February - March - April 2017 Selected Content Updates. Approved to treat chorea associated with Huntington disease

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1 Selected Content for Customer Newsletter and Content Link February March April 2017 FDA Approvals new monographs and patient medication instructions Abaloparatide (Tymlos ) Approved to reduce the risk of vertebral and nonvertebral fractures in postmenopausal women Avelumab (Bavencio ) Approved to treat metastatic Merkel cell carcinoma in adults and pediatric patients 12 years of age or older Brigatinib (Alunbrig ) Approved to treat patients with metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer who have progressed on or are intolerant of crizotinib. Brodalumab (Siliq ) Cerliponase alfa (Brineura ) Approved to treat moderate-to-severe plaque psoriasis in adult patients Approved to slow the progression of a specific form of Batten disease Selected New Drug Approvals Dapagliflozin/ saxagliptin (Qtern ) Deflazacort (Emflaza ) Dermatophagoides farinae/dermatophagoides pteronyssinus extracts (Odactra ) Desmopressin acetate (Noctiva ) Deutetrabenazine (Austedo ) Dupilumab (Dupixent ) Durvalumab (Imfinzi ) Etelcalcetide (Parsabiv ) Infliximab-abda (Renflexis ) Methotrexate (Xatmep ) Midostaurin (Rydapt ) Naldemedine (Symproic ) Niraparib (Zejula ) Approved this once daily oral tablet as an adjunct to diet and exercise in adults with type 2 diabetes mellitus Approved to treat Duchenne muscular dystrophy in patients aged 5 years and older Approved to treat house dust mite allergic rhinitis in adult patients 18 to 65 years of age Approved to treat adult patients who awaken at least 2 times per night to void due to nocturnal polyruria Approved to treat chorea associated with Huntington disease Approved this subq injection to treat adults with moderate-to-severe eczema not adequately controlled by or not recommended for treatment with topical therapies Approved to treat adult patients with locally advanced or metastatic urothelial carcinoma who previously received platinum-containing chemotherapy Approved to treat secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis Approved infliximab biosimilar to treat adult and pediatric Crohn disease, and for adults with ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis Approved new oral solution formulation to treat acute lymphoblastic leukemia and to manage polyarticular juvenile idiopathic arthritis Approved to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive in combination with cytarabine and daunorubicin; also approved to treat adult patients with rare blood disorders Approved to treat opioid-induced constipation in adult patients with chronic non-cancer pain Approved for maintenance treatment in adult patients with recurrent epithelial ovarian, fallopian tube, or primary

2 Ocrelizumab (Ocrevus ) Ribociclib (Kisqali ) Safinamide (Xadago ) Sodium nitroprusside (Nipride RTU) Telotristat ethyl (Xermelo ) Valbenazine (Ingrezza ) peritoneal cancer Approved to treat adults with relapsing or primary progressive forms of multiple sclerosis Approved as first-line therapy in combination with any aromatase inhibitor to treat postmenopausal women with metastatic breast cancer Approved as add-on therapy for patients with Parkinson disease inadequately controlled on levodopa/carbidopa treatment. Approved the first ready-to-use injection to immediately reduce blood pressure in adult and pediatric patients in hypertensive crises Approved to treat carcinoid syndrome diarrhea in combination with somatostatin analog therapy in adults Approved to treat adults with tardive dyskinesia EMA Approvals (not already approved by FDA) new monographs Follitropin delta (Rekovelle) Indicated for controlled ovarian stimulation to develop multiple follicles in women undergoing assisted reproductive technologies Baricitinib (Olumiant) Indicated as monotherapy or in combination with methotrexate to treat moderate to severe active rheumatoid arthritis in adult patients New FDA-approved indications revised monographs and patient medication instructions Antithymocyte globulin rabbit (Thymoglobulin ) Atezolizumab (Tecentriq ) Ledipasvir/sofosbuvir, sofosbuvir (Harvoni, Sovaldi ) Lenalidomide (Revlimid ) Palbociclib (Ibrance ) Pembrolizumab (Keytruda ) Ranibizumab (Lucentis ) Regorafinib (Stivarga ) Now approved to prevent acute kidney transplant rejection in conjunction with concomitant immunosuppression therapy Expanded to include the initial treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are unable to receive cisplatin chemotherapy Now includes hepatitis C virus treatment in pediatric patients 12 years of age or older and weighing at least 35 kg Expanded to include maintenance treatment of patients with multiple myeloma following autologous stem cell transplant Expanded to include use in combination with any aromatase inhibitor to treat postmenopausal women with advanced or metastatic breast cancer Now approved to treat adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after 3 or more previous treatment Expanded to include treatment of all forms of diabetic retinopathy Now approved to treat patients with hepatocellular carcinoma who have received previous sorafenib treatment Tiotropium bromide (Spiriva Respimat ) Topiramate (Qudexy XR, Trokendi XR ) Now includes pediatric patients aged 6 years and older for long-term, once-daily maintenance asthma treatment Expanded to include migraine headache prophylaxis in adult and pediatric patients 12 years of age or older

3 Drug Safety Other Significant Other Significant Drug Safety revised monographs and patient medication instructions Codeine- or tramadolcontaining The US FDA announced the restricted use of codeine-containing cough and pain medicines and tramadol- cough and pain containing pain medicines in pediatric patients younger than 12 years of age and a recommendation against the medications use in breastfeeding mothers due to the serious risks, including respiratory depression and death. General anesthesia and sedatives Drug Levocetirizine (Xyzal Allergy 24HR) Disease The US FDA approved product labelling changes to the warnings, pregnancy, and pediatric use sections of the prescribing information for a select group of general anesthetics and sedation drugs. This decision is a result of a December 2016 FDA safety communication regarding the potential negative effects on brain development with use of these drugs in young pediatric patients and pregnant patients. The US FDA approved this once prescription antihistamine as an over-the-counter (OTC, nonprescription) treatment for seasonal and year-round allergies. Updated topics Diabetes mellitus HPV immunizations Influenza Sepsis Diabetes mellitus was update with the following guidelines: Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline Update from the American College of Physicians HPV immunizations was updated with the following guidelines: Use of a 2-Dose Schedule for Human Papillomavirus Vaccination Updated Recommendations of ACIP Influenza was update with the following guidelines: Prevention and Control of Seasonal Influenza with Vaccines Recommendations of the Advisory Committee on Immunization Practices United States, Influenza Season Sepsis was updated with the following guidelines: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) Zika Zika was updated with the following guideline: CDC: Additional Considerations for the Evaluation and Management of Infants with Possible Congenital Zika Virus Infection

4 NeoFax New Monographs and Calculators Revised Monographs Gatifloxacin, nusinersen 1st Quarter 2017 Selected NeoFax and Pediatrics Content Acetaminophen, amikacin, amphotericin B liposome, azithromycin, buprenorphine, calfactant, caspofungin, cefepime, cefotaxime, ceftazidime, chlorothiazide, ciprofloxacin, clindamycin, dexamethasone, DT/Td vaccine, DTaP vaccine, emtricitabine, fentanyl, fosphenytoin, furosemide, gentamicin, haemophilus b (Hib) conjugate vaccine, hepatitis B vaccine (recombinant), Hib conjugate/hepatitis B combination vaccine, hydrocortisone, ibuprofen, ibuprofen lysine, imipenem/cilastatin, indomethacin, insulin, levalbuterol, levothyroxine, meropenem, methadone, morphine, moxifloxacin, naloxone, piperacillin/tazobactam, pneumococcal 13-valent conjugate vaccine (PCV13), poliovirus vaccine enhanced-inactivated, rotavirus vaccine, sodium nitroprusside, sotalol, ticarcillin/clavulanate, tobramycin, topiramiate, vaccination schedule ACIP- 2017, vancomycin, vitamin K1, zidovudine. Dose and dose-related changes Pediatrics New Monographs and Calculators Chlorothiazide, fosphenytoin, imipenem/cilastatin, morphine, piperacillin-tazobactam, vitamin K1. Allopurinol, deflazacort, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, gatifloxacin, insulin degludec/insulin aspart, insulin detemir, lurasidone, naftifine, nusinersen, paricalcitol. Revised Monographs Abatacept, abobotulinumtoxina, acetaminophen, acetaminophen/codeine, adalimumab, amikacin, amoxicillin/clavulanate, amphetamine, amphotericin B liposome, ampicillin/sulbactam, anakinra, antihemophilic factor VIII (recombinant) pegylated, asenapine, azithromycin, budesonide/formoterol, buprenorphine, canakinumab, caspofungin, cefepime, cefixime, cefotaxime, cefprozil, ceftazidime, chlorothiazide, ciprofloxacin, citalopram, clindamycin, cyclosporine, daptomycin, dexamethasone, dextroamphetamine, dextroamphetamine/amphetamine, doxycycline, DT/Td vaccine, DTaP vaccine, duloxetine, eculizumab, elvitegravir/cobicistat/emtricitabine/tenofovir, emtricitabine, emtricitabine/rilpivirine/tenofovir disoproxil, emtricitabine/tenofovir alafenamide, epoprostenol, etanercept, etanercept-szzs, fentanyl, fluoxetine, fluticasone, fluticasone/salmeterol, fluvoxamine, foscarnet, fosphenytoin, furosemide, gentamicin, haemophilus b (Hib) conjugate vaccine, hepatitis A vaccine, hepatitis B vaccine (recombinant), Hib conjugate/hepatitis B combination vaccine, human papillomavirus (HPV) vaccine, hydrocodone/acetaminophen, hydrocortisone, ibuprofen, imipenem/cilastatin, indomethacin, infliximab, influenza virus vaccine, insulin, leflunomide, levalbuterol, levothyroxine, lisdexamfetamine, measles/mumps/rubella (MMR) virus vaccine (live), measles/mumps/rubella/varicella (MMRV) vaccine, meningococcal vaccine group B, meningococcal vaccine Group A, C, Y, and W-135, meningococcal/hib conjugate combination vaccine, meropenem, methadone, methamphetamine, methotrexate, morphine, moxifloxacin, nalbuphine, naloxone, olanzapine, ondansetron, oxycodone, oxycodone/acetaminophen, piperacillin/tazobactam, pneumococcal 13-valent conjugate vaccine (PCV13), pneumococcal polysaccharide vaccine (PPSV23), poliovirus vaccine enhanced-inactivated, prednisone, risperidone, rotavirus vaccine, sodium nitroprusside, somatropin, sotalol, tacrolimus, Tdap vaccine, tenofovir disoproxil fumarate,

5 ticarcillin/clavulanate, tiotropium, tobramycin, tocilizumab, topiramate, tramadol, vaccination schedule ACIP- 2017, vancomycin, varicella virus vaccine, live, venlafaxine, vitamin K1, zidovudine. Dose and dose-related changes Abatacept, adalimumab, abobotulinumtoxina, antihemophilic factor VIII (recombinant) pegylated, cefprozil, ciprofloxacin, daptomycin, doxycycline, fosphenytoin, furosemide, hepatitis B vaccine (recombinant), human papillomavirus (HPV) vaccine, imipenem/cilastatin, indomethacin, influenza virus vaccine, meningococcal vaccine group B, ondansetron, paricalcitol, piperacillintazobactam, prednisone, Tdap vaccine, tiotropium, vancomycin, vitamin K1.