News

News

June 10, 2021

June ID Upate

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.
 

June 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.

  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • May 26: FDA EUA for sotrovimab. Healthcare providers fact sheet here.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). Available here.
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021 Mar 10 [Epub ahead of print]). Available at PMC.

New Product Approvals

  • Ibrexafungerp* (Brexafemme) for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis. Ibrexafungerp is the first triterpenoid antifungal to be approved by the US FDA. The recommended dosage is two doses of 300 mg (two 150 mg tablets) administered approximately 12 hours apart, with or without food. Verify pregnancy status in females of reproductive potential prior to initiating treatment.
  • Brincidofovir (Tembexa) for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. Because smallpox is eradicated, the effectiveness of brincidofovir was studied in animals infected with viruses that are closely related to the variola virus. Safety information was derived from clinical trials of the drug for a non-smallpox use. The recommended dosage for adults ≥48 kg is 200 mg (tablets or oral suspension) once weekly for two doses (tablets on an empty stomach or with a low-fat meal, suspension on an empty stomach).

New or Updated Treatment Guidelines

A Brief Review of a New Type of Antifungal

  • Ibrexafungerp* is the first triterpenoid antifungal to be approved by the US FDA. It works by inhibiting the biosynthesis of β-(1,3)-D-glucan, a key component of the fungal cell wall. This mechanism of action is like that of an echinocandin, so (not surprisingly) ibrexafungerp is fungicidal against multiple Candida species and fungistatic against Aspergillus. However, ibrexafungerp and echinocandins do not share the same binding site on the target enzyme (β-(1,3)-D-glucan synthase), so limited cross-resistance is expected. A unique feature of ibrexafungerp is its oral bioavailability. It is highly protein bound, its distribution volume is large, and tissue distribution is generally good (although not the CNS). Activity seems enhanced at low pH. Serum half-life is prolonged (about 20 hours), and elimination is mainly via feces and bile. Ibrexafungerp is a CYP3A4 substrate, so moderate to strong inducers and inhibitors will affect its serum concentration. It also inhibits certain CYP enzymes and transporters, but the short duration of treatment should limit clinical significance. The drug is generally well tolerated, although it is contraindicated in pregnancy because of fetal harm observed in animal studies. Ibrexafungerp is approved for the treatment of vulvovaginal candidiasis at a dose of 300 mg q12h x2 doses, with or without food. Commercial launch in the US is expected sometime this year (J Fungi 2021;7:163).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of June 8, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since May 9, 2021Neomycin tablets
    • Shortage recently resolvedAzithromycin injection, Rifampin injection, YF-VAX
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Tobramycin 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, 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 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)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Clotrimazole 10 mg oral troches
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • 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).
May 14, 2021

May ID Upate

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.
 

May 2021

2021 Sanford Guides Available

  • 2021 editions of The Sanford Guide to Antimicrobial Therapy are now available for immediate shipping from the Sanford Guide Store. This year's books include a 1-month trial of our digital editions.

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • CDC: Updated interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • May 10: the US FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age. Full FDA news release here.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2020;370:m3379). Available here.
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021 Mar 10 [Epub ahead of print]). Available at PMC.

New or Updated Treatment Guidelines

  • 2021 clinical guidelines for the diagnosis and treatment of botulism (MMWR Recomm Rep 2021;70(2):1-30). The guidelines are available here.
  • Clinical practice guidelines for nucleic acid-based testing for noninfluenza viral pathogens in adults with suspected community-acquired pneumonia, from the  American Thoracic Society (Am J Respir Crit Care Med 2021;203:1070). The guidelines are available here.
  • 2020 updated guidelines for primary prophylaxis of bacterial infections and Pneumocystis jirovecii pneumonia in patients with hematologic malignancies and solid tumors, from the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (Ann Hematol 2021 Apr 13 [online ahead of print]). The guidelines were last updated in 2013. Available here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of May 9, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since April 11, 2021None
    • Shortage recently resolvedCefoxitin injection, Ethambutol tablets, Tobramycin lyophilized powder for injection
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Tobramycin 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, 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
      • Rifampin injection
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Clotrimazole 10 mg oral troches
      • 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 scheduled for re-launch in the US during  the week of April 5).
  • Antimicrobial drugs recently discontinued: 
    • 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).
April 14, 2021

April 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.
 

April 2021

2021 Sanford Guides Available for Preorder

  • 2021 editions of The Sanford Guide to Antimicrobial Therapy are now available for preorder from the Sanford Guide Store. We expect to begin shipping in the next few weeks. This year's books include a 1-month trial of our digital editions.

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • 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 here.
  • A living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021 Mar 10 [Epub ahead of print]). Available at PMC.

CDC Health Alert Network

  • HAN #442 (Health Alert): The US CDC and FDA are reviewing data involving six US cases of cerebral venous sinus thrombosis in combination with thrombocytopenia in individuals who received the Johnson & Johnson (Janssen) COVID-19 vaccine. As of April 12, 2021, approximately 6.85 million doses of the J&J COVID-19 vaccine have been administered in the US. All six cases occurred among women aged 18–48 years. The interval from vaccine receipt to symptom onset ranged from 6–13 days. One patient died. Until the review is complete, CDC and FDA are recommending a pause in the use of the J&J COVID-19 vaccine out of an abundance of caution. Click here for the full Health Alert.

New Product Approval

  • Oritavancin (Kimyrsa) for the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible gram-positive microbes, including MRSA. This is the same indication as Orbactiv, the initial formulation of oritavancin to be FDA approved. The key difference of the new formulation is a one hour duration of infusion, rather than three hours. It also is supplied in different dose strengths and has different preparation instructions, including differences in reconstitution, dilution, and compatible diluents. Recommended dosage: 1200 mg IV over one hour as a single dose. A summer launch of the product is planned.

New or Updated Treatment Guidelines

Return of YF-VAX

  • Sanofi Pasteur has announced that yellow fever vaccine YF-VAX is once again available for purchase in the United States. They expect to begin allowing orders through www.VaccineShoppe.com and www.VaxServe.com the week of April 5th. For more information, click here.

Commercial Availability of Artesunate for Injection

  • Injectable Artesunate* for treatment of severe malaria is now commercially available in the US. There may be a delay before drug is stocked in pharmacies and hospitals. CDC will continue to distribute artesunate under its IND protocol in situations where the FDA-approved product is not yet available within 24 hours of a clinician requesting the drug. For more information, click here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of April 11, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since March 8, 2021None
    • Shortage recently resolvedPosaconazole injection
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin 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, Rifampin injection
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
      • Antifungal drugs: Clotrimazole 10 mg oral troches
      • 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 scheduled for re-launch in the US during  the week of April 5).
  • 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).
March 10, 2021

March 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.
 

March 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.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Janssen (J&J) vaccineFDA EUA on 27 Feb 2021. Fact sheet for healthcare providers here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • 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 here.
  • Bamlanivimab + Etesevimab combination monoclonal antibody therapy for mild-moderate COVID-19. FDA EUA on 9 Feb 2021.
  • NEW: a living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.

CDC Health Alert Network

  • HAN #439 (Health Advisory): CDC is providing information on extensively drug-resistant (XDR) Salmonella Typhi (Typhi) infections among US residents without international travel, and treatment recommendations for XDR Typhi infection. Click here for the full health advisory.

2021 CDC Immunization Schedules

  • Advisory Committee on Immunization Practices Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger — United States, 2021 (MMWR Morb Mortal Wkly Rep 2021;70:189). Immunization schedules are available here.
  • Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2021 (MMWR Morb Mortal Wkly Rep 2021;70:193). Immunization schedules are available here.

New or Updated Treatment Guidelines

  • Summary of the recently published WHO/PAHO guidelines for diagnosing and managing disseminated histoplasmosis in people living with HIV (J Fungi [Basel] 2021;7:134); available at PMC. Full guidelines available here.
  • Updated (2020) guidelines for the treatment of complicated skin and soft tissue infections, from the Surgical Infection Society (Surg Infect [Larchmt] 2021 Feb 26 [Epub ahead of print]). This is an update of the guidelines published in 2009.

Azole Dosing in Hepatic Impairment

  • Two recent publications fill a few gaps in our knowledge of azole dosing in hepatic impairment. For isavuconazonium*, we know that no dosage adjustment is required in patients with mild to moderate impairment (Child-Pugh Class A and B), but no recommendations for severe impairment (Child-Pugh Class C) have been possible. However, recent pharmacokinetic data support a 50% dosage reduction in severe (Child-Pugh Class C) impairment (Antimicrob Agents Chemother 2021 Feb 22 [Epub ahead of print]).
  • For voriconazole*, the manufacturer recommends that in patients with mild to moderate impairment, the standard loading dose is appropriate, but the maintenance dose should be halved. No recommendations for patients with severe impairment are provided. However, a pharmacokinetic study suggests that these recommendations may result in supratherapeutic concentrations. Study data indicate that a halved loading dose regimen be considered in cirrhotic patients, with a maintenance dose of 33% of the non-cirrhotic dose in patients with mild to moderate impairment, and 25% of the non-cirrhotic dose in patients with severe impairment (Pharmacotherapy 2021;41:172).

Quick Drug Interaction Reminder

  • Ritonavir-boosted antiretroviral (ARV) regimens are associated with an increased risk of drug-drug interactions, with potentially serious outcomes. A patient stable on boosted fosamprenavir plus emtricitabine/tenofovir for ten years experienced significant hyperkalemia after beginning treatment with eplerenone, a mineralocorticoid receptor antagonist, for left ventricular dysfunction. ARVs and eplerenone were held, and the potassium normalized. Subsequent use of a dolutegravir-based regimen allowed for reinstitution of eplerenone with no recurrence of hyperkalemia. Eplerenone is a CYP3A4 substrate, fosamprenavir and ritonavir are potent inhibitors of CYP3A4, and dolutegravir does not inhibit CYP enzymes (Int J STD AIDS 2021 Feb 25 [Epub ahead of print]).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of March 8, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since February 9, 2021Gentamicin injection, Rifampin injection
    • Shortage recently resolvedAmphotericin B injection, Fluconazole injection
    • 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: Clotrimazole 10 mg oral troches, Posaconazole 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).
February 10, 2021

February 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.
 

February 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.
  • Surviving Sepsis Campaign guidelines on the management of adults with COVID-19 in the ICU: first update (Crit Care Med 2021 Jan 28 [Epub ahead of print]). Available on the journal website.

New Product Approvals

  • Cabotegravir injectable and rilpivirine injectable (Cabenuva), a two-drug co-packaged product, indicated to replace the current antiretroviral regimen in adult patients with HIV-1 infection who are virologically suppressed (RNA <50 copies/mL) on a stable regimen with no history of treatment failure and no known or suspected resistance to either component. Lead-in dosing with oral cabotegravir and oral rilpivirine should be used for one month before initiation of injectable dosing to assess tolerance. Recommended dosing schedule: Cabotegravir/rilpivirine 600 mg/900 mg IM on the last day of oral lead-in, then 400 mg/600 mg IM every month thereafter.
  • Cabotegravir tablets (Vocabria) for use (in combination with oral rilpivirine) as oral lead-in therapy to assess tolerability prior to administration of the injectable forms, and as oral therapy for patients who will miss planned injection dosing. Lead-in dosing is cabotegravir 30 mg (+ rilpivirine 25 mg) once daily for one month. If a patient plans to miss a scheduled injection by more than seven days, daily oral therapy with cabotegravir 30 mg plus rilpivirine 25 mg is taken to replace up to two consecutive monthly injections. The first dose of oral therapy should be taken approximately one month after the last injections and continued until the day injection dosing is resumed. Product availability: 30 mg tablets.

New or Updated Treatment Guidelines

  • Updated evidence-based treatment guidelines for MRSA from the UK (JAC-Antimicrobial Resistance 2021;3:dlaa114). The guidelines were last updated in 2008 and are available on the journal website.
  • Evidence-based guidelines for the treatment of Helicobacter pylori infection in Korea in 2020 (Gut Liver 2021 Jan 20 [Epub ahead of print]). Available on the journal website.
  • Chinese clinical practice guidelines for the prevention of mother-to-child transmission of hepatitis B virus, launched by the Society of infectious Diseases, Chinese Medical Association (J Clin Transl Hepatol 2020;8:397). Available at PMC.
  • Prophylaxis, diagnosis and therapy of infections in patients undergoing high-dose chemotherapy and autologous haematopoietic stem cell transplantation. 2020 update of the recommendations of the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (Ann Hematol 2021;100:321). Available at PMC.
  • Clinical practice guidelines for adult appendicitis, from the French Society of Digestive Surgery and the Society of Abdominal and Digestive Imaging (J Visc Surg 2021 Jan 5 [Epub ahead of print]).
  • Executive summary of the JSMM clinical practice guidelines for the diagnosis and treatment of Cryptococcosis 2019, from the Japanese Society for Medical Mycology (Med Mycol J 2020;61:61). The executive summary is available here.

A Few Drug Pearls

  • Based on a pharmacokinetic study in six critically ill hematology patients, no a priori dose adjustment of posaconazole during ECMO is recommended. Some trough concentrations were below the lower limit for treatment, however, so therapeutic drug monitoring is recommended to ensure adequate drug exposure (J Antimicrob Chemother 2021 Jan 29 [Epub ahead of print]).
  • A recent report describes the inappropriate use of IM benzylpenicillin G rather than benzathine penicillin G in one patient with syphilis (resulting in treatment failure), and the attempted use of IM benzylpenicillin G in another. Other disturbing treatment errors with long-acting penicillin G products have occurred, such as the improper use of the procaine-benzathine preparation of penicillin G (instead of benzathine) in 429 syphilis patients over a five-year period (MMWR 2005;54:217). Recent product shortages have likely increased the risk of error (Sex Transm Infect 2020;96:552).
  • The effects of ECMO on vancomycin pharmacokinetic parameters are conflicting and poorly understood. Changes may be minimal, and no standard dosage adjustment seems reasonable. However, aggressive therapeutic drug monitoring is recommended to achieve efficacy and safety targets. Continuous infusion may lessen PK changes. References: Antimicrob Agents Chemother 2021;65:e02408-20J Clin Pharm Ther 2020;45:1066Clin Pharmacokinet 2020;59:1575.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of February 9, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since January 13, 2021Posaconazole injection
    • Shortage recently resolvedFluconazole injection, Tobramycin lyophilized powder for injection
    • Antibacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Tobramycin 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
      • 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).