Epocrates Drug Updates - Editor's Pick

August 31, 2015
Technivie Approved for Hepatitis C

The FDA recently approved Technivie (ombitasvir/paritaprevir/ritonavir) for the treatment of chronic hepatitis C infection (genotype 4). Technivie is given orally once daily in combination w/ ribavirin for 12 weeks. Of note, ritonavir is used to boost the levels of paritaprevir, and does not have activity against hepatitis C virus. Due to the potential for significant transaminase elevation, patients must discontinue use of ethinyl estradiol-containing products prior to initiating Technivie. Patients may restart these products 2 weeks after Technivie is discontinued. It is also contraindicated to use Technivie in the setting of severe hepatic impairment (Child-Pugh Class C).

Noteworthy Recent Updates

August 31, 2015
Praluent Approved for Primary Hyperlipidemia
The FDA recently approved Praluent (alirocumab), a monoclonal antibody, indicated as adjunct therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. Praluent is the first available proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. PCSK9 inhibitors prevent PCSK9 binding to LDL receptors, decreasing LDL receptor degradation and increasing LDL clearance. Praluent is administered as a subcutaneous injection every 2 weeks.

August 31, 2015
Entresto Approved for Chronic Heart Failure
The FDA recently approved Entresto (sacubitril/valsartan), a new drug therapy for treating NYHA Class II-IV heart failure patients. Entresto is the first combination product containing an ARB and sacubitril, a neprilysin inhibitor. Neprilysin inhibition decreases natriuretic peptide degradation, which results in vasodilation, natriuresis, and diuresis. Entresto is contraindicated with concomitant ACE inhibitor use as clinical trials demonstrated combined ACE and neprilysin inhibition was associated with increased angioedema risk. A 36-hour washout period is needed after ACE inhibitor discontinuation and Entresto initiation.

Clinical Impact: Sacubitril represents a new pharmacological class, neprilysin inhibitors, which are a novel treatment option for chronic heart failure patients. Additional clinical experience is needed to determine the long-term safety of the drug.

July 24, 2015
FDA MedWatch Safety Alert for Proglycem
The FDA is warning that infants and newborns treated with Proglycem (diazoxide) for hypoglycemia may develop pulmonary HTN. The agency has identified 11 cases of pulmonary HTN in infants and newborns treated with diazoxide since its approval in 1973. Clinicians should closely monitor babies receiving Proglycem, especially those with risk factors for pulmonary HTN. If pulmonary HTN is identified, Proglycem should be discontinued.

July 24, 2015
Kybella Approved for Submental Fat
Kybella (deoxycholic acid) is the first injectable treatment available to improve the appearance of fullness associated with submental fat. The drug is indicated for the reduction of moderate to severe submental fat convexity and is administered as up to 50 SC injections per treatment. The safe and effective use of Kybella for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

July 24, 2015
FDA MedWatch Safety Alert for NSAIDs
The FDA is strengthening an existing warning that non-aspirin NSAIDs increase MI and stroke risk. MI and stroke risk may occur within the first weeks of NSAID treatment, and risk may increase with higher doses or longer treatment duration. Advise patients to use the lowest effective amount for the shortest effective treatment duration, and to seek immediate medical attention if cardiac signs or symptoms occur.
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August 31, 2015
The Anaspaz monograph has been updated to clarify the age ranges for pediatric dosing. For the treatment of GI tract spasm and bladder spasms in patients 2-11 yo, Anaspaz should be given at a dose of 0.0625-0.125 mg PO/SL q4h prn. Please update your Epocrates app regularly to ensure that you always have the latest content.