Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic [MHRA/CHM advice] (advice in acenocoumarol, apixaban, dabigatran etexilate, edoxaban, phenindione, rivaroxaban, warfarin sodium; see example in warfarin sodium). Neratinib for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer [SMC guidance]. The dosing intervals should be 4 to 8 hours apart during the waking day. • 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]. Date of Original Approval: November 4, 2015. The peak activity is noted after 2 to 3 hours. SPRAVATO nasal spray is intended for nasal administration. Vedolizumab for the treatment of adults with moderately to severely active Crohn’s disease [SMC guidance]. • Ofloxacin [update to dosing for lower respiratory-tract infections]. Includes Spravato side effects, interactions and indications. Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor. Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. This update contains 29 significant changes, 5 dose changes and 4 new monographs. • Lenvatinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older. The mechanism by which esketamine exerts its antidepressant effect is unknown. • Elleste-Duet® Conti (estradiol with norethisterone) [update to dosing]. Date of Original Approval: October 21, 2019. Date of Original Approval: April 8, 2019. Spravato is a brand-name prescription drug that's … It is trusted by health professionals worldwide as their primary source for minimising medication errors. The lowest GoodRx price for the most common version of generic Meclizine Non-Prescription is around $2.89, 42% off the average retail price of $5.04. • Regorafenib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Efficacy of esketamine was evaluated in 3 short-term (4-week) clinical trials and 1 longer-term maintenance-of-effect trial. Entrectinib for treating NTRK fusion-positive solid tumours [NICE guidance]. Date of Original Approval: November 14, 2001. Having said that, there seems to be some general consensus about the dosing regimen for ketamine infusion for depression among some providers. IVIG dosing strategy is changing for the Medicare Part B medical specialty drug program, starting Dec. 7. Esketamine (Spravato™) is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist. Vimpat (lacosamide) is an anti-convulsant indicated for the treatment of partial-onset seizures, and as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. Hepatitis A vaccine: updated guidance in-line with Public Health England recommendations. The BNF is the only drug formulary in the world that is both independent, and has rigorous, accredited content creation processes. More information about our website, visitor information, etc. • Evorel® Sequi (estradiol with norethisterone) [update to dosing]. New Formulation Approved: October 9, 2020 Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. • Atezolizumab (Tecentriq®) with nab-paclitaxel for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer [NICE guidance]. Date of Original Approval: December 1, 2006. New Dosage Regimen: September 3, 2020 Date of Original Approval: September 18, 2014. Spravato (esketamine) nasal spray is used for treatment-resistant depression and major depressive disorder (MDD) with acute suicidal ideation or behavior. Tick-borne encephalitis vaccine: updated guidance in-line with Public Health England recommendations. Significant Changes: • Andexanet alfa (Ondexxya®): avoid use of andexanet prior to heparinisation [MHRA/CHM advice]. Date of Original Approval: October 18, 2017. Skin infections, antibacterial therapy: new guidance for the management of insect bites and stings. Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). Gilteritinib for treating relapsed or refractory acute myeloid leukaemia [NICE guidance]. Poisoning, emergency treatment: updated guidance on the management of paracetamol poisoning in-line with TOXBASE recommendations. • Frequently asked questions—clinical: updated guidance for expiration of eye preparations. There are no head-to-head studies comparing esketamine and ketamine infusion. Pembrolizumab [dosing information updated]. • Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency [MHRA/CHM advice]. • Doxorubicin hydrochloride: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice]. SPRAVATO ® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of: . Sodium picosulfate: Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use [MHRA/CHM advice]. Date of Original Approval: December 22, 2014, New Indication Approved: September 30, 2020 (click to open and close) We launched the site in 2017 on a voluntary basis and it was a free service. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. 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). • Venetoclax (Venclyxto®) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) [SMC guidance]. Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated. 5-Fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity [MHRA/CHM advice] (advice in fluorouracil, capecitabine and tegafur with gimeracil and oteracil; see example in fluorouracil). 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. New Indication Approved: July 30, 2020 Kineret (anakinra) is an interleukin-1 receptor antagonist indicated for the treatment of rheumatoid arthritis, Cryopyrin-Associated Periodic Syndromes (CAPS), and Deficiency of Interleukin-1 Receptor Antagonist (DIRA). Bisacodyl: Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use [MHRA/CHM advice]. SUMMARY For most drugs, the selection of a product’s dosing regimen is based upon efficacy, safety and pharmacokinetics (plasma half-life) 1.In the esketamine (ESK) program for treatment-resistant depression (TRD), the dosing regimen also accounted for the pharmacodynamic properties of ESK nasal spray, namely durability of the antidepressant effect. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis. Cookies remember you so we can grant you access to our online services. • Fingolimod (Gilenya®): updated advice about the risks of serious liver injury and herpes meningoencephalitis [MHRA/CHM advice]. This update contains 29 significant changes, 4 dose changes, 7 new monographs and 2 new preparations. British National Formulary February 2021 Update, British National Formulary January 2021 Update, British National Formulary December 2020 Update, British National Formulary November 2020 Update, British National Formulary October 2020 Update, British National Formulary September 2020 Update. Trulicity (dulaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Quetiapine: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. • Sarclisa® [isatuximab]. Labeling Revision Approved: December 21, 2020 This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ketamine infusion has not been approved by the FDA to treat depression. Date of Original Approval: July 7, 2015. Date of Original Approval: January 31, 2014. for the treatment of adult patients with unresectable, Stage III, in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage. Spravato (esketamine) is the S-enantiomer of racemic ketamine, and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. Influenza vaccine: updated guidance in-line with Public Health England recommendations. This update contains 25 significant changes, 9 dose changes, 5 new monographs, 3 new preparations, 3 deleted monographs and 3 deleted preparations. There is an urgent need to develop additional treatment strategies for patients with treatment-resistant depression (TRD). The duration of action of one single dose is 6 to 12 hours in a dose dependent manner. Date of Original Approval: February 7, 2012. • Ponatinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. It is also used to treat depression and anxiety disorders, such as panic disorder, social anxiety disorder, and post-traumatic stress disorder. Date of Original Approval: May 1, 2020. • Dimethyl fumarate (Tecfidera®): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia [MHRA/CHM advice]. Pembrolizumab with axitinib for first-line treatment of advanced renal cell carcinoma [SMC guidance]. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. Spravato contains the drug esketamine. Pertuzumab in combination with trastuzumab and chemotherapy for the treatment of adults with HER2-positive early breast cancer [SMC guidance]. New Preparations: Remsima® solution for injection in pre-filled pens or syringes [infliximab]; Rybelsus®▼ [semaglutide]. New Dosage Regimen: September 3, 2020 Pembrolizumab for the treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma [SMC guidance]. • BNF updates for Community Practitioner Nurse Prescribers: For BNF app and online versions of the BNF – list of medicinal preparations (renamed as Approved list for prescribing by Community Practitioner Nurse Prescribers (NPF)) updated with indications for use by Community Practitioner Nurse Prescribers and links to BNF monographs; general guidance and treatment summaries for use by Community Practitioner Nurse Prescribers have also been added. Results: The onset of action is within 1 hour after oral dosing. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM). • Axitinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. • Siponimod for treating secondary progressive multiple sclerosis [NICE guidance]. Esketamine is classified as a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor. Esketamine (Spravato™) is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo. Spravato (esketamine) is the S-enantiomer of racemic ketamine, and is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamatereceptor. • Atezolizumab (Tecentriq®) in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression at a level of 1 % or more and who have not received prior chemotherapy for metastatic disease [SMC guidance]. • Novofem® (estradiol with norethisterone) [update to dosing]. • Evorel® Conti (estradiol with norethisterone) [update to dosing]. ), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe and fatal toxicity [MHRA/CHM advice]. For further details on changes in the BNF click on http://www.medicinescomplete.com/mc/bnf/current/PHP107699-changes.htm. Pembrolizumab with axitinib for untreated advanced renal cell carcinoma [NICE guidance]. as adjuvant therapy after tumor resection in adult patients with non small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Significant Changes: • Antibacterials, use for prophylaxis: updated guidance for the prevention of secondary Haemophilus influenzae type b disease. For patients receiving 300 mg/day to 400 mg/day of levodopa as immediate-release carbidopa-levodopa, the suggested starting regimen of Sinemet CR is carbidopa 50 mg/levodopa 200 mg twice daily. • Enerzair Breezhaler® [mometasone furoate with glycopyrronium bromide and indacaterol]. Andexanet alfa for adults treated with apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding [SMC guidance]. Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma [NICE guidance]. New Indication Approved: December 1, 2020 Frontline multiple myeloma (non-transplant) Approved Approved Approval announced May 7, 2018. Date of Original Approval: September 4, 2020. Major depressive disorder (MDD) Approved Approved FDA approval announced August 3, 2020. • Tivozanib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. 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. Date of Original Approval: May 1, 2017. New Indication Approved: September 9, 2020 The present invention is directed to methods and dosing regimens for the treatment of depression (preferably, treatment resistant depression), for the treatment of depression in a suicidal patient, and/or for the treatment and/or prevention of suicidality (e.g. Patient Population Altered: December 18, 2020 This update contains 25 significant changes, 2 dose changes, 4 new monographs, 4 deleted monographs and 1 deleted preparation. Opioids: risk of dependence and addiction [MHRA/CHM advice] (advice in alfentanil, buprenorphine, co-codamol, codeine phosphate, co-phenotrope, diamorphine hydrochloride, dihydrocodeine tartrate, fentanyl, hydromorphone hydrochloride, kaolin with morphine, meptazinol, methadone hydrochloride, morphine, oxycodone hydrochloride, pentazocine, pethidine hydrochloride, remifentanil, tapentadol, tramadol hydrochloride; see example in morphine). • Methylprednisolone as sodium succinate (Solu-Medrone®) 40 mg powder and solvent for solution for injection: change from lactose-containing to a lactose-free formulation; risk of serious allergic reactions if formulations are confused [MHRA/CHM advice]. • Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer [NICE guidance]. Immunoglobulins: updated guidance in-line with Public Health England recommendations for the use of normal immunoglobulin for protection against hepatitis A infection. • Carfilzomib for previously treated multiple myeloma [NICE guidance]. Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer [NICE guidance]. Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer. for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Cariprazine for the treatment of schizophrenia [AWMSG guidance]. Humira (adalimumab) is a recombinant human IgGl monoclonal antibody specific for human tumor necrosis factor (TNF) indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis, ulcerative colitis, hidradenitis suppurativa, and certain types of uveitis. Benlysta (belimumab) is B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE), and adult patients with active lupus nephritis. • Liraglutide for managing overweight and obesity [NICE guidance]. Cannabidiol with clobazam for therapy of seizures associated with Lennox-Gastaut syndrome [SMC guidance]. PDF | Background: Esketamine nasal spray was recently approved for treatment-resistant depression (TRD). 14 Date of Original Approval: June 20, 2003, New Indication Approved: December 1, 2020 However, illicit use of the medication comes with risks, and the DEA has been following its distribution closely. • Eye: updated guidance for expiration of eye preparations. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: New Indication Approved: November 16, 2020 Approve for 2 months if the patient meets the following 14 Simponi Aria (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of: New Indication Approved: September 25, 2020 Patient Population Altered: September 24, 2020 SPRAVATO® is an FDA-approved nasal spray for TRD and MDSI. Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy [NICE guidance]. Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis. • Daunorubicin: Liposomal and lipid-complex formulations: name change to reduce medication errors [MHRA/CHM advice]. The mechanism by which esketamine exerts its antidepressant effect is unknown. • Sunitinib: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection [MHRA/CHM advice]. Date of Original Approval: May 18, 2016. Sulpiride: Clozapine and other antipsychotics: monitoring blood concentrations for toxicity [MHRA/CHM advice]. New Indication Approved: August 6, 2020 Haemophilus influenzae type B conjugate vaccine: updated guidance in-line with Public Health England recommendations. Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration [SMC guidance]. Date of Original Approval: August 26, 2011. New Indication Approved: December 18, 2020 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), … There has been much interest in the role of ketamine as a … Date of Original Approval: November 13, 2015, New Indication Approved: December 18, 2020 Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta2-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.