Recombinant human granulocyte colony stimulating factor (G-CSF, filgrastim) conjugated to polyethylene glycol (pegfilgrastim, Neulasta - Amgen) has been approved by the FDA for use in neutropenic patients with non-myeloid malignancies who are at high risk for infection. Filgrastim (Neupogen - Amgen) has been available in the US since 1991.

A reader expressed disappointment that our recent listing of “Some Warfarin Drug Interactions”1 did not include acetaminophen. Perhaps it should have. Acetaminophen can increase the anticoagulant effect of warfarin, particularly with continued use, but it does so inconsistently. The mechanism of this interaction has not been established, but may be related to an acetaminophen metabolite inhibiting vitamin K-epoxide reductase, the target for warfarin’s anticoagulant effect.2Patient susceptibility varies, possibly on a genetic basis; occasional use of acetaminophen generally has little or...

Gabapentin enacarbil (Horizant – GlaxoSmithKline), a new extended-release (ER) tablet formulation of gabapentin, has been approved by the FDA for treatment of moderate-to-severe restless legs syndrome (RLS). The immediate-release (IR) formulation of gabapentin (Neurontin,and others), which is approved for treatment of epilepsy and postherpetic neuralgia, has been used for many years to treat RLS. Another ER tablet formulation of gabapentin (Gralise) has been approved by the FDA for treatment of postherpetic neuralgia.

The FDA has approved vismodegib (vis moe deg´ ib; Erivedge – Genentech), the first hedgehog (Hh) pathway inhibitor, for oral treatment of metastatic basal cell cancer, locally advanced basal cell carcinoma that has recurred after surgery, or locally advanced basal cell carcinoma in adults who are not candidates for surgery or radiation.

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.

The FDA has approved a once-daily, extended-release chewable tablet formulation of methylphenidate (QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first long-acting chewable formulation of the drug to be marketed in the US. Immediate-release chewable methylphenidate tablets (Methylin, and generics) have been available since 2003.

Eteplirsen (Exondys 51 – Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the dystrophin gene that is amenable to exon 51 skipping. It is the first drug to be approved for treatment of DMD.

The FDA has approved lisocabtagene maraleucel (Breyanzi – BMS) for treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B who have disease refractory to first-line chemoimmunotherapy, relapsed within 12 months of or after first-line chemoimmunotherapy, are not eligible for hematopoietic stem cell transplantation due to comorbidities or age, or have relapsed or refractory disease after ≥2 lines of...

The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for this indication. A 10.3% gel formulation of berdazimer (Zelsuvmi), a nitric oxide-releasing agent, has also been approved by the FDA for treatment of molluscum contagiosum (in patients ≥1 year old); it will be reviewed in a future issue.

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.