November 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 received this message from a colleague, subscribe now.
 

NOVEMBER 2019

New or Updated Treatment Guidelines

New for H. pylori Treatment

  • The US FDA has approved the three-drug combination of rifabutin, amoxicillin, and omeprazole (Talicia*) for the treatment of Helicobacter pyloriinfection in adults. Each capsule contains rifabutin 12.5 mg (immediate-release), amoxicillin 250 mg (immediate-release), and omeprazole 10 mg (delayed-release). Recommended dosage is four capsules q8h for 14 days, with food. US product launch is expected in the first quarter of 2020.

Intron A Discontinued

  • Based on an evaluation of clinical use and the availability of alternative therapies, Merck is discontinuing recombinant interferon alfa-2b (Intron A), in all strengths. Supply availability should continue over the next 1-2 years depending on product formulation and dose strength.

CABP Indication for Delafloxacin

  • Delafloxacin* is now indicated in adults for the treatment of community-acquired bacterial pneumonia due to S. pneumoniae, MSSA, K. pneumoniae, E. coli, P. aeruginosa, H. influenzae, H. parainfluenzae, C. pneumoniae, L. pneumophila, and M. pneumoniae. This is the drug's second FDA-approved indication.

Baloxavir Indication Expanded to High-Risk Patients

  • Baloxavir* is now indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for ≤48 hours and are 1) otherwise healthy, or 2) at high risk of developing influenza-related complications. High risk factors include underlying asthma or chronic lung disease, diabetes, heart disease, morbid obesity, and age ≥65 years.

Second Drug Approved for PrEP

  • Descovy (emtricitabine 200 mg + TAF 25 mg) is the second drug to be approved by the US FDA for HIV-1 pre-exposure prophylaxis (PrEP)*. It is indicated in at-risk adults and adolescents weighing at least 35 kg to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must be screened for HIV-1 infection immediately prior to starting PrEP, and then at least once every three months. The recommended dosage is one tablet orally once daily, with or without food. The first drug to be approved for PrEP was Truvada (emtricitabine 200 mg + TDF 300 mg) in 2012.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 8, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list since October 17]: None
    • [Shortage recently resolved]: Erythromycin lactobionate 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
      • Clindamycin injection
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Daptomycin injection, Vancomycin injection
      • Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin 0.5% ophthalmic ointment
      • Nitrofurantoin oral suspension
      • Nitroimidazoles: Metronidazole injection
      • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
      • Tetracyclines: Doxycycline hyclate injection
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment (unavailable), Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
      • Antifungal drugs: Clotrimazole 10 mg oral troches, Fluconazole injection, Griseofulvin oral tablets and suspension, Nystatin oral suspension
      • Antiparasitic drugs: Pentamidine isethionate
      • Antiretroviral drugs: None
      • Antiviral drugs: Acyclovir injection, Cidofovir injection, Letermovir injection (unavailable)
      • Vaccines: Hepatitis B vaccine recombinant, Rabies vaccine (and immune globulin), 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: 
    • Recent discontinuations: Interferon alfa-2b (Intron A, in October 2019), Quinidine gluconate IV (in December 2017), 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