid (an OAT1/3 inhibitor), which may increase plasma concentrations of other drugs dependent on OAT1/3 for elimination. In two phase 3 studies, the most common adverse reactions leading to treatment discontinuation were gastrointestinal. One tablet contains 500 mg of sulopenem etzadroxil and 500 mg of probenecid. The approved dose is one tablet q12h x5 days. Administration in patients with CrCl <15 mL/min or on hemodialysis is not recommended.

AMS Pearl: Patients’ Expectations of Antibiotics

U.S. Antibiotic Awareness Week and World AMR Awareness Week are November 18-24, 2024, and November is also C. difficile Awareness Month. Among the key messages related to these campaigns is working together to improve the prescribing and use of antibiotic and antifungal agents.
A recent study evaluated patient antibiotic expectations through a survey of 564 patients in public and private primary care clinics. Overall, 37% of patients lacked knowledge of antibiotic risks. This was associated with increased antibiotic expectations for diarrhea and cold/flu symptoms. Ann Fam Med. 2024;22(5):421-425.
Including patients in the efforts to improve antibiotic use should be a priority for Antimicrobial Stewardship Programs. Programs should consider distributing patient education materials that include information on appropriate antibiotic use and adverse events. Sanford Guide provides links to CDC patient education materials in both English and Spanish available free of charge to all users of the mobile app.

Antimicrobial Shortages (US)

New shortages:
- Cidofovir injection (01 Nov 2024)
- Linezolid injection (16 Oct 2024)
Resolved shortages:
- Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 10 November 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
- Antibacterial drugs:
  - Aminoglycosides:
    - Gentamicin injection (22 Feb 2021)
  - Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
  - Cephalosporins:
    - Cefazolin injection (4 Jun 2018)
    - Cefdinir 300 mg capsules (29 Jun 2023)
    - Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
    - Cefotaxime injection (10 Jun 2015)
      - 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.
  - Chloramphenicol injection (9 Oct 2023)
  - Clindamycin phosphate injection (25 Jun 2015)
  - Fluoroquinolones:
    - Ciprofloxacin injection (13 Jan 2023)
    - Levofloxacin injection in D5W (29 May 2024)
    - Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
    - Moxifloxacin 400 mg tablets (6 Dec 2023)
    - Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
  - Glycopeptides, glycolipopeptides, lipopeptides:
    - Vancomycin injection (1 Jun 2015)
  - Metronidazole injection (20 Oct 2021)
  - Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
  - Nitrofurantoin oral suspension (5 Jun 2018)
  - Penicillins:
    - Amoxicillin, all oral formulations (18 Oct 2022)
    - Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
    - Ampicillin injection (19 Oct 2023)
    - Dicloxacillin 250 mg, 500 mg capsules (18 Aug 2021)
    - Nafcillin injection (20 Mar 2024)
    - Penicillin G benzathine injection (1 Feb 2023) Availability update here
    - Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
    - Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
    - Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
  - Rifaximin 200 mg tablets (11 Apr 2024)
- Antifungal drugs:
  - Amphotericin B Lipid Complex (5 Aug 2022)
  - Fluconazole injection (9 Aug 2024)
  - Nystatin oral suspension (21 June 2024)
- Antimycobacterial drugs:
  - Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
- Antiparasitic drugs:
  - Mefloquine 250 mg tablets (14 May 2024)
  - Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
- Antiviral drugs:
  - Acyclovir injection (21 Feb 2024)
  - Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
  - Oseltamivir powder for oral suspension (1 Nov 2022)
  - Ribavirin for inhalation solution (23 May 2023)

Antimicrobial drugs recently discontinued:
- Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
- Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
- Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
- Ritonavir oral solution 80 mg/mL (Jan 2023)

For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/