News

News

August 14, 2018

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 would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

August 2018

Drug Safety Communications

  • The US FDA is warning that azithromycin should not be given long-term to prevent bronchiolitis obliterans syndrome (BOS) in patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) for hematological malignancy. This alert follows the early termination of a trial investigating the efficacy of long-term azithromycin for preventing BOS after an increased risk of relapse and death was observed in patients taking azithromycin compared with placebo. A plausible mechanism has not been identified. The full Drug Safety Communication can be found here.

New Drug Approvals

  • Arakoda (tafenoquine), approved for malaria prophylaxis in patients aged 18 and older. The recommended dosage is a loading regimen of 200 mg once daily for each of the three days before travel to a malarious area, a maintenance regimen of 200 mg once weekly while in the malarious area (starting seven days after the last loading regimen dose), and then 200 mg (a single dose) in the week following exit from the malarious area (seven days after the last maintenance dose). Product availability: 100 mg tablets.
  • Krintafel (tafenoquine)*, approved for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 and older. The recommended dosage is a single 300 mg dose coadministered on the first or second day of appropriate therapy for acute P. vivax malaria. Product availability: 150 mg tablets.
  • Symtuza* (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg), approved for the treatment of HIV-1 infection in adults who are 1) treatment naive, or 2) virologically suppressed on an ARV regimen for at least 6 months and have no known substitutions associated with darunavir or tenofovir resistance. The recommended dosage is one tablet once daily with food.
  • TPOXX (tecovirimat)*, approved for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg. Clinical studies in humans have not been conducted; the effectiveness of tecovirimat was established based on animal efficacy studies. The drug works by inhibiting the orthopoxvirus VP37 envelope wrapping protein. Recommended dosage in patients weighing ≥40 kg is 600 mg (three 200 mg capsules) po bid for 14 days. Pediatric dosage: weight 13 to <25 kg, 200 mg bid; 25 to <40 kg, 400 mg bid.

New or Updated Treatment Guidelines

  • Updated recommendations regarding the use of antiretroviral drugs for treatment and prevention of HIV infection in adults, from the International Antiviral Society-USA (IAS-USA) Panel (Saag MS et al, JAMA 320:379, 2018). These recommendations update the 2016 version and are available on the JAMA website.
  • Updated recommendations regarding testing and monitoring for antiretroviral drug resistance in HIV-infected individuals, from the International Antiviral Society-USA (IAS-USA) Panel (Clin Infect Dis 2018 July 20 [Epub ahead of print]). These recommendations update the 2008 version.
  • Belgian guidelines for the screening for latent tuberculosis in HIV-infected patients, from members of the Belgian LTBI group in consultancy with the AIDS Reference Center College (Acta Clin Belg 2018 July 23 [Epub ahead of print]).
  • A summary of the updated guidelines on primary antifungal prophylaxis in adult hematology patients, from The European Conference on Infections in Leukaemia (ECIL). Compared to the 2011 version, major changes include implementation of the IDSA grading system and extension of the recommendations to other hematological diseases besides AML and allogeneic HSCT recipients. This publication summarizes the proposals agreed upon at ECIL-5 and ECIL-6 (J Antimicrob Chemother 2018 Aug 1 [Epub ahead of print]).
  • Updated clinical practice guidelines for the treatment of chronic hepatitis C, from the Korean Association for the Study of the Liver (Clin Mol Hepatol 2018 August 10 [Epub ahead of print]). The last update was in 2015. These guidelines are available on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Ciprofloxacin 0.3% ophthalmic solution
    • [Shortage recently resolved]: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment, Tobramycin injection
      • Cephalosporins: Cefazolin, Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Gemifloxacin tablets, Moxifloxacin injection (unavailable)
      • Penicillins: Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Clindamycin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension, Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A virus vaccine inactivated (Vaqta), Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), 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: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: 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 11, 2018

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 would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

July 2018

 

New Drug Approval

  • Plazomicin, a new aminoglycoside derived from sisomicin, was approved by the US FDA in late June 2018 for treatment of adults with complicated urinary tract infections (UTIs), including pyelonephritis, caused by these susceptible microbes: E. coli, K. pneumoniae, P. mirabilis, and E. cloacae. The clinical significance of in vitro activity against other gram-negative bacilli is unknown at this time. Activity against P. aeruginosa is variable, and the drug has no activity against A. baumannii, S. maltophilia, or anaerobes. Safety and efficacy data are limited, so Plazomicin should be used only where there are limited or no alternative treatment options. The recommended dosage is 15 mg/kg IV q24h for 4-7 days.

New or Updated Treatment Guidelines

  • Guidelines for proper utilization of the microbiology laboratory for diagnosis of infectious diseases, from the Infectious Diseases Society of America (IDSA) and American Society for Microbiology (ASM) (Clin Infect Dis 2018 June 28 [Epub ahead of print]). These guidelines update recommendations published in 2013 and are available on the IDSA website.

  • Executive summary of clinical practice guidelines (2018 update) for the management of invasive aspergillosis, prepared by The Study Group of Fungal Infections (GEMICOMED) from the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) (Enferm Infecc Microbiol Clin 2018 June 27 [Epub ahead of print]).

From CDC

  • Updated recommendations for use of once-weekly INH-rifapentine for LTBI. In 2011, CDC recommended 3 months of once-weekly isoniazid and rifapentine (3HP) by directly observed therapy (DOT) for treatment of latent tuberculosis infection (LTBI), with limitations for use in children <12 years and in patients with HIV. Based on a systematic review of published evidence and after consideration of input from TB experts, the Advisory Council for the Elimination of TB, and the public, CDC continues to recommended 3HP for adults with LTBI and now recommends it (1) for persons aged 2-17, (2) for persons with HIV infection, including AIDS, who are taking antiretroviral drugs with manageable drug-drug interactions with rifapentine, and (3) by DOT or self-administered therapy in persons ≥2 years of age. Full discussion: MMWR 67(25): 723-726, 2018.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Azithromycin ophthalmic solution 1% (unavailable)
    • [Shortage recently resolved]: Dalbavancin injection, Doxycycline injection, Oseltamivir oral suspension, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R)
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Cephalosporins: Cefazolin, Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Gemifloxacin tablets, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A virus vaccine inactivated (Vaqta), Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), 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: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: 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)
June 13, 2018

June 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 would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

June 2018

 

Drug Safety Communications

  • The US FDA has issued a Drug Safety Communication regarding the possible increased risk of neural tube defects among infants born to women who became pregnant while on a dolutegravir-based regimen, based on preliminary results from an ongoing observational study in Botswana. There is no evidence from this study of neural tube defects occurring among infants born to women who initiated a dolutegravir-based regimen after becoming pregnant. Dolutegravir is available as a single agent (brand name Tivicay*) and is also part of the combination products Juluca* and Triumeq*. The full Drug Safety Communication can be found here. The most current recommendations from the HHS Antiretroviral Guidelines Panels, with clinical scenarios and alternatives to treatment with dolutegravir, can be found here. An interim statement from CDC can be found here.

CDC Health Alert Network #411

  • HAN #411 provides current CDC recommendations on the management and reporting of Shigella* infections that have been treated with ciprofloxacin or azithromycin and resulted in possible clinical treatment failure. This is a follow-up to HAN #401 (April 2017) which described an increase in the percentage of Shigella isolates in the US with ciprofloxacin MICs of 0.12–1 μg/mL (classified as susceptible by CLSI criteria). This percentage continues to rise. Molecular data indicate that Shigella isolates in this ciprofloxacin MIC range harbor at least one quinolone resistance mechanism. CDC has also identified an increasing number of Shigella isolates with azithromycin MICs that exceed the epidemiological cutoff value (ECV), and requests reports of any possible azithromycin treatment failures.

New or Updated Treatment Guidelines

Antiretroviral Labeling Changes

  • The approved labeling for darunavir/cobicistat (Prezcobix*) now specifically states that this combination product is not recommended for use in pregnant women due to substantially lower exposures of darunavir and cobicistat. Treatment should not be initiated in pregnant women, and an alternative regimen should be used in women who become pregnant during Prezcobix therapy. 
  • The US FDA has approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada*), in combination with safe sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents weighing at least 35 kg. Truvada was approved for PrEP in adults in 2012.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Cefazolin, Nitrofurantoin oral suspension (unavailable), Recombinant zoster vaccine (Shingrix)
    • [Shortage recently resolved]: Doxycycline injection, Oseltamivir oral suspension, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R)
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), 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: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: 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 7, 2018

May 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 would like to automatically receive our monthly ID Updates by e-mail, subscribe now.

 

May 2018

  

New Drug Approvals

  • Cimduo* (lamivudine, tenofovir disoproxil fumarate) for the treatment of HIV-1 infection (in combination with other antiretroviral agents) in adult and pediatric patients weighing at least 35 kg. Recommended dosage: one tablet once daily, with or without food.
  • Trogarzo* (ibalizumab-uiyk), in combination with other antiretrovirals, for the treatment heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current regimen. Ibalizumab is a monoclonal antibody that prevents HIV fusion and entry into the CD4 cell. Recommended dosage: 2 gm IV loading dose, then 800 mg IV every two weeks.

New FDA Indication

  • Otiprio (ciprofloxacin* 6% otic suspension) for the treatment of acute otitis externa due to P. aeruginosa and S. aureus in patients 6 months of age and older. The product was previously approved for bilateral otitis media with effusion in patients (age 6 months and older) undergoing tympanostomy tube placement. Recommended dosage for acute otitis externa: a single 0.2 mL administration to the external ear canal of each affected ear.

New or Updated Treatment Guidelines

  • Clinical practice guidelines for the diagnosis and treatment of cutaneous leishmaniasis (CL) in Turkey. These guidelines are a consensus text prepared by 18 experienced CL specialists who have been working for many years in areas where the disease is endemic (Int J Dermatol 2018 Apr 16 [Epub ahead of print]).

  • Guidelines for vaccine use in cancer patients, including autologous stem cell transplant recipients, from the Infectious Diseases Working Party (AGIHO) of the German Society for Hematology and Medical Oncology (DGHO) (Ann Oncol 2018 Apr 24 [Epub ahead of print]). the guidelines are available on the journal website.

  • Korean clinical practice guidelines for the antibiotic treatment of community-acquired urinary tract infections (Infect Chemother 50:67, 2018). These guidelines update the 2011 Korean guidelines and are available on the journal website.

  • Updated clinical practice guidelines from the US Public Health Service for the use of pre-exposure prophylaxis (PrEP) to prevent HIV infection, available on the CDC website. They include new information on the safety and efficacy of PrEP, indications for PrEP use, and links to further information. Changes in the updated guidelines are highlighted.

  • 2017 guidelines for HIV pre-exposure prophylaxis (PrEP) from the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine. These guidelines update the 2015 version and represent an adaptation and update of the 2014 US CDC PrEP guidelines (J Virus Erad 4:143, 2018).

From the Centers for Disease Control and Prevention

  • A recently published report compiles and summarizes all recommendations from CDC’s Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of tetanus, diphtheria, and pertussis in the US. As a comprehensive summary of previously published recommendations, this report does not contain any new recommendations and it replaces all previously published reports and policy notes. It is intended for use by clinicians and public health providers as a resource (MMWR 67(2):1-44, 2018).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Gentamicin ophthalmic ointment (unavailable)
    • [Shortage recently resolved]: Ofloxacin 0.3% ophthalmic solution
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection, Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: Oseltamivir oral suspension
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), 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: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: 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 detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages
April 10, 2018

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. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.

 

April 2018

  

Newly Released Treatment Guidelines

From the Centers for Disease Control and Prevention

  • yellow fever* outbreak began in Brazil in December 2016. Since January 2018, 10 travel-related cases, including four deaths, have been reported in international travelers returning from Brazil. Eight of the travelers acquired the disease on the island of Ilha Grande, off the Rio de Janeiro coast. All 10 travelers were unvaccinated. Yellow fever vaccination is recommended for all eligible persons aged ≥9 months traveling to many areas of Brazil. YF-VAX, the US FDA-approved vaccine, is currently unavailable; an alternative vaccine not licensed in the US, Stamaril, can be obtained through a limited number of clinics in the US (click here). Vaccination should occur at least 10 days before travel, and recommendations to avoid mosquito bites should be followed (MMWR 67:340, 2018).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Cefpodoxime oral suspension (unavailable)
    • [Shortage recently resolved]: Ofloxacin 0.3% ophthalmic solution
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection (unavailable), Doxycycline injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: Oseltamivir oral suspension
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: 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 detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages