October ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. 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

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)