Efbemalenograstim alfa-vuxw (Ryzneuta – Evive), a nonpegylated granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG2, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia. It is the first nonpegylated, long-acting G-CSF to become available in the US. Two pegylated, long-acting G-CSFs, pegfilgrastim (Neulasta, and biosimilars) and eflapegrastim (Rolvedon), are...

The FDA has approved Odefsey (Gilead), a once-daily, fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection in patients with HIV-1 RNA (viral load) ≤100,000 copies/mL or to replace a stable antiretroviral regimen in patients who have been virologically suppressed (viral load <50 copies/mL) for at least six months with no history of treatment failure.

The FDA has approved daclizumab (Zinbryta – Biogen/Abbvie), an interleukin-2 (IL-2) receptor blocking monoclonal antibody, for treatment of adults with relapsing forms of multiple sclerosis (MS). It is the first subcutaneously injected monoclonal antibody to be approved for treatment of MS.

A reader suggested that our July 23 article on Drugs for Urinary Tract Infection (Med Lett Drugs Ther 2012; 54:57)1 should have included information on the cost of the drugs we recommended for treatment of acute uncomplicated cystitis.Trimethoprim/sulfamethoxazole DS — Generic formulations are available at large discount pharmacies for $4 for 20 tablets. Trimethoprim/sulfamethoxazole DS is generally found on tier 1 (lowest co-pay) of insurance company formularies.Nitrofurantoin monohydrate/macrocrystals — The wholesale acquisition cost of the generic formulation is about $2.50 per tablet...

Famciclovir (Famvir - SmithKline Beecham) is now available in the USA for oral treatment of acute uncomplicated herpes zoster (shingles). The manufacturer claims that use of the drug reduces the duration of postherpetic neuralgia. Famciclovir is similar to acyclovir (Zovirax - Burroughs Wellcome), which has been the drug of choice for treatment of varicella-zoster and herpes simplex virus infections (Medical Letter, 36:27, 1994).

Valacyclovir (Valtrex - GlaxoSmithKline) was recently approved by the FDA for one-day oral treatment of patients at least 12 years old with orolabial herpes simplex infections. The drug was previously approved for treatment and suppression of genital herpes and for treatment of herpes zoster (shingles).

The recent Medical Letter article on vancomycin dosing and monitoring briefly mentioned use of an alternative antibiotic for treatment of methicillin-resistant Staphylococcus aureus (MRSA) with reduced susceptibility to vancomycin. Some readers have asked for more information on this subject.

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The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile rheumatoid arthritis or Still’s disease) in children ≥2 years old. Canakinumab was approved earlier for treatment of cryopyrin-associated periodic syndromes (CAPS). Tocilizumab (Actemra), an interleukin-6 (IL-6) inhibitor that has been available since 2010 for treatment of rheumatoid arthritis in adults, was also recently approved by the FDA for sJIA. Canakinumab is the only IL-1 inhibitor approved...

The FDA has approved anifrolumab-fnia (Saphnelo – AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available in the US.

The US Food and Drug Administration recently approved the marketing of G-CSF (recombinant human granulocyte colony-stimulating factor, generic name filgrastim, Neupogen - Amgen) and GM-CSF (recombinant human granulocyte-macrophage colony-stimulating factor, generic name sargramostim, Leukine - Immunex, Prokine - Hoechst-Roussel). G-CSF is approved for use after cancer chemotherapy in patients with non-myeloid malignancies to decrease the incidence of infection. GM-CSF is approved for acceleration of myeloid recovery after autologous bone marrow transplantation in non-Hodgkin's lymphoma,...