The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no alternative options. It is the first new drug to become available in the US in more than 15 years for treatment of systemic Candida infections.

Gallium nitrate (Ganite - Fujisawa, USA), originally an anticancer drug, was recently marketed for treatment of cancer-associated hypercalcemia that has not responded to hydration. Other drugs used for treatment of hypercalcemia include furosemide (Lasix, and others), the bisphosphonate etidronate (Didronel IV), calcitonin (Calcimar), and plicamycin (Mithracin, formerly mithramycin) (RAB Schaiff et al, Clin Pharm, 8:108, 1989). Newer bisphosphonates are available in Europe.

An intranasal formulation of the corticosteroid triamcinolone (Nasacort - Rh ne- Poulenc Rorer) was recently approved by the US Food and Drug Administration for once-daily treatment of seasonal and perennial allergic rhinitis.

S-adenosyl-methionine (SAM; SAMe; ademetionine; adomet), an endogenous compound synthesized from methionine and adenosine-triphosphate (ATP), has been marketed in stores and on the internet as a dietary supplement to promote "emotional well being."

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...

Isatuximab-irfc (Sarclisa – Sanofi), a CD38-directed cytolytic antibody, has been approved by the FDA for treatment of newly diagnosed multiple myeloma in adults who are not eligible for autologous stem cell transplantation (ASCT). The drug was approved earlier for treatment of relapsed or treatment-refractory multiple myeloma.

Mitoxantrone (Novantrone - Lederle), a synthetic anthracene related to the anthracyclines doxorubicin (Adriamycin) and daunorubicin (Cerubidine), has now been marketed in the USA to be used in combination with other drugs for initial treatment of acute nonlymphocytic leukemia in adults.

The FDA has approved Sinuva (Intersect ENT), a sinus implant that gradually releases the corticosteroid mometasone furoate over a 90-day period, for treatment of nasal polyps in adults who have had ethmoid sinus surgery. Propel, a sinus implant that releases mometasone furoate over 30 days, is FDA-approved to maintain the sinus opening after ethmoid sinus surgery; it is marketed by the same manufacturer as Sinuva.

Patients who receive pretravel advice can reduce their risk for many travel-related conditions. Vaccines recommended for travelers are reviewed in a separate issue.