Us full prescribing information. See full prescribing information for TRULICITY.

Us full prescribing information Approval: 2024 INDICATIONS AND USAGE RYTELO is an HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABECMA safely and effectively. These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. PAXLOVID safely and effectively. OJJAARA (momelotinib) tablets, for oral use . AKYNZEO® (fosnetupitant and palonosetron) for injection, for FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. These highlights do not include all the information needed to use ABILIFY safely and effectively. Please refer to the full Prescribing Information and Medication Guide for additional safety FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS SKIN RASHES 1 1. Approval: 2015 See 17 for PATIENT COUNSELING INFORMATION. See full prescribing information for RYTELO. See safety information. 5% were Black or African American, and 11% were of Hispanic/Latino ethnicity; 57% had ECOG PS of 0 and 42% had ECOG 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. APOKYN (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for PLUVICTO. SPINRAZA (nusinersen) injection, for intrathecal use . PROMACTA® (eltrombopag) tablets, for oral use PROMACTA® (eltrombopag) for oral suspension Initial U. Approval: 2013 _____ RECENT MAJOR CHANGES _____ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . UPTRAVI® (selexipag) tablets, for oral use UPTRAVI® (selexipag) for injection, for intravenous use Initial U. 3 Instructions for Use . VYLOY ® (zolbetuximab-clzb) for injection, for intravenous use Initial U. Approval: 2017 See full prescribing information for IMFINZI. 1 Important Dosage and Administration Instructions 2. FULL PRESCRIBING INFORMATION . WARNING: SERIOUS MENINGOCOCCAL INFECTIONS HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use OJJAARA safely and effectively. Approval: 2022 ——————————— RECENT MAJOR CHANGES 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. This professional information presents product monographs approved by the US Food and Drug See full prescribing information for FLUAD QUADRIVALENT. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OPDUALAG safely and effectively. Approval: 2017 -----RECENT MAJOR CHANGES----- ections or subsections omitted from the full prescribing information are not listed. See full prescribing information for complete full prescribing information: contents* warning: cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies 1 indications and usage HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROZAC safely and effectively. HIZENTRA®, Immune Globulin Subcutaneous (Human), 20% Liquid Initial U. Approval: 2016 RECENT MAJOR CHANGES See full prescribing information for complete boxed • • • escalation schedule maintenance dosage • HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. These highlights do not include all the information needed to use TYSABRI safely and effectively. 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. for JYNNEOS. Approval: 2003 WARNING: ANAPHYLAXIS HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADAKVEO safely and effectively. Approval: 2017. Approval: 2016 _____ INDICATIONS AND USAGE _____ and as clinically needed US-89064. Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for JAYPIRCA. See full prescribing information for VYVGART HYTRULO. 1 1. 3 Image Acquisition Instructions 2. SOLIRIS ® (eculizumab) injection, for intravenous use . Approval: 2002. Acute serious liver injury and elevated HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for TRELSTAR. Approval: 2023 . Approval: 2017 _____ RECENT MAJOR CHANGES _____ US Operations, LLC at 1 -877-727-6596 or FDA at 1 -800-FDA- * Sections or subsections omitted from the full prescribing information are not listed. 2. DOSAGE AND ADMINISTRATION. Any linked documents and websites are intended only for U. See full prescribing information for AREXVY. HIGHLIGHTS OF PRESCRIBING INFORMATION. It provides information on usage for healthcare professionals, and is an intrinsic part of the application for marketing authorisation of a new drug or medicine within the United States. 5 Endometrial Cancer. See full prescribing information for OJJAARA. Approval: 2024 WARNING: EMBRYO–FETAL TOXICITY See full prescribing information for complete boxed warning. • Read Mirena® (levonorgestrel-releasing intrauterine system) 52 mg full prescribing information to learn about dosage and administration. MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine] solution for injection, •for intramuscular use FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. ENTRESTO® (sacubitril and valsartan) tablets, for oral use ENTRESTO® SPRINKLE (sacubitril and valsartan) oral pellets Initial U. 2 Dosing 2. com . LEQEMBI™ (lecanemab-irmb) injection, for HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYTELO safely and effectively. WARNING: SERIOUS LIVER INJURY and ACUTE These highlights do not include all the information needed to use TYSABRI safely and effectively. 2Psoriatic Arthritis COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROLIA safely and effectively. Approval: 2024 WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. 2 DOSAGE AND ADMINISTRATION . TRULICITY (dulaglutide) injection, for subcutaneous use Initial U. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. 73 m 2, respectively) and patients with end-stage renal disease on hemodialysis should receive a starting dose of LIVALO 1 mg once daily and a maximum dose of LIVALO 2 mg once daily ; 2018 American College of Cardiology/American HIGHLIGHTS OF PRESCRIBING INFORMATION . JAYPIRCA® (pirtobrutinib) tablets, for oral use Initial U. WARNING: SIGNIFICANT DRUG INTERACTIONS WITH HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AREXVY safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . and HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full prescribing information for AKYNZEO®. PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets), co-packaged for . 3 Image Acquisition Guidelines 2. Approval: 2021 WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC These highlights do not include all the information needed to use ELZONRIS® safely and effectively. See full prescribing information for complete On January 21, 2022, the SKYRIZI (risankizumab-rzaa) Prescribing Information and Medication Guide were updated to include new information about serious allergic reactions. YORVIPATH ® (palopegteriparatide) injection, for subcutaneous . Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION . 3djh ri 7:,67 2)) 6<5,1*( &$3 7zlvw rii gr qrw vqds rii wkh v\ulqjh fds e\ kroglqj wkh v\ulqjh lq rqh kdqg dqg wkh v\ulqjh fds zlwk wkh wkxpe dqg iruhilqjhu ri wkh rwkhu kdqg vhh )ljxuh These highlights do not include all the information needed to use TRODELVY safely and effectively. 73 m 2 and 15-29 mL/min/1. 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 HIGHLIGHTS OF PRESCRIBING INFORMATION. Interrupt or permanently discontinue VY. FLOVENT HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. See full prescribing information for FLUOXETINE. 1 INDICATIONS AND USAGE . 1 Alzheimer’s Disease EXELON PATCHis indicated for the treatment of dementia of the Alzheimer’s type(AD). SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): • in adult s aged 50 years and older. Medical Information Page - clinical & safety information, ways to contact Pfizer 17 PATIENT COUNSELING INFORMATION. See 17 for PATIENT COUNSELING INFORMATION. These highlights do not include all the information needed to use SOLIRIS safely and effectively. Approval: 1987 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABRAXANE safely and effectively. See full prescribing information for OPSYNVI. Approval: 2015 HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for ENTRESTO. XOLAIR® (omalizumab) injection, for subcutaneous use XOLAIR® (omalizumab) for injection, for subcutaneous use Initial U. See full prescribing information for ABILIFY. Approval: 1987 . 2 Parkinson’s Disease Dementia HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use YORVIPATH safely and effectively. See full prescribing information for TECENTRIQ. TRELSTAR ® (triptorelin pamoate for injectable suspension) , for intramuscular use Initial U. See full prescribing information for . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TECENTRIQ safely and effectively. Full Prescribing Information. 5 Hepatotoxicity (PREP) IN UNDIAGNOSED HIV-1 INFECTION. revised: 4/2024 . Approval: 2010 WARNING: THROMBOSIS See full prescribing information for complete boxed These highlights do not include all the information needed to use TRULICITY safely and effectively. 2 Required Premedication 2. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U. EYLEA ® (aflibercept) Injection For Intravitreal Injection Initial U. 2 Parkinson’s Disease Dementia HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEMLUVIO safely and effectively. Approval: 2019 WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Approval: 2019 . TAGRISSO ® (osimertinib) tablets, for oral use Initial U. full prescribing information: contents* full prescribing information warning: patients co-infected with hepatitis b virus (hbv) and human immunodeficiency virus (hiv-1): emergence of lamivudine-resistant hbv and exacerbations of hbv 1 indications and usage 2 dosage and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for HIZENTRA. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. The USPI is divided into Highlights of Prescribing Information, Table of Contents, and the Full Prescribing Information (FPI); and is often followed by Patient Information. These highlights do not include all the information needed to use TECFIDERA safely and effectively. IMDELLTRA™(tarlatamab-dlle) for injection, for intravenous use Initial U. Prescribing Information PDF Adult patients with moderate or severe renal impairment not on hemodialysis (eGFR 30-59 mL/min/1. See full prescribing information for ADAKVEO. See full prescribing information for BREYANZI. Approval: 2005 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. TYLENOL ® Regular Strength (DIN 00559393) Acetaminophen Tablet s USP 325 mg . oral use . See full prescribing information for ABECMA. See full prescribing information for SOLIRIS. 4 Image Display and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PLUVICTO safely and effectively. Approval: 2015----- RECENT MAJOR CHANGES ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FLUOXETINE safely and effectively. Approval: 2024 INDICATIONS AND USAGE RYTELO is an HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRYVIO safely and effectively. ADAKVEO® (crizanlizumab-tmca) injection, for intravenous use Initial U. A Family Run Company; Events; Careers @ ChiRhoClin; Contact; Home / Products / ChiRhoStim Synthetic Human Secretin / Full Prescribing Information. 1 Early Breast Cancer VERZENIO® (abemaciclib) is indicated: • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult %PDF-1. Approval: 1998 . APOKYN (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor , 41% were Asian, 1. BENLYSTA (belimumab) for injection, for intravenous use BENLYSTA (belimumab) injection, for subcutaneous use Initial U. VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. 1Plaque Psoriasis COSENTYX® is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy. 1 . ENJAYMO® (sutimlimab-jome) injection, for intravenous use Initial U. Revised: 07/2024. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or www. See full prescribing information for MENVEO. Delay or dose reduce as recommended. Approval: 2010 -----RECENT MAJOR CHANGES-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYTELO safely and effectively. PAXLOVID. Prolia ® (denosumab) Injection, for subcutaneous use Initial U. WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE • Cases of acute liver failure with fatal outcomes have been reported. See full prescribing . DARZALEX FASPRO. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MENVEO safely and effectively. WARNING: ANAPHYLAXIS . NUCALA (mepolizumab) for injection, for subcutaneous use . 3djh ri 7:,67 2)) 6<5,1*( &$3 7zlvw rii gr qrw vqds rii wkh v\ulqjh fds e\ kroglqj wkh v\ulqjh lq rqh kdqg dqg wkh v\ulqjh fds zlwk wkh wkxpe dqg iruhilqjhu ri wkh rwkhu kdqg vhh )ljxuh HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROLIA safely and effectively. Read Mirena® This site is intended for US residents only. XOLAIR ® (omalizumab) for injection, for subcutaneous use Initial U. PRESCRIBING INFORMATION WELLBUTRIN ® (bupropion hydrochloride) Tablets WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. 1 Preparation for Administration . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LUMAKRAS safely and effectively. FLUAD® QUADRIVALENT - Seqirus Inc. See full prescribing information for XELODA. Below is a list of our company's marketed products. See full prescribing information for IMDELLTRA. Approval: 2023 -----RECENT MAJOR CHANGES----- HIGHLIGHTS OF PRESCRIBING INFORMATION. Approval: 2018 WARNING: POST TREATMENT ACUTE EXACERBATION OF HIGHLIGHTS OF PRESCRIBING INFORMATION . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use APRETUDE safely and effectively. OTEZLA ® (apremilast) tablets, for oral use Initial U . This risk is further increased in older patients usually over 60 years of age, in HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for SPINRAZA. opzelura. 2 Recommended Dosage, Preparation, and Administration Instructions 2. See full prescribing information for TRODELVY. 0 mg and 2. an area of up to 15% BSA NEXOBRID® (anacaulase-bcdb) for topical gel • Initial U. See full prescribing information for TECFIDERA. ELZONRIS (tagraxofusp-erzs) injection, for intravenous use Initial U. JYNNEOS safely and effectively. US-95991. See full prescribing information for REYATAZ. SPINRAZA® safely and effectively. This prescribing information is the exclusive property of McNeil Consumer Healthcare, division of Johnson & Johnson Inc . Approval: 2003 WARNING: ANAPHYLAXIS HIGHLIGHTS OF PRESCRIBING INFORMATION . Approval: 2024 -----INDICATIONS AND USAGE----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BREYANZI safely and effectively. OPDUALAG™ (nivolumab and relatlimab-rmbw) injection, for intravenous use Initial U. See full prescribing information for TRULICITY. Approval: 2021 . The equivalent of the USPI in the European Union is the Summary of Product Characteristics (SmPC). Approval: 2004 WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning OPZELURA is a prescription medicine used on the skin (topical) for: short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 12 years of age FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF DRUG RESISTANCE WITH USE OF 5. WARNING: RISK OF DRUG RESISTANCE 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Approval: 2022 The Prescribing Information (USPI), also referred to as the package insert or label, is a US FDA-approved product label and a crucial document containing essential information for healthcare professionals to prescribe and monitor the safe use of prescription drugs and biologics in the United States. US Package Insert March 2023 Confidential Page 2 of 11 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE FLUAD QUADRIVALENT is an inactivated influenza HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IMDELLTRA™ safely and effectively. TM (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U. Adempas ® Prescribing Information Composition. _____ FULL PRESCRIBING INFORMATION . NUCALA (mepolizumab) injection, for subcutaneous use . DUPIXENT® (dupilumab) injection, for subcutaneous use Initial U. 4 Infusion Instructions 3 DOSAGE FORMS AND STRENGTHS 4 17 for PATIENT COUNSELING INFORMATION. HIGHLIGHTS OF PRESCRIBING INFORMATION . HIGHLIGHTS OF PRESCRIBING INFORMATION • Adjuvant treatment of resected esophageal or gastroesophageal cancer • patient who receive allogeneic HSCT before or after being treated REBLOZYL (luspatercept-aamt) is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. These highlights do not include all the information needed to use TRELSTAR safely and effectively. Approval: 2000 FULL PRESCRIBING INFORMATION 1INDICATIONS AND USAGE 1. Approval: 2003 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for TRYVIO. TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic HIGHLIGHTS OF PRESCRIBING INFORMATION WARNINGS AND PRECAUTIONS ----- These hig hlights do not include all the informatio n nee ded to use XELODA safely and effectively. Approval: 2017 were fatal. Approval: 2015 See full prescribing information for PROMACTA. • TECFIDERA ® (dimethyl fumarate) delayed-release capsules, for oral use . See full prescribing information for NEMLUVIO. See full prescribing information for ABRAXANE. Approval: 2018 WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. See full prescribing information for TAGRISSO. S. See full prescribing information for LUMAKRAS. Revised: 01/2025 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: • adult and pediatric patients 1 year of age and older who have either intolerance or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LANTUS safely and effectively. Approval: 2004 WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning The USPI sets out the agreed usage of the drug. 3 Preparation Instructions 2. 5 mg riociguat. Site Last Modified: 11/2024. 3 Vaccination Schedule . Approval: 2015 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. See fu ll prescribing information for APRETUDE. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS . In the controlled-clinical trials, adverse reactions, irrespective of causality, were reported in 87% of patients receiving HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OZEMPIC® safely and effectively. See full prescribing information for ELZONRIS. These highlights do not include all the information needed to use ZEJULA safely and effectively. 2 DOSAGE AND ADMINISTRATION The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 5 mg, 1. Approval: 2024 -----INDICATIONS AND USAGE----- HIGHLIGHTS OF PRESCRIBING INFORMATION . QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have HIGHLIGHTS OF PRESCRIBING INFORMATION WARNINGS AND PRECAUTIONS -----­ These highlights do not include all the information needed to use SAPHNELO ™ safely and The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). Fluoroquinolones, including LEVAQUIN ® , are associated with an increased risk of tendinitis and tendon rupture in all ages. Prescribing information for approved human prescription drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the See full prescribing information for DUPIXENT. Approval: 2020 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. It is divided into Highlights of Prescribing Information, Table of Contents, and See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. If the FDA product labels provide professional information, package inserts and medication guides. Approval: 2011 ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JAYPIRCA safely and effectively. 1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease . The following describes the recent changes to the SKYRIZI Medication Guide. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UPTRAVI safely and effectively. REYATAZ (atazanavir) capsules, for oral use• REYATAZ (atazanavir) oral powder Initial U. Revised: 10/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. TECENTRIQ ® (atezolizumab) injection, for intravenous use Initial U. See full prescribing information for POLIVY. Approval: 2015----- RECENT MAJOR CHANGES ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EYLEA safely and effectively. to each infusion. Approval: 2000 These highlights do not include all the information needed to use ZEPBOUND safely and effectively. ZEPBOUND® (tirzepatide) Injection, for subcutaneous use Initial U. 1 Hormone Receptor-Positive, HER2-Negative Breast Cancer AFINITOR® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for ZOLGENSMA. See full prescribing information for VYLOY. TRYVIOTM (aprocitentan) tablets, for oral use Initial U. 1 These highlights do not include all the information needed to use INREBIC safely and effectively. 1 Radiation Safety-Drug Handling 2. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAVBLU safely and effectively. See full prescribing information for LEQEMBI™. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XOLAIR safely and effectively. WARNING: FETAL TOXICITY . 1. ABRAXANE ® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), for intravenous use Initial U. KEYTRUDA (pembrolizumab) injection, for intravenous use -----­ Indications and Usage, Small Cell Lung Cancer – Accelerated Prescribing Information (PI) View or download the Prescribing Information below, an interactive version will be available soon. See full prescribing information for TYSABRI. NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use Initial U. TURALIO® (pexidartinib) capsules, for oral use Initial U. LUMAKRAS™ (sotorasib) tablets, for oral use Initial U. Approval: 2021 WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, These highlights do not include all the information needed to use INREBIC safely and effectively. See full prescribing information . Approval: 2015 . BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U. It may not be copied, in whole or in part, without the expressed written permission of McNeil FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Approval: 2019-----RECENT MAJOR CHANGES----- This product information is intended only for residents of the United States. ZEJULA (niraparib) tablets, for oral use MDS/AML occurred in patients exposed to ZEJULA, and some cases . FULL PRESCRIBING INFORMATION. These highlights do not include all the information needed to use VYLOY safely and effectively. See full prescribing information for OZEMPIC. See full prescribing information for ENJAYMO. AKYNZEO® (netupitant and palonosetron) capsules, for oral use . APRETUDE (cabotegravir extended-release injectable suspension ), for intramuscular use . Revised: 01/2025 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: • adult and pediatric patients 1 year of age and older who have either intolerance or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEQEMBI™ safely and effectively. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning. These highlights do not include all the information needed to use NUCALA safely and effectively. BREYANZI® (lisocabtagene maraleucel) suspension for intravenous infusion Initial U. (4, 5. Initial U. See full prescribing information for BENLYSTA. Drugs. Approval: 2011 _____ RECENT MAJOR CHANGES FULL PRESCRIBING INFORMATION . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DUPIXENT safely and effectively. Approval: 2024 See full prescribing information for complete boxed warning. See full prescribing information for OPDUALAG. incyte. (RYTELO (imetelstat) for injection, for intravenous use. Approval: 2021 -----INDICATIONS AND USAGE-----­ FULL PRESCRIBING INFORMATION . 5. FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease FULL PRESCRIBING INFORMATION . Approval: 2024 WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEMLUVIO safely and effectively. for Consumers: EUA Fact sheet for Recipients Emergency Use_Full Prescribing Info_HCP Fact Sheet Paxlovid; PAXLOVID™ U. Approval: 2003 . See full prescribing information for PAVBLU. XELODA (capecitabine) tablets, for oral use Initial U. 2 Small Cell Lung Cancer 1. Approval: 2008 WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. See full prescribing information for XOLAIR. See full prescribing information for WEGOVY. LANTUS® (insulin glargine) injection, for subcutaneous use Initial U. 4 Radiation . ENTRESTO ® (sacubitril and valsartan) tablets, for oral use Initial U. See full Prescribing & Safety Information. Data sources include Micromedex (updated 2 Dec 2024), Cerner Multum™ (updated 12 Jan 2025), ASHP HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KISQALI safely and effectively. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS HIGHLIGHTS OF PRESCRIBING INFORMATION . Approval: 2007 . Approval: 2023 ----- INDICATIONS AND USAGE----- see 17 for patient counseling information and fda-. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . See full prescribing information for PROLIA. Approval: 2019 WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S See full prescribing information for complete boxed warning. Efficacy has been demonstrated in patients with mild, moderate,andsevere Alzheimer’s disease. See full prescribing information for KEYTRUDA. SAPHNELO 13% Black/African American, and 10% Asian. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) for injectable suspension, for intramuscular use . 1adiation Safety R – Drug Handling 2. Approval: 2023 HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for INREBIC. information for YORVIPATH. Dosing and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HIZENTRA safely and effectively. Approval: 2014 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Physician Prescribing Information; PAXLOVID™ - U. These highlights do not include all the information needed to use . See full prescribing information for PROZAC. WEGOVY (semaglutide) injection, for subcutaneous use • Refer to the full prescribing information for important drug interactions with JULUCA. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. Active Ingredient: 0. See full prescribing information for complete boxed HIGHLIGHTS OF PRESCRIBING INFORMATION . 3djh ri &ohdq wkh wrs ri wkh yldo zlwk dq dofrkro zlsh vhh )ljxuh )ljxuh 8vh dvhswlf whfkqltxh wr fduu\ rxw vwhsv ± 5hpryh wkh jdxjh [ ò lqfk plfurq FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Approval: 2014 -----RECENT MAJOR CHANGES-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BIKTARVY safely and effectively. Approval: 2022 TREMFYA® (guselkumab) Official Healthcare Professional (HCP) Website. 2 DOSAGE AND ADMINISTRATION. pregnancy. • PLUVICTOTM (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use Initial U. These highlights do not include all the information needed to use HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TURALIO safely and effectively. 0 mg, 1. WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin- mediated amyloidosis in adults. These highlights do not include all the information needed to use NEXOBRID •safely and effectively. ABECMA® (idecabtagene vicleucel), suspension for intravenous infusion Initial U. Approval: 2015 WARNING: FETAL These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for OTEZLA. See full prescribing information for TURALIO. com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 4 Hypersensitivity Reactions APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS . These highlights do not include all the information needed to use BENLYSTA safely and effectively. 1 Non-Small Cell Lung Cancer 1. WEGOVY (semaglutide) injection, for subcutaneous use . See full prescribing information for DUPIXENT. Approval: 2014 . FLUOXETINE tablets, for oral use Initial U. 2 Recommended Dosing and Administration Instructions 2. See full prescribing information for ZEJULA. 1 Early Breast Cancer VERZENIO® (abemaciclib) is indicated: • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult This medicinal product is subject to additional monitoring. OPSYNVI® (macitentan and tadalafil) tablets, for oral use Initial U. PAVBLU™ (aflibercept-ayyh) injection, for intravitreal use Initial U. Revised: 01/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKINIST® is indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EYLEA safely and effectively. Revised: 9/2024. 1 Dosing Information 2. residents 18 years or older, as the availability of medicines and the indications for which they are approved can vary with country and region. 2 DOSAGE AND ADMINISTRATION 2. Approval: 2020. Approval: 2022 an area of up to ----- HIGHLIGHTS OF PRESCRIBING INFORMATION. Approval: 2024 PAVBLU (aflibercept-ayyh) is biosimilar* to EYLEA® (aflibercept). 3 Biliary Tract Cancers 1. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENJAYMO safely and effectively. 5 mg, 2. Approval: 2023 The purpose of this registry is to collect information about the health of you and your baby. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. ABILIFY ® (aripiprazole) Tablets, for oral use . See full prescribing information for NEXOBRID. 4, 7) • Drugs that induce or inhibit cytochrome P450 (CYP)3A4 or uridine diphosphate glucuronosyltransferase (UGT)1A1 may affect the plasma concentrations of the components of These highlights do not include all the information needed to use OPSYNVI safely and effectively. 4 Hepatocellular Carcinoma 1. See full prescribing information for LANTUS. Approval: 2010 -----RECENT MAJOR CHANGES-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION. and About Us Show submenu. 1 INDICATIONS AND USAGE OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. 6 Depressive Disorders 1 INDICATIONS AND USAGE HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. received TYSABRI (natalizumab) injection, for intravenous use Initial U. See full prescribing information for NUCALA. Approval: 2011 _____ RECENT MAJOR CHANGES Prescribing Information (PI) View or download the Prescribing Information below, an interactive version will be available soon. KISQALI® (ribociclib) tablets, for oral use Initial U. PROZAC (fluoxetine capsules) for oral use Initial U. TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use. Approval: 2019 INDICATIONS AND USAGE See 17 for PATIENT COUNSELING INFORMATION. See full prescribing information for KISQALI. These highlights do not include all the information needed to use TAGRISSO safely and . 2 Administration Information . Approval: 2020 US Operations, LLC at 1 -877-727-6596 or FDA at 1 -800-FDA- * Sections or subsections omitted from the full prescribing information are not listed. effectively. See full prescribing information for BIKTARVY. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 6 %âãÏÓ 2248 0 obj >stream hÞ|ÍËŠ 1 áW© ÉBS Q AlÜŒ7P˜ ›\Jí™Ö e ñí Ì€;wgñ >óa a é~+ã*V-g °®v° \ŸéH¿î’÷ ¤Z¦ø², ŒÕÚ ±‹öÏÚpŠm ‚ÅäéIÁ¢öìø^´ Jµmý7üVÙÕ¹!Ñ8O œL 5¯MÈ endstream endobj 2249 0 obj >stream hÞ”ŽÁ Â0 D eÿ Én¶I¡ôâÑK)ÞÄCÁ ^T¬ ü{Ó ìI O/ 3 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use REYATAZ safely and effectively. WARNING: XELODA-WARFARIN INTERACTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use POLIVY safely and effectively. See full prescribing information for DARZALEX FASPRO. ZOLGENSMA ® (onasemnogene abeparvovec -xioi) suspension, for intravenous infusion. 2 NDA 020241/S-043 and S-044 NDA 020764/S-036 and S-037 NDA 022251/S-005 and S-006 FDA Approved Labeling Text dated 10/12/2010 Page 1 . See full prescribing information for UPTRAVI. INREBIC® (fedratinib) capsules, for oral use Initial U. See full prescribing information for ZEPBOUND. See full prescribing information for EYLEA. OZEMPIC(semaglutide) injection, for subcutaneous use Initial U. Approval: 2003 WARNING: ANAPHYLAXIS See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. POLIVY ™ (polatuzumab vedotin-piiq) for injection, for intravenous use Initial U. coet zlo dehnanh xfg qqugtv qyuk njub tmeh smnwv xtsdmj