April '24 Infectious Diseases Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD. on Apr 16th 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.

APRIL 2024

Ceftobiprole Medocaril Approved

Ceftobiprole medocaril* (Zevtera) has been approved by the US FDA for (1) adults with S. aureus bacteremia, including those with right-sided IE, caused by MSSA and MRSA, (2) adults with ABSSSI caused by MSSA, MRSA, S. pyogenes, and K. pneumoniae, and (3) adults and pediatric patients with CAP caused by MSSA (not MRSA), S. pneumoniae, H. influenzae, H. parainfluenzae, and K. pneumoniae. It is not approved for VAP. Ceftobiprole medocaril is a prodrug that is rapidly converted to ceftobiprole presumably by plasma esterases. Its spectrum of activity is similar to that of ceftaroline. Recommended dosing is 667 mg IV q6-8h (depending on the indication). 667 mg of ceftobiprole medocaril is equivalent to 500 mg of ceftobiprole.

Chikungunya Vaccine

Single-dose, live attenuated chikungunya virus vaccine (Ixchiq)* for persons aged ≥18 years is now available in the US through the usual vaccine wholesalers.
Recommended for persons aged ≥18 years with travel to a country or territory with a current CDC-declared Chikungunya outbreak.
May be considered for certain persons traveling to non-outbreak countries or territories with transmission among humans within the past five years, as determined by CDC.
- Persons with long-stay travel (cumulative >6 months).
- All persons aged >65 years (especially with comorbidities) who might have at least ≥2 weeks (cumulative) exposure to mosquitoes in indoor or outdoor settings.
- Excludes those traveling for business and likely to be mainly in mosquito-protected indoor settings.

Mpox Vaccine

As of April 2024, Jynneos (mpox and smallpox vaccine, live, non-replicating) is available commercially through usual vaccine wholesalers. Public health advice should be sought prior to use for smallpox prevention, also an FDA-approved indication.
The intradermal and subcutaneous routes of Jynneos administration are interchangeable. Persons who received dose 1 of Jynneos via the intradermal route during the mpox emergency may receive dose 2 subcutaneously. In case of another outbreak and a vaccine shortage, persons may receive dose 2 via the intradermal route regardless of route of administration of dose 1.

New Rilpivirine Pediatric Dosage Formulation

Rilpivirine* 2.5 mg tablets for oral suspension (EDURANT PED) have been approved by the US FDA for the treatment of HIV-1 in combination with other antiretroviral therapies in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg. They must be dispersed in 5 mL water and ingested immediately (not chewed or swallowed whole). The new 2.5 mg tablets and the original 25 mg film-coated tablets differ in bioavailability and are thus not interchangeable on a mg-per-mg basis.

AMS Pearl: Stewardship Recommendations Reduce Adverse Drug Events

A recent study from a four-hospital system investigated the impact of an antimicrobial stewardship (AMS) intervention. An infectious diseases physician left a note in the electronic healthcare record and paged the treating team to suggest antibiotic discontinuation for patients who were considered unlikely to have a bacterial infection.
Of the 253 patients included in the study, 45% had their antibiotic stopped within 48 hours of the recommendation. The number of adverse drug events (ADEs) was 34 in the group that continued antibiotics compared to 9 in the group that discontinued antibiotics (p=0.001). The most common ADEs were hematologic and nausea. The mean total days of antibiotics was higher in the group that continued antibiotics (5 days) compared to the group that followed the recommendation to discontinue therapy (1 day, p<0.001). There were no differences between the groups in 30-day readmission or mortality.
AMS teams can use the findings of this study to develop interventions targeting duration of therapy in patients unlikely to have a bacterial infection. Antimicrob Steward Healthc Epidemiol. 2024 Mar 18;4(1):e36. doi: 10.1017/ash.2024.29.

Drug Shortages (US)

Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
New shortages:
- Nafcillin injection (20 Mar 2024)
- Rifaximin 200 mg tablets (11 Apr 2024)
Shortages recently resolved:
- Doxycycline oral suspension (22 Mar 2024)
Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 14 April 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
- Antibacterial drugs:
  - Aminoglycosides:
    - Amikacin injection
    - Gentamicin injection (22 Feb 2021)
    - Tobramycin injection
  - Bacitracin ophthalmic ointment
  - Carbapenems:
    - Meropenem injection
  - Cephalosporins:
    - Cefazolin injection (4 Jun 2018)
    - Cefdinir, all oral formulations (29 Jun 2023)
    - Cefixime 400 mg capsules (21 Jan 2022)
    - 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).
  - Chloramphenicol injection (9 Oct 2023)
  - Clindamycin phosphate injection (25 Jun 2015)
  - Fluoroquinolones:
    - Ciprofloxacin injection (13 Jan 2023)
    - Ciprofloxacin 0.3% ophthalmic solution
    - Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
    - Moxifloxacin 400 mg tablets (6 Dec 2023)
    - Ofloxacin 0.3% ophthalmic solution
  - Glycopeptides, glycolipopeptides, lipopeptides:
    - Vancomycin injection (1 Jun 2015)
  - Macrolides/azalides:
    - Azithromycin ophthalmic solution 1%
    - Erythromycin 0.5% ophthalmic ointment (8 Jul 2022)
  - 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 capsules (250 mg, 500 mg)
    - Penicillin G benzathine injection (Bicillin-LA) (1 Feb 2023)
    - Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (31 Mar 2023)
    - Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (17 May 2023)
    - Piperacillin-tazobactam injection
  - Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
  - Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (21 Sep 2023)
  - Sulfanilamide 15% vaginal cream (unavailable)
- Antifungal drugs:
  - Amphotericin B injection (10 Nov 2022)
  - Amphotericin B Lipid Complex (5 Aug 2022)
  - Nystatin topical powder (18 Aug 2023)
- Antimycobacterial drugs:
  - Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
  - Isoniazid injection 100 mg/mL (24 Jan 2024)
  - Rifampin capsules
- Antiparasitic drugs:
  - Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  - Primaquine tablets 26.3 mg
- Antiviral drugs:
  - Acyclovir injection (21 Feb 2024)
  - Nirsevimab-alip injection (24 Oct 2023)
  - Oseltamivir capsules, powder for oral suspension (1 Nov 2022)
  - Podofilox 0.5% topical gel
  - Ribavirin for inhalation solution (23 May 2023)
  - Valganciclovir tablets, powder for oral solution (7 Feb 2023)
- Vaccines:
  - None

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/