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.
New Drug Approvals
- Juluca*, an INSTI/NNRTI combination formulation of dolutegravir + rilpivirine, is a complete two-drug regimen for treatment of HIV-1 infection in adult patients who 1) are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months, 2) have no baseline pre-therapy resistance mutations, and 3) have no history of virologic treatment failure. Standard HIV-1 treatment consists of three or more drugs.
- Shingrix (zoster vaccine recombinant, adjuvanted) is a new vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older. The recommended administration schedule is two 0.5 mL IM doses, given first at month zero and then anytime between 2-6 months later. In late October the Advisory Committee on Immunizations Practices (ACIP) voted that this new vaccine is 1) recommended for healthy adults of age ≥50 to prevent shingles and related complications, 2) recommended for adults who previously received the current vaccine (Zostavax), and 3) the preferred vaccine for preventing shingles and related complications. These recommendations will be published in MMWR and become official policy once they are approved by the CDC director.
First-Time Generic Approvals (US)
- Darunavir ethanolate tablets, 600 mg (Teva), approved November 28.
- Caspofungin injection, 50 mg and 70 mg vials (Mylan, Gland Pharma), approved September 29.
Newly Released Treatment Guidelines
- New guidelines for the prevention, diagnosis and treatment of BK polyomavirus-associated hemorrhagic cystitis in hematopoietic stem cell transplant recipients from the ECIL-6 (6th European Conference on Infections in Leukemia) have been published (J Antimicrob Chemother 2017 Sept 8 [Epub ahead of print]).
- Updated guidelines for the diagnosis and management of gastrointestinal complications in adult cancer patients from the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) have been published (Ann Hematol 2017 Nov 24 [Epub ahead of print]). These guidelines update the 2013 release and are available for download on the journal website.
- Updated guidelines for primary prophylaxis of invasive fungal infections in patients with hematological malignancies from the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) have been published (Ann Hematol 2017 Dec 7 [Epub ahead of print]). These guidelines update the 2014 release and are available for download on the journal 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]: None
- [Shortage recently resolved]: Cefpodoxime oral suspension, Gentamicin injection
- [Continue to be in reduced supply]:
- Aminoglycosides: Amikacin injection, Tobramycin injection
- Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Ceftazidime, Ceftriaxone, Cefuroxime injection
- Fluoroquinolones: Ciprofloxacin oral suspension, Moxifloxacin injection, Ofloxacin 0.3% ophthalmic solution
- Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G benzathine, Penicillin G benzathine 900,000 units/Penicillin G procaine 300,000 units (Bicillin C-R 900/300), Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R), Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
- Other antibacterials: Clindamycin 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
- Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, Yellow Fever vaccine (unavailable)
- [New on the list]: None
- Antimicrobial drugs newly discontinued: None
- 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