Epocrates Drug Updates - Editor's Pick

August 28, 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 28, 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.

Noteworthy Recent Updates

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.
Epocrates Online

July 13, 2015
FDA MedWatch Safety Alert for Codeine in Pediatric Patients
The FDA is investigating the safety of codeine-containing cough-and-cold products in pediatric patients due to risk of serious adverse effects, including respiratory depression. In April 2015, the European Medicines Agency (EMA) warned that codeine use for cough and cold is now contraindicated in patients.
codeine/guaifenesin Glatopa

July 6, 2015
Glatopa Available for Multiple Sclerosis
Glatopa (glatiramer) is the first branded generic available for Copaxone for the treatment of relapsing forms of multiple sclerosis. The drug is available in a 1-mL, 20-mg/mL injection for once-daily subcutaneous use. The 20-mg/mL dosage form is not additive or interchangeable with the Copaxone 40-mg/mL dosage form. Glatopa should not be used in patients with a hypersensitivity to glatiramer or mannitol.

New Drug Monographs

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June 18, 2015
The Hemangeol monograph has been updated to correct the duration of the Start dosing for infantile hemangioma in patients 5 weeks to 5 months old. Hemangeol should be started at a dose of 0.15 mL/kg PO bid x1wk, then 0.3 mL/kg PO bid x1wk. Please update your Epocrates app regularly to ensure that you always have the latest content.