Belimumab (Benlysta – Human Genome Sciences/GlaxoSmithKline) has been approved by the FDA for treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE). It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in >50 years.

The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.

Tovorafenib (Ojemda – Day One), a type II RAF kinase inhibitor, has received accelerated approval from the FDA for treatment of patients ≥6 months old with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or a BRAF V600 mutation. Tovorafenib is the first systemic treatment to be approved in the US for pediatric low-grade gliomas with BRAF fusions. Accelerated approval of tovorafenib was based on response rates and duration of response.

The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

Accidental needlesticks can lead to infection with hepatitis viruses, human immunodeficiency virus, and other blood-borne bacterial, viral, and fungal pathogens (DK Henderson et al, Ann Intern Med, 113:740, 1990). Re-capping used needles is the most frequent cause of needlestick injuries (J Jagger et al, N Engl J Med, 319:284, 1988; MH Becker et al, Am J Infect Control, 18:232, 1990).

The FDA has approved the nucleoside analog telbivudine (Tyzeka - Novartis/Idenix) for treatment of patients ≥16 years old with active chronic hepatitis B virus (HBV) infection. It is the fourth oral drug marketed for this indication in the US.

Persons planning to travel outside the US should be up to date on routine vaccines and, depending on their destination, duration of travel, and planned activities, may also receive certain travel-specific vaccines. Tickborne encephalitis and dengue vaccines, which are not available in the US, are reviewed in a separate article available online. Detailed advice for travel to specific destinations is available from the Centers for Disease Control and Prevention (CDC) at www.cdc.gov/travel/destinations/list. Recommendations for administration of vaccines as part of routine...

Adalimumab (Humira - Abbott), a tumor necrosis factor alpha (TNF-α) inhibitor, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA). A genetically engineered human IgG1 monoclonal antibody, adalimumab is approved for subcutaneous (SC) injection in adults who have failed at least one disease-modifying anti-rheumatic drug (DMARD), for use either alone or with other DMARDs such as methotrexate (Rheumatrex, and others). Two other TNF-α antagonists, etanercept (Enbrel) and infliximab (Remicade), are already on the market for treatment of RA (Treatment...

Sertaconazole nitrate (Ertaczo - OrthoNeutrogena), an imidazole antifungal similar to clotrimazole and miconazole, has been approved by the FDA as a 2% cream for topical treatment of interdigital tinea pedis infection. It has been available in Europe for many years.

The FDA has approved an adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix – GSK) for prevention of herpes zoster (shingles) in adults ≥50 years old. Shingrix is the second herpes zoster vaccine to be approved in the US; Zostavax, a live-attenuated VZV vaccine approved for the same indication, has been available since 2006.