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.
New Print Editions Now Available
- Sanford Guide’s 2019 print editions are now available for immediate shipping. New this year is a spiral-bound edition combining HIV/AIDS Therapy and Hepatitis Therapy.
New Drug Approvals
- Avaclyr (acyclovir* 3% ophthalmic ointment), approved for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with HSV-1 and HSV-2. Recommended dosage: one ribbon of ointment in the lower cul-de-sac of the affected eye 5 times a day until ulcer has healed, then 3 times daily for 7 days. Product availability: 3.5 gm tubes.
- Dengvaxia (Dengue Tetravalent Vaccine, Live), approved by the US FDA for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3, and 4). There are major restrictions: the vaccine is approved only for use in individuals age 9-16 with laboratory-confirmed previous dengue infection and living in endemic areas. It is a live, attenuated vaccine that is administered as three separate injections six months apart. The vaccine has already been approved in 19 countries and the European Union.
- Tolsura (itraconazole*), approved for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary) in patients who are intolerant of or who are refractory to amphotericin B*. This product is a new formulation with improved bioavailability. Availability: 65 mg capsules.
Updated Pediatric HIV Guidelines
- Updated Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection from the HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV are available on the AIDSinfo website.
New or Updated Treatment Guidelines
- Updated guidelines for the epidemiology, diagnosis, prevention, and management of infection due to Arenaviruses and West Nile Virus (WNV) in the pre- and post-transplant period, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Apr 25 [Epub ahead of print]).
- Updated guidelines for the diagnosis, prevention and management of Human T-cell lymphotrophic virus 1 (HTLV)-1 in the pre- and post-transplant period, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Apr 25 [Epub ahead of print]).
- Updated guidelines for the prevention and management of Clostridium difficile infection in solid organ transplant (SOT) recipients from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Apr 19 [Epub ahead of print]).
- Updated guidelines for the vaccination of solid organ transplant candidates and recipients from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Apr 19 [Epub ahead of print]).
- Eculizumab is a monoclonal antibody that binds to complement protein C5, inhibiting its cleavage to C5a and C5b and thereby inhibiting deployment of the terminal complement system. It is indicated for paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and anti-acetylcholine receptor antibody-positive generalized myasthenia gravis. Unfortunately, complement blockade at C5 interferes with the immune system’s ability to respond effectively to Neisseria infection. Therapy with eculizumab is thought to increase the risk of meningococcal disease 1000- to 2000-fold. The product labeling includes a black box warning about life-threatening and fatal infection due to N. meningitidis*, but infection due to other Neisseria species is less well characterized. The first case series of N. gonorrhoeae* infections in patients receiving eculizumab was recently published. Eight of nine cases of N. gonorrhoeae infection identified by an FDA spontaneous safety report search were disseminated gonococcal infection (DGI). All eight DGI patients were hospitalized, seven were bacteremic, and two required pressor support (one of whom also required mechanical ventilation). The limited data suggest that patients treated with eculizumab may be at higher risk of DGI than the general population (Clin Infect Dis 2018 Nov 12 [Epub ahead of print]).
Drug Shortages (US)
- Antimicrobial drugs or vaccines in reduced supply or unavailable (as of May 4, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
- [New on the list since April 21]: Doxycycline injection
- [Shortage recently resolved]: Ciprofloxacin 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 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
- Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
- Macrolides/azalides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable), Erythromycin 0.5% ophthalmic ointment
- Penicillins: Ampicillin/sulbactam 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: Amphotericin B injection (unavailable), Clotrimazole 10 mg oral troches, Fluconazole injection, Nystatin oral suspension (unavailable)
- Antiparasitic drugs: Pentamidine isethionate
- Antiretroviral drugs: Nelfinavir tablets
- Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection (unavailable), Valganciclovir oral powder for solution
- 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