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.
 

October 2018

New Drug Approvals

• Arikayce (amikacin* liposome inhalation suspension), approved for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. It is the first product approved via the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), which serves to advance the development of new antibacterial drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs. The recommended dosage is once-daily inhalation of the contents of one 590 mg/8.4 mL vial, using the Lamira Nebulizer System.
• Nuzyra (omadacycline*), a tetracycline-like drug approved for the treatment of community-acquired pneumonia and acute bacterial skin and skin structure infections. The recommended dosage for CAP is 200 mg IV load, followed by 100 mg IV (or 300 mg po) q24h x7-14 days. For ABSSSI, the recommended dosage is 200 mg IV (or 450 mg po q24h x2) load, followed by 100 mg IV (or 300 mg po) q24h x7-14 days. Product availability: Injection (100 mg single-dose vials), 150 mg tablets.

New or Updated Treatment Guidelines

• Guidelines for the treatment of hepatitis C virus infection, from the Spanish Association for the Study of the Liver (AEEH) (Gastroenterol Hepatol 2018 Sept 27 [Epub ahead of print]).

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]: Dalbavancin injection, Mafenide powder for solution, Meropenem injection
  • [Shortage recently resolved]: Moxifloxacin injection
  • [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 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
    • Other antibacterials: Clindamycin injection, Daptomycin injection, 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, 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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages

 
Sperryville, VA – Vikor Scientific™ and Sanford Guide® announce the release of a new integrated product that combines advanced molecular diagnostics with industry-leading infectious disease treatment guidelines. This new offering provides clinicians access to the most advanced molecular technology to accurately and efficiently detect pathogens, identify antibiotic resistance markers, and receive live data feeds on regional antibiotic sensitivity and susceptibility patterns. The strategic collaboration between Vikor Scientific and Sanford Guide aims to combat the global epidemic of antibiotic resistance through the use of advanced genomic testing and trusted treatment guidelines to enable patient-specific treatment plans.
 
Vikor Scientific’s ABXAssist™, an intelligent, molecular diagnostic solution, assists the clinician in forming a cost-sensitive treatment plan for patients within 24 hours of sample arrival at the lab. Vikor Scientific has the ability to test for over 125 pathogens and to identify 30 resistance gene markers, the most comprehensive resistance gene testing panel on the commercial market today. By integrating these results with trusted Sanford Guide treatment guidelines and narrow-spectrum antibiotic recommendations, Vikor Scientific and Sanford Guide provide clinicians with the information they need to optimize patient care.
 
ABXAssist can be accessed from any mobile device, web-portal, or EHR, and is seamlessly integrated with Sanford Guide content to allow clinicians ease in accessing the most relevant guidance when creating a plan for treatment. Sanford Guide content is updated on an ongoing basis to provide clinicians with expert recommendations based on the latest available evidence.
 
About Vikor Scientific
Vikor Scientific is a molecular diagnostics company in Charleston, SC, focused on delivering test results that improve clinical and economic outcomes. Vikor Scientific believes the success of an Antibiotic Stewardship program is multi-faceted and begins with having access to the most rapid and accurate diagnostics.
 
About Sanford Guide
Since 1969, Sanford Guide has been a leader in point-of-care recommendations for the treatment of infectious diseases. Widely used by pharmacists, physicians, physician assistants, and nurses, Sanford Guide helps to improve patient care by providing carefully curated recommendations based on the latest evidence. Sanford Guide takes pride in responsiveness to customers, the development of innovative solutions, and providing content that is unparalleled in quality and clinical applicability.
 

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.
 

September 2018

Sanford Guide App Upgrades

• In the next few weeks, Sanford Guide mobile app users will begin receiving content updates in real time, replacing our monthly content update cycle. This will allow users to access new guidelines as soon as our editorial board publishes them, and eliminate interruptions by downloading updates in the background. Keep an eye out for app updates and download the latest versions to begin utilizing this new functionality as it becomes available. Tutorials for our mobile apps are available on our YouTube channel.

Drug Safety Communications

• Based on its recent review, the US FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. These labeling changes are required only of systemic fluoroquinolone formulations. Blood sugar disturbances are already included as a warning in most fluoroquinolone drug labels; the FDA is adding that hypoglycemia can lead to coma. The new label changes will make the mental health side effects of fluoroquinolones more prominent and more consistent; side effects to be added or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium. The full Drug Safety Communication can be found here.

New Drug Approvals

• Xerava (eravacycline*), a tetracycline-like drug approved for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. The recommended dosage is 1 mg/kg (over 60 minutes) IV q12h x4-14 days depending on infection severity and clinical response. Product availability: 50 mg single-dose vials.
• Pifeltro (doravirine*), a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV-1 infection (in combination with other antiretroviral agents) in treatment-naive adults. The recommended dosage is 100 mg orally once daily, with or without food. Product availability: 100 mg film-coated tablets.
• Delstrigo*, a fixed-dose combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg), approved for the treatment of HIV-1 infection in treatment-naive adults. The recommended dosage is one tablet orally once daily, with or without food. Product availability: film-coated tablets.
• Moxidectin*, an antihelmintic approved for the treatment of onchocerciasis due to Onchocerca volvulus in patients 12 years of age and older. The recommended dosage is a one-time dose of 8 mg, taken with or without food. Product availability: 2 mg tablets.

New or Updated Treatment Guidelines

• Updated clinical practice guidelines for antimicrobial prophylaxis in adult patients with cancer-related immunosuppression, from the American Society of Clinical Oncology in partnership with the Infectious Diseases Society of America (J Clin Oncol 2018 Sept 4 [Epub ahead of print]). This release updates the 2013 guidelines and is available on the JCO website.
• Recommendations for routine use of the seasonal influenza vaccine and antiviral medications for the prevention and treatment of influenza in children, from the American Academy of Pediatrics (AAP) for the upcoming 2018-2019 season (Pediatrics 2018 Sept 3 [Epub ahead of print]). The recommendations are available on the AAP website.

From CDC

• The 2018–19 recommendations of the Advisory Committee on Immunization Practices (ACIP) concerning the use of seasonal influenza vaccines in the US have been released (MMWR Recomm Rep 2018; 67(No. RR-3):1–20. Routine annual vaccination of all persons aged ≥6 months without contraindications continues to be recommended. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended, and appropriate product is available. Other important updates:

  1. Vaccine viruses will be an A/Michigan/45/2015 (H1N1)pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain these three viruses and an additional influenza B vaccine virus, a B/Phuket/3073/2013–like virus (Yamagata lineage).
  2. For the 2018–19 season, vaccination providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 (not recommended the last two seasons) is an option for those for whom it is appropriate. Note: IIV=inactivated influenza vaccine, RIV=recombinant influenza vaccine, LAIV=live attenuated influenza vaccine; 4=quadrivalent vaccine.
  3. Persons with a history of egg allergy of any severity may receive any licensed, recommended, and age-appropriate influenza vaccine (IIV, RIV4, or LAIV4) that is otherwise appropriate for their health status. Additional recommendations concerning vaccination of egg-allergic persons are discussed.
  4. Recent licensure and labeling changes are reviewed, including expansion of the age indication for Afluria Quadrivalent (IIV4) from ≥18 years to ≥5 years and expansion of the age indication for Fluarix Quadrivalent (IIV4), previously licensed for ≥3 years, to ≥6 months.

  The full report is available on the MMWR 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]: Daptomycin
  • [Shortage recently resolved]: Moxifloxacin injection
  • [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 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • 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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages

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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages

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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages