NEW DRUG UPDATE SERIES 6 JAN 2020 NEW DRUG UPDATE SERIES 4, NOV 2019 1. KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Centre and Hospital Limited) Coimbatore, Tamilnadu SERIES 6 JAN 2020 DEPARTMENT OF PHARMACOLOGY- NEW DRUG UPDATE Contents Strive for Novelty FDA – NEW DRUG APPROVALS 1. Golodirsen 2. Enfortumab vedotin-ejfv 3. Brilliant Blue G Ophthalmic Solution 4. Lumateperone tosylate 5. Lemborexant 6. Fam-trastuzumab deruxtecan-nxki 7. Ubrogepant D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R Page 1 NEW DRUG UPDATE SERIES 6 JAN 2020 Date of Adverse Drug Dosage S.No Drug Name Mechanism of Action Indications FDA Reactions Formulation Approval 1. Golodirsen An antisense Duchenne muscular Headache, pyrexia, Intravenous 12/12/2019 oligonucleotide. Binds to dystrophy with fall, abdominal pain, Injection exon 53 of dystrophin mutation of the DMD nasopharyngitis, pre-mRNA exclusion gene that is amenable cough, vomiting, and of exon 53 to exon 53 skipping nausea 2. Enfortumab Nectin-4-directed IgG1 Locally advanced or Fatigue, peripheral Intravenous 18/12/2019 vedotin-ejfv antibody and metastatic refractory neuropathy, loss of Injection microtubule inhibitor urothelial cancer appetite, rash, conjugate alopecia, nausea, dry eye, diarrhea 3. Brilliant Blue Selectively stain the Dye used in eye Due to surgical Intraocular 20/12/2019 G Ophthalmic internal limiting surgery to selectively procedure - retinal Injection Solution membrane stain the internal - break, tear, limiting membrane hemorrhage, detachment & cataract 4. Lumateperone 5-HT2A antagonism and An atypical Somnolence / Capsule 20/12/2019 tosylate central D2 postsynaptic antipsychotic to treat sedation and dry antagonism schizophrenia mouth (No EPS & Metabolic syndrome) 5. Lemborexant Orexin receptor Insomnia with sleep Somnolence Tablet 20/12/2019 antagonist onset and/or sleep maintenance difficulty 6. Fam- HER2-directed antibody Unresectable or Nausea, alopecia, Intravenous 20/12/2019 trastuzumab and topoisomerase metastatic refractory constipation or Injection deruxtecan- inhibitor conjugate HER2-positive breast diarrhea, loss of nxki cancer appetite, anemia, pancytopenia and cough 7. Ubrogepant Calcitonin gene-related Acute treatment of Nausea and Tablet 23/12/2019 peptide receptor migraine with or somnolence antagonist without aura in adults Kindly Mail Your Suggestions To: [email protected] Access this series COMPILED & EDITED by through the KMCH website Department of Pharmacology www.kmchihsr.edu.in KMCHIHSR, Coimbatore, 641014 D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R Page 2 NEW DRUG UPDATE SERIES 7 FEB 2020 NEW DRUG UPDATE SERIES 4, NOV 2019 1. KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Centre and Hospital Limited) Coimbatore, Tamilnadu SERIES 7 FEB 2020 DEPARTMENT OF PHARMACOLOGY- NEW DRUG UPDATE Date of Mechanism Adverse Drug Dosage S.No Drug Name Indications FDA of Action Reactions Formulation Approval 1. Avapritinib Tyrosine Unresectable or Edema, nausea, Tablet 09/01/2020 kinase metastatic fatigue/asthenia, inhibition Gastrointestinal cognitive impairment, stromal tumor vomiting, decreased harboring a platelet- appetite, diarrhea, hair derived growth color changes, increased factor receptor lacrimation, abdominal alpha exon 18 pain, constipation, rash mutation and dizziness. 2. Teprotumumab-trbw Insulin-like Thyroid eye disease Muscle spasm, nausea, Intravenous 21/01/2020 growth alopecia, diarrhea, Injection – factor-1 fatigue, headache Lyophilized receptor hyperglycemia, hearing powder in a inhibition impairment, dry skin, single vial for dysgeusia reconstitution 3. Tazemetostat Histone Locally advanced Pain, fatigue, nausea, Tablet 23/01/2020 methyl Epithelioid sarcoma decreased appetite, transferase in adults and vomiting, and constipation inhibition pediatric patients aged 16 years and older Kindly Mail Your Suggestions To: [email protected] COMPILED & EDITED by Access this series Department of Pharmacology through the KMCH website KMCHIHSR, Coimbatore, 641014 www.kmchihsr.edu.in Strive For Novelty D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R Page 1 New drug update Series 8 March 2020 NEW DRUG UPDATE SERIES 4, NOV 2019 1. KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Center and Hospital Limited) Coimbatore, Tamilnadu SERIES 8 MARCH 2020 DEPARTMENT OF PHARMACOLOGY- NEW DRUG UPDATE Creating the Future Inside this series New Drug Approvals by FDA 1. Eptinezumab-jjmr 2. Bempedoic acid 3. Amisulpride 4. Bempedoic acid and Ezetimibe New drugs Available drugs with new 5. Rimegepant formulation D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R Page 1 New drug update Series 8 March 2020 1. Eptinezumab-jjmr 2. Bempedoic acid 3. Amisulpride • Date of Approval: February 21, • Date of Approval: February 21, • Date of Approval: February 26, 2020 2020 2020 • Mechanism of action: • Mechanism of action: First-in- • Mechanism of action: Monoclonal antibody - CGRP class, Adenosine triphosphate- Dopamine antagonist antagonist citrate lyase inhibitor • Indication: Post-Operative • Indication: Preventive • Indication: Heterozygous Nausea & Vomiting treatment of Migraine in adults Familial Hypercholesterolemia • Dosage Formulation: Injection • Dosage Formulation: Injection • Dosage Formulation: Tablet for Intravenous Infusion for Intravenous use 4. Bempedoic acid and 5. Rimegepant Ezetimibe • Date of Approval: February 27, •Date of Approval: February 26, 2020 2020 • Mechanism of action: •Mechanism of action: Adenosine Calcitonin gene-related peptide triphosphate-citrate lyase inhibitor receptor antagonist and a cholesterol absorption inhibitor combination • Indication: Acute treatment of Migraine •Indication: Heterozygous Familial Hypercholesterolemia • Dosage Formulation: Orally •Dosage Formulation: Tablet Disintegrating Tablet Kindly Mail Your Suggestions To: COMPILED & EDITED by [email protected] Department of Pharmacology KMCHIHSR, Coimbatore, 641014 Access this series through KMCHIHSR website www.kmchihsr.edu.in D E P A R T M E N T O F P H A R M A C O L O G Y , K M C H I H S R Page 2 KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Center and Hospital Limited) Coimbatore, Tamil Nadu Every Day, A New Discovery Department Of Pharmacology New Drug Update (New Drugs and Available Drugs with New Formulation) Series - 9 April 2020 In this series 1.Isatuximab-irfc Date of Approval: March 2, 2020 New drugs approved by FDA Mechanism of action: CD38-directed cytolytic antibody Indication: Multiple Myeloma in combination with Pomalidomide and Dexamethasone 1. Isatuximab-irfc Dosage Formulation: IV Infusion 2. Bimatoprost Implant 2.Bimatoprost Implant Date of Approval: March 3, 2020 3. Osilodrostat Mechanism of action: PG-F2α analogue, reduces IOP Indication: Open Angle Glaucoma 4. Ozanimod Dosage Formulation: Intra-cameral, Biodegradable Sustained-Release Implant 3.Osilodrostat (Received Orphan Drug Designation) Date of Approval: March 6, 2020 Mechanism of action: Cortisol synthesis inhibitor COMPILED & EDITED by Indication: Adults with Cushing's Syndrome who cannot undergo pituitary gland surgery or have undergone Department of Pharmacology surgery KMCHIHSR, Coimbatore. Dosage Formulation: Tablet **************************************************** Kindly Mail Your Suggestions To: 4.Ozanimod [email protected] Date of Approval: March 25, 2020 Access this series through website: Mechanism of action: Sphingosine 1-phosphate receptor www.kmchihsr.edu.in modulator Indication: Relapsing Multiple Sclerosis 641014 Dosage Formulation: Capsule Department of Pharmacology, KMCHIHSR 1| P a g e KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH (A unit of Kovai Medical Center and Hospital Limited) Coimbatore,Tamilnadu Series 10 Department of Pharmacology May 2020 New drug update Inside the series a ❖ Sacituzumab-govitecan-hziy A passion for better medicine ❖ Coagulation factor VIIa recombinant-jncw ❖ Selumetinib Compiled & Edited by ❖ Tucatinib Department of Pharmacology, KMCHIHSR, ❖ Opicapone Coimbatore, 641014. ❖ Pemigatinib Kindly Mail Your Suggestions To: ❖ Ephedrine sulphate (premixed hodpharmacology@ kmchihsr.edu.in formulation) ❖ Mitomycin(pyelocalyceal solution) Access this series through the KMCH website www.kmchihsr.edu.in Department of Pharmacology, KMCHIHSR PAGE 1 Sacituzumab-govitecan-hziy Coagulation factor VIIa recombinant-jncw Approval date – April 22, 2020 Approval date – April 1, 2020 Mechanism of Trop-2-directed antibody and Mechanism of Coagulation factor VIIa action topoisomerase inhibitor action concentrate conjugate Indication Previously-treated metastatic Indication Patients aged 12 years and older Triple-Negative Breast Cancer with Hemophilia A or B with (mTNBC) inhibitors Dosage IV infusion (as Lyophilized Dosage IV injection (as Lyophilized formulation powder for reconstitution) formulation powder for reconstitution) Selumetinib Tucatinib Approval date – April 10, 2020 Approval date – April 17, 2020 Mechanism of A mitogen activated protein Mechanism of action A kinase inhibitor kinases1&2(MEK1/2)inhibitor action Indication Paediatric patients aged 2 years & Indication Patients with advanced metastatic older with symptomatic inoperable HER2 +ve Breast carcinoma along Neurofibromatosis 1(NF1) with trastuzumab &capecitabine Dosage Dosage Tablet formulation Capsule formulation Opicapone Pemigatinib Approval date – April 24, 2020 Approval date –