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