Epocrates Drug Updates - Editor's Pick
January 19, 2016
Genvoya Approved for HIV-1 Infection
Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is a new fixed-dose, once-daily complete regimen for HIV-1 infection treatment in pts 12 yrs and older. Its boxed warning states that it can cause lactic acidosis and severe hepatomegaly. Genvoya contains tenofovir alafenamide, a new prodrug that appears to be associated w/ less kidney toxicity and loss in bone density than the previously approved tenofovir disoproxil, and has a different drug interaction profile.
October 30, 2015
Praxbind Approved for Pradaxa Reversal
The FDA recently granted accelerated approval for Praxbind (idarucizumab) as a reversal agent for the oral anticoagulant Pradaxa (dabigatran etexilate). Praxbind represents the first drug-specific reversal agent for a novel oral anticoagulant. Based on the interim analysis of the RE-VERSE AD trial, over 88% of patients attained immediate and complete reversal of Pradaxa with Praxbind administration.
October 23, 2015
Addyi Available for Female Hypoactive Sexual Desire Disorder
The FDA recently approved Addyi (flibanserin), the first available drug therapy for treating acquired, generalized hypoactive sexual desire disorder in premenopausal women. Addyi is given by mouth at bedtime and should be discontinued if no improvement is seen after 8 weeks. It contains a boxed warning regarding severe hypotension and syncope, and is contraindicated with strong and moderate CYP3A4 inhibitors, with alcohol, and in patients with hepatic impairment. Addyi is available only through a restricted distribution program called the Addyi REMS Program.
October 16, 2015
Keveyis, New Treatment for Periodic Paralysis, Now Available
Keveyis (dichlorphenamide) is the first FDA-approved drug for the treatment of primary hyperkalemic and hypokalemic periodic paralysis and related variants. Contraindications include hepatic impairment and severe pulmonary disease; the drug is also contraindicated in patients taking high-dose aspirin. Keveyis is taken orally twice daily and is titrated weekly until the desired effect or maximum dose is reached. Adverse effects include hypokalemia, metabolic acidosis, paresthesia, and cognitive impairment.
Opdivo and Keytruda Approved for New or Expanded Indications
The FDA recently approved broader use of Opdivo (nivolumab) and Keytruda (pembrolizumab), both of which are monoclonal antibodies that harness the immune system to fight cancer by binding to the PD-1 receptor on T-cells. Opdivo was previously approved for melanoma as a single agent only, but now it can be combined with ipilimumab, another monoclonal antibody, to treat unresectable or metastatic melanoma in patients without BRAF mutations. Likewise, the indications for Opdivo in treating NSCLC have been expanded to include the nonsquamous subtype. Keytruda was also cleared for use in patients with NSCLC, though more specifically for patients with documented tumor expression of PD-1 receptor ligands. The toxicity profiles of both agents were largely consistent with previous experience, with potentially life-threatening immune-mediated events involving any organ system being most concerning.
New Drug Monographs
- Addyi (flibanserin)
- Alka-Seltzer Plus Severe Sinus & Cold (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)
- Durlaza (aspirin)
- dutasteride (generic for Avodart)
- Larin 24 Fe (norethindrone/ethinyl estradiol)
- Odomzo (sonidegib)
- Onivyde (irinotecan liposomal)
- pimozide (generic for Orap)
- Praxbind (idarucizumab)
- Setlakin (levonorgestrel/ethinyl estradiol)
- Strensiq (asfotase alfa)
- Synjardy (empagliflozin/metformin)
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