The medical letter on drugs and therapeutics august 18 2014

Two New Drugs for Skin and Skin Structure Infections The FDA has approved two new drugs for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Dalbavancin... Sucroferric Oxyhydroxide (Velphoro) for Hyperphosphatemia Most patients with end-stage renal disease develop hyperphosphatemia, which can lead to secondary hyperparathyroidism, vascular calcification, and cardiovascular mortality. The FDA has approved... Glycerol Phenylbutyrate (Ravicti) for Urea Cycle Disorders The FDA has approved an oral liquid formulation of glycerol phenylbutyrate (Ravicti – Hyperion) for chronic management of patients ≥2 years old with urea cycle disorders that cannot... A Transcutaneous Electrical Nerve Stimulation Device (Cefaly) for Migraine Prevention The FDA has approved the use of a transcutaneous electrical nerve stimulation device (Cefaly – Cefaly Technology) for prevention of episodic migraine in patients ≥18 years old. The...

The Medical Letter ® on Drugs and Therapeutics Objective Drug Reviews Since 1959 Volume 56 ISSUE ISSUE No 1433 1449 Volume 56 August 18, 2014 IN THIS ISSUE Two New Drugs for Skin and Skin Structure Infections p 73 Sucroferric Oxyhydroxide (Velphoro) for Hyperphosphatemia p 76 Glycerol Phenylbutyrate (Ravicti) for Urea Cycle Disorders p 77 A Transcutaneous Electrical Nerve Stimulation Device (Cefaly) for Migraine Prevention p 78 Important Copyright Message FORWARDING OR COPYING IS A VIOLATION OF U.S AND INTERNATIONAL COPYRIGHT LAWS The Medical Letter, Inc publications are protected by U.S and international copyright laws Forwarding, copying or any distribution of this material is prohibited Sharing a password with a non-subscriber or otherwise making the contents of this site available to third parties is strictly prohibited By accessing and reading the attached content I agree to comply with U.S and international copyright laws and these terms and conditions of The Medical Letter, Inc For further information click: Subscriptions, Site Licenses, Reprints or call customer service at: 800-211-2769 Published by The Medical Letter, Inc • A Nonprofit Organization The Medical Letter publications are protected by US and international copyright laws Forwarding, copying or any other distribution of this material is strictly prohibited For further information call: 800-211-2769 The Medical Letter ® on Drugs and Therapeutics Objective Drug Reviews Since 1959 Volume 56 August 18, 2014 Take CME exams ISSUE ISSUE No 1433 1449 Volume 56 ▶ ALSO IN THIS ISSUE Sucroferric Oxyhydroxide (Velphoro) for Hyperphosphatemia p 76 Glycerol Phenylbutyrate (Ravicti) for Urea Cycle Disorders p 77 A Transcutaneous Electrical Nerve Stimulation Device (Cefaly) for Migraine Prevention p 78 Two New Drugs for Skin and Skin Structure Infections The FDA has approved two new drugs for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria Dalbavancin (Dalvance – Durata) is a longacting intravenous (IV) lipoglycopeptide antibiotic similar to telavancin (Vibativ).1 Tedizolid phosphate (Sivextro – Cubist) is an IV and oral oxazolidinone antibacterial drug similar to linezolid (Zyvox).2 A third IV antibiotic, oritavancin (Orbactiv), recently approved by the FDA for the same indication, will be reviewed in a future issue STANDARD TREATMENT — Patients hospitalized for non-purulent skin and soft-tissue infections, which are often caused by streptococci, can usually be treated empirically with IV penicillin, cefazolin, ceftriaxone, or clindamycin.3 Purulent skin infections are now caused predominantly by methicillin-resistant Staphylococcus aureus (MRSA) in many parts of the US Patients hospitalized for complicated MRSA skin and soft-tissue infections are usually treated with IV vancomycin Alternatives include linezolid, daptomycin, clindamycin, telavancin, and ceftaroline fosamil For less serious MRSA infections, incision and drainage alone or with oral trimethoprim/sulfamethoxazole (TMP/SMX) or doxycycline is usually effective.4 Table Some IV Drugs for MRSA Skin and Skin Structure Infections Some Available Formulations Usual Adult Dosage1 FDA-Approved Duration Ceftaroline fosamil3 – Teflaro (Forest) 400, 600 mg vials 600 mg q12h 5-14 days Dalbavancin3 – Dalvance (Durata) 500 mg vials 1000 mg x 1, then 500 mg wk later 14 days (2 doses week apart) Daptomycin – Cubicin (Cubist) 500 mg vials mg/kg q24h 7-14 days Linezolid – Zyvox (Pfizer) 200, 400, 600 mg infusion bags5 600 mg q12h6 10-14 days Tedizolid3 – Sivextro (Cubist) 200 mg single-use vials7 200 mg once/d days Telavancin3 – Vibativ (Theravance) 250, 750 mg vials 10 mg/kg q24h 7-14 days Vancomycin – generic 500, 750 mg, 1, 5, 10 g vials 15 mg/kg (max g) q12h8 Drug Cost2 $126.30 1490.004 354.704 278.90 235.00 309.50 – 12.30 Dosage adjustment may be needed for renal or hepatic impairment Approximate wholesale acquisition cost (WAC) for day’s treatment of a 70-kg patient with the lowest usual dosage Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) August 5, 2014 Reprinted with permission by FDB, Inc All rights reserved ©2014 www.fdbhealth.com/policies/drug-pricingpolicy Actual retail prices may be higher Not FDA-approved for use in children Cost for one 500-mg vial Also available for oral administration in 600-mg tabs and a 100 mg/5 mL oral suspension Dosage for children