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.