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Home , Emapalumab, Ibalizumab, Mogamulizumab

NEW DRUG UPDATE 2019

KATIE BOYD, PHARMD, BCPS ASSISTANT PROFESSOR OF PHARMACY PRACTICE SAMFORD UNIVERSITY DISCLOSURES

• The presenter has nothing to disclose LEARNING OBJECTIVES

• Name the major new chemical entities approved by the FDA in 2018 • Recognize the major therapeutic aspects of new drugs approved by the FDA in 2018 (eg, indications, adverse reactions, drug interactions). • Evaluate the new drugs' place in possible disease state therapy. • Review new warnings added to in 2018 RARE DISEASES BUROSUMAB-TWZA (CRYSVITA®) Approved 4/17/18

• Mechanism of Action: Crysvita is a human monoclonal IgG1 antibody that binds to and inhibits FGF23, restoring renal phosphate reabsorption in x-linked hypophosphatemia (XLH). • How Supplied: • 10mg/mL, 20mg/mL, 30mg/mL Solution for Injection • Dosage: 1mg/kg SubQ every 4 weeks; max dose 90mg. • Special Considerations • Contraindications: Concomitant use of oral phosphate and active vitamin D analogs; serum phosphorus within or above normal range; severe renal impairment or ESRD MIGALASTAT (GALAFOLD™) Approved 8/10/18

• Mechanism of Action: Binds to and stabilizes alpha-galactosidase A protein • Indicated for Fabry disease with amenable GLA • How Supplied: • 123 mg oral capsule • Dosage: 123 mg once every other day (do not administer on 2 consecutive days) • Special Considerations • Administer on an empty stomach; do not consume food at least 2 hours before or 2 hours after the migalastat dose, although clear liquids may be consumed. • If more than 12 hours have passed since missed dose, skip and administer at next schedule dosing time AMIFAMPRIDINE (FIRDAPSE®) Approved 11/28/2018

• Mechanism of Action: potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults • How Supplied: • 10 mg tablets, functionally scored • Dosage: starting dosage is 15 mg to 30 mg daily taken orally in divided doses (3 to 4 times daily) • Special Considerations

• May induce seizures -LZSG (GAMIFANT®) Approved 11/20/2018

• Mechanism of Action: an gamma (IFNγ) blocking antibody • How Supplied: • 10 mg/2 mL and 50 mg/10 mL single-use glass vials • Dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week , concomitantly with dexamethasone • Special Considerations • adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) • with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. STIRIPENTOL (DIACOMIT®) Approved 8/20/2018

• Mechanism of Action: may enhance GABAergic inhibitory neurotransmission in Dravet syndrome • How Supplied:

• 250 mg, 500 mg oral capsule • 250 mg, 500 mg oral powder for suspension • Dosage: Titrate to 50 mg/kg daily divided in 2-3 doses. • Special Considerations

• Only for use in conjunction with clobazam and valproate WHICH OF THE FOLLOWING RARE DISEASES HAVE A NEW THAT WAS FDA APPROVED IN 2018?

• Select all that apply A. Fabry disease B. Lambert-Eaton myasthenic syndrome C. Dravet syndrome D. Hemophagocytic lymphohistiocytosis E. X-linked hypophosphatemia WHICH OF THE FOLLOWING RARE DISEASES HAVE A NEW MEDICATION THAT WAS FDA APPROVED IN 2018?

• Select all that apply A. Fabry disease B. Lambert-Eaton myasthenic syndrome C. Dravet syndrome D. Hemophagocytic lymphohistiocytosis E. X-linked hypophosphatemia INFECTIOUS DISEASES , , (BIKTARVY®) Approved 2/7/18

• Mechanism of Action: Bictegravir: Emtricitabine & Tenofovir alafenamide: Nucleoside Reverse Transcriptase Inhibitor (NRTIs) for treatment of HIV-1 infection • How Supplied: • 50mg-200mg-25mg oral tablet • Dosage: 1 tablet daily (50mg-200mg-25mg) • Special Considerations: • Contraindications: Coadministration with dofetilide, rifampin • US Boxed Warning: Severe acute exacerbations of HBV have been reported -UIYK (TROGARZO™) Approved 3/6/18

• Mechanism of Action: post-attachment inhibitor. It blocks HIV-1 from infecting CD4 T cells. • How Supplied: • 200mg/1.33mL Solution for Infusion • Dosage: Initial: 2,000mg IV as a single dose, followed by a maintenance dose of 800mg every 14 days thereafter. • Special Considerations: • Do not administer IV push or bolus PLAZOMICIN (ZEMDRI™) Approved 6/25/18

• Mechanism of Action: aminoglycoside antibiotic • For use in complicated urinary tract infections • How Supplied: • 500 mg/10 mL (10 mL) IV solution • Dosage: 15 mg/kg once daily for 4 to 7 days • Special Considerations • For patients with TBW greater than ideal body weight (IBW) by ≥25%, use adjusted body weight (ABW) for dosing. • Trough <3 mcg/mL RIFAMYCIN (AEMCOLO™) Approved 11/16/2018

• Mechanism of Action: a rifamycin antibacterial indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults • How Supplied:

• 194 mg tablets packaged in blister cards of 12 tablets contained in a cardboard carton • Dosage: 388mg(two tablets) orally twice daily for three days • Special Considerations • not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli. TAFENOQUINE (KRINTAFEL ®™) Approved 7/20/18

• Mechanism of Action: aminoquinoloine antimalarial • How Supplied: • 150 mg oral tablet • Dosage: 300mg as a single dose on the first or second day of the appropriate antimalarial therapy • Special Considerations • Radical cure (prevention of relapse) of P. vivax malaria in patients ≥16 years of age who are receiving appropriate antimalarial therapy for acute P. vivax infection OMADACYCLINE (NUZYRA™) Approved 10/3/2018

• Mechanism of Action: • Dosage: • Antibiotic of the tetracycline class • Community acquired pneumonia • Treats community acquired pneumonia • 200 mg IV loading dose followed by 100 and skin/skin structure infections mg IV daily OR 300 mg oral daily • How Supplied: • 7-14 days • Skin and skin structure infections • 100 mg vial IV solution, reconstituted • Loading dose: 200 mg IV once OR • 150 mg oral tablet 450 mg oral for 2 days • Maintenance dose: 100 mg IV daily OR 300 mg oral daily • 7-14 days TECOVIRIMAT (TPOXX®) Approved 7/13/18

• Mechanism of Action: antiviral for smallpox • How Supplied: • Tpoxx will be available initially only through the US government's Strategic National Stockpile. • Dosage: 600 mg twice daily for 14 days • Special Considerations • Developed to address the risk of bioterrorism ERAVACYLCLINE (XERAVA™) Approved 8/27/2018

• Mechanism of Action: antibiotic of the tetracycline class • Complicated intra-abdominal infections • How Supplied:

• 50 mg vial IV solution, reconstituted • Dosage: 1 mg/kg IV every 12 hours for 4-14 days • Special Considerations

• Must be adjusted with strong inducers or with severe hepatic impairment (PIFELTRO™) Approved 8/30/2018

• Mechanism of Action: Pyridinone non-nucleoside reverse transcriptase inhibitor for HIV-1 infection • How Supplied:

• 100 mg oral tablet • Dosage: 100 mg orally daily • Special Considerations

• Must be given in combination with other antiretroviral agents BALOXAVIR MARBOXIL (XOFLUZA™) Approved 10/24/2018

• Mechanism of Action: an with activity against influenza virus

• How Supplied: Patient Body Weight (kg) Recommended Oral Dose 40 kg to less than 80 kg Single Dose of 40 mg At least 80 kg Single Dose of 80 mg • Dosage: within 48 hours of influenza symptom onset. XOFLUZA is taken orally as a single dose and may be taken with or without food. • Special Considerations

• Avoid dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) SARECYCLINE (SEYSARA™) Approved 10/1/2018

• Mechanism of Action: Antibiotic of the tetracycline class • Moderate to severe non-nodular acne vulgaris • How Supplied:

• 60 mg, 100 mg, 150 mg oral tablet • Dosage: (weight based)

• 33-54 kg: 60 mg once daily

• 55-84 kg: 100 mg once daily

• 84-136 kg: 150 mg once daily • Special Considerations

• Administer with fluid to decrease risk of esophageal irritation or ulceration WHICH OF THE FOLLOWING IS TRUE REGARDING XOFLUZA?

A. It is active within 72 hours of symptoms of influenza virus

B. It is a single oral dose

C. Must be taken with milk WHICH OF THE FOLLOWING IS TRUE REGARDING XOFLUZA?

A. It is active within 72 hours of symptoms of influenza virus

B. It is a single oral dose

C. Must be taken with milk NEUROLOGICAL DISORDERS ERENUMAB-AOOE (AIMOVIG™) Approved 5/17/18

• Mechanism of Action: Aimovig is a human IgG2 that has high affinity binding to the CGRP receptor and antagonizes the receptor. • Migraine Prophylaxis • How Supplied: • 70mg/mL Autoinjector Solution for Injection • Dosage: 70mg SubQ once a month • Special Considerations: • Keep solution out of direct sunlight. Allow solution to come to room temperature. Do not shake. FREMANEZUMAB-VFRM (AJOVY™) Approved 9/14/2018

• Mechanism of Action: Antagonizes CGRP receptor function • Migraine prophylaxis • How Supplied:

• 225 mg/1.5 mL prefilled syringe • Dosage: 225 mg SQ monthly or 675 mg SQ every 3 months • Special Considerations

• 675 mg dose should be administered in 3 consecutive 225 mg doses GALCANEZUMAB-GNLM (EMGALITY®) Approved 9/27/2018

• Mechanism of Action: Antagonizes CGRP receptor function • Migraine prophylaxis • How Supplied:

• 120 mg/1 mL prefilled syringe • 120 mg/1 mL autoinjector • Dosage: 240 mg SQ loading dose followed by 120 mg SQ monthly • Special Considerations

• Administer 240 mg loading dose as two consecutive 120 mg doses WHICH OF THE FOLLOWING MEDICATIONS ARE INDICATED FOR MIGRAINE PROPHYLAXIS?

A. ERENUMAB-AOOE (AIMOVIG™)

B. FREMANEZUMAB-VFRM (AJOVY™)

C. GALCANEZUMAB-GNLM (EMGALITY®) WHICH OF THE FOLLOWING MEDICATIONS ARE INDICATED FOR MIGRAINE PROPHYLAXIS?

A. ERENUMAB-AOOE (AIMOVIG™)

B. FREMANEZUMAB-VFRM (AJOVY™)

C. GALCANEZUMAB-GNLM (EMGALITY®) HEART, LUNG, AND CIRCULATORY DISEASES TEZACAFTOR; IVACAFTOR (SYMDEKO®) Approved 2/13/18

• Mechanism of Action: Symdeko increases the quantity and function of the CFTR protein, resulting in increases in chloride transplant in cystic fibrosis patients. • How Supplied: • Copackaged as Tezacaftor-100mg/Ivacaftor-150mg and Ivacaftor 150mg • Dosage: Tezacaftor-100mg/Ivacaftor-150mg in the morning and Ivacaftor 150 mg in the evening (~12 hours apart) • Special Considerations: • Take with fat containing foods (eggs, butter, oils, dairy products) • Avoid food or drink containing grapefruit or Seville oranges REVEFENACIN (YUPELRI™) Approved 11/8/2018

• Mechanism of Action: an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) • How Supplied:

• 175 mcg vial (3 mL)

• Dosage: 1 vial of YUPELRI, 1 time each day inhaled through your nebulizer • Special Considerations

• Caution in narrow angle glaucoma, urinary retention, allergic reactions WOMEN’S HEALTH SEGESTERONE ACETATE AND ETHINYL ESTRADIOL VAGINAL SYSTEM (ANNOVERA™) Approved 8/10/18

• Mechanism of Action: estrogen and progestin combination contraceptive • How Supplied: • vaginal ring; anticipated availability late 2019 • Dosage: Insert 1 ring vaginally. Following insertion, ring should remain in place for 21 continuous days (3 weeks), then removed for 7 days (1 week). This pattern (3 weeks in and 1 week out) is one cycle; one ring provides contraception for 13 cycles (1 year). • Special Considerations • Wash ring with mild soap and lukewarm water, dry, and store in provided case until next use ELAGOLIX SODIUM (ORILISSA™) Approved 7/23/18

• Mechanism of Action: Gonadotropin Releasing Hormone Antagonist • Treats Endometriosis and Endometriosis with dyspareunia • How Supplied: • 150mg, 200mg oral tablet • Dosage: Endometriosis- Initial: 150 mg once daily; Maximum treatment duration: 24 months; Endometriosis with dyspareunia- Initial: Consider an initial dose of 200 mg twice daily; Maximum treatment duration: 6 months • Special Considerations • Decreased bone mineral density- consider calcium and vitamin D supplementation THE NEW CONTRACEPTIVE ANNOVERA™ PREVENTS PREGNANCY FOR HOW LONG?

A. 1 month B. 6 months C. 9 months D. 1 year THE NEW CONTRACEPTIVE ANNOVERA™ PREVENTS PREGNANCY FOR HOW LONG?

A. 1 month B. 6 months C. 9 months D. 1 year CANCER AND BLOOD DISORDERS LUTETIUM LU 177 DOTATATE (LUTATHERA®) Approved 1/26/18

• Mechanism of Action: Lutathera binds to somatostatin receptors inducing cellular damage by the formation of free radicals in somatostatin receptor-positive cells and neighboring cells to treat gastroenteropancreatic neuroendocrine tumors. • How Supplied: • 370 MBq/mL Solution for Injection • Dosage: 7.4 GBq IV every 8 weeks for a total of 4 doses. • Special Considerations: Administer an IV amino acid solution 30 minutes prior to Lutathera administration. Continue the infusion during and for at least 3 hours post infusion. Administer antiemetics 30 minutes prior to amino acid infusion. APALUTAMIDE (ERLEADA™) Approved 2/14/18

• Mechanism of Action: Erleada is a nonsteroidal androgen receptor inhibitor. It results in decreased proliferation of tumor cells and increased apoptosis in non-metastatic, castration resistant prostate cancer • How Supplied: • 60mg oral tablet • Dosage: 240mg once daily • Special Considerations: • Can cause hypercholesterolemia, hyperglycemia, hypertriglyceridemia, hypertension, fatigue, and skin rash FOSTAMATINIB (TAVALISSE™) Approved 4/17/18

• Mechanism of Action: Tavalisse is a tyrosine kinase inhibitor. Its major metabolite r406 reduces antibody-mediated destruction of platelets in patients with immune thrombocytopenia • How Supplied: • 100mg & 150mg oral tablet • Dosage: Initial: 100mg twice daily. After 1 month if platelet count is not at least 50,000 mm3, increase dose to 150mg twice daily. • Special Considerations: • May cause hypertension and increased ALTs FOSNETUPITANT & PALONOSETRON (AKYNZEO®) Approved 4/19/18

• Mechanism of Action: Fosnetupitant: selective substance P neruokinin 1 (NK1) receptor

antagonist; Palonosetron: selectively blocks serotonin 5-HT3 receptors • How Supplied: • 235mg-0.25mg Powder for Solution for Injection • Dosage: IV 235mg-0.25mg 30 minutes before on day 1. • Special Considerations • Avoid use if ESRD, CrCL < 30mL/minute, or Severe hepatic impairment AVATROMBOPAG (DOPTELET®) Approved 5/21/18

• Mechanism of Action: Doptelet is a receptor agonist that stimulates proliferation and differentiation of megakaryocytes, resulting in increased platelet production in patients with chronic liver disease-associated thrombocytopenia. • How Supplied: • 20mg oral tablet • Dosage: Platelet count 40,000-50,000mm3: 40 mg once daily for 5 consecutive days. Platelet count <40,000mm3: 60 mg once daily for 5 consecutive days. • Special Considerations • Administer with food CANNABIDIOL (EPIDIOLEX®) Approved 6/25/18

• Mechanism of Action: unknown MOA for treatment of seizure disorders, but does NOT appear to involve its effects on cannabinoid receptors • How Supplied: • Oral solution 100 mg/mL (100 mL) [contains alcohol, usp, sesame oil; strawberry flavor] • Dosage: Initial: 2.5 mg/kg twice daily (maximum dosage of 10 mg/kg twice daily) • Special Considerations • C-V • Maximum dose of 20mg/kg/day = lower seizure rates, but an increase in adverse effects CALASPARAGASE PEGOL-MKNL (ASPARLAS™) Approved 12/20/2018

• Mechanism of Action: asparagine specific enzyme indicated as a component of a multi- agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia • How Supplied: • 3,750 units/5 mL (750 units/mL) in a single-dose vial. • Dosage: 2,500units/m2 intravenously no more frequently than every 21 days. • Special Considerations

• Special caution in patients with previous hypersensitivity to L- or peg asparaginase (ULTOMIRIS™) Approved 12/21/2018

• Mechanism of Action: a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) • How Supplied: Body Weight Loading Dose Maintenance Range (kg) (mg) Dose (mg) • 300 mg/30 mL (10 mg/mL) in a single-dose vial greater or equal to 40 to less than 2,400 3,000 • Dosage: 60 greater than or equal to 60 to 2,700 3,300 less than 100 • Special Considerations greater than or 3,000 3,600 • Black box warning: serious meningococcal infection equal to 100 TAGRAXOFUSP-ERZS (ELZONRIS™) Approved 12/21/2018

• Mechanism of Action: CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) • How Supplied: • 1,000 mcg in 1 mL in a single-dose vial. • Dosage: 12 mcg/kg over 15 minutes once daily on days 1 to 5 of a 21-day cycle • Special Considerations

• Black box warning: capillary leak syndrome -KPKC (POTELIGEO®) Approved 8/8/18

• Mechanism of Action: Antineoplastic Agent, Anti-CC Receptor 4 Antibody • Treats relapsed or refractory and Sézary syndrome • How Supplied: • 20 mg/5 mL (5 mL) IV solution • Dosage: 1 mg/kg on days 1, 8, 15, and 22 of cycle 1, followed by 1 mg/kg on days 1 and 15 of each subsequent cycle • Special Considerations • Administer premedication (diphenhydramine and acetaminophen) prior to the first mogamulizumab-kpkc infusion (MEKTOVI®) Approved 6/27/18

• Mechanism of Action: antineoplastic agent, MEK inhibitor • Melanoma, unresectable or metastatic (with BRAF V600E or BRAF V600K mutation) • How Supplied: • 15 mg oral tablet • Dosage: 45 mg twice daily (in combination with ) • Special Considerations • This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Binimetinib may cause reproductive toxicity, teratogenicity, and has a structural or toxicity profile similar to existing hazardous agents. ENCORAFENIB (BRAFTOVI®) Approved 6/27/18

• Mechanism of Action: antineoplastic agent, BRAF kinase inhibitor • Melanoma, unresectable or metastatic (with BRAF V600E or BRAF V600K mutation) • How Supplied: • 50 mg, 75 mg oral capsule • Dosage: 450 mg once daily (in combination with binimetinib) • Special Considerations • This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Encorafenib may cause teratogenicity, carcinogenicity, and reproductive toxicity, and has a structural or toxicity profile similar to existing hazardous agents. DUVELISIB (COPIKTRA™) Approved 9/24/2018

• Mechanism of Action: Oral inhibitor of PI3K which is expressed in hematologic malignancies • To treat relapsed or refractory small lymphocytic leukemia and follicular lymphoma • How Supplied:

• 15 mg, 25 mg oral capsule • Dosage: 25 mg orally twice daily • Special Considerations

• Must be adjusted if symptoms of toxicity occur (XOSPATA®) Approved 11/28/2018

• Mechanism of Action: a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation • How Supplied:

• 40 mg tablets • Dosage: 120 mg orally once-daily • Special Considerations • May cause posterior reversible encephalopathy syndrome (PRES), prolonged QT interval, pancreatitis, embryo-fetal toxicity (VITRAKVI®) Approved 11/26/2018

• Mechanism of Action: kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation • How Supplied:

• 25 mg and 100 mg capsules • 20 mg/mL oral solution • Dosage: 100 mg orally twice daily • Special Considerations

• Caution: neurotoxicity and liver toxicity MOXETUMOMAB PASUDOTOX-TDFK (LUMOXITI™) Approved 9/13/2018

• Mechanism of Action: CD22 directed cytotoxin • For treatment of relapsed/refractory hairy cell leukemia • Toxin is a pseudomonas endotoxin! • How Supplied:

• 1 mg vial IV solution, reconstituted • Dosage: 0.4 mg/kg IV on days 1, 3, and 5 of each 28-day cycle for max of 6 cycles • Special Considerations

• 1 L of isotonic IV solution should be given before and after each infusion • Appropriate pre-medications, post-medications, and thromboprophylaxis should be considered -RWLC (LIBTAYO®) Approved 9/28/2018

• Mechanism of Action: Binds and inhibits PD-1 interaction with PD-L1 and PD-L2 leading to anti-tumor response in metastatic or locally advanced cutaneous squamous cell carcinoma • How Supplied:

• 350 mg/7 mL IV solution • Dosage: 350 mg IV every 3 weeks • Special Considerations

• Must be diluted with NS or D5W to 1-20 mg/mL prior to administration (TIBSOVO®) Approved 7/20/18

• Mechanism of Action: antineoplastic agent, IDH1 Inhibitor • For relapsed or refractory acute myeloid leukemia • How Supplied: • 250mg oral tablet • Dosage: 500mg once daily for a minimum of 6 months • Special Considerations • Confirm IDH1 mutation status in the blood or bone marrow prior to therapy initiation. GLASDEGIB (DAURISMO™) Approved 11/21/2018

• Mechanism of Action: a hedgehog pathway inhibitor indicated, in combination with low- dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) • How Supplied:

• 100 mg and 25 mg tablets • Dosage: 100 mg once daily • Special Considerations

• For use in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy (LORBRENA®) Approved 11/2/2018

• Mechanism of Action: a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) • How Supplied:

• 25 mg or 100 mg tablets • Dosage: 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity • Special Considerations • disease has progressed on other ALK inhibitors including , , and TALAZOPARIB (TALAZOPARIB™) Approved 10/16/2018

• Mechanism of Action: a poly (ADP-ribose) polymerase (PARP) inhibitor • How Supplied:

• 0.25 mg capsules • 1 mg capsules • Dosage: 1 mg taken orally once daily, with or without food. • Special Considerations • human epidermal growth factor receptor 2 [HER2]-negative breast cancer • an abnormal inherited BRCA gene • metastatic breast cancer INOTERSEN (TEGSEDI™) Approved 10/5/2018

• Mechanism of Action: Causes degradation of TTR mRNA reducing TTR protein deposits in tissues of patients with polyneuropathy of hereditary transthyretin mediated amyloidosis • How Supplied:

• 284 mg/1.5 mL prefilled syringe • Dosage: 284 mg SQ once weekly • Special Considerations

• Must be administered on the same day every week (VIZIMPRO®) Approved 9/27/2018

• Mechanism of Action: Irreversible inhibitor of EGFR tyrosine kinase • First line for metastatic non-small cell lung cancer • How Supplied:

• 15 mg, 30 mg, 45 mg oral tablets • Dosage: 45 mg orally daily • Special Considerations

• Must confirm tumor EGFR exon 19 deletions or exon 21 L858R substitution mutations prior to treatment WHICH OF THE FOLLOWING ANTINEOPLASTIC AGENTS ARE FDA APPROVED TO BE GIVEN TOGETHER?

A. VIZIMPRO® + VITRAKVI®

B. TEGSEDI™ + TALAZOPARIB™ C. MEKTOVI® + BRAFTOVI® D. ULTOMIRIS™ + ELZONRIS™ WHICH OF THE FOLLOWING ANTINEOPLASTIC AGENTS ARE FDA APPROVED TO BE GIVEN TOGETHER?

A. VIZIMPRO® + VITRAKVI®

B. TEGSEDI™ + TALAZOPARIB™ C. MEKTOVI® + BRAFTOVI® D. ULTOMIRIS™ + ELZONRIS™ OTHER DISEASES (ILUMYA™) Approved 3/20/18

• Mechanism of Action: humanized IgG1/k monoclonal antibody. Ilumya prevents the release of proinflammatory and given for plaque psoriasis • How Supplied: • 100mg/mL Prefilled Syringe Solution for Injection • Dosage: 100mg SubQ at weeks 0, 4, and then every 12 weeks thereafter • Special Considerations • Screening for Latent TB before initiating therapy is beneficial LOFEXIDINE HYDROCHLORIDE (LUCEMYRA™) Approved 5/16/18

• Mechanism of Action: Lucemyra is a central alpha-2 agonist that binds to adrenergic receptors, resulting in a reduction in the release of NE and a decrease in sympathetic tone in patients with opioid withdrawal. • How Supplied: • 0.18mg oral tablet • Dosage: Initial: 0.54mg 4 times daily during peak withdrawal symptoms; adjust based on symptoms. • Special Considerations: • Taper dose over 2-4 days. Reduce by 0.18mg per dose every 1-2 days. SODIUM ZIRCONIUM CYCLOSILICATE (LOKELMA™) Approved 5/18/18

• Mechanism of Action: Lokelma is a potassium binder with high affinity for potassium ions. Fecal excretion of potassium is increased due to binding of potassium in the GI tract in patients with hyperkalemia. • How Supplied: • 5mg & 10mg powder for oral suspension • Dosage: Initial: 10g 3 times daily for up to 48 hours. Maintenance: 10 g once daily • Special Considerations • May increase serum concentration of Warfarin • Administer other oral medications ≥ 2 hours before or 2 hours after dose PEGVALIASE-PQPZ (PALYNZIQ®) Approved 5/24/18

• Mechanism of Action: Palynziq is a pegylated phenylalanine ammonia lyase enzyme that converts phenylalanine to ammonia and trans-cinnamic acid in patients with phenylketonuria (PKU). • How Supplied: • 2.5mg/0.5mL, 10mg/0.5mL, 20mg/1mL Solution for Injection • Dosage: Induction: 2.5mg SubQ once weekly for 4 weeks. Maintenance: 20mg SubQ once weekly for at least 24 weeks. • Special Considerations: • US Boxed Warning: Anaphylaxis has been reported and may occur at any time during therapy. • Prescribe an auto-injectable epinephrine to all patients (OLUMIANT®) Approved 5/31/18

• Mechanism of Action: Olumiant is a (JAK) Inhibitor given for patients with rheumatoid arthritis • How Supplied: • 2mg oral tablet • Dosage: 2mg once daily • Special Considerations: • US Boxed Warning: Patients are at an increased risk for serious infections, malignancy, and thrombosis. MOXIDECTIN Approved 6/13/18

• Mechanism of Action: anthelminthic agent active against non-adult stage Onchocerca volvulus • How Supplied: • 2mg oral tablet • Dosage: 8mg as a single dose • Special Considerations: • *Product will be available for onchocerciasis endemic parts of the world • Can be used in patients > 12 years old • Also used in the treatment of heartworms for dogs, cats, horses etc FISH OIL TRIGLYCERIDES (OMEGAVEN®) Approved 7/27/18

• Mechanism of Action: metabolized and utilized as an energy source • Indicated for treatment of Pediatric Parenteral nutrition-associated cholestasis • How Supplied: • 5 g/50 mL (50 mL); 10g/100mL (100 mL) IV emulsion • Dosage: 1 g/kg/day infused over 8 to 24 hours; maximum: 1 g/kg/day • Special Considerations • Caloric content: 1.12 kcal/mL LUSUTROMBOPAG (MULPLETA®) Approved 7/31/18

• Mechanism of Action: small molecule thrombopoietin (TPO) receptor agonist • Chronic liver disease-associated thrombocytopenia • How Supplied: • 3 mg oral tablet • Dosage: 3 mg once daily for 7 days • Special Considerations • Begin lusutrombopag 8 to 14 days prior to the scheduled procedure. Patients should undergo procedure 2 to 8 days after the last lusutrombopag dose. Obtain a platelet count prior to therapy administration and not more than 2 days before the procedure. PATISIRAN (ONPATTRO™) Approved 8/10/18

• Mechanism of Action: Anti-Transthyretin Small Interfering Ribonucleic Acid (siRNA) Agent • Treatment of polyneuropathy • How Supplied: • 10 mg/5 mL (5 mL) IV solution • Dosage: <100 kg: 0.3 mg/kg once every 3 weeks, ≥100 kg: 30 mg once every 3 weeks (dose based on actual body weight) • Special Considerations • At least 60 minutes prior to administration of patisiran, premedicate with a corticosteroid, acetaminophen, an H1 blocker, and an H2 blocker to reduce the risk of infusion-related reactions (IRR). CENEGERMIN-BKBJ (OXERVATE™) Approved 8/22/2018

• Mechanism of Action: Mimics endogenous nerve growth factor in the eye • For treatment of neurotrophic keratitis • How Supplied:

• 1 mL of 0.002% opthalmic solution • Dosage: Instill 1 drop into affected eye 6 times daily for 8 weeks • Special Considerations

• Remove contacts prior to use • Separate from other medications by 15 minutes (TAKHZYRO™) Approved 8/23/2018

• Mechanism of Action: Binds and inhibits kallikrein, decreasing bradykinin generation • Hereditary angioedema prophylaxis • How Supplied:

• 300 mg/2 ml solution for injection • Dosage: 300 mg SQ every 2 weeks • Special Considerations

• May space out to every 4 weeks if well controlled for >6 months ELAPEGADEMASE-LVLR (REVCOVI™) Approved 10/5/2018

• Mechanism of Action: exogenous adenosine deaminase that reduces levels of toxic adenosine and deoxyadenosine and increases lymphocytes • Treatment of severe combined immune deficiency • How Supplied:

• 2.4 mg/1.5 mL IM solution • Dosage: 0.2 mg/kg twice weekly for 12-24 weeks • Special Considerations

• Initial dosing based on ideal body weight • Titration based on laboratory values PRUCALOPRIDE (MOTEGRITY™) Approved 12/14/2018

• Mechanism of Action: serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. • How Supplied:

• 1 mg, 2 mg tablets • Dosage: 2 mg once daily, with or without food • Special Considerations

• Avoid in intestinal obstruction, perforation, Crohn’s disease, ulcerative colitis, or other inflammatory diseases NEW FDA WARNINGS

WHICH OF THE FOLLOWING IS A NEW WARNING FOR FLUOROQUINOLONES

A. Ruptures or tears in aorta B. Low blood sugar levels C. Mental health side effects D. Fouriner’s gangrene WHICH OF THE FOLLOWING IS A NEW WARNING FOR FLUOROQUINOLONES

A. Ruptures or tears in aorta B. Low blood sugar levels C. Mental health side effects D. Fouriner’s gangrene NEW DRUG UPDATE 2019

KATIE BOYD, PHARMD, BCPS ASSISTANT PROFESSOR OF PHARMACY PRACTICE SAMFORD UNIVERSITY