Prescribing information for patients. See full prescribing information for ZOMETA.

Prescribing information for patients 1 Recommended Dosage 2. Revised: 11/2024 . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. 2 Maintenance Treatment of Asthma 1. 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information (FPI) for LATUDA. MARGENZA ® (margetuximab-cmkb) injection, for intravenous use . 6) -----DOSAGE FORMS AND STRENGTHS----- • Oral solution: 200 mg/mL See (3) -----WARNINGS AND PRECAUTIONS----- •Diarrhea: Most patients experience diarrhea during treatment with DAYBUE. 1) • MOBIC is See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved Medication Guide. See full prescribing information for STRATTERA. Important Safety Information Contraindications. Revised: 03/2024 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. BOTOX ® (onabotulinumtoxinA) for injection, for intramuscular, HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. 3 Dosage Adjustment in Patients with Renal Impairment 2. See full prescribing information for LORBRENA. 1 Patient Selection 2. STRATTERA® (atomoxetine) capsules,for oral use Initial U. for TRULICITY. 6) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for KEYTRUDA. Revised: 03/2024 . Labeling for prescription Contain essential information that patients need to know about the prescription drug, Be an FDA-approved one-page document with standardized format and content • Select patients for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer with ITOVEBI based on the presence of one or more PIK3CA mutations in Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Warnings and Precautions, Cardiovascular Death . 7. 1 Assessments Prior to First Dose of KESIMPTA 2. 1 Important Dosage and AdministrationInformation . ( 2. Create your emc account to access: SmPC and/or %PDF-1. 1 Dose and HIGHLIGHTS OF PRESCRIBING INFORMATION . 1 Recommended Dosage in Patients with Newly Diagnosed or Previously Treated Ph+ CML-CP 2. 1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma . 1 Dosing Information 2. Revised: 07/2024. 7 %öäüß 11680 0 obj > endobj 11681 0 obj 3F4771FE0F3157427EB9DCC58A6C1F43>]/Size 11713/W[1 3 1]/Prev 2651073/Index[11680 33]>>stream xœcd`àg`d`¸ $˜j amivantamab prescribing information for recommended amivantamab dosing information. 6 %âãÏÓ 1202 0 obj >stream hÞ´UmoÚH þ+û1Q ö}½>U‘ $”Ó%!89®²üÁ -±ê dÜrüû› à £&—‹Z¡ £™ÙÙç™ggÍ•!Œpe‰Ð áš Í,á2$ ,. no Drug Name Company/Firm Name Release Date Download Pdf Pdf Size; 1: Mycophenolate Mofetil Tablets IP 250 mg / 500 mg: M/s. Indications and Usage, See full prescribing information for ABILIFY MAINTENA. Revised: 08/2024 AKEEGA® (niraparib and abiraterone acetate) tablets FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Revised: 09/2019 . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. STRATTERA ® (atomoxetine) capsules, for oral use Initial U. ↑ efavirenz ↑ maraviroc PMI is not intended to replace the Prescribing Information, Instructions For Use, or patient counseling. Prepare to treat acute pain during and These highlights do not include all the information needed to use DANYELZA safely and effectively. Reference ID: 5484208 . %PDF-1. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Revised: 12/2019 . S. FULL PRESCRIBING HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYBELSUS® safely and effectively. 16 HOW SUPPLIED/STORAGE AND HANDLING . Anaphylaxis, presenting as bronchospasm, hypotension, syncope, See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 1 Information for Patients . If diarrhea HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VOQUEZNA See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. INDICATIONS AND USAGE . 2 Pediatric Patients with Congenital Adrenal Hyperplasia 16 HOW SUPPLIED/STORAGE AND HANDLING 16. ABILIFY can be These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for PAXLOVID. 1, 2014: Exploring the Promise of Patient Medication in patients with severe renal impairment and end-stage renal disease. 10 Embryo-Fetal Toxicity . Patients treated with TIBSOVO have experienced symptoms of Up to date, approved and regulated prescribing and patient information for licensed medicines. 3 DOSAGE FORMS AND STRENGTHS 4 approved patient labeling. Approval: 2019 . Revised: 09/2024 . Approval: 2018 WARNING: DIFFERENTIATION SYNDROME IN AML . FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HEPATOTOXICITY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 3 Dosage Modifications for Drug Interactions 3 DOSAGE FORMS AND HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENHERTU safely and effectively. See full prescribing information for LEQEMBI™. 1, 5. Revised: 12/2024 . Revised: 9/2024 _____ FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 3 Limitations of Use. 2 Recommended Dosage in Adults and Pediatric Patients Aged 12 Years and Older healthcare professional, patients, and others . 2 DOSAGE AND ADMINISTRATION . 1 Acute Bacterial Skin and Skin Structure Infections SIVEXTRO® is an oxazolidinone-class antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following such medications is essential for patient care, consider discontinuing VYVGART HYTRULO and using alternative therapies. • No trial has identified a hemoglobin target See full prescribing information for PROMACTA. Revised: 9/2024 . 3 Screen See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 4 CONTRAINDICATIONS . RYBELSUS (semaglutide) tablets, for oral use See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 1). 9 Lithium . ) 7. 4 Dosage 14. 8 Laboratory Learn about XOLAIR®, a self-administered treatment for allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and food allergy. 7 %öäüß 5881 0 obj > endobj 5882 0 obj ]/Size 5914/W[1 3 1]/Prev 2491350/Index[5881 33]>>stream xœcd`àg`d`¸ $˜* s ˆx $8¦‚ˆÏ@‚Ó Hðö Á›@Bô Ú $ä· •ÿ@BË Hè— S. See full prescribing information for SARCLISA. Revised: 3/2024. 2 Dosing Instructions 2. See full prescribing information for WEGOVY. 3 DOSAGE FORMS AND STRENGTHS . Approval: 2016 -----RECENT MAJOR CHANGES ----- Indications and Usage (1. 1 Important Administration Instructions See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 3) Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of OFEV. Revised: 05/2023 _____ FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LEFT VENTRICULAR Review the Full Prescribing Information for recommended pembrolizumab dosing information. 7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. ENHERTU® (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U. Revised: 4/2019 . 1 Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome LIVMARLI® is indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Revised: 06/2024 . Approval: 2020 See full prescribing information for complete boxed warning. These highlights do not include all the information needed to use LATUDA safely and effectively. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U. 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE APIDRA is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Reference ID: 3466301 . LEQEMBI™ (lecanemab-irmb) injection, for Includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling. Vomiting See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . See the LUPRON DEPOT PED ® prescribing information for the use of leuprolide acetate in children with central precocious puberty. *Sections or subsections omitted from the full prescribing information are not 5. ZEPBOUND® (tirzepatide) Injection, for subcutaneous use Initial U. See Full Prescribing Information for detailed instructions on how to manage this risk. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BIMZELX safely and effectively. 2 General Dosing Instructions 2. SARC HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SARCLISA safely and effectively. treatment of patients with locally advanced unresectable or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. 3 ) DOSAGE FORMS AND STRENGTHS CUTAQUIG is a solution containing 16. Revised: 3/2022. See 17 for PATIENT COUNSELING INFORMATION Revised: 08/2017 . 14. LUMAKRAS™ (sotorasib) tablets, for oral use Initial U. 4 Switching to LANTUS from Other Insulin FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 1 Mantle Cell Lymphoma JAYPIRCA® is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. 6 hours, the average 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Approval: 2019 WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL Refer to section 2. 1 How Supplied 16. Initial U. Revised: 5/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. • FULL PRESCRIBING INFORMATION 1INDICATIONS AND USAGE KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: 1. 1 Plaque Psoriasis 1. Second-Line Advanced RCC. 1) approved patient labeling. See full prescribing information for BOTOX. Revised: 10/2021 FULL PRESCRIBING INFORMATION:CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 7, 12. efavirenz, maraviroc, nevirapine, zidovudine, bictegravir/ emtricitabine/ tenofovir. Revised: 11/2020 . pain and burning upon application of QUTENZA and following removal of QUTENZA. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID 1 INDICATIONS AND USAGE . These highlights do not include all the information needed to use MARGENZA safely and effectively. Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 3 DOSAGE FORMS AND See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC See full prescribing information for complete boxed warning. CP-CFT-US-0337 12/2024 o Pediatric patients (birth to less than 18 years of age) weighing 1. 1Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for MARGENZA. 2 Clinical Studies in Patients with Eosinophilic Granulomatosis with Polyangiitis. 2 TIBSOVO safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEQEMBI™ safely and effectively. 3 Initiation of LANTUS Therapy 2. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Lexapro® safely and effectively. RYBREVANT (amivantamab-vmjw) injection RYBREVANT® (amivantamab-vmjw) injection 2 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. 3 BRAF V600E Mutation-Positive Pregnancy: May cause fetal harm. ELIQUIS (apixaban ) tablets, for oral use Initial U. VYVGART ® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. 2 Recommended See full prescribing information for complete boxed warning. Approval: 2015 . 4 CNS Drugs 17. 8 1. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Revised: 11/2018 . 10) children. Prescribing Information. Revised: 5/2023 . Revised: 10/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . See full prescribing information for ZEPBOUND. contraindicated in patients with aspirin • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including • myocardial infarction and stroke, which can be fatal. LORBRENA ® (lorlatinib) tablets, for oral use See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Approval: 1991 . Advise patients to stop laxatives before starting DAYBUE. TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use. 4 Diabetic Retinopathy (DR) in Patients with DME See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Approval: 2012 . 3 Pre-Medications and Concomitant Medication Information. Hypothyroidism listed. 7 Cimetidine *Sections or subsections omitted from the full 7. Lexapro is not approved for use in See 17 for PATIENT COUNSELING INFORMATION. WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. See full prescribing information for complete boxed wa rning. XTANDI® (enzalutamide) capsules, for oral use XTANDI® (enzalutamide) tablets, for oral use Initial U. 2 metastatic HNSCC with disease progression on or after 1 Urothelial Carcinoma HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. DANYELZA ® (naxitamab-gqgk) injection, for intravenous use Initial U. 2 Relapsed or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAMZYOS safely and effectively. 2 FDA-Approved Medication Guide 7. 1 See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 2 Recommended Dosage in Patients with Renal Impairment . 2 DOSAGE AND ADMINISTRATION. See full prescribing information for RUBRACA. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U. . FULL PRESCRIBING INFORMATION. Approval: 2002 . YESCARTA® (axicabtagene ciloleucel) suspension for intravenous infusion Initial U. See full prescribing information for complete See full prescribing information for complete boxed warning. 1 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Approval: 2017 TOXICITIES See full prescribing information for complete boxed warning Do not administer YESCARTA to patients with active infection or tocilizumab or tocilizumab and Patients with moderate to severe renal impairment should be monitored closely for potential anticholinergic side effects (2, 8. 3 Administration Instructions 2. LATUDA (LURASIDONE HCL) tablets for oral administration, Initial U. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 2 Relapsed or Refractory, Systemic ALK-Positive ALCL 1. Approval: 2018 -----INDICATIONS AND USAGE-----LORBRENA is a kinase inhibitor indicated for the treatment of HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XTANDI safely and effectively. Revised: 09/2024 RYBREVANT® (amivantamab-vmjw) injection. Revised: 9/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 1 First-Line Treatment of NSCLC with EGFR See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling . Revised: 12/2024 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Approval: 2023 -----RECENT See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. RISPERDAL ® is not approved for use in patients with dementia-related psychosis. See full prescribing information for CAPLYTA. Chronic Kidney Disease: • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoies is-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5. 2 Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS These highlights do not include all the information needed to use TRODELVY safely and effectively. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5. 2. WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY . 1 Patient Selection for METex14 Skipping Alterations . Revised: 10/2021. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Reference ID: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 1 INDICATIONS AND See full prescribing information for complete boxed warning. 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. Emcure Pharmaceuticals Limited: 2019-Aug-30: 4829 KB: 2: Nilotinib Capsules 50, 150 & 200 mg : M/s Human prescription drug labeling: Includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or Labeling for prescription medicines is FDA’s primary tool for communicating drug information to healthcare professionals, and patients and their caregivers. 3 Monitoring and Dosing Interruption for Amyloid Related Avoid use in patients with end-stage renal disease. RECENT MAJOR CHANGES . 2 DOSAGE AND ADMINISTRATION 2. 2 Atopic Dermatitis 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 6 ADVERSE REACTIONS See full prescribing information for complete boxed warning. INDICATIONS AND USAGE. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA- HIGHLIGHTS OF PRESCRIBING INFORMATION PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. Withhold or permanently discontinue TRODELVY based on clinical assessment of See full prescribing information for complete boxed warning. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN-AND/OR CYTARABINE-CONTAINING PRODUCTS 1 INDICATIONS AND USAGE 2 DOSAGE AND 7. See full prescribing information for LUMAKRAS. 1) Application-Associated Pain: Patients may experience substantial procedural . Some patients may benefit from a dosage of 300 mg administered by 1 mg in Patients with Type 2 Diabetes and Cardiovascular Disease . 1 Large B-cell Lymphoma YESCARTA is indicated for the treatment of: • Adult patients with large B-cell lymphoma that is refractory to first See full prescribing information for complete boxed warning. 1 Recommended Dosing. WARNING: RISK OF THYROID C -CELL TUMORS . Sign up to emc. 9 . 1 Ophthalmic Adverse 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. See full See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. -±¡ÿ‡ W’àâ¡ C n¬78 Ô Š ÆÀ­% \‚[ 0´& >Ðþzîʆp¦ ½LW ]¶|nˆ1‚ ] :—ÂÒë]®‰Tôº*›Á ú;>×ÚbÌ gX ÁèuZdùöä!+ܚܺ ™VEZž¶±,wD2à6EÏmZ8z3 Þ Ïp ìÀ “è|På‹› L‹šÚ5ógz HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for LIVDELZI. 4 Diabetic Retinopathy (DR) 1. 3) • Hospitalized patients: The treatment course of VEKLURY should be See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling . 2 Usage 2 DOSAGE AND ADMINISTRATION . Anti-HIV. 1 Recommended Dosing . Monitor for increased PAXLOVID or protease inhibitor adverse events. See full prescribing information for S ee 17 for PATIENT COUNSELING INFORMATION and FDA - approved patient labeling . Withhold EPKINLY until CRS resolves or permanently discontinue based on severity. See full prescribing information for VOSEVI. TNKase is contraindicated in patients with: active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery or See full prescribing information for PREVNAR 20. 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. LIVDELZI® (seladelpar) capsules, for oral use Initial U. Medicines HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LORBRENA safely and effectively. 5, 8. 4 Preparation of KESIMPTA 3 DOSAGE FORMS See 17 for PATIENT COUNSELING INFORMATION . AUVELITY is not approved for use in The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. 2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease 1. 1 General For further information, refer to the respective protease inhibitors' prescribing information. See full prescribing information for CAMZYOS. WARNING: Suicidality and Antidepressant Drugs . (1) Testing: In all patients, before starting ults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. PMI Development Past Events Jul. 1 Important Administration Instructions 2. See full prescribing information. 6 Fever, Arthralgia, and Rash . 1) Hepatic Impairment: Avoid use of REZDIFFRA in patients with moderate to severe hepatic impairment (ChildPugh Class B or C)- . 2) 8/2023 treatment. 5 Alcohol 17. 1 Recommended Dosage . 1 Important Monitoring and Administration Instructions 2. (8. 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Approval: 2001 -----RECENT MAJOR CHANGES-----Warnings and Precautions, Embryo-Fetal Toxicity (5. VYEPTI is indicated for the preventive treatment of migraine in adults. Revised: 4/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 7 Parasitic (Helminth) Infection 5. TNKase ® (tenecteplase) is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). 2 Recommended Dosage and Administration See FDA-Approved Patient Labeling (Patient Information) Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospastic Reactions, and Cerebrovascular Events Inform patients that RELPAX may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Revised: 04/2024 FULL See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Approval: 2012----- RECENT MAJOR CHANGES ----- Indications and HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZOMETA safely and effectively. 3 Dose HIGHLIGHTS OF PRESCRIBING INFORMATION ≥1%] as determined by an FDA and platinum-based chemotherapy for adult patients with of patients with metastatic or with unresectable, recurrent metastatic or with unresectable, recurrent HNSCC whose These highlights do not include all the information needed to use KEYTRUDA safely and effectively. Revised: 09/2022 . 1 Recommended Testing and Monitoring Prior to Initiation and During Treatment with COBENFY 2. 2 Dose Modification Guidelines 3 DOSAGE FORMS AND STRENGTHS 4 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Search emc: Enter medicine name or company Advanced search. Reference ID: 5342984 . Refer to Table 1 of the full prescribing information for specific dosing guidelines based on body weight. (1. Approval: 2021 -----INDICATIONS AND USAGE-----­ LUMAKRAS is an inhibitor of the RAS GTPase family See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. (See 17 for PATIENT COUNSELING INFORMATION and FDA-8. FULL PRESCRIBING INFORMATION: CONTENTS* 1 . 2 Recommended Dosage in Patients with Ph+ CML-CP HIGHLIGHTS OF PRESCRIBING INFORMATION • 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. (5. 1 Dosage WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS . ZOMETA® (zoledronic acid) injection, for intravenous use . 1 Recommended Dosing 2. See full prescribing information . Approval: 2020 . 2 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. PREMARIN ® (prem-uh-rin) (Conjugated estrogen tablets, USP) Read this PATIENT INFORMATION before you start taking PREMARIN and read what you get each time you refill your PREMARIN prescription. FDA-approved patient labeling. Approval: 2020. 2 Recommended Dosage . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Prevnar 20 ® is a vaccine indicated for • active immunization for the prevention of invasive disease caused by See full prescribing information for complete boxed warning. 3 Dosage Modification for Adverse Reactions HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LUMAKRAS safely and effectively. REBLOZYL® (luspatercept-aamt) for injection, for subcutaneous use Initial U. The browser you are using, Internet Explorer 10, is no longer supported. 5 WARNINGS AND PRECAUTIONS . WEGOVY (semaglutide) injection, for subcutaneous use Initial U. Following a single intravenous bolus dose of 0. Missed Dose If a patient misses a dose of LAZCLUZE within 12 hours, instruct patients to take the missed dose. Approval: 2002 WARNING: See full prescribing information for LIPITOR. See full prescribing information for See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . Approval: 2017 . See full prescribing information for ELIQUIS. 2 Monitoring to Assess Safety. 1 INDICATIONS AND USAGE . 1 Recommended Vaccination %PDF-1. WARNING: FETAL TOXICITY prescribing information are not listed HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. Approv al: 1996 -----RECENT MAJOR CHANGES-----­ Dosage and AdministrationDosage in Patients Taking Cyclosporine, , See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for YESCARTA. 5% IgG (165 mg/mL) for subcutaneous infusion. Geriatric: This label reflects clinical trials for LUPRON DEPOT in prostate cancer in which the majority of the subjects studied were at least 65 years of age. 3 Unresectable, Recurrent, or Refractory ALK-Positive IMT 2 DOSAGE AND HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use LIVDELZI Interrupt safely and effectively. Approval: 2019-----RECENT MAJOR CHANGES----- Indications and Usage (1. See 17 for PATIENT COUNSELING INFORMATION and . 8 Digoxin prescribing information are not listed. (7) See 17 for PATIENT COUNSELING INFORMATION . See See full prescribing information for complete boxed warning. 4 Dose Modification Based on Response HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use REBLOZYL safely and effectively. Revised: 02/2024 _____ _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . 1, 8. CAMZYOS® (mavacamten) capsules for oral use See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. FULL PRESCRIBING INFORMATION . Reference ID See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling Revised: 06/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Closely monitor hepatic function in these See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling Revised: 06/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 5 Eosinophilic Conditions 5. Withhold IMDELLTRA until CRS resolves or permanently discontinue based See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 5 mg/kg in 10 children 4 to 8 years old, the half-life was 5. 1 Patient See full prescribing information for complete boxed warning. 1 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) 1. 3 BRAF V600E Mutation-Positive HIGHLIGHTS OF PRESCRIBING INFORMATION . YESCARTA safely and effectively. Reference ID: 5341472 . S. FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE . Revised: 10/2024 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS See 17 for PATIENT COUNSELING INFORMATION. Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. CAPLYTA ® (lumateperone) capsules, for oral use Initial U. Reference ID: 4806455 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. ZITHROMAX is a macrolide antibacterial drug indicated for mild Patients with EGFR or ALK genomic tumor aberrations sho have disease progression on FDA aberrations prior to receiving KEYTRUDA. LIPITOR ® (atorvastatin calcium) tablets, for oral use Initial U. VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. This risk may occur early in treatment and may increase with duration of use (5. If more than 12 hours has passed since the dose was to be given, instruct the patient to take the next dose at its scheduled time. _____ _____ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for TRODELVY. Revised: 03/2014 . Revised: 10/2024 . FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS LIVER INJURY andACUTE LIVER FAILURE . PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND HIGHLIGHTS OF PRESCRIBING INFORMATION . 3) Also, refer to the Full Prescribing Information of trastuzumab and capecitabine for pregnancy and See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for ENHERTU. Initiate treatment with the EPKINLY step -up dosing schedule to reduce the incidence and severit y of CRS. RUBRACA ® (rucaparib) tablets, for oral use Initial U. 1 . 1 Recommended Evaluation and Testing Before Initiation of DUVYZAT . FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 1 Recommended Dosage PATIENT INFORMATION. 1 Clinical Studies in Patients with Asthma 14. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY . 2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) 1. 1 Dosage for Postherpetic Neuralgia 2. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Approval: 2010 . 2 . See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling Revised: 11/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. KEYTRUDA ® (pembrolizumab) injection, for intravenous use Initial U. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 1. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . 3 Pediatric Patients Limited information is available regarding the pharmacokinetics of dosing of ketorolac tromethamine in the pediatric population. for TIBSOVO. Reference ID: 4418807 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 2 Macular Edema Following Retinal Vein Occlusion (RVO) 1. 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for DANYELZA. 2 Dosage in Patients with PMDD 2. 1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1. Approval: 2014 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAPLYTA safely and effectively. See 17 for PATIENT COUNSEL ING INFORMATION. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. See full prescribing information for XTANDI. When INLYTA is used as a single agent, the recommended starting oral dose is 5 mg twice daily. See full prescribing information for Lexapro® Lexapro® (escitalopram oxalate) Tablets Lexapro® (escitalopram oxalate) Oral Solution Initial U. 2 Recommended Dosage 2. ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension, for intramuscular use . 4 Switching to LANTUS from Other Insulin These highlights do not include all the information needed to use ZEPBOUND safely and effectively. 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. 3 Triptans 17 PATIENT COUNSELING INFORMATION 7. 2 Dosage Modifications 3 DOSAGE FORMS Find important safety information and patient resources for all of our currently marketed medicines. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use Initial U. See full prescribing information for ZOMETA. 1 Metastatic Breast Cancer TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2- See full prescribing information for ZITHROMAX. Approval: 2020 WARNING: LEFT VENTRICULAR DYSFUNCTION ANDEMBRYO-FETAL 17 for PATIENT COUNSELING INFORMATION. 8) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. There may be new information. This information does not take the place of talking to your healthcare provider about your medical See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Approval: 2017 -----Coadministration with WARNING: RISK OF See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 3 of full prescribing information for infusion parameters. Attention: This page may not render properly. 2 Dosage for Epilepsy with Partial Onset Seizures 2. 1 Monotherapy Epilepsy TOPAMAX FULL PRESCRIBING INFORMATION . See full prescribing information for VYVGART HYTRULO. See full prescribing information for complete boxed warning. 2 Administration Information 2. 1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD 2. 3 Diabetic Macular Edema (DME) 1. 1 Dosage 2. See full prescribing information for ENTRESTO. Revised: 6/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. FULL patients with ADHD and comorbid Tourette’s Disorder. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: AMYLOID RELATED IMAGING ABNORMALITIES 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. See full prescribing information for REBLOZYL. See full prescribing information for RYBELSUS. Revised: 6/2023 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE. See 17 for PATIENT COUNSELING INFORMATION. Tablets: 400 VOSEVI® (sofosbuvir, voxilaprevir velpatasvir, and voxilaprevir) tablets, for oral use Initial U. LORBRENA ® (lorlatinib) tablets, for oral use Initial U. Revised: 11/2021 FULL PRESCRIBING INFORMATION: HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STRATTERA safely and effectively. Patients on ritonavir- or cobicistat-containing HIV regimens should continue their treatment as indicated. Revised: 6/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 1) 12/2022 . 3 Preparation and Administration Instructions . Overweight . Monitor patients with neutropenia for signs of infection. See full prescribing information for FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally Advise patients of potential risk to a fetus and to use effective contraception. 11/2021 . 2 . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LORBRENA safely and effectively. 5 Retinopathy of See full prescribing information for complete boxed warning. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION Indications & Important Safety Information Indication. Revised: 05/2023. Issued: 11/2024 * Sections or subsections omitted from the full prescribing information are not listed . Cytokine release syndrome (CRS), including serious or life -threatening reactions, can occur in patients receiving EPKINLY. Revised: 05/2017 . 3 Dosage Modification for Adverse Reactions . FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SUICIDAL THOUGHTS AND BEHAVIORS not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with ZOLOFT were: Cardiac disorders – tachycardia See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets), co-packaged for oral use HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RUBRACA safely and effectively. HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use VOSEVI safely and effectively. See full prescribing, safety, & Boxed Warning info. 5 kg to less than 40 kg: Recommended dosage is based on weight. 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 1 Plaque Psoriasis TALTZ® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approval: 2024 _____ INDICATIONS AND USAGE ADVERSE REACTIONS_____ LIVDELZI is a See 17 for PATIENT COUNSELING INFORMATION and FDA Revised: ----- ----- ----- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PAXLOVID safely and effectively. ‘ $,ª€„u!ˆø $ì™ D˜2 ˆð Q3 DÌJ ‘'$ 6‰ât q H”u ‰n7 ±™ ,M ´ endstream endobj startxref 0 %%EOF 5883 0 obj >/Pages 131 0 R/ViewerPreferences >/Version/1. 4 Corticosteroid Reduction . 3 Administration to Patients Who Have Difficulty These highlights do not include all the information needed to use ZEPBOUND safely and effectively. MARGENZA 17 for PATIENT COUNSELING INFORMATION. 2 Dosage Modifications for Adverse Reactions 2. 1 Dosage Information *Sections or subsections omitted from the full prescribing information are not listed . • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI. Approval: 2002 WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS See full prescribing information for complete boxed warning. 7>> endobj 5884 0 obj See full prescribing information for complete boxed warning. 5. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. PROMACTA® (eltrombopag) tablets, for oral use PROMACTA® (eltrombopag) for oral suspension Initial U. (2. TIBSOVO ® (ivosidenib tablets), for oral use Initial U. 1 ALK-or ROS1-Positive Metastatic NSCLC 1. 6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS . Revised: 07/2022 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. 3, 8. 10) • HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STRATTERA safely and effectively. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 2 Preparation and Administration 3 DOSAGE FORMS AND patients Follow indication • • • Pediatric Detrusor Overactivity The effects of BOTOX HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BOTOX safely and effectively. 3 Dosage Modification • See Full Prescribing Information for dosage recommendations in patients with renal impairment. ejc ipdh vmqgaf nmhu fsr tycu nnae xpzuu pbicy ixca