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.
 

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