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News

November 12, 2020

November 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.
 

November 2020

 

Sanford Guide Announcements

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • IgG1 monoclonal antibody. Bamlanivimab. FDA EUA (11/9/20) for outpatient use in mild to moderate COVID-19 in adolescents (age >12 yrs and wt > 40 kg) and adults who are at risk of progression to severe disease.
  • 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). The first version of this living guidance focuses on corticosteroids. Available on the BMJ website.
  • Vaccine development pipeline: see COVID-19, Prevention for summary of vaccine development and clinical trials.

New Drug Approvals

  • Inmazeb*, a combination of three monoclonal antibodies (atoltivimab, maftivimab, and odesivimab-ebgn in a 1:1:1 ratio), approved by the US FDA for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Recommended dosage: 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg IV as a single infusion. Product availability: single-dose vials, 241.7 mg of each antibody per 14.5 mL.

New or Updated Treatment Guidelines

Practice Pearls from the Recent Literature

  • No data on CSF penetration of ceftolozane-tazobactam have previously been available. In ten critically ill patients with an indwelling external ventricular drain, CSF penetration ratios of ceftolozane and tazobactam were both 0.2, and 3 gm IV q8h achieved a >90% probability of target attainment in the CSF only when MICs were ≤0.25 µg/mL. These data suggest inadequate CSF exposure for gram-negative infection using maximal dosing of ceftolozane-tazobactam unless pathogen MICs are very low (Antimicrob Agents Chemother 2020 Oct 19 [Epub ahead of print]).
  • Pharmacokinetic/pharmacodynamic data for minocycline are limited, given that the drug was approved about a half-century ago. In a PK study in 55 patients, IV minocycline (200 mg IV q12h) was predicted to result in a suboptimal PK/PD profile for Acinetobacter baumannii infection with MIC values ≥1 µg/mL (CLSI susceptibility breakpoint ≤4 µg/mL), emphasizing the importance of considering combination therapy when using minocycline for A. baumannii and raising questions about current interpretive breakpoints (Antimicrob Agents Chemother 2020 Nov 9 [Epub ahead of print]).
  • A patient with COVID-19 administered remdesivir (RDV) developed marked sinus bradycardia on day two of treatment (heart rate 38 bpm, baseline 60-70 bpm). No cardiotoxic drugs in her regimen were identified, and her bradycardia was attributed to COVID-19. After two days of persistent bradycardia with eventual QRS complex widening and other cardiac symptoms, RDV was discontinued and atropine administered. Her bradycardia, widened QRS, and other symptoms resolved rapidly, suggesting a possible rare RDV adverse effect (JACC Case Rep 2020 Oct 28 [Epub ahead of print]).
  • Pharmacokinetic changes commonly associated with extracorporeal membrane oxygenation (ECMO) include increased volume of distribution and alterations in drug clearance. Published data regarding caspofungin have been inconclusive, but two recent studies (in critically ill and lung transplant patients) suggest no significant effect of ECMO on caspofungin pharmacokinetics (Antimicrob Agents Chemother 2020;64:e00345-20; Antimicrob Agents Chemother 2020 Aug 17 [Epub ahead of print]).
  • Remdesivir (RDV) is not recommended in its EUA for patients with eGFR <30 mL/min in part because the drug vehicle, sulfobutylether-β-cyclodextrin (SBECD), may accumulate to toxic concentrations. However, each 100 mg of lyophilized powder and solution of RDV contain only 3 gm and 6 gm of SBECD, respectively, compared to the maximum recommended safety threshold of 250 mg/kg/day for SBECD. Although conclusive safety data in patients with eGFR <30 mL/min are lacking, the recommended 5-10 day RDV treatment duration and relatively low concentrations of SBECD suggest benefit may outweigh risk, particularly since SBECD is readily removed by hemodialysis and CRRT (J Am Soc Nephrol 2020;31:1384).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 10, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since October 13: None
    • Shortage recently resolved: Metronidazole 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
      • 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: Doxycycline injection
      • 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, Pentamidine isethionate
      • 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).
October 15, 2020

October 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 receive these updates via email, subscribe now.
 

OCTOBER 2020

 

Announcements

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • 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). The first version of this living guidance focuses on corticosteroids. Available on the BMJ website.
  • Updated guidance on the management of COVID-19 from a joint American Thoracic Society/European Respiratory Society Task Force (Eur Respir Rev 2020;29:200287). This release updates prior guidance from the Task Force on the pharmacological management of acute COVID-19, including remdesivir, HCQ, and dexamethasone. Available at PMC.
  • Vaccine development pipeline: see COVID-19, Prevention for summary of vaccine development and clinical trials.

New or Updated Treatment Guidelines

  • 2020 updated guidelines on diagnosis, management, and prevention of central venous catheter-related infections in hematology and oncology, by the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (Ann Hematol 2020 Sep 30 [Epub ahead of print]). These guidelines update the 2012 release and are available on the journal website.
  • 2020 recommendations from the International Antiviral Society-USA Panel regarding the use of antiretroviral drugs for the treatment and prevention of HIV infection in adults (JAMA 2020 Oct 14 [Epub ahead of print]). These recommendations update the 2018 release.

Practice Pearls from the Recent Literature

  • Population pharmacokinetic modeling suggests that in critically ill patients treated with caspofungin, the standard fixed-dose regimen may achieve inadequate drug exposure in all patients weighing ≥120 kg, over 80% of median-weight (78 kg) patients, and about 25% of lower-weight (≤50 kg) patients. A weight-based dosing regimen (2 mg/kg loading dose, then 1.25 mg/kg q24h) might be more appropriate (Antimicrob Agents Chemother 2020;64: e00905-20).

  • In a large, retrospective cohort study from the UK, macrolide use during the first trimester of pregnancy was associated with an increased risk of any major malformation, and specifically cardiovascular malformations, compared to penicillins. Macrolide prescribing in any trimester was associated with an increased risk of genital malformations (BMJ 2020;368:m331).

  • Penicillins, including piperacillin-tazobactam, delay the elimination of high-dose methotrexate by interfering with renal proximal tubular secretion of MTX. Severe toxicity (renal, neurologic, hepatic, hematologic, dermatologic, GI, pulmonary) may result from concomitant use (J Oncol Pharm Pract 2020 Sept 2 [Epub ahead of print]).

  • Hyponatremia is a known but probably underappreciated adverse effect of TMP-SMX. Natriuresis is thought to be the most likely explanation, although a recent report provides evidence more consistent with SIADH (Medicine 2020;99:e20746).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 13, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since September 13: Amphotericin B injection
    • Shortage recently resolved: Metronidazole 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
      • 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: Doxycycline injection
      • 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, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets, Pentamidine isethionate
      • 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).
September 15, 2020

September 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. If you received this message from a colleague, subscribe now.
 
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. If you received this message from a colleague, subscribe now.
 

SEPTEMBER 2020

Announcements

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • 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). The first version of this living guidance focuses on corticosteroids. Available on the BMJ website.
  • Vaccine development pipeline: see COVID-19, Prevention for summary of vaccine development and clinical trials.

New Drug Approvals

  • Nifurtimox* (Lampit), approved by the U.S. FDA for the treatment of Chagas disease (American Trypanosomiasis*), caused by Trypanosoma cruzi, in pediatric patients. Approval is based on serological results from the first part of a double-blind, randomized Phase 3 study conducted in South America; continuation may be contingent upon demonstration of clinical benefit. Recommended dosage (age <18 years): 8-10 mg/kg/day (divided tid) for body weight ≥40 kg; 10-20 mg/kg/day (divided tid) for body weight <40 kg.

New or Updated Treatment Guidelines

  • Clinical practice guidelines for the evaluation, diagnosis, treatment, and prevention of diabetic foot disease, under the leadership of the Jiangsu Medical Association and the Diabetes Society of the Chinese Medical Association (Burns Trauma 2020;8:tkaa017). The guidelines are available at PMC.
  • 2019 update of the European AIDS Clinical Society Guidelines for treatment of people living with HIV version 10.0 (HIV Med 2020 Sept 3 [Epub ahead of print]). The update is available here.

Practice Pearls

  • There continues to be uncertainty about the impact of non-enzyme-inducing antibiotics on the efficacy of hormonal contraceptives. The argument against the existence of an adverse interaction is based largely on small studies that contain one or more flaws in the way the evidence is interpreted. In a recent analysis of 173,073 spontaneous reports submitted to the UK’s Medicines and Healthcare products Regulatory Agency, unintended pregnancies were seven times more commonly reported with non-enzyme-inducing antibiotics compared to control medicines. No increase in secondary outcomes (such as diarrhea) was observed. Given the life-changing nature of an unintended pregnancy, these data support advising women to take extra conceptive precautions during a course of antibiotics, despite recent recommendations to the contrary (BMJ Evid Based Med 2020 Aug 18 [Epub ahead of print]).
  • We normally think of intravenous acyclovir as a drug administered by intermittent infusion. However, the drug exhibits time-dependent pharmacodynamics vs. herpes simplex virus (HSV), which supports administration by continuous infusion. This report describes two cases of confirmed or suspected neonatal HSV encephalitis successfully treated at home with continuous infusion acyclovir (60 mg/kg/day). In both cases, initial treatment with a few days of intermittent acyclovir was followed by administration via continuous infusion to complete 21 days of therapy, allowing for earlier hospital discharge. No treatment-related adverse effects were observed (Pediatr Infect Dis J 2020;39:830).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of September 13, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since August 9: None
    • Shortage recently resolved: Bacitracin ophthalmic ointment, Daptomycin injection, Griseofulvin oral tablets and suspension, Mupirocin calcium 2% cream (Glenmark)
    • 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
      • 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
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline injection
      • 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, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets, Pentamidine isethionate
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in coninued 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).
August 11, 2020

August 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. If you received this message from a colleague, subscribe now.
 
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. If you received this message from a colleague, subscribe now.
 

AUGUST 2020

Announcements

  • Sanford Guide recently released a new AUC Dosing Calculator* which uses two serum concentration measurements to determine AUC24, the preferred method for vancomycin dosing for Staph bacteremia, endocarditis and invasive infection pursuant to new guidelines.
  • Sanford Guide is hosting a Virtual Open House from September 22-24, beginning with a COVID-19 Panel Discussion with members of our editorial board. Pre-registration is required.

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • Guidelines on COVID-19 diagnosis, treatment and management, and infection prevention: IDSA and NIH.
  • Guidelines (available at PMC) for the pharmacological treatment of COVID-19 from the Brazilian Association of Intensive Care Medicine, the Brazilian Society of Infectious Diseases, and the Brazilian Society of Pulmonology and Tisiology (Rev Bras Ter Intensiva 2020;32:166).
  • Remdesivir for severe COVID-19: a clinical practice guideline (BMJ 2020;370:m2924). Available on the BMJ website.
  • Comprehensive review of pathophysiology, transmission, diagnosis and treatment of COVID-19 in JAMA online 10 July 2020 doi:10.1001/jama.2020.12839.
  • Vaccine development pipeline: see COVID-19, Prevention for summary of vaccine development and clinical trials.

New or Updated Treatment Guidelines

  • Full clinical practice guidelines for the treatment of nontuberculous mycobacterial pulmonary disease, from the ATS, ERS, ESCMID, and IDSA (Eur Resp J 2020;56:2000535). The guidelines are available on the journal website.

Practice Pearls

  • Posaconazole has recently been associated with pseudohyperaldosteronism (secondary hypertension, hypokalemia, and sometimes metabolic acidosis). The drug inhibits adrenal 11β-hydroxylase and 11β-hydroxysteroid dehydrogenase type 2, resulting in accumulation of metabolites with mineralocorticoid effects (11-deoxycorticosterone, 11-deoxycortisol) and reduced inactivation of cortisol. This study found a positive correlation between serum posaconazole concentrations and systolic blood pressure and serum 11-deoxycortisol concentrations, and a negative correlation between posaconazole concentrations and serum potassium concentrations. Posaconazole-induced pseudohyperaldosteronism occurred at posaconazole concentrations (median 3.0 μg/mL) lower than previously reported, suggesting that the issue is underrecognized (Clin Infect Dis 2020;70:2593).

  • When considering cephalosporin cross-reactivity with other β-lactams, we often focus only on the R1 side chain. A recent report describes a 17-year-old female who twice experienced anaphylaxis to cefuroxime. Skin prick test results were negative for all antibiotics; intradermal test results, along with R1 and R2 side chain similarity to cefuroxime, are seen below. Provocation tests with oral amoxicillin, oral cefadroxil (different R1 and R2 side chains), and IM ceftriaxone were negative. These data suggest hypersensitivity to cefuroxime and cefotaxime due to similar R2 side chains (Ann Allergy Asthma Immunol 2020;125:101).

    Drug Intradermal test R1 R2
    Ampicillin Negative Different N/A
    Amoxicillin/clavulanate Negative Different N/A
    Benzylpenicillin Negative Different N/A
    Cefazolin Negative Different Different
    Cefotaxime Positive Similar Similar
    Ceftriaxone Negative Similar Different
    Cefuroxime Positive – –

  • 2,478 TB patients treated with standard firstline drugs (INH, rifampin, PZA, ethambutol) were reviewed for the occurrence of serious adverse effects (SAEs). 407 patients (16.4%) experienced a SAE (most commonly hepatotoxicity, followed by cutaneous reaction, GI intolerance, and arthropathy) that led to drug discontinuation. The most common causative drug was PZA (55.8%), followed by ethambutol (23.3%), rifampin (13.8%), and INH (6.4%). The incidence of SAEs increased with age, and this held true for all individual drugs except rifampin (PLoS ONE 2020;15:e0236109).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 9, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since July 7: Cefotetan injection
    • Shortage recently resolved: Bacitracin ophthalmic ointment, Daptomycin injection, Griseofulvin oral tablets and suspension, Mupirocin calcium 2% cream (Glenmark)
    • 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), Cefoxitin injection, Ceftazidime injection, Ceftazidime/avibactam 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
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline injection
      • 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, Fluconazole injection
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets, Pentamidine isethionate
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in coninued 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).
July 9, 2020

July 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. If you received this message from a colleague, subscribe now.
 

JULY 2020

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • Guidelines on COVID-19 diagnosis, treatment and management, and infection prevention: IDSA and NIH.

New Drug Approval

  • Fostemsavir (Rukobia), an HIV-1 attachment inhibitor, indicated (in combination with other antiretrovirals) for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations. Recommended dosage: one 600 mg extended-release tablet twice daily, with or without food.

Possible Remdesivir Drug Interaction

  • A critically ill COVID-19 patient developed liver toxicity five days after initiation of remdesivir therapy. Two days after beginning remdesivir he was also administered amiodarone for new onset atrial fibrillation, and he had recently received a five-day course of chloroquine (last dose nine days before beginning remdesivir). Remdesivir is a P-glycoprotein (PGP) substrate, and amiodarone and chloroquine inhibit PGP. PGP is an efflux transporter present in the intestine, liver, and kidney; in the liver it transports drug molecules from the hepatocyte into the bile for excretion. It is thus possible that this case of presumed remdesivir hepatotoxicity was fostered by a drug-drug interaction that raised hepatocellular concentrations of remdesivir above the toxicity threshold (Clin Infect Dis 2020 Jun 28 [Epub ahead of print]).

Dolutegravir Dispersible Tablets for Pediatric Patients

  • Dolutegravir* 5 mg tablets for oral solution (Tivicay PD) have been approved for the treatment of HIV-1 infection in pediatric patients (treatment-naive or -experienced but INSTI-naive) aged at least 4 weeks and weighing at least 3 kg. These tablets are not bioequivalent to the previously approved dolutegravir tablets and not interchangeable on a mg-per-mg basis.

New or Updated Treatment Guidelines

  • Guidelines on diagnostic procedures for suspected beta-lactam antibiotic hypersensitivity from the German and Austrian professional associations for allergology, and the Paul-Ehrlich Society for Chemotherapy (Allergol Select 2020;4:11). The guidelines are available at PMC.
  • Clinical practice guidelines for the diagnosis and management of acute otitis media in children (2018 update), from committee members of the Japan Otological Society, Japan Society for Infection and Aerosol in Otorhinolaryngology, and the Japan Society for Pediatric Otorhinolaryngology (Auris Nasus Larynx 2020 June 20;S0385-8146). The guidelines are available on the journal website.
  • Executive summary of clinical practice guidelines for the treatment of nontuberculous mycobacterial pulmonary disease, from the ATS, ERS, ESCMID, and IDSA (Clin Infect Dis 2020;Jul 6 [Epub ahead of print]). The summary is available on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of July 7, 2020) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since June 10: Ceftazidime/avibactam injection
    • Shortage recently resolved: Cefuroxime injection, Erythromycin 0.5% ophthalmic ointment, Gentamicin injection, Gentamicin 3% ophthalmic ointment
    • 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), Cefoxitin injection, Ceftazidime 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
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline injection
      • Topical (miscellaneous) antibacterials: Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), 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, Fluconazole injection, Griseofulvin oral tablets and suspension
      • Antiparasitic drugs: Chloroquine tablets, Hydroxychloroquine tablets, Pentamidine isethionate
      • Antiviral drugs: Acyclovir injection, Cidofovir injection
    • Vaccines in coninued 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: Bacitracin ophthalmic ointment (in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 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).