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.
 

January 2019

Drug Safety Communications

• Following a review of reported cases and four published observational studies, the US FDA has issued a warning that fluoroquinolone antibiotics* can increase the occurrence of aortic aneurysm or dissection. This is the latest in a series of Drug Safety Communications regarding fluoroquinolones dating back to 2008. The drugs should not be prescribed to patients who have an aortic aneurysm or are at risk for one unless no other options are available. The underlying mechanism for the increased risk of an aortic aneurysm event cannot be determined from these studies, and the background risk varies among populations; nevertheless, the data suggest about a two-fold increase in risk in patients taking a fluoroquinolone antibiotic. A warning about this risk will be added to the prescribing information and patient medication guide for all fluoroquinolones. The full communications can be found here.

New Vaccine Approval

• Vaxelis, a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to H. influenzae type b. It is approved as a 3-dose series in children 6 weeks through 4 years of age (0.5 mL IM at 2, 4, and 6 months of age). The 3-dose series constitutes a primary immunization course against diphtheria, tetanus, polio, and invasive Hib. This combination vaccine may be used to complete the hepatitis B immunization series, and an additional dose of pertussis-containing vaccine is required to complete the primary immunization series against pertussis. Vaxelis is not expected to be commercially available in the US prior to 2020.

New or Updated Treatment Guidelines

• Updated clinical practice guidelines for the diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza* from the Infectious Diseases Society of America (Clin Infect Dis 2018 Dec 19 [Epub ahead of print]). These guidelines update the 2009 version (published prior to the 2009 H1N1 pandemic) and are available on the IDSA website.

• Practice guidelines for the individualized use of voriconazole* from the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society (Ther Drug Monitor 40:663, 2018). The guidelines are available on the journal website.

• The latest revisions to the Italian guidelines for the use of antiretroviral agents in HIV-infected patients from the Italian Society for Infectious and Tropical Diseases (New Microbiol 41:247, 2018). This publication updates the 2017 guidelines and are available on the journal website.

Drug Shortages (US)

• Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 7, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
  • [New on the list]: Valganciclovir oral powder for solution
  • [Shortage recently resolved]: Dalbavancin injection
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam injection, Oxacillin injection, Penicillin G procaine injection, Piperacillin/tazobactam injection
    • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • Antifungal drugs: Fluconazole injection, Nystatin oral suspension (unavailable)
    • Antiparasitic drugs: None
    • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection
    • 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

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.
 

December 2018

New Drug Approvals

• Aemcolo (rifamycin SV*), approved for the treatment of travelers' diarrhea caused by non-invasive strains of E. coli in adults. Rifamycin SV is a poorly absorbed member of the rifamycin (technically ansamycin) class of antibiotics that was actually the first to be used in clinical practice (1963). In theory the product's MMX (multimatrix) technology allows for release of active antibiotic only after it reaches intestinal pH levels of ≥7 in the distal small bowel and colon, with an additional 1 hour delay upon reaching this pH. The recommended dosage is 388 mg po bid x3 days, with or without food (but not with alcohol). Tablets should be swallowed whole (not crushed, chewed, or broken) with 6-8 ounces of fluid. Rifamycin SV interacts with many CYP450 and transporter proteins, but because of negligible systemic rifamycin concentrations no clinically relevant drug interactions are expected. Product availability: 194 mg tablets.

• Temixys* (lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg), approved (in combination with other antiretroviral agents) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. This product is a generic formulation that has essentially the same activity and safety profile as Truvada (emtricitabine + tenofovir disoproxil fumarate). The recommended dosage is one tablet once daily, with or without food.

New or Updated Treatment Guidelines

• Updated clinical practice guidelines for the management of outpatient parenteral antimicrobial therapy from the Infectious Diseases Society of America (Clin Infect Dis 2018 Nov 13 [Epub ahead of print]). These guidelines update the 2004 version and are available on the IDSA 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]: Nystatin oral suspension
  • [Shortage recently resolved]: Cefpodoxime oral suspension, Mafenide powder for solution
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopeptides: Dalbavancin injection, Daptomycin injection, Vancomycin injection
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam injection, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
    • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • Antifungal drugs: Fluconazole injection
    • Antiparasitic drugs: None
    • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection
    • 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

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. If you would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

November 2018

Counterfeit Book Alert

• It has come to our attention that Amazon.com has been selling and fulfilling orders for The Sanford Guide to Antimicrobial Therapy with counterfeits. We cannot vouch for the accuracy of these books, and strongly discourage their use in clinical situations. For more information on how to detect a counterfeit and what to do if you have one, visit https://www.sanfordguide.com/products/print-guides/.

New Drug Approvals

• Xofluza (baloxavir marboxil), approved for the treatment of acute uncomplicated influenza in patients ≥12 years of age who have been symptomatic for ≤48 hours. The recommended dosage is a single dose (within 48 hours of symptom onset) with or without food (40 mg for body weight 40 to <80 kg, 80 mg for ≥80 kg). Product availability: 20 mg and 40 mg tablets.

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]: Cidofovir injection (unavailable), Letermovir injection
  • [Shortage recently resolved]: Moxifloxacin injection
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Cefpodoxime oral suspension, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopetides: Dalbavancin injection, Daptomycin injection, Vancomycin injection
    • 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, Mafenide powder for solution, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • 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

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.