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New Drugs 2018, Part 3

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New Drugs 2018, Part 3 1.5 1.5 ANCC CONTACT HOURS PHARMACOLOGY CREDITS NNew e w DDrugs r u g s PART 3 BY DANIEL A. HUSSAR, PhD REMINGTON PROFESSOR OF PHARMACY PHILADELPHIA COLLEGE OF PHARMACY UNIVERSITY OF THE SCIENCES PHILADELPHIA, PA. Abstract: This article discusses eight THIS ARTICLE REVIEWS select drugs recently approved by drugs recently approved by the FDA, the FDA, including: including their indications and contrain- • three antibacterial drugs. dications, precautions, dosage, and • a new treatment for secondary hyperparathyroidism in nursing considerations. The article also adults with chronic kidney disease on hemodialysis. includes summary charts on 14 recently • 14 antineoplastic drugs. approved antineoplastic drugs and • four new approvals for certain rare disorders. four drugs approved for rare disorders. Unless otherwise specified, the information in the follow- Keywords: abaloparatide, abemaciclib, ing summaries applies to adults, not children. Consult a phar- acalabrutinib, avelumab, axicabtagene, macist or the package insert for information on drug safety benznidazole, brigatinib, cerliponase alfa, during pregnancy and breastfeeding. Consult a pharmacist, copanlisib dihydrochloride, deflazacort, the prescribing information, or a current and comprehensive delafloxacin meglumine, durvalumab, drug reference for more details on precautions, drug interac- emicizumab-kxwh, enasidenib mesylate, tions, and adverse reactions for all these drugs. etelcalcetide hydrochloride, latanoprostene SELECTED REFERENCES bunod, letermovir, meropenem trihydrate, Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons, Inc.; 2018. midostaurin, neratinib maleate, niraparib Nursing2018 Drug Handbook. Philadelphia, PA: Lippincott Williams & Wilkins; 2018. Physician’s Desk Reference. 71st ed. Montvale, NJ: Medical Economics; 2018. tosylate monohydrate, ribociclib succinate, secnidazole, telotristat ethyl, The author and planners have disclosed no potential conflicts of interest, financial or otherwise. tisagenlecleucel, vestronidase alfa-vjbk 32 l Nursing2018 l Volume 48, Number 10 www.Nursing2018.com Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. ANTIBACTERIAL DRUGS of treatment was defined as a 20% neuropathy; central nervous system or greater decrease in infected lesion effects such as dizziness, confusion, size. This response was achieved in and tremors; and exacerbation of my- Delafloxacin approximately 80% of the patients asthenia gravis. Because these disor- meglumine with both treatment regimens in ders are associated with serious and both studies. The success of treat- potentially irreversible complications, First fluoroquinolone effective ment at about 14 days exceeded treatment with a fluoroquinolone against MRSA infections 95% for both treatment regimens. should be immediately discontinued A fluoroquinolone antibacterial agent, Delafloxacin was well tolerated in in patients who experience these ad- delafloxacin meglumine (Baxdela, the clinical studies. Treatment was verse reactions. (4) In patients with Melinta) has properties similar to oth- discontinued because of adverse re- severe renal impairment (estimated er members of this class such as levo- actions in less than 1% of patients, glomerular filtration rate [eGFR] 15 to floxacin, moxifloxacin, and cipro- compared with discontinuation in 29 mL/min/1.73 m2) in whom dela- floxacin. Available in formulations for approximately 3% of patients treated floxacin is to be administered I.V., the oral and I.V. administration, it is indi- with vancomycin and aztreonam. dosage should be reduced because of cated to treat adults with acute bacte- Phototoxicity and QT interval pro- potential accumulation of the I.V. ve- rial skin and skin structure infections longation have been reported with hicle, sulfobutylether-beta-cyclodextrin. (ABSSSI) caused by susceptible iso- the use of other fluoroquinolones, Serum creatinine concentrations lates of the Gram- positive bacteria but were not experienced with dela- should be closely monitored in these Staphylococcus aureus (including floxacin in the clinical studies. patients. If serum creatinine concen- methicillin-resistant [MRSA] and Because fluoroquinolones have trations increase, consideration should methicillin-susceptible isolates), been reported to cause degenerative be given to changing to oral adminis- Staphylococcus haemolyticus, Staphylo- changes in articular cartilage and ar- tration of the drug. If eGFR decreases coccus lugdunensis, Streptococcus aga- thropathy in skeletally immature ani- to less than 15 mL/min/1.73 m2, lactiae, Streptococcus anginosus Group mals, the use of delafloxacin in chil- delafloxacin should be discontinued. (including Streptococcus anginosus, dren is not recommended. Use of any Delafloxacin is not recommended in Streptococcus intermedius, and Strepto- systemic fluoroquinolone in children patients with end-stage renal disease. coccus constellatus), Streptococcus pyo- is limited to treating serious infec- (5) Fluoroquinolones may form che- genes, and Enterococcus faecalis, and the tions such as inhalational anthrax or lates with multivalent metal cations Gram-negative bacteria Escherichia coli, plague for which very few antimicro- (such as those in antacids and vitamin/ Enterobacter cloacae, Klebsiella pneu- bial treatment options are available. mineral formulations) that may reduce moniae, and Pseudomonas aeruginosa.1 absorption of the drug following oral Delafloxacin is the first fluoroqui- Precautions: (1) Monitor patients for administration. Delafloxacin should be nolone demonstrated to be effective signs and symptoms of Clostridium administered at least 2 hours before against infections caused by MRSA. difficile-associated diarrhea, which has or 6 hours after products containing Its spectrum of antibacterial action, been reported with the use of almost metal cations. When administered I.V., which also includes problem patho- all systemic antibacterial agents. delafloxacin should not be coadminis- gens such as P. aeruginosa, is broader (2) Immediately discontinue the drug tered with any solution containing than that of other antimicrobial drugs if the patient experiences signs and multivalent cations (such as magne- indicated to treat ABSSSI. symptoms of a hypersensitivity reac- sium) through the same I.V. line. The effectiveness of delafloxacin tion, such as rash, which may occur was demonstrated in two noninferi- after the first dose or after subsequent Adverse reactions: nausea, vomit- ority studies in approximately 1,500 doses. (3) Avoid use of delafloxacin ing, diarrhea, headache, serum patients, in which it was compared and other fluoroquinolones in patients transaminase elevations with I.V. vancomycin and aztreo- with a history of tendon disorders, nam. Aztreonam was discontinued if peripheral neuropathy, or myasthenia Supplied as: oral tablets or a no Gram-negative bacteria were gravis. As with other fluoroquinolones, lyophilized powder for injection in identified in the baseline cultures. the labeling for delafloxacin includes quantities equivalent to 450 mg An objective clinical response at boxed warnings regarding the risks of delafloxacin (tablets) and 300 mg 48 to 72 hours following initiation tendonitis; tendon rupture; peripheral for injection www.Nursing2018.com October l Nursing2018 l 33 Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. Dosage: 300 mg every 12 hours ever, an increasing number of bac- tazobactam. Treatment was discon- over 60 minutes by I.V. infusion, or teria can produce beta-lactamases tinued because of adverse reactions 450 mg every 12 hours orally for (penicillinases, cephalosporinases, in 3% of patients treated with 5 to 14 days. The bioavailability of and carbapenemases) that break meropenem/vaborbactam and in 5% a single 450 mg oral dose is compa- the beta-lactam ring and inactivate of patients treated with piperacillin/ rable to that of a single 300 mg I.V. the antibacterial drug. To address tazobactam. dose. Treatment may be initiated I.V. this common mechanism of resis- and then switched to oral adminis- tance, pharmaceutical companies Precautions: (1) Contraindicated tration as appropriate. In patients have developed beta-lactamase in- in patients with known hypersensi- with severe renal impairment, the hibitors that preserve and extend tivity to any component of the I.V. dosage should be reduced to the activity of the beta-lactam anti- product or to other drugs in the 200 mg every 12 hours. bacterial drugs with which they are same class, and in patients who have combined. experienced anaphylactic reactions Nursing considerations: (1) The Carbapenem antibacterial drugs to any beta-lactam antibacterial contents of a vial for I.V. use must be marketed in the US include imipe- agent. Hypersensitivity reactions reconstituted with 10.5 mL of 5% nem (used in combination with were experienced by 2% of the pa- Dextrose Injection or 0.9% Sodium cilastatin), ertapenem, doripenem, tients who received meropenem/ Chloride Injection. Shake the vial and meropenem. Indications for vaborbactam in the clinical studies. vigorously until the contents are meropenem include complicated (2) Monitor patients for diarrhea dissolved, then dilute the reconsti- skin and skin structure infections, during and after treatment. Almost tuted solution with the same vehicle complicated intra-abdominal infec- all systemic antibacterial drugs, in- to a total volume of 250 mL to tions, and bacterial meningitis. cluding meropenem, have been achieve a concentration of
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