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

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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 delafloxacin. 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 1.2 mg/ Meropenem trihydrate/ reported to cause Clostridium difficile- mL. (2) Tell patients prescribed vaborbactam (Vabomere, The associated diarrhea; this possibility the oral formulation that they may Medicines Company) combines should be considered in all patients take tablets without regard to food. meropenem with the new beta- who experience diarrhea follow- (3) Instruct patients not to drive lactamase inhibitor vaborbactam. ing use of an antibacterial drug. or engage in other activities that Although vaborbactam has no anti- (3) Meropenem has been infrequently require mental alertness and coordi- bacterial activity, it protects meropenem associated with seizures and other nation until they know how the from degradation by certain adverse central nervous system drug affects them. (4) Teach patients beta-lactamases such as Klebsiella (CNS) reactions such as delirium or to recognize signs and symptoms of pneumoniae carbapenemase. Admin- headache that could interfere with tendonitis or tendon rupture, such istered I.V., the new product is mental alertness and/or cause mo- as pain, edema, or inflammation of indicated for patients age 18 and tor impairment. The risk of serious a tendon or weakness or inability to older with complicated urinary CNS adverse reactions is greater in use one of their joints. Tell them to tract infections including pyelone- patients with underlying CNS dis- discontinue the drug and contact the phritis caused by Escherichia coli, orders, such as a seizure disorder. healthcare provider immediately if Klebsiella pneumoniae, and Entero- (4) In patients whose seizures are these occur. bacter cloacae species complex.1 well controlled with the antiepilep- The effectiveness of meropenem/ tic drugs (AEDs) valproic acid or REFERENCE vaborbactam was demonstrated divalproex sodium, concurrent use 1. Baxdela (delafloxacin) tablets, for oral use; in a multicenter trial in which it of meropenem/vaborbactam is gen- Baxdela (delafloxacin) for injection, for intravenous use. Prescribing information. www.baxdela.com. was compared with piperacillin/ erally not recommended. Merope- tazobactam. At the end of I.V. treat- nem and other carbapenems may ment with meropenem/vaborbactam, reduce the concentration of these Meropenem 98% of patients had cure or im- AEDs, increasing the risk of break- provement of symptoms and a through seizures. (5) Concurrent trihydrate/ negative urine culture, compared use of probenecid is not recom- vaborbactam with 94% of patients treated with mended because probenecid piperacillin/tazobactam. Approxi- competes with meropenem for Teaming up to defeat drug resistance mately 7 days after completing active renal tubular secretion, in- Beta-lactam antibacterial drugs treatment, 77% of patients treated creasing plasma concentrations of such as the penicillins, cephalo- with meropenem/vaborbactam had meropenem. (6) The dosage of sporins, and carbapenems are resolved symptoms and a negative meropenem/vaborbactam should highly effective treatments for urine culture, compared with 73% be reduced in patients with im- many bacterial infections. How- of patients treated with piperacillin/ paired renal function. For patients

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Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. with changing renal function, fever), and inform them that this with the medication than in those serum creatinine concentrations adverse reaction can develop days receiving placebo. and the eGFR should be monitored or even months after treatment. Other nitroimidazole antimicro- at least daily and the drug dosage Tell them to report such signs bial agents have been reported to be adjusted as indicated. and symptoms to the healthcare carcinogenic in animal studies, but provider immediately. whether a single dose of secnidazole Adverse reactions: headache, phlebitis/ is associated with a cancer risk in infusion site reactions, diarrhea REFERENCE humans is unknown. 1. Vabomere (meropenem and vaborbactam) Metronidazole and tinidazole are for injection, for intravenous use. Prescribing Supplied as: a sterile powder for Information. www.vabomere.com/media/pdf/ contraindicated during the first tri- constitution in single-dose vials con- vabomere-us-prescribing-information.pdf. mester of pregnancy, but no adverse taining meropenem trihydrate in an developmental outcomes were found amount equivalent to 1 g of merope- with secnidazole in animal reproduc- nem and 1 g of vaborbactam Secnidazole tion studies and the labeling for the new drug does not include a restric- Dosage: In adult patients with Offering relief from bacterial tion for use in pregnancy. However, an eGFR of 50 mL/min/1.73 m2 or vaginosis because nitroimidazole derivatives more: 4 g (meropenem 2 g and Bacterial vaginosis (BV) is the most are present in human milk, breast- vaborbactam 2 g) every 8 hours by common cause of vaginal discharge feeding is not recommended during I.V. infusion over 3 hours for up to in women of childbearing age. Symp- treatment with secnidazole or for 96 14 days. Consult the Prescribing In- tomatic women typically present hours following administration. formation for recommended dosage with vaginal discharge and/or vaginal Disulfiram-like reactions follow- reductions for patients with an eGFR odor. The discharge is off-white, thin, ing the consumption of alcoholic less than 50 mL/min/1.73 m2. and homogeneous; the odor is an beverages have been reported with unpleasant “fishy smell” that may use of metronidazole and tinidazole; Nursing considerations: (1) Before be more noticeable after sexual in- these may include flushing, tachy- drug administration, assess patients tercourse and during menses. BV cardia, palpitations, nausea, vomit- for any previous hypersensitivity is thought to result from a shift in ing, and acidosis.4 But because in reactions to meropenem and vabor- vaginal flora away from Lactobacillus vitro studies showed that secnida- bactam, penicillins, cephalosporins, species toward more diverse bacterial zole has no effect on aldehyde dehy- other beta-lactams, or other aller- species, including facultative anaer- drogenase activity, its labeling does gens. Discontinue the infusion if obes. The altered microbiome causes not include a precaution regarding signs and symptoms of a hypersen- a rise in vaginal pH and symptoms.1 the use of alcoholic beverages. sitivity reaction develop during Risk factors for BV include sexual treatment. Teach patients to recog- activity and douching. The treat- Precaution: Contraindicated in nize and immediately report signs ment options for nonpregnant patients with a history of hypersensi- and symptoms of a hypersensitivity women with BV include oral or in- tivity to any nitroimidazole derivative. reaction they experience during or travaginal metronidazole and oral after the infusion. (2) Reconstitute or intravaginal clindamycin.1,2 Adverse reactions: vulvovaginal the sterile powder with 0.9% Sodium Secnidazole (Solosec, Symbiomix) candidiasis, headache, nausea, dys- Chloride Injection and dilute with is a nitroimidazole antimicrobial geusia, vomiting, diarrhea, abdomi- the same vehicle as directed in the with properties similar to those of nal pain, vulvovaginal pruritus Prescribing Information. Complete metronidazole and tinidazole. It is the I.V. infusion of the diluted solu- active in vitro against most isolates of Supplied as: oral granules in a unit- tion within 4 hours if stored at the following organisms with BV: of-use foil packet, with each packet room temperature or 22 hours if Gardnerella vaginalis, Mobiluncus containing 2 g of the drug stored in a refrigerator. (3) Warn spp., Bacteroides spp., Prevotella spp., patients being treated as outpatients and Megasphaera-like type I/II.3 Dosage: a single dose of 2 g sprinkled not to drive, operate machinery, or Administered orally, secnidazole is on applesauce, yogurt, or pudding engage in any other activity requir- indicated to treat BV in adult wom- ing alertness until they determine en. Its effectiveness as a single-dose Nursing considerations: (1) Tell how the drug affects them. (4) Warn treatment was demonstrated in two patients to sprinkle the contents of patients about the risk of C. difficile- placebo-controlled clinical trials in the foil packet onto applesauce, yo- associated diarrhea, characterized which the percentage of patients gurt, or pudding, and to consume by watery and bloody stools (with experiencing a clinical response was the mixture within 30 minutes with- or without abdominal cramps and significantly greater in those treated out chewing or crushing the granules. www.Nursing2018.com October l Nursing2018 l 35

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. Patients may drink a glass of water years of infection, patients may ex- ness have also been reported. after administration of the drug to perience serious heart disease, such (4) Monitor complete blood cell aid in swallowing, but warn them as cardiomyopathy, and gastrointes- counts for signs of bone marrow not to mix the medication with any tinal complications.2 depression, such as neutropenia, liquid because the granules will not Indicated for pediatric patients ages thrombocytopenia, anemia, and dissolve. The dose may be taken 2 to 12 years, benznidazole is a nitro- leukopenia. Total and differential without regard to meals. (2) Teach imidazole antimicrobial with proper- leukocyte counts are recommended patients to recognize and report signs ties similar to those of metronidazole before, during, and after therapy. and symptoms of vulvovaginal can- and tinidazole. It is the first medication (5) Benznidazole is contraindicated didiasis, the most common adverse to be approved in the US for treatment in patients who have taken disulfi- reaction to secnidazole. These may of Chagas disease. It was approved ram within the previous 2 weeks include vulvar pruritus, burning, and under the provisions of the accelerated because of the potential for psychot- irritation, with or without discharge, approval program based on patients ic reactions. Alcohol consumption is possibly leading to dysuria and dys- who became immunoglobulin G also contraindicated. These bever- parenunia.1 Symptomatic vulvovagi- antibody-negative against the recom- ages and any products containing nal candidiasis may require treatment binant antigens of T. cruzi. Studies propylene glycol should be avoided with antifungal medication. to determine the clinical benefit of during treatment and for at least 3 treatment are continuing.1,3 days following treatment to prevent REFERENCES The effectiveness of benznidazole disulfiram-like reactions such as 1. Sobel JD. Bacterial vaginosis: clinical was evaluated in two placebo- flushing, abdominal cramping, manifestations and diagnosis. 2017. UpToDate. www.uptodate.com. controlled clinical trials in children headache, nausea, and vomiting. 2. Sobel JD. Bacterial vaginosis: treatment. ages 6 to 12 years. The percentage UpToDate. 2018. www.uptodate.com. of patients who seroconverted from Adverse reactions: abdominal pain, 3. Solosec (secnidazole) oral granules. Prescribing positive to negative was significantly rash, weight loss, headache, nausea, Information. www.solosechcp.com. greater in the patients treated with vomiting, neutropenia, urticaria, 4. Johnson M. Metronidazole: an overview. UpToDate. 2018. www.uptodate.com. benznidazole compared with patients pruritus, eosinophilia, anorexia who received placebo. An additional study of the safety and pharmacoki- Supplied as: 12.5 mg and 100 mg ANTIPARASITIC DRUG netics of the drug in patients ages oral tablets 2 to 12 years was the basis for dosage Benznidazole recommendations for children as Dosage: 5 mg/kg to 8 mg/kg/day young as age 2 years. The effectiveness administered in two divided doses First FDA-approved treatment for and safety of benznidazole have not separated by approximately 12 Chagas disease been established in patients below hours for 60 days Also known as American trypanoso- age 2 years and above age 12 years. miasis, Chagas disease is a parasitic Nursing considerations: (1) The infection caused by the protozoal or- Precautions: (1) Contraindicated in drug may be administered without ganism Trypanosoma cruzi. Although patients with a history of hypersen- regard to food. (2) Tablets containing Chagas disease primarily affects sitivity to any of the nitroimidazoles. 100 mg of the drug are functionally people in South and Central America, (2) If the patient experiences serious scored twice and can be adminis- an estimated 300,000 people in the cutaneous reactions such as erythe- tered whole or broken at the scored US may have the infection.1 ma multiforme, treatment should be lines to provide smaller doses (25 mg, An infected triatomine insect vec- immediately discontinued. If less 50 mg, and 75 mg). Consult the tor (or “kissing” bug) takes a blood serious skin reactions occur and Prescribing Information for details meal and releases trypomastigotes additional signs or symptoms of about preparing a slurry of the tablets in its feces near the site of the bite systemic involvement such as fever in water as an alternative for children wound. Trypomastigotes enter the or purpura are experienced, discon- who cannot swallow tablets. host through the bite wound or tinuing treatment is recommended. through intact mucosal membranes, (3) If the patient experiences neuro- REFERENCES such as the conjunctiva. Transmis- logic signs and symptoms, immedi- 1. US Food & Drug Administration. FDA approves sion can also occur congenitally ate discontinuation of treatment is first US treatment for Chagas disease. News release. August 29, 2017. from mother to infant, via transfu- recommended. Benznidazole may 2. Bern C. Chagas disease: acute and congenital sion of blood components, via cause paresthesia or symptoms of Trypanosoma cruzi infection. UpToDate. 2017. transplantation of an organ from an peripheral neuropathy that may take www,uptodate.com. 3. Benznidazole tablets, for oral use. Prescribing infected donor, and via consumption several months to resolve; central Information. www.accessdata.fda.gov/drugsatfda_ of contaminated food or drink. After nervous system effects such as dizzi- docs/label/2017/209570lbl.pdf.

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Drug (trade name, manufacturer, description) Route Indications

Abemaciclib (Verzenio, Lilly) Oral • In combination with fulvestrant for women with An inhibitor of cyclin-dependent kinases 4 and 6, hormone receptor (HR)-positive, human epidermal enzymes that promote cell proliferation in estrogen growth factor receptor 2 (HER2)-negative ad- receptor-positive breast cancer cell lines vanced or metastatic breast cancer with disease progression following endocrine therapy • As monotherapy for adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

Acalabrutinib (Calquence, AstraZeneca) Oral Adults with mantle cell lymphoma who have re- An inhibitor of Bruton tyrosine kinase, an enzyme ceived at least one prior therapy involved in activation of pathways necessary for B-cell proliferation

Avelumab (Bavencio, EMD Serono) I.V. infusion • Patients age 12 years and older with Merkel cell A programmed death ligand-1 (PD-L1) blocking carcinoma, a rare, aggressive form of skin cancer antibody that blocks the interaction between PD-L1 • Patients with locally advanced or metastatic uro- and its receptors, resulting in the restoration of thelial carcinoma (UC) who: immune responses, including antitumor immune – have disease progression during or following responses platinum-containing chemotherapy – have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Axicabtagene ciloleucel (Yescarta, Kite; Gilead) I.V. infusion Adults with relapsed or refractory large B-cell lym- A chimeric antigen receptor (CAR) T-cell therapy. phoma after two or more lines of systemic therapy, This CD19-directed genetically modified autologous including diffuse large B-cell lymphoma (DLBCL) T-cell immunotherapy binds to CD19-expressing not otherwise specified, primary mediastinal large cancer cells and normal B cells. A patient’s own T B-cell lymphoma, high grade B-cell lymphoma, and cells are harvested and genetically modified to ex- DLBCL arising from follicular lymphoma press a CAR. The anti-CD19 CAR T cells are infused back into the patient, where they can recognize and eliminate CD19-expressing cancer cells.

Brigatinib (Alunbrig, Ariad) Oral Patients with ALK-positive metastatic non–small cell A tyrosine kinase inhibitor with activity against multiple lung cancer who have progressed on or are intoler- kinases including anaplastic lymphoma kinase (ALK) ant to crizotinib

Copanlisib dihydrochloride (Aliqopa, Bayer) I.V. infusion Adults with relapsed follicular lymphoma (a slow- Inhibitor of phosphatidylinositol-3-kinase isoforms growing type of non-Hodgkin lymphoma) who have expressed in malignant B cells received at least two prior systemic therapies

Durvalumab (Imfinzi, AstraZeneca) I.V. infusion Patients with locally advanced or metastatic UC A programmed death-ligand 1 (PD-L1) blocking who have disease progression during or following antibody that blocks the interaction between PD-L1 platinum-containing chemotherapy, or who have and its receptors, restoring immune responses disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

(continued) www.Nursing2018.com October l Nursing2018 l 37

Drug (trade name, manufacturer, description) Route Indications Enasidenib mesylate (Idhifa, Celgene) Oral Adults with relapsed or refractory acute myeloid An isocitrate dehydrogenase-2 (IDH2) inhibitor leukemia with an IDH2 mutation as detected by an FDA-approved test Midostaurin (Rydapt, Novartis) Oral Indicated in combination with standard cytarabine A tyrosine kinase inhibitor with activity against and daunorubicin induction and cytarabine consolida- multiple kinases including FLT3 tion chemotherapy for treatment of adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation positive, as detected by an FDA-approved test. Also indicated for adults with aggressive systemic mastocytosis, systemic mastocytosis with associated hematologic neoplasm, or mast cell leukemia. Neratinib maleate (Nerlynx, Puma) Oral Indicated for the extended adjuvant treatment of A kinase inhibitor that irreversibly binds to epider- adults with early-stage HER2-overexpressed/amplified mal growth factor receptor, HER2, and HER4 breast cancer, to follow trastuzumab-based therapy Niraparib tosylate monohydrate (Zejula, Tesaro) Oral Maintenance treatment of adults with recurrent epi- A poly (ADP-ribose) polymerase inhibitor; this action thelial ovarian, fallopian tube, or primary peritoneal may result in a reduction in the repair of DNA inside cancer who are in a complete or partial response to cancer cells resulting in cell death and possibly a platinum-based chemotherapy delay or inhibition of tumor growth Ribociclib succinate (Kisqali, Novartis) Oral Indicated in combination with an aromatase inhibi- An inhibitor of cyclin-dependent kinases 4 and 6, tor as initial endocrine-based therapy for treatment enzymes that promote cell proliferation in breast of postmenopausal women with HR-positive, HER2- cancer cell lines negative advanced or metastatic breast cancer Telotristat ethyl (Xermelo, Lexicon) Oral Indicated in combination with a somatostatin ana- Metabolized to telotristat, which inhibits tryptophan logue (SSA), such as octreotide or lanreotide, to treat hydroxylase, the enzyme that mediates the rate- carcinoid syndrome diarrhea in adults whose symp- limiting step in serotonin biosynthesis. Serotonin is toms are inadequately controlled by SSA therapy overproduced in patients with carcinoid syndrome, which may result in uncontrolled diarrhea; this drug reduces the production of peripheral serotonin. Tisagenlecleucel (Kymriah, Novartis) I.V. infusion • Children and adults up to age 25 with B-cell pre- A CAR T-cell therapy. This CD19-directed genetically cursor acute lymphoblastic leukemia that is refrac- modified autologous T-cell immunotherapy eliminates tory or in second or later relapse CD19-expressing malignant and normal cells. A pa- • Adults with relapsed or refractory large B-cell tient’s T cells are harvested and genetically modified to lymphoma after two or more lines of systemic express a CAR. The anti-CD19 CAR T cells are infused therapy, including DLBCL not otherwise specified, back into the patient, where they can recognize and high-grade B-cell lymphoma, and DLBCL arising eliminate CD19-expressing cancer cells. from follicular lymphoma REFERENCES 1. Verzenio (abemaciclib) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716s000lbl.pdf. 2. Calquence (acalabrutinib) capsules, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf. 3. Bavencio (avelumab) injection, for intravenous use. Prescribing Information. www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/ pi/bavencio-pi.pdf. 4. Yescarta (axicabtagene ciloleucel) suspension, for intravenous infusion. www.fda.gov/downloads/UCM581226.pdf. 5. Alunbrig (brigatinib) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf. 6. Aliqopa (copanlisib dihydrochloride) for injection, for intravenous use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf. 7. Imfinzi (durvalumab) injection, for intravenous use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf. 8. Idhifa (enasidenib mesylate) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf. 9. Rydapt (midostaurin) capsules, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf. 10. Nerlynx (neratinib maleate) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf. 11. Zejula (niraparib tosylate monohydrate) capsules, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf. 12. Kisqali (ribociclib succinate) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf. 13. Xermelo (telotristat ethyl) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/208794s000lbl.pdf. 14. Kymriah (tisagenlecleucel) suspension for intravenous infusion. Prescribing Information. www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kymriah.pdf.

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Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. ANTIVIRAL DRUG ders such as acute myeloid leukemia, recommended. In patients in whom myelodysplastic syndrome, and lym- cyclosporin is not co-administered, phoma who received an HSCT. The the dosage of atorvastatin should not Letermovir primary efficacy endpoint was the exceed 20 mg daily. (4) Concurrent incidence of clinically significant use of letermovir with rifampin is not Protecting patients from CMV CMV infection through Week 24 recommended. (5) Concurrent use of infection after hematopoietic stem posttransplant (prophylaxis failure). letermovir may increase the action of cell transplantation Significantly fewer patients in the sirolimus, tacrolimus, alfentanil, fen- After a person is exposed to cyto- letermovir group (38%) failed pro- tanyl, midazolam, quinidine, amio- megalovirus (CMV), a common her- phylaxis, compared with 61% of darone, glyburide, rosiglitazone, and pesvirus, it remains in the body for those in the placebo group. All-cause repaglinide. (6) Letermovir may de- life, usually in an inactive or latent mortality at Week 24 posttransplant crease the action of warfarin, phe- form. Many adults have CMV anti- was also lower in those treated with nytoin, voriconazole, omeprazole, bodies in their blood and are CMV letermovir (12%) than in those re- and pantoprazole; closely monitor seropositive, indicating a previous ceiving placebo (17%). patients for reduced effectiveness of exposure to or primary infection Letermovir appears less likely to these drugs. (7) Letermovir is not with CMV. People with normal im- cause serious adverse reactions than recommended for use in patients mune function rarely develop signs ganciclovir or valganciclovir, two with severe hepatic impairment. and symptoms of CMV infection antivirals currently available to treat (8) The vehicle for the parenteral after an initial infection, which is CMV infection. Unlike the labeling formulation of letermovir includes typically mild in severity. However, for letermovir, the labeling for those hydroxypropyl betadex that may patients with compromised immune drugs includes boxed warnings accumulate in patients with creati- function face a greater risk of viral regarding the risks of hematologic nine clearance less than 50 mL/min; reactivation, causing symptomatic toxicity, impairment of fertility, tera- closely monitor serum creatinine infection or a secondary infection togenicity, and carcinogenicity. concentrations in these patients. due to other pathogens. In these Letermovir interacts with many patients, CMV infection may cause other medications. It inhibits the Adverse reactions: nausea, diar- serious complications such as retini- CYP3A metabolic pathway and in- rhea, vomiting, peripheral edema, tis and possibly blindness, pneumo- creases the action of medications cough, headache, fatigue, abdominal nia, and gastrointestinal disorders.1 that are substrates for this pathway, pain Recipients of stem cell and organ such as pimozide and ergot alka- transplants are particularly vulner- loids. Consult the Prescribing Infor- Supplied as: For oral use: 240 mg able to CMV infection and complica- mation for full details about drug and 480 mg tablets. For I.V. injection: tions, including transplant failure interactions and recommended pre- single-dose vials containing 240 and death. Hematopoietic stem cell cautions. mg/12 mL (20 mg/mL) and 480 transplantation (HSCT) is performed mg/24 mL (20 mg/mL). in some patients with certain blood Precautions: (1) Contraindicated for or bone marrow cancers. Although concurrent use with pimozide, ergot Dosage: 480 mg once a day. Treat- HSCT offers many patients the best alkaloids, and pitavastatin and sim- ment should be initiated between hope for a continuing remission, the vastatin when coadministered with Day 0 and Day 28 posttransplanta- procedure and associated immuno- cyclosporine. In patients in whom tion and continued through Day 100 suppression increase the risk of cyclosporine is not coadministered, posttransplantation. CMV infection.1 the concurrent use of letermovir with Letermovir (Prevymis, Merck) is pitavastatin or simvastatin is not rec- Nursing considerations: (1) Leter- an antiviral agent with activity ommended. (2) The concurrent use movir tablets may be administered against CMV that inhibits the CMV of letermovir and cyclosporine in- without regard to food. (2) Tell pa- DNA terminase complex required creases the activity of both drugs. In tients that if they miss a dose, they for viral DNA processing and pack- patients treated concurrently with should take it as soon as they re- aging. Administered orally or as an both drugs, the dosage of letermovir member, unless it is nearly time for I.V. infusion, it is indicated for pro- should be reduced to 240 mg once a the next dose. In that case, they phylaxis of CMV infection and disease day and cyclosporine concentrations should skip the missed dose and in adult CMV-seropositive recipients should be frequently monitored. The take the next dose at the scheduled (R+) of an allogeneic HSCT.2 use of repaglinide is not recommend- time. Warn them not to take two The effectiveness of letermovir was ed in these patients. (3) Concurrent doses at the same time to make up evaluated in a placebo-controlled use of letermovir and cyclosporin for a missed dose. (3) Letermovir clinical trial in patients with disor- with atorvastatin or lovastatin is not injection should be used only in www.Nursing2018.com October l Nursing2018 l 39

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. patients who cannot take oral therapy. receptor agonist that stimulates bone or in patients who have an underly- Patients should be switched to the formation; the other prescription ing hypercalcemic disorder, such tablet formulation as soon as they medications used for postmenopausal as primary hyperparathyroidism. can take oral medications; dosage osteoporosis inhibit bone resorption. (4) Patients may experience orthostatic adjustment is not necessary when Administered subcutaneously, abalo- hypotension, typically within 4 hours switching formulations. (4) To pre- paratide is specifically indicated for of injection. The first several doses pare letermovir for I.V. infusion, add postmenopausal women with osteo- should be administered where the the contents of a vial into a 250 mL porosis at high risk for fracture, de- patient can sit or lie down if necessary. prefilled I.V. bag containing either fined as patients with a history of (5) Cumulative use of abaloparatide 0.9% Sodium Chloride Injection or osteoporotic fracture, those with mul- and parathyroid hormone analogues 5% Dextrose Injection. Consult the tiple risk factors for fracture, and those such as teriparatide for more than 2 Prescribing Information for informa- who have failed or are intolerant to years during a patient’s lifetime is not tion regarding compatible I.V. bags other available osteoporosis therapy.2 recommended. and infusion set materials. (5) Ad- The effectiveness of abaloparatide minister the diluted formulation via was demonstrated in a placebo- Adverse reactions: hypercalciuria, a peripheral or central venous access controlled clinical study in which dizziness, nausea, headache, palpita- device at a constant infusion rate most patients had experienced at least tions, fatigue, upper abdominal over 1 hour. (6) Monitor patients for one prior fracture. The primary end- pain, vertigo CMV reactivation following comple- point was the incidence of new verte- tion of therapy with letermovir. bral fractures. Over an 18-month Supplied as: single-patient-use treatment period, a significant reduc- prefilled pens. Each pen delivers REFERENCES tion in the incidence of these fractures 30 doses, each containing 80 mcg 1. Merck receives FDA approval of Prevymis™ was found in patients treated with of the drug in 40 mcL of sterile (letermovir) for prevention of cytomegalovirus (CMV) infection and disease in adult allogeneic the new drug (0.6%) compared with solution. stem cell transplant patients. Merck. News release. patients receiving placebo (4.2%). November 9, 2017. The incidence of nonvertebral frac- Dosage: 80 mcg once a day at ap- 2. Prevymis (letermovir) tablets, for oral use; Prevymis (letermovir) injection, for intravenous tures was also significantly reduced. proximately the same time each day use. Prescribing Information. www.accessdata.fda. High dosages of abaloparatide gov/drugsatfda_docs/label/2017/209939Orig1s000 ,209940Orig1s000lbl.pdf. caused an increased incidence of Nursing considerations: (1) Ad- osteosarcoma in rats. Although vise patients to sit or lie down if they whether the drug will cause osteo- experience signs and symptoms of DRUG FOR OSTEOPOROSIS sarcoma in humans is unknown, the hypotension, such as dizziness and labeling for abaloparatide includes a palpitations. (2) Teach patients Abaloparatide boxed warning regarding this risk. how to administer abaloparatide subcutaneously into the periumbili- Indicated for postmenopausal women Precautions: (1) Because of the cal region. (3) Instruct patients to with osteoporosis at high risk for potential risk of osteosarcoma, abalo- promptly report signs and symptoms fracture paratide should not be used in of osteosarcoma, such as persistent Characterized by a reduction in bone patients at increased risk for osteo- localized pain or a new soft tissue mineral density and bone strength, sarcoma, including those with Paget mass that is tender to palpation. osteoporosis is often asymptomatic disease of bone or unexplained eleva- (4) Instruct patients to promptly until a fracture occurs. It is most tions of serum alkaline phosphatase, report signs and symptoms of hyper- commonly experienced in women open epiphyses, bone metastases or calcemia, such as nausea, vomiting, following menopause when a reduc- skeletal malignancies, hereditary dis- constipation, lethargy, and muscle tion in estrogen concentrations orders predisposing to osteosarcoma, weakness. (5) Tell patients to store causes a bone remodeling imbalance or prior external beam or implant the pens in a refrigerator before use. in which bone loss (resorption) ex- radiation therapy involving the skel- After first use, they may store pens at ceeds bone formation. An estimated eton. (2) Because abaloparatide may room temperature for up to 30 days. 8 million women in the US have os- cause hypercalciuria, measurement teoporosis, and two million osteopo- of urinary calcium excretion should REFERENCES 1 rotic fractures occur each year. be considered in patients in whom 1. FDA approves Radius Health’s Tymlos™ (abalo- Abaloparatide (Tymlos, Radius), a preexisting hypercalciuria or active paratide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high synthetic 34-amino acid peptide, is urolithiasis is suspected. (3) Because risk for fracture. Radius. News release. April 28, 2017. an analogue of human parathyroid abaloparatide may cause hypercalce- 2. Tymlos (abaloparatide) injection, for subcutaneous hormone-related peptide. Like teripa- use. Prescribing Information. http://radiuspharm. mia, it is not recommended in pa- com/wp-content/uploads/tymlos/tymlos-prescribing- ratide, it is a parathyroid hormone tients with preexisting hypercalcemia information.pdf.

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Drug (trade name, manufacturer, description) Route Indications Cerliponase alfa (Brineura, BioMarin) Intraventricular infusion Indicated to slow the loss of ambula- A recombinant human tripeptidyl peptidase-1 into cerebrospinal fluid via a tion in symptomatic pediatric patients (rhTPP1), a lysosomal exopeptidase, and an surgically implanted reservoir age 3 years and older with late infan- enzyme replacement therapy and catheter followed by tile neuronal ceroid lipofuscinosis type Intraventricular Electrolytes 2 (CLN2), a form of Batten disease Injection also known as tripeptidyl peptidase 1 (TPP1) deficiency Deflazacort (Emflaza, PTC) Oral Indicated to treat Duchenne muscular A corticosteroid prodrug whose active dystrophy in patients age 5 years and metabolite exerts anti-inflammatory and older immunosuppressive effects Emicizumab-kxwh (Hemlibra, Genentech) Subcutaneous injection Indicated for routine prophylaxis to A humanized monoclonal antibody with a bispe- prevent or reduce the frequency of cific antibody structure binding factor IXa and bleeding episodes in adult and pediat- factor X. By bridging activated factor IX and factor ric patients with hemophilia A (con- X, it restores the function of missing activated genital factor VIII deficiency) with fac- factor VIII needed for effective hemostasis. tor VIII inhibitors Vestronidase alfa-vjbk (Mepsevii, Ultragenyx) I.V. infusion Indicated to treat pediatric and adult A recombinant human lysosomal beta glucuroni- patients with mucopolysaccharidosis dase; this is an enzyme replacement therapy VII (MPS VII, Sly syndrome)

REFERENCES 1. Brineura (cerliponase alfa) injection, for intraventricular use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761052lbl.pdf. 2. Emflaza (deflazacort) tablets, for oral use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf. 3. Hemlibra (emicizumab-kxwh) injection, for subcutaneous use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf. 4. Mepsevii (vestronidase alfa-vjbk) injection, for intravenous use. Prescribing Information. www.accessdata.fda.gov/drugsatfda_docs/label/2017/761047s000lbl.pdf.

DRUG FOR HYPERPARATHYROIDISM calcium-sensing receptors in the Etelcalcetide hydrochloride (Pars- parathyroid glands.1 abiv, Amgen) is a synthetic peptide Secondary HPT involves the ex- calcium-sensing receptor agonist Etelcalcetide cessive secretion of PTH in response with properties similar to those of to decreased renal function and im- cinacalcet. However, unlike cinacal- hydrochloride paired mineral metabolism. The el- cet, which is administered orally, the evated concentrations of PTH can new drug is administered I.V.2 Treatment for secondary increase the release of calcium and Indicated to treat secondary HPT hyperparathyroidism in adults phosphate from the bones. Approxi- in adults with CKD on hemodialysis, with chronic kidney disease on mately 470,000 patients in the US etelcalcetide is administered three hemodialysis are receiving dialysis, and almost times a week by the dialysis health- The parathyroid glands secrete para- 90% of patients with chronic kidney care team at the end of hemodialysis thyroid hormone (PTH), which helps disease (CKD) on hemodialysis will treatment. Its effectiveness was dem- maintain the appropriate balance of develop secondary HPT. Treatment onstrated in two placebo-controlled calcium and phosphorus in the body. options for secondary HPT include studies involving more than 1,000 Hyperparathyroidism (HPT) disrupts phosphate binders, active vitamin D patients who were also receiving this balance and serum calcium con- analogues such as calcitriol, and standard of care that could include centrations increase. The secretion of calcimimetics. Cinacalcet, the first vitamin D and/or phosphate binders. PTH is regulated by changes in ex- marketed calcimimetic agent, acts The primary endpoint of both stud- tracellular calcium concentrations by increasing the sensitivity of the ies was the proportion of patients and, when the concentration of ex- calcium-sensing receptors in the achieving greater than a 30% reduc- tracellular calcium is decreased, the parathyroid glands to activation by tion in PTH concentrations from amount of PTH secreted is increased. extracellular calcium.1 baseline to the efficacy assessment This autoregulation is controlled by www.Nursing2018.com October l Nursing2018 l 41

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. phase (mean PTH concentrations for cetide. (4) Some patients in the clini- Nursing considerations: (1) Teach weeks 20 through 27, inclusive). cal studies experienced hypotension patients to recognize and report signs Secondary endpoints included the and worsening heart failure; heart fail- and symptoms of hypocalcemia, heart proportion of patients with a mean ure requiring hospitalization occurred failure, and GI bleeding. (2) Inform PTH of less than or equal to 300 pg/ in 2% of the patients treated with patients about the importance of reg- mL percent reductions in PTH, cor- etelcalcetide, compared with 1% of ular blood tests as directed by the rected serum calcium, and phos- those receiving placebo. (5) Patients healthcare provider. (3) Store vials in phate concentrations. In both stud- with risk factors for upper gastrointes- the refrigerator in the original carton ies, significantly more patients treat- tinal (GI) bleeding such as gastritis or to protect the medication from light. ed with etelcalcetide had a greater ulcers may be at increased risk for GI bleeding while being treated with than 30% reduction in PTH (77% REFERENCES and 79%) than in those receiving etelcalcetide. Patients who experi- 1. FDA approves Amgen’s Parsabiv™ (etelcalcetide), placebo (11% in each study). PTH ence worsening of GI symptoms first new treatment In more than a decade for secondary hyperparathyroidism in adult patients concentrations of 300 pg/mL or less such as nausea and vomiting should on hemodialysis. Amgen. News release. February were achieved in 52% and 56% of be monitored for GI bleeding and 7, 2017. the patients treated with the new ulceration. (6) If PTH concentrations 2. Parsabiv (etelcalcetide) injection, for intravenous use. Prescribing Information. https://pi.amgen. drug, compared with 6% and 5% of are chronically suppressed and com/~/media/amgen/repositorysites/pi-amgen- those in the placebo groups. In addi- decrease below the recommended com/parsabiv/parsabiv_pi.pdf. tion, patients treated with etelcalce- target range, adynamic bone may tide experienced greater reductions develop. The dosage of etelcalcetide in corrected calcium and phosphate and/or vitamin D should be reduced DRUG FOR GLAUCOMA concentrations in patients. or therapy discontinued. Following Because etelcalcetide has not been discontinuation of treatment, thera- studied in patients with CKD who py can be resumed at a lower dose Latanoprostene are not on hemodialysis or in pa- to maintain PTH concentrations in bunod tients with other parathyroid disor- the target range. ders, it is not recommended for use Managing intraocular pressure in in these patients. Adverse reactions: muscle spasms, patients with open-angle glaucoma diarrhea, nausea, vomiting, head- or ocular hypertension Precautions: (1) Hypocalcemia is ache, hypocalcemia, paresthesia Latanoprostene bunod (Vyzulta, Vale- associated with symptomatic reduc- ant) is a prostaglandin analogue with tions in corrected serum calcium less Supplied as: single-dose vials in properties similar to those of bimato- than 8.3 mg/dL and may be severe. etelcalcetide concentrations of 2.5 prost, latanoprost, tafluprost, and tra- Significant lowering of serum calcium mg/0.5 mL, 5 mg/mL, and 10 mg/2 mL voprost. These drugs are available in can cause paresthesias, myalgia, solutions for ophthalmic administra- muscle spasms, seizures, QT interval Dosage: Starting dosage: 5 mg ad- tion to reduce elevated intraocular prolongation, and ventricular dys- ministered by I.V. bolus injection pressure (IOP) in patients with open- rhythmias; patients at added risk for into the venous line of the dialysis angle glaucoma or ocular hypertension. these adverse reactions should be circuit three times a week at the Prostaglandin analogues lower IOP closely monitored. (2) Corrected se- end of hemodialysis treatment. by increasing the outflow of aqueous rum calcium should be determined Maintenance dosage: individualized humor. Latanoprostene is thought to before initiation of treatment with according to titration based on act via both the trabecular meshwork etelcalcetide, and treatment should PTH and corrected serum calcium and uveoscleral routes. Following not be started if the corrected serum response, ranging from 2.5 mg ocular administration, it is rapidly calcium is less than the lower limit three times a week to a maximum metabolized in the eye to latanoprost of normal. Corrected serum calcium maintenance dosage of 15 mg three acid and butanediol mononitrate.1 levels should be monitored within times a week. The dosage may be The effectiveness of the new drug 1 week after initiation or dose adjust- increased in 2.5 mg or 5 mg incre- was demonstrated in clinical studies ment, and every 4 weeks during treatments no more frequently than of up to 12 months in duration in ment. (3) The concurrent use of every 4 weeks. Consult the Pre- patients with average baseline IOP of etelcalcetide with cinacalcet could scribing Information for details approximately 27 mm Hg. The IOP- result in life-threatening hypocalce- regarding the determination of lowering effect of latanoprostene was mia. Patients switching to the new PTH and calcium concentrations, 7 to 9 mm Hg. Its effectiveness ap- drug should discontinue cinacalcet for dosage adjustments, and suspension/ pears to be similar to that of the re- at least 7 days before initiating etelcal- discontinuation of treatment. lated drugs.

42 l Nursing2018 l Volume 48, Number 10 www.Nursing2018.com

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved. Like the other prostaglandin an- generally not recommended for pat- more frequent administration may alogues used to reduce elevated ents with active intraocular inflam- actually lessen the IOP-lowering ef- IOP, latanoprostene may cause mation because it may exacerbate fect. (2) Instruct patients who take brownish pigmentation of the iris inflammation. (3) Patients who ex- more than one ophthalmic drug to and eyelid due to increased mela- perience increased iris pigmentation administer latanoprostene at least 5 nin content in the melanocytes. should be closely monitored because minutes apart from another ophthal- Increased pigmentation of the eye- the long-term effects of increased mic medication. (3) Tell patients who lid is reversible in most patients pigmentation are not known. wear contact lenses to remove them but pigmentation of the iris is like- before drug administration to pre- ly to be permanent. Use in pediat- Adverse reactions: conjunctival vent damaging them. Lenses may be ric patients younger than age 16 hyperemia, eye irritation, eye pain, reinserted 15 minutes after adminis- years is not recommended because instillation site pain tration. (4) Inform patients about the of potential safety concerns related risk of potentially permanent chang- to increased pigmentation follow- Supplied as: sterile ophthalmic so- es in iris pigmentation, which may ing long-term use. lution containing the drug in a con- not be noticeable for months or Changes in eyelash length, color, centration of 0.024% (0.24 mg/mL). years. (5) Tell patients to store un- thickness, shape, and number may Five milliliters of solution are pro- opened bottles in a refrigerator. Once also occur. These changes are likely vided in polyethylene bottles with a a bottle is opened, it may be stored at to be reversible upon discontinua- dropper tip. room temperature for 8 weeks. ■ tion of treatment. Dosage: one drop in the conjuncti- REFERENCE Precautions: (1) Use latanoprostene val sac of the affected eye(s) once a 1. Vyzulta (latanoprostene bunod ophthalmic solution) 0.024%, for topical ophthalmic use. with caution in patients with risk day in the evening Prescribing Information. www.bausch.com/ factors for macular edema. (2) Use Portals/69/-/m/BL/United%20States/USFiles/ Package%20Inserts/Pharma/vyzulta-prescribing- caution in patients with a history of Nursing considerations: (1) Warn information.pdf. intraocular inflammation such as patients not to administer the drug iritis or uveitis. Latanoprostene is more often than once a day because DOI-10.1097/01.NURSE.0000545013.60672.65

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