May2013 CPG Updates
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New Drugs May 2013 (Original New Drug Applications: FDA) Generic Name Trade Name Indication(s) CPG Action/Date January 2013 Icosapent Ethyl Vascepa Cardiovascular Agents: 5/20/13 Antihyperlipidemic Agents. CTP holder may Indicated as an adjunct prescribe. to diet to reduce triglyceride levels in adult patients with severe (500mg/dL or more) Formulary Pg. 12 hypertriglyceridemia. Linaclotide Linzess Gastrointestinal Agents: 5/20/13 Linaclotide. Indicated for the CTP holder may treatment of chronic prescribe. idiopathic constipation in adults and for the treatment of irritable bowel syndrome with Formulary Pg. 21 constipation in adults. Teriflunomide Aubagio Biologic/ Immunologic 5/20/13 Agents: Immunologic Agents: Physician Initiated/ Immunomodulators. Physician Consult Indicated for the treatment of patients with relapsing forms of Formulary Pg. 24 multiple sclerosis. February 2013 Vitamin A Palmitate Aquasol Nutrients & Nutritional 5/20/13 Injection Agents: Vitamins. Indicated for the CTP holder may treatment of vitamin A prescribe. Formulary Pg. 5 deficiency. Perampanel Fycompa Central Nervous System 5/20/13 Agents: Anticonvulsants: Adjuvant Physician Initiated/ Anticonvulsants. Physician Consult Indicated as an adjunctive therapy for the treatment of partial- onset seizures with or without secondarily Formulary Pg. 19 generalized seizures in 1 CPG Updates May 2013 patients with epilepsy who are 12 years and older. Regorafenib Stivarga Antineoplastic Agents: 5/20/13 Kinase Inhibitors. Indicated for the CTP holder May treatment of patients NOT prescribe. with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an antivascular endothelial growth factor (VEGF) therapy, and, if KRAS wild type, an antiepidermal growth factor receptor (EGFR) Formulary Pg. 29 therapy. Omacetaxine Synribo Antineoplastic Agents: 5/20/13 Mepesuccinate Protein Synthesis Injection Inhibitor. CTP holder May Indicated for the NOT prescribe. treatment of adults with chronic or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to 2 or more tyrosine kinase Formulary Pg. 29 inhibitors. March 2013 Tofacitinib Citrate Xeljanz Biologic Immunologic 5/20/13 Oral Agents: Antirheumatic Agents. Physician Initiated/ Indicated for the Physician Consult treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate as monotherapy or in combination with methotrexate or other nonbiologic disease Formulary Pg. 24 modifying antirheumatic 2 CPG Updates May 2013 drugs. Triamcinolone Trivaris Ophthalmic Agents: 5/20/13 Acetonide – Corticosteroids. Intravitreal Injection Indicated for the CTP holder May treatment of sympathetic NOT prescribe. ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive Formulary Pg. 26 to topical corticosteroids. Ocriplasmin Jetrea Ophthalmic Agents: 5/20/13 Ophthalmic Proteolytic Enzymes. CTP holder May Indicated for the NOT prescribe. treatment of symptomatic Formulary Pg. 26 vitreomacular adhesion. Sulfacetamide Sulster Ophthalmic Agents: 5/20/13 Sodium - Ophthalmic Ophthalmic Antibiotics. Indicated for the CTP holder may treatment of prescribe. conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide Formulary Pg. 26 therapy of trachoma. Vincristine Sulfate Marqibo Antineoplastic Agents: 5/20/13 Liposome Antimitotic Agents. Indicated for the CTP holder May treatment of adult NOT prescribe. patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following 2 or more anti- Formulary Pg. 27 leukemia therapies. April 2013 Apixaban Eliquis Hematological Agents: 5/20/13 Anticoagulants. Indicated to reduce the Physician Initiated/ risk of stroke and Physician Consult systemic embolism in Formulary Pg. 7 patients with nonvalvular 3 CPG Updates May 2013 atrial fibrillation. Pasireotide Signifor Endocrine & Metabolic 5/20/13 Diaspartate Injection Agents: Somatostatin Analogs. CTP holder may Indicated for the prescribe. treatment of adult patients with Cushing disease for whom pituitary surgery is not an option or has not Formulary Pg. 9 been curative Lomitapide Juxtapid Cardiovascular Agents: 5/20/13 Antihyperlipidemic Agents. CTP holder may Indicated as an adjunct prescribe. to a low fat diet and other lipid-lowering treatments, including low-density lipoprotein apheresis where available, to reduce low- density lipoprotein cholesterol, total cholesterol, apolipoprotein, and non- high-density lipoprotein cholesterol in patients with homozygous Formulary Pg. 12 familiar hypercholesterolemia. Mometasone Furoate Propel Respiratory Agents: 5/20/13 Miscellaneous Respiratory Agents. CTP holder May Indicated to maintain NOT prescribe. patency following Formulary Pg. 14 ethmoid sinus surgery. Teduglutide Gattex Gastrointestinal Agents: 5/20/13 Glucagon-Like Peptide-2 Analogs. CTP holder may Indicated for the prescribe. treatment of adult patients with short bowel syndrome who are dependent on parenteral Formulary Pg. 21 support. Crofelemer Fulyzaq Gastrointestinal Agents: 5/20/13 Antidiarrheals. Indicated for CTP holder may symptomatic relief of prescribe. 4 CPG Updates May 2013 Formulary Pg. 21 noninfectious diarrhea in patients with HIV/AIDS on antiretroviral therapy. Unoprostone Rescula Ophthalmic Agents: 5/20/3 Isopropyl Ophthalmic Agents for Glaucoma. Indicated for lowering Physician Initiated/ intraocular pressure in Physician Consult patients with open-angle glaucoma or ocular Formulary Pg. 26 hypertension. Cysteamine Cystaran Ophthalmic Agents: 5/20/3 Hydrochloride Cystine-Depleting Ophthalmic Agents. Physician Initiated/ Indicated for the Physician Consult treatment of corneal cysteine crystal accumulations in Formulary Pg. 26 patients with cystinosis. Ponatinib Iclusig Antineoplastic Agents: 5/20/13 Kinase Inhibitors. Indicated for the CTP holder May treatment of adult NOT prescribe. patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy and for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase Formulary Pg. 29 inhibitors. Cabozantinib Cometriq Antineoplastic Agents: 5/20/13 Kinase Inhibitors. Indicated for the CTP holder May treatment of patients NOT prescribe. with progressive metastatic medullary Formulary Pg. 29 thyroid cancer. 5 CPG Updates May 2013 New Drugs Indications/ Warnings May 2013 (New Drug Indications/ Black Box Warnings: FDA Generic Name Trade Name Indication(s) CPG Action/Date January 2013 Pregabalin Oral Lyrica Central Nervous System Current: CTP holder Agents: Anticonvulsants. may prescribe. New indication for the management of 5/20/13 neuropathic pain No Changes associated with spinal Formulary Pg. 19 cord injury. February 2013 Levofloxacin Oral and Levaquin Anti-Infectives, Current: CTP holder Injection Systemic: may prescribe. Fluoroquinolones. New indication for 5/20/13 treatment of plague, No changes including pneumonic and septicemic plague, due to Yersinia pestis and prophylaxis of plague in adults and pediatric patients 6 months and Formulary Pg. 22 older. Emtricitabine/ Truvada Anti-Infectives, Current: Physician Tenofovir Disoproxil Systemic: Antiretroviral Initiated/ Physician Fumarate Agents: Nucleoside Consult Analog Reverse Transcriptase Inhibitor 5/20/13 Combinations. No Change New indication for pre- exposure prophylaxis to reduce sexually acquired HIV-1 in adults at high Formulary Pg. 24 risk. Ranibizumab Lucentis Ophthalmic Agents: Current: CTP holder Selective Vascular May NOT prescribe. Endothelial Growth Factor Antagonist. 5/20/13 New indication for the No Change treatment of patients with diabetic macular Formulary Pg. 26 edema. Aflibercept Eylea Ophthalmic Agents: Current: CTP holder Selective Vascular May NOT prescribe. Endothelial Growth Factor Antagonists. 5/20/13 New indication for the No Change treatment of neovascular (wet) age-related 6 CPG Updates May 2013 macular degeneration. Formulary Pg. 26 Cetuximab Erbitux Antineoplastic Agents: Current: CTP holder Monoclonal Antibodies. May NOT prescribe. New indication for treatment of K-Ras 5/20/13 mutation-negative (wild- No Change type), epidermal growth factor receptor expressing metastatic Formulary Pg. 29 colorectal cancer. March 2013 Tapentadol Nucynta ER Central Nervous System Current: CTP holder Agents: Schedule II may prescribe for analgesics. initial therapy or in New indication for the an institutional management of setting per neuropathic pain institutional associated with diabetic standards. peripheral neuropathy in Physician Initiated/ adults when a Physician Consult continuous, around-the- for CTPs holder clock opioid analgesic is initiating therapy needed for an extended with a schedule II period of time. medication for more Formulary Pg. 16 than a 7-day supply. 5/20/13 No Change Calcipotriene/ Taclonex Dermatologic Agents: Current: CTP holder Betamethasone Antipsoriatic Agents. may prescribe. Dipropionate New indication for the topical treatment of 5/20/13 plaque psoriasis of the No Change scalp and body in patients 18 years and Formulary Pg. 25 older. Pazopanib Votrient Antineoplastic Agents: Current: CTP holder Kinase Inhibitors.