continuing education for pharmacists Volume XXXV, No. 12 New Drugs for CNS, Endocrine, and Infectious Diseases

Karen L. Kier, PhD, MSc, R.Ph., BCPS, BCACP, CTTS, Professor of Clinical Pharmacy, Director of Drug and Health Information, Raabe College of Pharmacy, Ohio Northern University

Dr. Karen Kier has no relevant financial being channeled through restricted including life-threatening and relationships to disclose. distribution systems. Some of these fatal events, as well as a caution drugs are not FDA-approved for for immune-mediated disorders of Goal. The goal of this lesson is first-line therapy, but rather offer the skin and liver. Patients need to to provide information on central viable alternatives when first-line have routine liver testing and phar- nervous system drugs approved by drugs fail. In addition, many of the macists should counsel patients to the Food and Drug Administration new drugs are for rare conditions comply with their clinic visits. (FDA) in 2016; endocrinology and that often do not have many treat- Patients on daclizumab must infectious disease new drugs; and ment options. FDA approved sev- be enrolled in the REMS program the new herpes zoster vaccine. eral orphan drugs, as well as drugs prior to administration of the for rare genetic diseases in 2016. drug. Despite safety concerns, the Objectives. At the completion of FDA also approved new indications clinical trials showed that patients this activity, the participant will be or formulations for drugs already had fewer relapses with the ac- able to: on the market with many of these tive drug. One trial that combined 1. recognize the targeted pa- being oncology agents or monoclo- daclizumab with interferon beta-1a ® thologies for the new drugs dis- nal antibody therapy. This lesson (Avonex ) for 144 weeks showed cussed in this lesson; will include CNS drugs approved a statistically and clinically sig- 2. select the indication(s), phar- in 2016, new drugs for endocrine nificant reduction in relapses. A macologic action(s), clinical appli- and infectious disease, and the new second 52-week study which com- cations, dosing regimens, mode of herpes zoster vaccine. pared daclizumab with placebo also administration, and availability for showed a significant reduction in each drug; Central Nervous System MS relapses. 3. list the most relevant ad- Prior to initiating daclizumab, ® verse effects, warnings, precau- Daclizumab (Zinbryta [zin- patients need to be screened for tions, contraindications, and BRIGHT-ta], AbbVie, Inc. and hepatitis B and C, and treatment significant drug-drug or drug-food Biogen). In May of 2016, FDA should be avoided in patients with interactions reported with these approved daclizumab injection as a severe active infection including medications; and a joint submission from AbbVie, tuberculosis. Patients with hepatic 4. list important patient coun- Inc. and Biogen. Daclizumab is dysfunction should not be started seling information to convey to an interleukin-2 receptor blocking on daclizumab. ® patients and/or caregivers. antibody that received approval Zinbryta is supplied as a for the treatment of adult patients 150 mg/1mL prefilled syringe with Many new drugs were approved in with relapsing forms of multiple no preservatives. It is administered 2016 and early 2017 for treatment sclerosis (MS). Due to safety risks, monthly as a 150 mg subcutaneous of diseases in the central nervous it should be reserved for patients injection. If the patient misses a system (CNS), endocrine system who have failed or had an inad- dose, the pharmacist should coun- and for infectious diseases. The equate response to two or more MS sel him/her to administer the dose trend in drug approvals contin- drugs. This is a long-acting medica- as soon as possible, if it is within ues to include more drugs with tion that can be self-administered two weeks of the missed dose. If FDA-mandated Risk Evaluation by the patient once monthly. the missed dose is more than two and Mitigation Strategies (REMS) Daclizumab has a Boxed weeks late, the patient should skip programs with many of those drugs Warning for severe liver injury, that dose and administer the next Table 1 CNS drugs approved in 2016

Generic Indication Dose Dosage Form Side Effects (Trade Name)

Daclizumab relapsing 150 mg subcutaneous Boxed Warning: liver injury; immune- (Zinbryta®) multiple MS monthly injection mediated disorders of skin and liver

Phentermine weight 8 mg three 8 mg scored pulmonary and cardiovascular hydrochloride loss times a day tablets complications (Lomaira™)

Pimavanserin Parkinson’s 34 mg 17 mg kidney dysfunction, peripheral edema, (Nuplazid®) disease daily tablets confusion; Boxed Warning: risk of death in elderly patients with dementia

dose at the next monthly scheduled should be aware that patients on monitor the patient’s blood pres- time. Patients should be counseled daclizumab should not receive live sure while taking this medication to never double the dose. vaccines during treatment and up to make sure that patients main- Daclizumab syringes should to four months after discontinua- tain good blood pressure control. be stored in the refrigerator and tion of treatment. Consideration The usual dose of Lomaira™ is never frozen. Counsel patients should be given for any necessary 8 mg three times per day, 30 min- to remove the syringe from the immunizations a patient may re- utes before meals. It is important refrigerator and allow to warm to quire prior to starting therapy. to counsel patients that, to be ef- room temperature for 30 minutes fective, the medication needs to be prior to injection. It is important Phentermine hydrochloride taken 30 minutes prior to a meal. that patients are trained on proper (Lomaira™ [low-MAIR-a], KVK- The butterfly-shaped 8 mg tablet administration technique and that Tech, Inc.) received FDA approval is scored so patients can split the they understand how to properly on September 13, 2016. Phenter- tablet if a lower dose is needed. dispose of the used syringe. The mine is a sympathomimetic amine Pharmacists should be aware syringe needs to be protected from anorectic meant for short-term use that Lomaira™ is intended for light while being stored and phar- in managing weight. It is indicated short-term treatment. This prod- macists should encourage patients for patients with an initial body uct is a C-IV controlled substance to leave the syringe in its protected mass index (BMI) ≥30 kg/m2 or ≥27 and is subject to state and federal box during storage. Patients should kg/m2 in the presence of other risk regulations pertaining to controlled not attempt to heat or warm the factors such as diabetes, hyperlip- substances and medications used to syringe by any manner other than idemia, and/or controlled hyperten- facilitate weight loss. allowing the syringe to remain at sion. room temperature. If the injection Phentermine has been on the Pimavanserin (Nuplazid® [NEW- is not given once it reaches room market in various formulations plaz-id]) was approved by FDA as temperature, the syringe may be in the past for the same weight novel treatment of Parkinson’s dis- used within 30 days, but should loss and obesity indications as ease psychosis in 2016. Pimavan- never be returned to the refrig- Lomaira™. There were concerns serin was given FDA breakthrough erator once it has reached room with these phentermine products status. Clinical studies showed it temperature. relating to the adverse event profile was superior to placebo in decreas- Due to potential liver dysfunc- and the development of pulmonary ing the frequency and/or severity of tion, pharmacists should counsel arterial hypertension and other hallucinations and delusions with- patients on avoiding medications pulmonary and cardiovascular out worsening the primary motor that can cause liver damage, which complications. The difference with symptoms of Parkinson’s disease. can include herbal and over-the- Lomaira™ is with the dose and This is because pimavanserin is a counter medications such as acet- dosage form. Lomaira™ labeling non-dopaminergic, selective sero- aminophen and green tea extract. still contains caution for side ef- tonin inverse agonist (SSIA) and Daclizumab can suppress the im- fects similar to previous products. is considered a second-generation mune system and patients should Pharmacists should counsel pa- antipsychotic. be counseled to notify a health tients to be aware of this potential Pimavanserin is dosed orally professional if they have signs and and to contact a healthcare pro- at 34 mg daily. However, pima- symptoms of an infection. fessional if they experience any vanserin has significant drug-drug Immunizing pharmacists of these effects. Pharmacists can interactions with CYP3A4 drugs. In patients taking concomitant CYP3A4 inhibitors, such as keto- Table 2 conazole, the daily dose should be Newly-approved endocrine formulations/drugs decreased to 17 mg while patients taking CYP3A4 inducers should Generic Indication Dose Dosage Form (Trade Name) still receive 34 mg daily but be monitored for changes in efficacy of Insulin aspart Types 1 and 2 patient- pre-filled FlexTouch the drug. The American Psychiatric (Fiasp®) diabetes based pen and vials, Association recommends that any 100 Units/mL for patient taking an antipsychotic subcutaneous injection medication be gradually tapered off to avoid withdrawal symptoms. Lixisenatide Type 2 10 mcg/day pre-filled pen for Not to stop taking this medication (Adlyxin™) diabetes x 14 days, subcutaneous injection abruptly is a critical counseling then 20 mcg daily point for patients and caregivers. ® Nuplazid is available as a Abaloparatide osteoporosis 80 mcg pre-filled pen for 17 mg tablet. It can be taken with- (Tymlos™) daily subcutaneous out regard to meals or food intake. injection Pimavanserin has an elimina- tion half-life of 57 hours with an active metabolite that has an elimi- patients to become more confused; to manage their blood sugar. nation half-life of approximately patients and caregivers should be Patients should be instructed and 200 hours. Upon discontinuation of counseled to contact a healthcare take classes to understand how to the drug, it may be present in the professional if this happens. The count their dietary carbohydrates body as an active metabolite for up dose may need to be decreased or and then calculate the units of to one week. the drug discontinued. insulin required to cover the meal Pimavanserin should not be for proper glycemic control. used in patients whose creatinine Endocrine System A new alert was issued in clearance is less than 30 mL/min- October 2017 by the Institute for ute with kidney dysfunction. Like Fiasp® (insulin aspart injection Safe Medication Practices (ISMP) other antipsychotics, pimavanserin [FEE-asp], Novo Nordisk) received National Medication Errors Re- has a Boxed Warning for increased FDA approval for a new formula- porting Program (MERP) on safety risk of death in elderly demen- tion of NovoLog®, enhanced by the regarding reports of patients incor- tia patients with psychosis when addition of niacinamide (vitamin rectly using insulin pens at home, compared to placebo. There are B3), which increases the speed of resulting in severe cases of hyper- no data specifically for this drug the initial insulin absorption. This glycemia. Patients were not remov- for increase in death compared to insulin aspart injection was ap- ing the inner cover of a standard placebo, but the FDA warning has proved on September 29, 2017 on a insulin pen needle prior to attempt- been applied to the antipsychotic second new drug application after ing to administer the insulin, and medication class. Novo Nordisk supplied FDA with thus were not receiving the insu- Pharmacists can make an more safety data. lin dose. Pharmacists and other impact with proper patient and Fiasp® is approved for both healthcare professionals should caregiver counseling in regard Type 1 and Type 2 diabetes mel- instruct patients on the proper use to the side effects profile prior to litus. The product is labeled as a of insulin pens and require patient dispensing the drug. In clinical fast-acting mealtime insulin to im- demonstration to verify under- studies, this drug caused periph- prove glycemic control. The rapid standing. More information can be eral edema and patients noted onset of this insulin allows it to be found at http://www.ismp.org/NAN/ swelling of the ankles, legs and dosed at the beginning of the meal, files/NAN-20171012.pdf. feet due to fluid accumulation. This or within 20 minutes of starting could be confused as development a meal. The onset of action after Lixisenatide (Adlyxin™ [ad-LIX- of congestive heart failure or an subcutaneous injection is approxi- in], sanofi-aventis) was approved exacerbation of heart failure. It is mately 2.5 minutes. for management of Type 2 diabetes important to counsel on this point Fiasp® is packaged in a pre- on July 27, 2016 based on 13 clini- and have patients or caregivers filled FlexTouch® pen and as 10 cal trials in adults demonstrating a contact a healthcare professional mL vial, both at a concentration of significant improvement in reduc- if the symptoms are present to dis- 100 Units/mL. As with any insulin tions in hemoglobin A1c (HgA1c). tinguish between heart failure and product, it is important to counsel Lixisenatide is a selective peripheral edema. patients on proper usage and prop- glucagon-like peptide-1 (GLP-1) Pimavanserin may cause some er way to calculate the dose needed receptor agonist that acts on the same receptor as the endogenous quality of life issues. Some patients sufficient vitamin D and calcium. hormone incretin. This mechanism will only be able to tolerate the It is critical that patients take a of lixisenatide then increases glu- lower dose of the drug. supplement with calcium and vi- cose-dependent insulin secretion, Patients should be counseled to tamin D, especially if they are not decreases inappropriate glucagon throw the pen away 14 days after getting the recommended amount secretion, and slows gastric empty- opening it for use. The pens should with their diet. Pharmacists can ing. be dated when they are activated. help patients select the most ap- The initial dose of lixisenatide Prior to being opened, pens should propriate calcium and vitamin D is 10 mcg once daily for 14 days, be stored in the refrigerator, then supplement for their age and their and then increased on day 15 to 20 stored at room temperature. Phar- other medications. mcg once daily. The medication is macists can help patients under- This product will be interesting supplied in a disposable prefilled stand how to store the pen away to follow because Radius Health is pen. The company makes a starter from light, and out of reach and partnering with 3M to develop a kit that contains 3 mL of solution, sight of children. It is important to transdermal patch to replace the so patients can give a 10 mcg/0.2 replace the cap after each use to injections currently available on mL injection for 14 days before keep the drug protected from light. the market. increasing the dose. To reduce The cap should also be replaced medication errors and confusion, prior to disposing in a sharps con- Triptorelin (TriptodurTM [TRIP- this 3 mL pen is green to distin- tainer. Disposal of the pen can be to-dur], Arbor Pharmaceuticals) guish it from the 20 mcg pen. Pens an essential counseling tip, as well received FDA approval on June 29, are also available in 20 mcg/0.2 mL as letting patients know when drug 2017 for precocious puberty. This is (3 mL total volume for 14 doses) for take-back days occur so that they a gonadotropin releasing hormone maintenance therapy. This pen is can take their sharps containers to (GnRH) agonist indicated for the burgundy in color. be disposed of properly. FDA has treatment of pediatric patients two Counseling patients on the provided the following link to help years of age and older with central proper use and administration of patients know how to properly use precocious puberty. The 22.5 mg the pens is important. The drug is sharps containers: http://www.fda. intramuscular (IM) injection has to administered subcutaneously in gov/safesharpsdisposal. be given under the supervision of the abdomen, thigh, or upper arm. a physician and is given every 24 The patient should rotate injection Abaloparatide (Tymlos™ [TIM- weeks or six months. It must be re- sites for each dose and should not los], Radius Health, Inc.). FDA ap- constituted in the office with 2 mL use the same site for each injection. proved abaloparatide on April 28, of sterile water prior to administra- The patient should administer the 2017 for the treatment of osteopo- tion. It is important that patients medication within one hour before rosis. Abaloparatide is a synthetic and caregivers comply with the the first meal of the day, prefer- peptide analog of hPTHrP (human necessary blood work, as well as ably the same meal each day. The parathyroid hormone related pro- monitoring height every three to solution should appear clear and tein) for postmenopausal women six months. Pharmacists can help colorless, and patients should be with osteoporosis at high risk patients and caregivers understand counseled not to use it if particu- for fracture, defined as history of the importance of following therapy late matter or coloration is seen. osteoporotic fracture, multiple risk guidelines. The GLP-1 drugs cause gastric factors for fracture, or patients who emptying to be slower, which has have failed or are intolerant of oth- both an effect on drug therapy as er therapy. The dose is 80 mcg once Infectious Disease well as adverse events. The slow- daily by subcutaneous injection. It ing of gastric emptying can alter is supplied as a prefilled pen device Shingrix ([SHIN-gricks] herpes absorption of some medications. that can deliver 30 doses. zoster vaccine, GlaxoSmith- For example, birth control pills This drug has a similar warn- Kline). FDA approved Shingrix, should be taken one hour prior to ing for the risk of osteosarcoma as a new herpes zoster vaccine on injecting lixisenatide or 11 hours teriparatide (Forteo®). The pharma- October 20, 2017. It is a non-live, after the medication is injected. cist can help patients understand recombinant adjuvanted vaccine Patients should be counseled that how to administer the injection, for the prevention of herpes zoster drugs like acetaminophen for pain as well as a few critical counseling in adults aged 50 years and older. will take longer to work due to points. Pharmacists should educate The new vaccine is formulated as a delayed absorption. Patients with patients on sitting or lying down two-dose intramuscular injection. slower gastric emptying may expe- when giving themselves the injec- In clinical trials, it had a higher rience nausea, vomiting and feeling tion due to the risk of orthostatic efficacy rate (over 90 percent) than full. This effect can help patients hypotension. the current live vaccine with a lose weight or negatively influence The action of abaloparatide is more sustained response over time. adherence to the medication due to dependent on patients receiving This vaccine was specifically de- Table 3 Newly-approved infectious disease drugs

Generic Indication Dose Dosage Form Side Effects (Trade Name)

Delafloxacin acute bacterial 450 mg PO 450 mg tablet; Boxed Warning: tendinitis, tendon rupture, (Baxdela™) skin and skin every 12 h; 300 mg for intravenous CNS effects, exacerbation of myasthenia structure 300 mg IV injection gravis infections every 12 h

Secnidazole bacterial 2 grams oral granules vulvovaginal candidiasis, long-term (Solosec™) vaginosis one-time carcinogenic potential dose

Benznidazole Chagas 5-8 mg/kg/ 12.5 mg and 100 mg skin rash, abdominal pain, weight loss disease day in 2 tablets divided doses x 60 days

Rabies immuno- post-exposure 20 IU/kg 2 mL and 10 mL vials pain at injection site, headache globulin human prophylaxis (150 IU/mL) for intra- (KedRAB™) rabies infection muscular injection

signed to overcome the age-related ing methicillin-resistant Staphylo- thy, central nervous system effects, decline in immunity. The sustained coccus aureus (MRSA). Within the and exacerbation of myasthenia efficacy was seen for a period of phase III trials, the discontinuation gravis. FDA issued a safety warn- four years after giving the vaccine rate was approximately 1 percent, ing on July 26, 2016 for the fluoro- in the phase III studies. It also but delafloxacin did not show a quinolone class of drugs regarding provides an opportunity to protect potential for QT prolongation or the side effect profile and that this patients who are not eligible for phototoxicity as is sometimes seen class of drugs should not be used as live vaccines. with other fluoroquinolones. first-line agents to treat infections The Centers for Disease Control The 300 mg intravenous dose is when alternatives are available. and Prevention’s (CDC) Advisory bioequivalent to the 450 mg tablet. Committee on Immunization Prac- The oral dose is 450 mg twice daily, Secnidazole oral granules tices (ACIP) voted October 25, 2017 approximately 12 hours apart. (Solosec™ [so-LOW-sek]) was to recommend that Shingrix be pre- The drug is not recommended in approved September 15, 2017 as ferred over Zostavax. At the time of patients with severe renal dysfunc- single-dose therapy for bacterial writing, updated recommendations tion. The package labeling indi- vaginosis in adult women. The for use of herpes zoster vaccine had cates that it can be given without drug is a potent, next-generation, not been published in Morbidity regard to food, however it still che- 5-nitroimidazole antibiotic that is and Mortality Weekly Report. lates with cations such as calcium. administered as a single 2-gram Therefore, the administration of dose. A new fluoroquinolone antibiotic delafloxacin should be at least two One risk factor is development delafloxacin (Baxdela™ [BAX- hours before or six hours after of vulvovaginal candidiasis, and del-a], Melinta Therapeutics) antacids containing magnesium or long-term use has the potential for was approved on June 19, 2017 aluminum, with sucralfate, with the risk of carcinogenicity. Chronic for treatment of acute bacterial metal cations such as iron, or with use should be avoided. Secnida- skin and skin structure infections multivitamin preparations contain- zole has the potential to pass into (ABSSSI) in both oral and intrave- ing zinc or iron, or with didanosine breast milk and patients should nous dosage forms. The drug was buffered tablets for oral suspension be counseled to discontinue breast approved based on two phase III or pediatric powder for oral solu- feeding for 96 hours after taking a studies in ABSSSI when compared tion. dose. to vancomycin with aztreonam and Delafloxacin has the same Patients should be counseled was shown to be non-inferior. Boxed Warning as other fluoroqui- to sprinkle the entire packet on Delafloxacin exhibits activity nolones indicating serious adverse applesauce, yogurt or pudding, against both gram-positive and reactions including tendinitis, ten- and to consume within 30 min- gram-negative pathogens, includ- don rupture, peripheral neuropa- utes without chewing or crushing the granules. It is very important facturers. This approval helps to and 2015, with those in 2016 being that patients understand that this make sure an adequate supply is the lowest in six years. It appears product should not be dissolved in available. the approval rate rebounded in liquids. 2017. More drugs are being chan- Hepatitis C. Several new drug neled through restricted distribu- FDA approved benznidazole combinations have been approved tion systems and many of the drugs tablets for treating the rare Chagas for managing patients with hepati- are for rare conditions with few disease on August 29, 2017. This tis C infection. In June of 2016, the treatment options. While only a drug is an antiprotozoal indicated new drug combination of sofos- limited number of pharmacists will for the treatment of Chagas dis- buvir and velpatasvir (Epclusa® be exposed to some of these newer ease, or American trypanosomiasis, [ep-CLUE-sa]) was the first oral medications at their practice site, a parasitic infection caused by medication to be FDA-approved all pharmacists should stay current Trypanosoma cruzi. The organ- for treatment of all genotypes. The with new drug and formulation ap- ism is transmitted through differ- combination is a nucleotide analog provals, as well as updates to treat- ent routes, including contact with polymerase inhibitor and pan-ge- ment guidelines that could include the feces of a certain insect, blood notypic NS5A inhibitor fixed-dose these new agents. transfusions, or from a mother to combination for the treatment of her child during pregnancy. chronic genotype 1-6 hepatitis C Benznidazole is most effective virus (HCV) infection. Sofosbuvir/ The author, the Ohio Pharmacists Foun- when used early in the treatment velpatasvir is intended for 12-week dation and the Ohio Pharmacists Associa- of the disease. It is FDA-approved therapy. The recommended dos- tion disclaim any liability to you or your patients resulting from reliance solely for treating ages two to 12 years. age is one tablet taken orally once upon the information contained herein. The oral dose is 5-8 mg/kg/day daily, with or without food. The Bibliography for additional reading and in two divided doses for 60 days. side effect profile includes head- inquiry is available upon request. Benznidazole is available as 12.5 ache and fatigue. As with other mg and 100 mg tablets. The 100 HCV treatments, this drug has a This lesson is a knowledge-based CPE mg tablet is scored into four equal activity and is targeted to pharmacists in Boxed Warning regarding the risk all practice settings. Disclosure: The OPF parts for ease of dosage adjust- of hepatitis B virus reactivation. trustees and other individuals responsi- ments based on patient weight. In July of 2017, sofosbuvir, ble for planning OPF continuing pharma- In addition, the 12.5 mg tablet velpatasvir and voxilaprevir cy education activities have no relevant can easily be made into a slurry (Vosevi® [voh-SEH-vee]) tablets financial relationships to disclose. for younger children or those who were approved as a fixed-dose are unable to swallow tablets. combination of a nucleotide ana- The manufacturer, Chemo Re- log NS5B polymerase inhibitor, a Program 0129-0000-17-012-H01-P search, has specific instructions for pan-genotypic NS5A inhibitor, and Release date: 12-15-17 preparation of a slurry both on the a pan-genotypic NS3/4A protease Expiration date: 12-15-20 website as well as in the package inhibitor for genotype 1-6 chronic CPE Hours: 1.5 (0.15 CEU) labeling. HCV infection. The overall clinical At the time of writing, the drug response is 96 percent. The recom- The Ohio Pharmacists Foundation Inc. is can only be procured through CDC. mended dosage is one tablet taken accredited by the Accreditation Council Pharmacists need to be informed orally once daily with food for 12 for Pharmacy Education as a provider of continuing pharmacy education. about the drug to help patients weeks. obtain the drug through the CDC AbbVie received approval of website. Mavyret™ [MAV-ih-reht] on Au- gust 3, 2017 for a fixed-dose com- Rabies immunoglobulin hu- bination of glecaprevir (NS3/4A man injection (KedRAB™ protease inhibitor) and pibrentas- [ked-RABE], Kamada Ltd and vir (NS5A inhibitor), indicated for Kedrion Biopharm) was approved the treatment of all major geno- on August 23, 2017. The product types of HCV infection. This is the is a human plasma derived anti- first product approved for an eight- rabies immunoglobulin indicated week treatment duration. Treat- for post-exposure prophylaxis of ment duration can also include 12 rabies infection. Kamada Ltd and weeks. The recommended dosage Kedrion Biopharm is the third is three tablets taken orally once manufacturer of rabies immuno- daily with food. globulin human injection approved due to market inconsistency in the Summary supply chain with previous manu- New drug approvals spiked in 2014 Please print. Program 0129-0000-17-012-H01-P continuing education quiz 0.15 CEU Name______

New Drugs for CNS, Endocrine and Infectious Address______Diseases City, State, Zip______1. Daclizumab has a Boxed Warning for: a. suicidal ideation. c. severe liver injury. Email______b. QT prolongation. d. kidney failure.

NABP e-Profile ID______Birthdate______(MMDD) 2. Once daclizumab has reached room temperature, it should Return quiz and payment (check or money order) to never be returned to the refrigerator. Correspondence Course, OPA, a. True b. False 2674 Federated Blvd, Columbus, OH 43235-4990

8. An important counseling point with abaloparatide is to 3. The usual dose of phentermine hydrochloride is: advise patients to: a. 4 mg three times a day with meals. a. administer abaloparatide intramuscularly. b. 4 mg three times a day 30 minutes prior to meals. b. take a magnesium supplement. c. 8 mg three times a day with meals. c. avoid calcium and vitamin D supplements. d. 8 mg three times a day 30 minutes prior to meals. d. sit or lie down when administering the injection.

4. Which of the following drugs has significant drug-drug 9. All of the following are true concerning triptorelin EX- interactions with CYP3A4 drugs? CEPT it: a. Phentermine hydrochloride c. Daclizumab a. is indicated in patients two years of age and older. b. Pimavanserin d. Lixisenatide b. is important to monitor the patient’s height annually.

c. must be administered under a physician’s supervi- 5. Fiasp®, the new formulation of NovoLog®, is what type of sion. insulin? d. is important to comply with necessary blood work. a. Fast-acting mealtime insulin b. Basal long-acting insulin 10. Shingrix injection is formulated as: c. Intermediate-acting insulin a. one subcutaneous dose. c. one intramuscular dose. d. Monoclonal antibody precipitate insulin b. two subcutaneous doses. d. two intramuscular doses. 6. Lixisenatide is a(n): 11. Delafloxacin is FDA-approved for: a. insulin antibody. a. acute bacterial skin and skin structure infections. b. glucagon-like peptide-1 receptor agonist. b. bone infections. c. gastric secretin mimetic. c. urinary tract infections. d. insulin resistance antagonist.

12. An important counseling point for secnidazole is to: 7. After opening, a lixisenatide prefilled pen should be thrown a. chew or crush granules before ingestion. away after: b. dissolve granules in 30 mL water before ingestion. a. 30 minutes. c. 14 days. c. sprinkle entire packet of granules on applesauce, yogurt b. 24 hours. d. 30 days. or pudding and consume within 30 minutes.

d. divide the packet of granules between breakfast and din- ner meals. Completely fill in the lettered box corresponding to your answer. 13. Trypanosoma cruzi can be transmitted through all the 1. [a] [b] [c] [d] 6. [a] [b] [c] [d] 11. [a] [b] [c] following routes EXCEPT: 2. [a] [b] 7. [a] [b] [c] [d] 12. [a] [b] [c] [d] a. blood transfusions. 3. [a] [b] [c] [d] 8. [a] [b] [c] [d] 13. [a] [b] [c] [d] b. sexual contact. 4. [a] [b] [c] [d] 9. [a] [b] [c] [d] 14. [a] [b] [c] c. mother to child during pregnancy. 5. [a] [b] [c] [d] 10. [a] [b] [c] [d] 15. [a] [b] [c] d. contact with feces of certain insects.

 I am enclosing $5 for this quiz made payable to: Ohio 14. Which of the following is the first drug approved for oral Pharmacists Association. treatment of all genotypes of hepatitis C infection? a. Epclusa® c. Vosevi® 1. Rate this lesson: (Excellent) 5 4 3 2 1 (Poor) b. Mavyret™ 2. Did it meet each of its objectives?  yes  no If no, list any unmet______3. Was the content balanced and without commercial bias? 15. Which of the following drugs is approved for eight-week  yes  no If no, why?______treatment? 4. Did the program meet your educational/practice needs? a. Epclusa® c. Vosevi®  yes  no b. Mavyret™ 5. How long did it take you to read this lesson and complete the quiz? ______To receive CPE credit, your quiz must be received no later than December 15, 2020. A passing grade of 80% must be attained. CPE credit for successfully completed quizzes will be uploaded to the CPE Monitor. CPE statements of credit can be printed from the CPE Moni- tor website. Send inquiries to [email protected]. december 2017