MAY 2024

by Editorial Board last updated May 14, 2024 03:52 PM

Pivmecillinam Approved

  • Pivmecillinam (Pivya) has been approved by the US FDA for female patients ≥18 years of age with uncomplicated UTI caused by susceptible isolates of E. coli, P. mirabilis and S. saprophyticus. It is a pivalate ester prodrug that is well absorbed and rapidly hydrolyzed to mecillinam (the active agent) by nonspecific esterases present in the blood, GI mucosa, and elsewhere. Unlike most other beta-lactams, mecillinam preferentially targets PBP-2 in the bacterial cell wall. The US recommended dose is 185 mg q8h x3-7 days, with or without food. Pivmecillinam 185 mg is equivalent to pivmecillinam hydrochloride 200 mg.

WHO Guidelines for Qdenga Published

  • US travelers may ask about use of Qdenga dengue vaccine (TAK-003; Takeda) which has not yet been submitted to the FDA but which is available commercially in Europe (including at some hub airports) and some other countries.  No other dengue vaccine is currently available anywhere.
    • WHO SAGE Wkly Epidemiol Rec. 2024 May 3;99:203
      • Consider for introduction in natives of high burden, high transmission settings.
        • For 6-16 yrs of age at 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations.
      • Recommendations for travelers:
        • Highest benefit is during an ongoing DENV2 or DENV1 epidemic at the destination.
        • Previously infected (any serotype) seropositive travelers MAY benefit from Qdenga vaccination.
          • Pre-vaccination serostatus screening is not required, but may be considered to inform the assessment of risks and benefits.
        • The benefits of vaccination are lower for seronegative travelers
          • Any protection of seronegative persons against DENV3 and DENV4 is uncertain and the circulating serotypes at any destination may vary over time. 
        • Protection starts 14 days after the first dose.

From CDC: Replenishing Tecovirimat (Tpoxx) Supply

  • The large-scale prepositioning of oral tecovirimat (Tpoxx) was discontinued on February 27, 2023, with the significant decline in mpox case that has continued to remain low. For contingency planning considerations, the ASPR/HHS has been accepting one-time, prepositioning requests for up to 20 bottles of oral tecovirimat for jurisdictions where the previously pre-positioned supply has been exhausted or has expired. The one-time, contingency supply request can be made directly to ASPR through HPOP. ASPR will follow up to review each request. For more information, please see TPOXX Operational Planning Guide. Stockpiled tecovirimat use for treatment of mpox must be in accordance with the CDC-held Tecovirimat Expanded Access Investigational New Drug (EA-IND) protocol.
  • Tecovirimat is not FDA-approved for treatment of human mpox. Oral tecovirimat is only available through the Study of Tecovirimat for Human Mpox Virus (STOMP), a clinical trial sponsored by NIH to evaluate efficacy of tecovirimat in treating human mpox, or for compassionate use under the CDC-held Tecovirimat Expanded Access Investigational New Drug (EA-IND) protocol. STOMP has a randomized arm and open-label tecovirimat arm. Non-pregnant adults with mild mpox are enrolled in the randomized arm at 2:1 ratio of tecovirimat to placebo. At any time during the study, if those enrolled in the randomized arm develop severe disease or persistent pain, they are crossed over to the open-label tecovirimat arm. Those with severe disease or severe immunocompromise, pregnant or lactating persons, and children are enrolled in the open-label tecovirimat arm.
  • Tecovirimat for treatment of mpox under CDC’s tecovirimat expanded access IND protocol is for patients who meet EA-IND eligibility (e.g., those with severe disease or severe immunocompromise OR pregnant or lactating persons and children irrespective of disease severity or immune status). Stockpiled oral or IV tecovirimat remains available for presenting mpox patients who meet EA-IND eligibility and can be requested by calling the CDC Emergency Operations Center (EOC) at (770) 488-7100. Any jurisdiction with remaining, unexpired supply can provide tecovirimat for patients who meet EA-IND eligibility. Providers may also want to contact their state or local health department to see if any local pre-positioned supply remains.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • New shortages:
    • None
  • Shortages recently resolved:
    • Doxycycline oral suspension (22 Mar 2024)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 12 May 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 (22 Dec 2022)
      • 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)
        • Nafcillin injection (20 Mar 2024)
        • 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)
      • Rifaximin 200 mg tablets (11 Apr 2024)
      • 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)