7/1/2014 New Drug Update LaKeisha Williams, PharmD, MSPH Drug Information Specialist Xavier University of Louisiana College of Pharmacy LPA Annual Convention –July 18, 2014 Speaker Disclosures • The speaker declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program. 1 7/1/2014 Learning Objectives • At the completion of this activity, PHARMACISTS will be able to: – Recognize the clinical indications for selected new therapeutic agents approved by the Food and Drug Administration (FDA). – Explain the mechanisms of action for new therapeutic agents discussed. – Identify common adverse reactions, relevant drug interactions and key contraindications for the new approved therapeutic agents. – Discuss pertinent patient education for newly approved agents. Learning Objectives • At the completion of this activity, PHARMACY TECHNICIANS will be able to: – Describe selected new therapeutic agents approved by the Food and Drug Administration (FDA). – Recognize the indications of selected new therapeutic agents. – Summarize adverse reactions and precautions when evaluating FDA approved agents. – List counseling tips for newly approved therapeutic agents. 2 7/1/2014 New Drug Approvals of 2013 • Food and Drug Administration (FDA) approved 27 new molecular entities (NMEs) – More than a third (36%) of novel drugs approved are for rare diseases – Nearly one out of three (32%) are the first in their class – Approximately three‐quarters (72%) of novel drugs were first approved in the U.S. Jenkins J. U.S. Food and Drug Administration/FY 2013 New Drug Review. www.fda.gov New Drug Approvals of 2014 • Food and Drug Administration (FDA) approved 16 new molecular entities (NMEs) – Innovative new products that never before have been used in clinical practice – Many contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product Food and Drug Administration. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products of 2014 http://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/default.htm. 3 7/1/2014 Assessment Question #1 Which of the following is indicated for the treatment of type 2 diabetes? a.Nesina (alogliptin) b.Kazano (alogliptin) c. Oseni (alogliptin/pioglitazone) d.Invokana (canagliflozin) e.All of the above Assessment Question #2 Brintellix (vortioxetine) is FDA indicated for: a.COPD b.Urea cycle disorder c.Breast cancer d.Depression e.Osteoporosis 4 7/1/2014 Assessment Question #3 Which of the following is indicated for pulmonary hypertension? a.Adempas (riociguat) b.Mekinist (trametinib) c. Osphena (ospemifene) d.Ravicti (glycerol phenylbutyrate) e.Tivicay (dolutegravir) Assessment Question #4 Pomalyst (pomalidomide) is indicated for which of the following? a.Hypercholesterolemia b.Multiple sclerosis c. Multiple myeloma d.HIV e.Pulmonary hypertension 5 7/1/2014 Assessment Question #5 Which of the following is a reputable source of evidence‐based information? a.Food and Drug Administration b.Pharmacist’s Letter c.Micromedex d.Access Pharmacy e.All of the above DIABETES 6 7/1/2014 New Approved Agents for Diabetes Class: Sodium‐glucose cotransporter 2 (SGLT2) inhibitors Farxiga™ (dapagliflozin) Invokana™ (canagliflozin) • Indication and Usage • Indication and Usage – Adjunct to diet and exercise to – Treatment of type 2 diabetes improve glycemic control in mellitus as an adjunct to diet adults with type 2 diabetes and exercise as monotherapy mellitus or in combination therapy with other antidiabetic agents – Assess volume status and renal function prior to therapy • Dosage • Dosage – 100 mg once daily prior to first meal of the day; may – 5 mg once daily in the morning, increase to 300 mg once daily with or without food; may – maximum dose: 300 mg once increase to 10 mg once daily daily Product Information: FARXIGA oral tablets, dapagliflozin oral tablets. Bristol‐Myers Squibb Company (per manufacturer), Princeton, NJ, 2014. Product Information: INVOKANA(TM) oral tablets, canagliflozin oral tablets. Janssen Pharmaceuticals, Inc. (per manufacturer), Titusville, NJ, 2013. Micromedex (electronic version). Retrieved April 10, 2014, http://www.micromedexsolutions.com/micromedex2/librarian. Greenwood Village, CO: Truven Health Analytics New Approved Agents for Diabetes Farxiga™ (dapagliflozin) Invokana™ (canagliflozin) • Contraindications • Contraindications – History of serious – History of serious hypersensitivity to hypersensitivity to dapagliflozin or any dapagliflozin or any component of the component of the formulation formulation – Severe renal impairment – Severe renal impairment – End‐stage renal disease – Dialysis (ESRD) or patients on dialysis Product Information: FARXIGA oral tablets, dapagliflozin oral tablets. Bristol‐Myers Squibb Company (per manufacturer), Princeton, NJ, 2014. Product Information: INVOKANA(TM) oral tablets, canagliflozin oral tablets. Janssen Pharmaceuticals, Inc. (per manufacturer), Titusville, NJ, 2013. Micromedex (electronic version). Retrieved April 10, 2014, http://www.micromedexsolutions.com/micromedex2/librarian. Greenwood Village, CO: Truven Health Analytics. 7 7/1/2014 New Approved Agents for Diabetes Farxiga™ (dapagliflozin) Invokana™ (canagliflozin) • Drug Interactions • Drug Interactions – None reported – Digoxin Fosphenytoin • Adverse Effects (serious) Phenobarbital – Hypotension, Hypoglycemia, Phenytoin Fracture of bone, Malignant Rifampin tumor of urinary bladder, Ritonavir Renal impairment, Volume • Adverse Effects (serious) depletion – Hypoglycemia, Pancreatitis, Renal impairment, Hypovolemia, Hyperkalemia, Angioedema Common adverse effects: Urinary tract infections, genital infections, nasopharnygitis (dapagliflozin), polyuria (canagliflozin) Product Information: FARXIGA oral tablets, dapagliflozin oral tablets. Bristol‐Myers Squibb Company (per manufacturer), Princeton, NJ, 2014. Product Information: INVOKANA(TM) oral tablets, canagliflozin oral tablets. Janssen Pharmaceuticals, Inc. (per manufacturer), Titusville, NJ, 2013. Micromedex (electronic version). Retrieved April 10, 2014, http://www.micromedexsolutions.com/micromedex2/librarian. Greenwood Village, CO: Truven Health Analytics New Approved Agents for Diabetes • Nesina® (alogliptin) – Dipeptidyl peptidase‐4 (DPP‐4) inhibitor • Oseni® (alogliptin/pioglitazone) – Dipeptidyl peptidase‐4 inhibitor and thiazolidinedione • Kazano® (alogliptin/metformin) – Dipeptidyl‐peptidase‐4 (DPP‐4) inhibitor and a biguanide • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus • Not for treatment of type 1 diabetes or diabetic ketoacidosis Product Information: NESINA oral tablets, alogliptin oral tablets. Takeda Pharmaceuticals America, Inc. (per manufacturer), Deerfield, IL, 2013. 8 7/1/2014 New Approved Agents for Diabetes Nesina® (alogliptin) • Recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily • Adjust dose if moderate or severe renal impairment or end‐stage renal disease (ESRD) • Common adverse effects include: nasopharyngitis, headache and upper respiratory tract infection Product Information: NESINA oral tablets, alogliptin oral tablets. Takeda Pharmaceuticals America, Inc. (per manufacturer), Deerfield, IL, 2013. New Approved Agents for Diabetes Nesina® (alogliptin) • Contraindicated in patients with history of serious hypersensitivity reactions to alogliptin‐containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions • Warn patients for signs and symptoms of pancreatitis, hypersensitivity reactions, hepatic effects, hypoglycemia, angioedema and macrovascular outcomes • Primarily renally excreted • Pregnancy Category B • No significant drug interactions Product Information: NESINA oral tablets, alogliptin oral tablets. Takeda Pharmaceuticals America, Inc. (per manufacturer), Deerfield, IL, 2013. 9 7/1/2014 New Approved Agents for Diabetes: Nesina® (alogliptin) Product Information: NESINA oral tablets, alogliptin oral tablets. Takeda Pharmaceuticals America, Inc. (per manufacturer), Deerfield, IL, 2013. New Approved Agents for Diabetes • Individualize the starting dose Oseni® based on the patient’s current regimen and concurrent (alogliptin/pioglitazone) medical condition – Do not exceed a daily dose of alogliptin 25 mg and pioglitazone 45 mg – Do not split tablet • Limit initial dose of pioglitazone to 15 mg once daily in patients with NYHA Class I or II heart failure • Caution in patients with liver disease Product Information: OSENI oral tablets, alogliptin pioglitazone oral tablets. Takeda Pharmaceuticals America, Inc. (per manufacturer), Deerfield, IL, 2013.. 10 7/1/2014 New Approved Agents for Diabetes • Adjust dose if moderate renal impairment Oseni® • Limit initial dose of pioglitazone (alogliptin/pioglitazone) to 15 mg once daily in patients with NYHA Class I or II heart failure • Not recommended for patients with severe renal impairment or end‐stage renal disease (ESRD) requiring dialysis • Maximum recommended dose of pioglitazone is 15 mg once daily in patients taking strong CYP2C8 inhibitors Product Information: OSENI oral tablets, alogliptin pioglitazone oral tablets. Takeda Pharmaceuticals America, Inc. (per manufacturer), Deerfield, IL, 2013.. New Approved Agents for Diabetes Oseni® (alogliptin/pioglitazone) • Contraindications: – History of serious hypersensitivity reactions, such as anaphylaxis,