Max: 15 mg/day PO. The safety and • Bupropion hydrochloride (Zyban®): risk of serotonin syndrome with use with other serotonergic drugs [MHRA/CHM advice]. • Romosozumab (Evenity®) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture [SMC guidance]. By using this website or closing this message, you are agreeing to our Cookies notice. Esketamine hydrochloride is contained as a solution in a stoppered glass vial within the nasal spray device. • Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia [NICE guidance]. Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate, Active Psoriatic Arthritis (PsA) in patients 2 years of age and older, Adult patients with active Ankylosing Spondylitis (AS), Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older. The BNF is the only drug formulary in the world that is both independent, and has rigorous, accredited content creation processes. ), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity [MHRA/CHM advice]. • Sunitinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Date of Original Approval: February 7, 2012. Date of Original Approval: December 14, 2012, New Indication Approved: December 18, 2020 Clarity’s Diagnosis and Treatment Guidance, Dale and Appelbe’s Pharmacy and Medicines Law, Drug Administration via Enteral Feeding Tubes, http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm, https://www.medicinescomplete.com/#/content/bnf/PHP107699. • Bevacizumab: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. The FDA, has approved a new medication for the treatment of Depression, Spravato (Esketamine) which is an isomer of the drug Ketamine. Tecartus ™ will require authorization for commercial members effective August and September 2020. e-referral system out of service for maintenance overnight August 15-16. Efficacy of esketamine was evaluated in 3 short-term (4-week) clinical trials and 1 longer-term maintenance-of-effect trial. FDA Approved Indication(s) Spravato is indicated for the treatment of treatment-resistant depression (TRD) in adults, in conjunction with an oral antidepressant. • Veklury® [remdesivir]. Simponi Aria (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of: New Indication Approved: September 25, 2020 1 , 2 Assessing and weighing the potential benefits and risks of an investigational drug is critical for decision making by regulators, clinicians, and patients. Bedaquiline in combination regimen for multiple-drug resistant pulmonary tuberculosis [AWMSG guidance]. Hetlioz (tasimelteon) is a melatonin receptor agonist for the treatment of Non-24-Hour Disorder in adults, and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. • Darolutamide (Nubeqa®) for the treatment of adult men with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease [SMC guidance]. For further information, see How to use the NPF above the list of medicinal preparations. Plegridy (peginterferon beta-1a) is a pegylated interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis. Note: The FDA has issued an emergency use authorization (EUA) during the coronavirus disease 2019 (COVID-19) pandemic to permit the emergency use of the unapproved product Fresenius Propoven 2% (propofol 20 mg/mL) emulsion.Because Fresenius Propoven 2% contains double the concentration of propofol (20 mg/mL) compared to the FDA-approved propofol products (10 mg/mL), … • Fluorouracil: Fluorouracil (i.v. • Ramucirumab: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer [NICE guidance]. Clozapine: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy [NICE guidance]. Influenza: updated guidance on management. • Upadacitinib for treating severe rheumatoid arthritis [NICE guidance]. the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). Caplacizumab for the treatment of adults with acquired thrombotic thrombocytopenic purpura [SMC guidance]. Acute Suicidal Ideation or Behavior. Patients requiring a nasal corticosteroid or nasal decongestant on dosing day should administer these medicines at least 1 hour before receiving esketamine. to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Date of Original Approval: May 1, 2017. Date of Original Approval: October 24, 2018. New Preparations: Remsima® solution for injection in pre-filled pens or syringes [infliximab]; Rybelsus®▼ [semaglutide]. • Atezolizumab with bevacizumab for treating advanced or unresectable hepatocellular carcinoma [NICE guidance]. Date of Original Approval: January 31, 2014. DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) Reimbursement Information Seeking Reimbursement Have Billing and Reimbursement Questions? • Dimethyl fumarate (Tecfidera®): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia [MHRA/CHM advice]. Hydroxycarbamide for the prevention of vaso-occlusive complications of sickle-cell disease in patients over 2 years of age [AWMSG guidance]. Date of Original Approval: October 18, 2017. in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults • COVID-19 vaccine: new guidance in-line with Public Health England recommendations. to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. © The Royal Pharmaceutical Society 2021. It is a non-selective, ... 54% of patients received AD plus augmentation regimen, and 6% received both AD monotherapy/AD plus augmentation regimen. for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). FDA Approved Indication(s) Spravato is indicated for the treatment of treatment-resistant depression in adults, in conjunction with an ... Drug Name Dosing Regimen Dose Limit/ This update contains 25 significant changes, 9 dose changes, 5 new monographs, 3 new preparations, 3 deleted monographs and 3 deleted preparations. Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients ≥6 years with severe eosinophilic asthma, for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and for the treatment of patients ≥12 years with hypereosinophilic syndrome (HES). Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. Dovato (dolutegravir and lamivudine) is a combination of the integrase strand transfer inhibitor dolutegravir (Tivicay) and the nucleoside analogue reverse transcriptase inhibitor lamivudine (Epivir) used for the treatment of HIV-1 infection in adults. • Lenvatinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. 14 Significant Changes: • Aflibercept: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Hepatic enzyme inhibitors Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults, and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Spravato is a brand-name prescription drug that's … Patient Population Altered: December 4, 2020 Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The DARZALEX FASPRO™ … New Dosage Regimen: August 20, 2020 Amisulpride: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. • Trabectedin (Yondelis®) for the treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents [SMC guidance]. Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma. (click to open and close) We launched the site in 2017 on a voluntary basis and it was a free service. Hydrocodone and acetaminophen combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.. Acetaminophen is used to relieve pain and reduce fever in patients. Date of Original Approval: September 18, 2017. Spravato (esketamine) nasal spray is used for treatment-resistant depression and major depressive disorder (MDD) with acute suicidal ideation or behavior. New Indication Approved: November 5, 2020 Speed and safety: Provides rapid reference to essential information on the selection of safe and effective medicines for individual patients, Evidence Grading: As part of NICE accreditation recommendations, BNF content is now evidence graded to reflect the strength of evidence behind them, increasing transparency to support healthcare professionals with clinical decision making, Always up-to-date: The content is revalidated, revised, and updated on a monthly basis, making sure you have access to the very latest prescribing knowledge, Worldwide credibility: The BNF uses clinical evidence from a diverse range of sources and a network of experts, giving you the confidence to select medicines safely, *based on average data in the last 12 months. Hydroxycarbamide for the prevention of vaso-occlusive complications of sickle-cell disease in patients over 2 years of age [SMC guidance]. Escitalopram [elderly dosing for panic disorder updated]. Fixed dosing: Infants ≥6 months, Children, and Adolescents: Oral: Initial: 1 to 2.5 mg 3 to 4 times daily; increase gradually as needed and tolerated (manufacturer's labeling).
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