Us full prescribing information 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. Approval: 2011 _____ RECENT MAJOR CHANGES Prescribing Information (PI) View or download the Prescribing Information below, an interactive version will be available soon. and HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use AKYNZEO® safely and effectively. 1 Preparation for Administration . See 17 for PATIENT COUNSELING INFORMATION. Approval: 2021 WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, These highlights do not include all the information needed to use INREBIC safely and effectively. 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. VYLOY ® (zolbetuximab-clzb) for injection, for intravenous use Initial U. See full prescribing information for . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use APRETUDE safely and effectively. FLOVENT HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. 5 Hepatotoxicity (PREP) IN UNDIAGNOSED HIV-1 INFECTION. Acute serious liver injury and elevated HIGHLIGHTS OF PRESCRIBING INFORMATION . 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. FLUAD® QUADRIVALENT - Seqirus Inc. 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. 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. WARNING: RISK OF DRUG RESISTANCE 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 5 mg, 2. 2 DOSAGE AND ADMINISTRATION 2. 1 Important Dosage and Administration Instructions 2. 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. See full prescribing information for NEXOBRID. 1 INDICATIONS AND USAGE OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. 0 mg and 2. 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. See full prescribing information for HIZENTRA. 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 HIGHLIGHTS OF PRESCRIBING INFORMATION. information for YORVIPATH. See full prescribing information for OPSYNVI. ENTRESTO® (sacubitril and valsartan) tablets, for oral use ENTRESTO® SPRINKLE (sacubitril and valsartan) oral pellets Initial U. TM (daratumumab and hyaluronidase-fihj) injection, for subcutaneous 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. ENJAYMO® (sutimlimab-jome) injection, for intravenous use Initial U. ADAKVEO® (crizanlizumab-tmca) injection, for intravenous use Initial U. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS . DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U. See full prescribing information for KEYTRUDA. If the FDA product labels provide professional information, package inserts and medication guides. Revised: 07/2024. KISQALI® (ribociclib) tablets, for oral use Initial U. Approval: 2000 FULL PRESCRIBING INFORMATION 1INDICATIONS AND USAGE 1. 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). and About Us Show submenu. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DUPIXENT safely and effectively. APRETUDE (cabotegravir extended-release injectable suspension ), for intramuscular use . BENLYSTA (belimumab) for injection, for intravenous use BENLYSTA (belimumab) injection, for subcutaneous use Initial U. Approval: 2015 See full prescribing information for PROMACTA. 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. 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. See full prescribing information for ENTRESTO. Approval: 2002. Dosing and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HIZENTRA safely and effectively. AKYNZEO® (netupitant and palonosetron) capsules, for oral use . HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use REYATAZ safely and effectively. See full prescribing information for OPDUALAG. Please refer to the full Prescribing Information and Medication Guide for additional safety FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS SKIN RASHES 1 1. Approval: 2011 ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JAYPIRCA safely and effectively. See full prescribing information for DUPIXENT. OJJAARA (momelotinib) tablets, for oral use . See full prescribing . revised: 4/2024 . AKYNZEO® (fosnetupitant and palonosetron) for injection, for FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Approval: 2019 INDICATIONS AND USAGE See 17 for PATIENT COUNSELING INFORMATION. LANTUS® (insulin glargine) injection, for subcutaneous use Initial U. See full prescribing information for MENVEO. These highlights do not include all the information needed to use . 1 Non-Small Cell Lung Cancer 1. ZEPBOUND® (tirzepatide) Injection, for subcutaneous use Initial U. Approval: 2015 HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for PLUVICTO. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. See full prescribing information for NUCALA. Approval: 2021 WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC These highlights do not include all the information needed to use ELZONRIS® safely and effectively. BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U. See full prescribing information for TRULICITY. Approval: 2015 . 0 mg, 1. See full prescribing information for AREXVY. 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. 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. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) for injectable suspension, for intramuscular use . DOSAGE AND ADMINISTRATION. 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. Approval: 2017 -----RECENT MAJOR CHANGES----- ections or subsections omitted from the full prescribing information are not listed. 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. Prolia ® (denosumab) Injection, for subcutaneous use Initial U. See full prescribing information for FLUOXETINE. Active Ingredient: 0. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . DUPIXENT® (dupilumab) injection, for subcutaneous use Initial U. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for UPTRAVI. com . 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. Approval: 2019 WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. 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 NEMLUVIO safely and effectively. Initial U. Approval: 2010 -----RECENT MAJOR CHANGES-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYTELO safely and effectively. 5 Endometrial Cancer. DARZALEX FASPRO. 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. Approval: 2024 WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Fluoroquinolones, including LEVAQUIN ® , are associated with an increased risk of tendinitis and tendon rupture in all ages. LEQEMBI™ (lecanemab-irmb) injection, for HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYTELO safely and effectively. See full prescribing information for SOLIRIS. A Family Run Company; Events; Careers @ ChiRhoClin; Contact; Home / Products / ChiRhoStim Synthetic Human Secretin / Full Prescribing Information. See full prescribing information for LANTUS. OPSYNVI® (macitentan and tadalafil) tablets, for oral use Initial U. for Consumers: EUA Fact sheet for Recipients Emergency Use_Full Prescribing Info_HCP Fact Sheet Paxlovid; PAXLOVID™ U. The following describes the recent changes to the SKYRIZI Medication Guide. UPTRAVI® (selexipag) tablets, for oral use UPTRAVI® (selexipag) for injection, for intravenous use Initial U. 3 Image Acquisition Guidelines 2. Approval: 2024 PAVBLU (aflibercept-ayyh) is biosimilar* to EYLEA® (aflibercept). TYLENOL ® Regular Strength (DIN 00559393) Acetaminophen Tablet s USP 325 mg . 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 . SOLIRIS ® (eculizumab) injection, for intravenous use . 2 Parkinson’s Disease Dementia HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use YORVIPATH safely and effectively. 4 Image Display and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PLUVICTO safely and effectively. Approval: 2024 WARNING: EMBRYO–FETAL TOXICITY See full prescribing information for complete boxed warning. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Approval: 2003 . BREYANZI® (lisocabtagene maraleucel) suspension for intravenous infusion Initial U. Approval: 2019 WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S See full prescribing information for complete boxed warning. Any linked documents and websites are intended only for U. Physician Prescribing Information; PAXLOVID™ - U. 1 Alzheimer’s Disease EXELON PATCHis indicated for the treatment of dementia of the Alzheimer’s type(AD). See full prescribing information for RYTELO. Approval: 2016 _____ INDICATIONS AND USAGE _____ and as clinically needed US-89064. XOLAIR® (omalizumab) injection, for subcutaneous use XOLAIR® (omalizumab) for injection, for subcutaneous use Initial U. 1 . 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. WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE • Cases of acute liver failure with fatal outcomes have been reported. Approval: 2017. Approval: 2023 . Approval: 1998 . NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use Initial U. (4, 5. Prescribing Information PDF Adult patients with moderate or severe renal impairment not on hemodialysis (eGFR 30-59 mL/min/1. INREBIC® (fedratinib) capsules, for oral use Initial U. TAGRISSO ® (osimertinib) tablets, for oral use Initial U. See full prescribing information for ENJAYMO. PROMACTA® (eltrombopag) tablets, for oral use PROMACTA® (eltrombopag) for oral suspension Initial U. Approval: 2020. PAVBLU™ (aflibercept-ayyh) injection, for intravitreal use Initial U. WARNING: XELODA-WARFARIN INTERACTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use POLIVY safely and effectively. FULL PRESCRIBING INFORMATION. Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION . ELZONRIS (tagraxofusp-erzs) injection, for intravenous use Initial U. Drugs. See safety information. 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. LUMAKRAS™ (sotorasib) tablets, for oral use Initial U. EYLEA ® (aflibercept) Injection For Intravitreal Injection Initial U. OTEZLA ® (apremilast) tablets, for oral use Initial U . See full prescribing information for TECENTRIQ. 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. See full prescribing information for INREBIC. REYATAZ (atazanavir) capsules, for oral use• REYATAZ (atazanavir) oral powder Initial U. Interrupt or permanently discontinue VY. These highlights do not include all the information needed to use ZEJULA safely and effectively. 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. 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 . WARNING: FETAL TOXICITY . See full prescribing information for XOLAIR. 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. 5 mg riociguat. See full prescribing information for OTEZLA. These highlights do not include all the information needed to use NUCALA safely and effectively. Revised: 10/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Approval: 2023 -----RECENT MAJOR CHANGES----- HIGHLIGHTS OF PRESCRIBING INFORMATION. See full prescribing information for SPINRAZA. Approval: 2017 were fatal. Approval: 2024 See full prescribing information for complete boxed warning. See full prescribing information for LEQEMBI™. Approval: 2023 The purpose of this registry is to collect information about the health of you and your baby. 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. See full prescribing information for JAYPIRCA. WARNING: SERIOUS LIVER INJURY and ACUTE These highlights do not include all the information needed to use TYSABRI safely and effectively. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for complete boxed HIGHLIGHTS OF PRESCRIBING INFORMATION . 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. Approval: 2000 These highlights do not include all the information needed to use ZEPBOUND safely and effectively. 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. 1 INDICATIONS AND USAGE . This prescribing information is the exclusive property of McNeil Consumer Healthcare, division of Johnson & Johnson Inc . 3 Biliary Tract Cancers 1. Medical Information Page - clinical & safety information, ways to contact Pfizer 17 PATIENT COUNSELING INFORMATION. See fu ll prescribing information for APRETUDE. 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. 2 Small Cell Lung Cancer 1. Efficacy has been demonstrated in patients with mild, moderate,andsevere Alzheimer’s disease. See full prescribing information for PROLIA. 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. SPINRAZA® safely and effectively. See full prescribing information for ZEPBOUND. See full prescribing information for VYLOY. Below is a list of our company's marketed products. 2 Recommended Dosage, Preparation, and Administration Instructions 2. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These highlights do not include all the information needed to use TYSABRI safely and effectively. ABRAXANE ® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), for intravenous use Initial U. Approval: 2015 See 17 for PATIENT COUNSELING INFORMATION. See full prescribing information for TYSABRI. It is divided into Highlights of Prescribing Information, Table of Contents, and See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for TRODELVY. Approval: 2014 -----RECENT MAJOR CHANGES-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BIKTARVY safely and effectively. These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. FLUOXETINE tablets, for oral use Initial U. 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. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . S. 1adiation Safety R – Drug Handling 2. Approval: 2011 _____ RECENT MAJOR CHANGES FULL PRESCRIBING INFORMATION . ENTRESTO ® (sacubitril and valsartan) tablets, for oral use Initial U. These highlights do not include all the information needed to use SOLIRIS safely and effectively. TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use. _____ FULL PRESCRIBING INFORMATION . WEGOVY (semaglutide) injection, for subcutaneous use • Refer to the full prescribing information for important drug interactions with JULUCA. Approval: 2022 an area of up to ----- HIGHLIGHTS OF PRESCRIBING INFORMATION. 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. 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. TURALIO® (pexidartinib) capsules, for oral use Initial U. See full prescribing information for WEGOVY. PAXLOVID. Approval: 2003 WARNING: ANAPHYLAXIS See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. SAPHNELO 13% Black/African American, and 10% Asian. 1 These highlights do not include all the information needed to use INREBIC safely and effectively. ZEJULA (niraparib) tablets, for oral use MDS/AML occurred in patients exposed to ZEJULA, and some cases . Full Prescribing Information. • Read Mirena® (levonorgestrel-releasing intrauterine system) 52 mg full prescribing information to learn about dosage and administration. ZOLGENSMA ® (onasemnogene abeparvovec -xioi) suspension, for intravenous infusion. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. See full prescribing information for TAGRISSO. 1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease . YORVIPATH ® (palopegteriparatide) injection, for subcutaneous . See full prescribing information for ELZONRIS. Approval: 2023 ----- INDICATIONS AND USAGE----- see 17 for patient counseling information and fda-. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAVBLU safely and effectively. VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. Approval: 2018 WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. 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. US-95991. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UPTRAVI safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TECENTRIQ safely and effectively. PROZAC (fluoxetine capsules) for oral use Initial U. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MENVEO safely and effectively. • TECFIDERA ® (dimethyl fumarate) delayed-release capsules, for oral use . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XOLAIR safely and effectively. Approval: 2003 WARNING: ANAPHYLAXIS HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADAKVEO safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LUMAKRAS safely and effectively. Delay or dose reduce as recommended. See full prescribing information for VYVGART HYTRULO. Read Mirena® This site is intended for US residents only. See full prescribing information for NEMLUVIO. These highlights do not include all the information needed to use TECFIDERA safely and effectively. Approval: 2014 . 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. Approval: 2013 _____ RECENT MAJOR CHANGES _____ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use . received TYSABRI (natalizumab) injection, for intravenous use Initial U. Approval: 2021 -----INDICATIONS AND USAGE-----­ FULL PRESCRIBING INFORMATION . The equivalent of the USPI in the European Union is the Summary of Product Characteristics (SmPC). 3 Vaccination Schedule . SPINRAZA (nusinersen) injection, for intrathecal use . See full Prescribing & Safety Information. 3 Image Acquisition Instructions 2. Approval: 2019-----RECENT MAJOR CHANGES----- This product information is intended only for residents of the United States. for JYNNEOS. See full prescribing information for IMDELLTRA. 2 Administration Information . See full prescribing information for KISQALI. TRELSTAR ® (triptorelin pamoate for injectable suspension) , for intramuscular use Initial U. WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin- mediated amyloidosis in adults. OPDUALAG™ (nivolumab and relatlimab-rmbw) injection, for intravenous use Initial U. PAXLOVID safely and effectively. TRYVIOTM (aprocitentan) tablets, for oral use Initial U. 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. Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information . 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. 1. Approval: 1987 . These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for DARZALEX FASPRO. Approval: 2020 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. 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: 2015----- RECENT MAJOR CHANGES ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EYLEA 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. 73 m 2 and 15-29 mL/min/1. Approval: 2021 . See full prescribing information for TECFIDERA. 2 Recommended Dosing and Administration Instructions 2. 4 Hepatocellular Carcinoma 1. 2 DOSAGE AND ADMINISTRATION . These highlights do not include all the information needed to use BENLYSTA safely and effectively. Approval: 2022 ——————————— RECENT MAJOR CHANGES 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. Site Last Modified: 11/2024. Approval: 2023 HIGHLIGHTS OF PRESCRIBING INFORMATION . (RYTELO (imetelstat) for injection, for intravenous use. 4 Infusion Instructions 3 DOSAGE FORMS AND STRENGTHS 4 17 for PATIENT COUNSELING INFORMATION. 1 Radiation Safety-Drug Handling 2. See full prescribing information for BREYANZI. See full prescribing information for POLIVY. IMDELLTRA™(tarlatamab-dlle) for injection, for intravenous use Initial U. opzelura. FULL PRESCRIBING INFORMATION . See full prescribing information for ZOLGENSMA. See full prescribing information for ABILIFY. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. WEGOVY (semaglutide) injection, for subcutaneous 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 LANTUS safely and effectively. Approval: 2015 WARNING: FETAL These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for XELODA. Approval: 2004 WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning The USPI sets out the agreed usage of the drug. HIZENTRA®, Immune Globulin Subcutaneous (Human), 20% Liquid Initial U. See full prescribing information for OZEMPIC. OZEMPIC(semaglutide) injection, for subcutaneous use Initial U. See full prescribing information for AKYNZEO®. 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. 4 Hypersensitivity Reactions APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS . JYNNEOS safely and effectively. WARNING: ANAPHYLAXIS . Approval: 2015 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. Approval: 2024 -----INDICATIONS AND USAGE----- HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for TRELSTAR. See full prescribing information for REYATAZ. See full prescribing information for TURALIO. NUCALA (mepolizumab) for injection, for subcutaneous use . 4 Radiation . Adempas ® Prescribing Information Composition. See full prescribing information for ABRAXANE. 2 Required Premedication 2. pregnancy. residents 18 years or older, as the availability of medicines and the indications for which they are approved can vary with country and region. 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. 5. Approval: 2010 -----RECENT MAJOR CHANGES-----­ HIGHLIGHTS OF PRESCRIBING INFORMATION. POLIVY ™ (polatuzumab vedotin-piiq) for injection, for intravenous use Initial U. 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. See full prescribing information for PAVBLU. 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. These highlights do not include all the information needed to use TAGRISSO safely and . 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: 2015----- RECENT MAJOR CHANGES ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FLUOXETINE safely and effectively. 2 DOSAGE AND ADMINISTRATION. Approval: 2003 WARNING: ANAPHYLAXIS HIGHLIGHTS OF PRESCRIBING INFORMATION . 1 1. an area of up to 15% BSA NEXOBRID® (anacaulase-bcdb) for topical gel • Initial U. ABILIFY ® (aripiprazole) Tablets, for oral use . 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. Revised: 9/2024. XELODA (capecitabine) tablets, for oral use Initial U. 5 mg, 1. • PLUVICTOTM (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use Initial U. HIGHLIGHTS OF PRESCRIBING INFORMATION . Approval: 2017 See full prescribing information for IMFINZI. See full prescribing information for TRYVIO. See full prescribing information for EYLEA. effectively. 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. 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. Revised: 01/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Approval: 2024 -----INDICATIONS AND USAGE----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BREYANZI safely and effectively. These highlights do not include all the information needed to use VYLOY safely and effectively. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning. 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. These highlights do not include all the information needed to use NEXOBRID •safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OPDUALAG safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION. ABECMA® (idecabtagene vicleucel), suspension for intravenous infusion Initial U. 1 Dosing Information 2. TRULICITY (dulaglutide) injection, for subcutaneous use Initial U. See full prescribing information for ADAKVEO. Approval: 2018 WARNING: POST TREATMENT ACUTE EXACERBATION OF HIGHLIGHTS OF PRESCRIBING INFORMATION . FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE. 3 Instructions for Use . 2 Dosing 2. See full prescribing information for ABECMA. oral use . 2. Approval: 2019 . com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. incyte. These highlights do not include all the information needed to use TRELSTAR safely and effectively. See full prescribing information for LUMAKRAS. Approval: 2007 . See full prescribing information for BIKTARVY. 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. 3 Preparation Instructions 2. 2 DOSAGE AND ADMINISTRATION The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the . See full prescribing information for OJJAARA. PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets), co-packaged for . 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. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use OJJAARA safely and effectively. NUCALA (mepolizumab) injection, for subcutaneous use . 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. Approval: 2022 TREMFYA® (guselkumab) Official Healthcare Professional (HCP) Website. This professional information presents product monographs approved by the US Food and Drug See full prescribing information for FLUAD QUADRIVALENT. JAYPIRCA® (pirtobrutinib) tablets, for oral use Initial U. to each infusion. TECENTRIQ ® (atezolizumab) injection, for intravenous use Initial U. See full prescribing information for PROZAC. FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease FULL PRESCRIBING INFORMATION . 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 ZEJULA. SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles): • in adult s aged 50 years and older. Approval: 2014 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. XOLAIR ® (omalizumab) for injection, for subcutaneous use Initial U. 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. Approval: 2005 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. See full prescribing information for BENLYSTA. 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. 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. dgqe hjxw bcl utf xmu oulg wrdq dxreuyd fvng cmnxap