January ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To sign up for ID updates to your inbox, register here.

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. If you received this message from a colleague, subscribe now.

January 2021

 

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • COVID-19 Vaccine (Emergency Use Authorization). See COVID-19 Prevention for summary of FDA Provider Fact Sheet / Emergency Prescribing Information for each.
    • Pfizer-BioNTech COVID-19 Vaccine on 11 Dec 2020 (US FDA).
    • Moderna COVID-19 Vaccine on 18 Dec 2020 (US FDA).
    • Oxford AstraZeneca COVID-19 Vaccine on 30 Dec 2020 (UK)
  • Vaccine development pipeline: see COVID-19, Prevention for summary of other vaccine development and clinical trials.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • A living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). Available on the BMJ website.

Voluntary Product Recall

  • Merck has initiated a global product recall of ceftolozane-tazobactam 1.5 gm vials. Due to a recent issue identified during routine testing (sterility test results of seven batches were out of specification), product manufacturing has been temporarily stopped. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. The seven batches were not released to the market. While all product distributed to the market has met the registered specifications for release, it was manufactured on the same equipment as the affected batches. As a result, the company has initiated a voluntary Class II (health care provider level) global recall of all ceftolozane-tazobactam within expiry.

New Product Approval

  • Ansuvimab-zykl (Ebanga), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. The recommended dosage is a single 50 mg/kg IV infusion. It is available in lyophilized form.

Update to CDC Treatment Guidelines for Gonococcal Infection

  • For treatment of uncomplicated urogenital, rectal, or pharyngeal gonorrhea, CDC now recommends a single 500 mg IM dose of ceftriaxone. For persons weighing ≥150 kg (300 lbs), a single 1 gm IM dose of ceftriaxone should be administered. If chlamydial infection has not been excluded, doxycycline 100 mg orally twice a day for 7 days (not azithromycin) is recommended (MMWR Morb Mortal Wkly Rep 2020;69:1911). The full update, which includes other changes such as ceftriaxone dosing for pharyngeal gonorrhea and cefixime dosing (alternative regimen), is available at PMC.

Other New or Updated Treatment Guidelines

  • Updated recommendations for the use of antiretroviral drugs in pregnant women with HIV infection and interventions to reduce perinatal HIV transmission in the US, from the HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission. The recommendations are available here.
  • Guidelines for diagnosis and management of intraabdominal infection, from the Chinese Society of Surgical Infection and Intensive Care and the Chinese College of Gastrointestinal Fistula Surgeons (Clin Infect Dis 2020;71(suppl 4):S337).
  • Updated guidelines for therapeutic drug monitoring of vancomycin, from the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society (Clin Infect Dis 2020;71(suppl 4):S363). The guidelines were last updated in 2015.
  • Southern African guidelines on the safe, easy, and effective use of pre-exposure prophylaxis to prevent HIV acquisition (South Afr J HIV Med 2020;21:1152). The guidelines were last updated in 2016 and are available at PMC.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 3, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since December 27, 2020Posaconazole injection
    • Shortage recently resolvedDoxycycline injection, Metronidazole injection, Pentamidine isethionate
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Tobramycin injection, Tobramycin lyophilized powder for injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Cefoxitin injection, Ceftazidime injection, Ceftazidime/avibactam injection, Ceftolozane/tazobactam injection
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antimycobacterial drugs
      • Ethambutol tablets
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Amphotericin B injection, Clotrimazole 10 mg oral troches, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant, Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: 
    • Recent discontinuations: Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).
  • For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/