DRUG Watch

NEW DRUG FOR MULTIPLE lower the annualized relapse rate treatment of infusion reactions, SCLEROSIS and the proportion of patients refer to the drug’s label: http://bit. whose disability progressed at 12 ly/2p19fp4. weeks compared with the active • Ocrelizumab (Ocrevus) is now approved by the Food and Drug drug comparator. In a third study, NEW DRUG APPROVED FOR Administration (FDA) to treat a randomized, double-blind, PARKINSON’S DISEASE adults with relapsing or primary placebo-controlled trial of 732 progressive forms of multiple patients with primary progressive • sclerosis (MS). Safinamide (Xadago) is the new- MS, patients who received ocreli- est drug approved for the treat- • It is the first FDA-approved drug zumab had a significantly longer to treat primary progressive MS. ment of Parkinson’s disease. time before disability progression • It is used as adjunct therapy with than those who received placebo. levodopa/carbidopa when symp- The most common adverse ef- toms are not well controlled by he Food and Drug Adminis- fects of ocrelizumab for both that medication alone. Ttration (FDA) has approved forms of MS are upper respira- ocrelizumab (Ocrevus), a recom- tory tract infections and infusion binant humanized monoclonal reactions, which can be severe afinamide (Xadago) is the new- antibody, to treat adults with re- and life threatening. Other com- Sest drug approved for Parkin- lapsing or primary progressive mon adverse effects for those son’s disease. It is used as adjunct forms of multiple sclerosis (MS). with primary progressive MS are therapy to levodopa/carbidopa Ocrelizumab is the first drug to skin infections and lower respira- (Sinemet and others) when Par- gain FDA approval for primary tory tract infections. Contraindi- kinson’s symptoms are not well progressive MS. It is administered cations to ocrelizumab include controlled by that medication as an infusion every 24 weeks. active hepatitis B virus infection alone. Times when Parkinson’s MS is a chronic autoimmune and a history of life-threatening symptoms aren’t being well con- disease of the nervous system that infusion reactions to ocrelizumab. trolled by treatment are referred can cause muscle weakness, dam- Ocrelizumab must be diluted to as “off episodes.” Safinamide age to coordination, and paraly- prior to administration. Nurses decreases the incidence of these sis. Most patients with MS have administering ocrelizumab via episodes. The drug is not effec- periods of remission followed by intravenous injection should pre- tive if used as monotherapy. relapse. However, patients with medicate patients with methylpred- Safinamide is a monoamine primary progressive MS (about nisolone or another corticosteroid oxidase type B (MAO-B) inhibi- 15% of MS patients) generally and an antihistamine, such as di- tor. MAO inhibitors are used in experience a steady worsening in phenhydramine, before every infu- the treatment of depression (likely function, without remissions. On- sion to prevent infusion reactions. because they increase serotonin set of this form of MS is usually Additional premedication with an levels), Parkinson’s disease (likely 10 years later than that of relaps- antipyretic is another option. Pa- because they increase available ing MS, and men and women are tients should be assessed for at least dopamine), and some other con- more equally effected (in relapsing one hour after infusion to confirm ditions. MAO-B inhibitors are MS, women are affected two to that no reactions have occurred. believed to achieve their therapeu- three times as often as men). (For Nurses should ensure that pa- tic effect by increasing the effect more information on MS, see tients are negative for active hepati- of levodopa/carbidopa, and ulti- www.nationalmssociety.org.) tis B viral infection—or any active mately raising levels of available Ocrelizumab is believed to exert infections—prior to beginning dopamine. its therapeutic effect by binding to ocrelizumab. If patients require Because it inhibits MAO, safin- CD20, a cell surface antigen found vaccination with live-attenuated amide may cause any of the fol- on pre-B and mature B lympho- or live vaccines, they should re- lowing: serotonin syndrome if cytes, and breaking the cells apart ceive these at least six weeks prior used with other MAO inhibitors, (cytolysis). Ocrelizumab was stud- to starting ocrelizumab treatment. antidepressants, or opioids; falling ied in two randomized, double- Nurses should teach patients about asleep during activities of daily liv- blind, double-dummy, active the potential adverse effects of ing; hallucinations/psychotic be- comparator–controlled clinical ocrelizumab, including the signs havior; problems with impulse trials of patients who had relaps- and symptoms of infusion reac- control/compulsive behaviors; and ing forms of MS. In both trials tions and the risk of infections. For retinal pathology (this precaution (a total of 1,656 patients), ocreli- specific information about dilution, is based only on findings from ani- zumab was found to significantly techniques for administration, and mal studies). It may also cause or

22 AJN ▼ July 2017 ▼ Vol. 117, No. 7 ajnonline.com By Diane S. Aschenbrenner, MS, RN

exacerbate dyskinesia and hyper- safinamide might increase somno- a greater response, defined as clear tension, and may produce with- lence. If patients experience any or almost clear skin and decreased drawal emergent hyperpyrexia new episodes of falling asleep dur- itching, after 16 weeks of treat- and confusion. ing normal daily activities, they ment. Safinamide is contraindicated should avoid dangerous activities Dupilumab has not been stud- in patients with severe hepatic im- such as driving or operating ma- ied in asthma. Patients who have pairment (because concentrations chinery. Other sedating medica- asthma and have been prescribed of the drug will be increased), and tions, alcohol, or central nervous dupilumab should not adjust or dose limitations are required if system depressants may increase stop their asthma treatments unless moderate hepatic impairment is the risk of sedation. If dyskinesia recommended by their health care present. Other contraindications occurs or worsens, NPs should provider. Dupilumab may alter the include use of other MAO inhibi- consider decreasing the dose of level of cytochrome P-450 (CYP) tors or potent inhibitors of MAO, levodopa/carbidopa. isoenzymes and affect the metabo- which may cause hypertension or To see complete prescribing lism of drugs dependent on those hypertensive crisis by increasing information for safinamide, see isoenzymes. nonselective MAO inhibition; http://bit.ly/2qJdwtw. The most common adverse ef- dextromethorphan, which may in- fects of dupilumab are injection duce psychosis or abnormal be- INJECTABLE DRUG APPROVED FOR site reactions, oral herpes, and havior; opioids such as tramadol, MODERATE-TO-SEVERE ECZEMA eye and eyelid inflammation. Se- meperidine, and related deriva- rious adverse effects include al- tives; certain antidepressants such lergic reactions, conjunctivitis, as serotonin–norepinephrine reup- •• Dupilumab (Dupixent) is now and keratitis (inflammation of approved to treat moderate-to- take inhibitors, tri- or tetracyclics, severe eczema (atopic dermati- the cornea). Nurses should tell or triazolopyridines; cyclobenza- tis) in adults whose eczema is not patients to contact a health care prine; methylphenidate, amphet- sufficiently controlled by topical provider if they develop new or amine, and their derivatives; and therapies or who cannot receive worsening eye symptoms, such St. John’s wort—all of these can topical therapies. as redness, itching, pain, or vi- induce life-threatening serotonin •• Dupilumab is administered sual changes. weekly as a subcutaneous in­ syndrome. jection and can be used with It is important to teach patients The most common adverse ef- or without topical corticosteroids. how to self-administer the pre- fects of safinamide are dyskinesia, filled syringe of dupilumab as a falls, nausea, and insomnia. Some subcutaneous injection into the people experienced increased som- thigh, abdomen, or upper arm. nolence and fell asleep during nor- upilumab (Dupixent) is now The drug comes in two forms, mal daily activities. Dapproved to treat moderate- with or without a needle shield. Patient education should in- to-severe atopic dermatitis, the For specific instructions on ad- clude information on potential most common form of eczema, ministration, patients should risks, drug warnings, and com- in adults whose eczema is not consult the drug’s labeling. Pa- mon adverse effects. Although sufficiently controlled by topical tients taking dupilumab should dietary tyramine restriction is not therapies or who cannot receive not receive live vaccines. Patients required with safinamide treat- topical therapies. It is administered prescribed dupilumab should ment (because of its MAO-B se- weekly as a subcutaneous injection complete a drug assessment to lectivity), eating large quantities and can be used with or without determine if they are also taking of food high in tyramine increases topical corticosteroids. drugs metabolized by the CYP the risk of hypertension. Nurses Dupilumab’s active ingredi- isoenzyme system. If so, nurses should teach patients to avoid ent is an antibody that binds to should assess for the continued more than 150 mg of aged, fer- interleukin-4—specifically to the effectiveness of these drugs once mented, cured, smoked, and receptor alpha subunit that causes dupilumab is started. pickled foods. Because the tuber- inflammation—and inhibits the in- For complete prescribing infor- culosis drug isoniazid has some flammatory response. Dupilumab mation for dupilumab, see http:// MAO inhibiting activity, patients was established as safe and effec- bit.ly/2pyOZbc. ▼ may be at increased risk for inter- tive in three placebo-controlled actions, including hypertension, if clinical studies that evaluated a to- Diane S. Aschenbrenner is an assistant taking safinamide, isoniazid, and tal of 2,119 adults with moderate-­ professor at Notre Dame of Maryland University in Baltimore. She also coordi- tyramine-containing foods. Nurses to-severe eczema. Generally, those nates Drug Watch: daschenbrenner@ndm.­ should also teach patients that who received dupilumab achieved edu. [email protected] AJN ▼ July 2017 ▼ Vol. 117, No. 7 23