Prescribing information for patients. See full prescribing information for ZOMETA.
Prescribing information for patients Cytokine release syndrome (CRS), including serious or life -threatening reactions, can occur in patients receiving EPKINLY. 2 . Approval: 2012 . FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE . for TIBSOVO. Revised: 08/2024 AKEEGA® (niraparib and abiraterone acetate) tablets FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 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. When INLYTA is used as a single agent, the recommended starting oral dose is 5 mg twice daily. VYEPTI is indicated for the preventive treatment of migraine in adults. 3 Preparation and Administration Instructions . See full prescribing, safety, & Boxed Warning info. 5 Eosinophilic Conditions 5. 5% IgG (165 mg/mL) for subcutaneous infusion. 7 Cimetidine *Sections or subsections omitted from the full 7. 2 Relapsed or HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAMZYOS safely and effectively. REBLOZYL® (luspatercept-aamt) for injection, for subcutaneous use Initial U. • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI. Monitor patients with neutropenia for signs of infection. 2 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 10) • HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STRATTERA safely and effectively. 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. 3 DOSAGE FORMS AND See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: AMYLOID RELATED IMAGING ABNORMALITIES 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 1) 12/2022 . 4 Dosage 14. Medicines HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LORBRENA safely and effectively. 1 ALK-or ROS1-Positive Metastatic NSCLC 1. See full prescribing information for S ee 17 for PATIENT COUNSELING INFORMATION and FDA - approved patient labeling . LORBRENA ® (lorlatinib) tablets, for oral use Initial U. Withhold IMDELLTRA until CRS resolves or permanently discontinue based See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 09/2024 . 3, 8. Revised: 09/2019 . Revised: 9/2024 . Approval: 2017 -----Coadministration with WARNING: RISK OF See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Approval: 2020 See full prescribing information for complete boxed warning. 1 Recommended Dosing . Following a single intravenous bolus dose of 0. 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. Tablets: 400 VOSEVI® (sofosbuvir, voxilaprevir velpatasvir, and voxilaprevir) tablets, for oral use Initial U. See full prescribing information for ZEPBOUND. Reference ID: 4806455 See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 3 Pediatric Patients Limited information is available regarding the pharmacokinetics of dosing of ketorolac tromethamine in the pediatric population. 1 Plaque Psoriasis 1. Revised: 06/2024 . The recommended dosage is 100 mg administered by intravenous infusion every 3 months. 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. Approv al: 1996 -----RECENT MAJOR CHANGES----- Dosage and AdministrationDosage in Patients Taking Cyclosporine, , See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 4 Switching to LANTUS from Other Insulin These highlights do not include all the information needed to use ZEPBOUND safely and effectively. 2 Dosage for Epilepsy with Partial Onset Seizures 2. Approval: 2016 -----RECENT MAJOR CHANGES ----- Indications and Usage (1. 2 Usage 2 DOSAGE AND ADMINISTRATION . 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. Patients on ritonavir- or cobicistat-containing HIV regimens should continue their treatment as indicated. 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. 1 Patient See full prescribing information for complete boxed warning. 4 Diabetic Retinopathy (DR) 1. Revised: 07/2022 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. See 17 for PATIENT COUNSELING INFORMATION and . 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 LATUDA safely and effectively. WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 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. 8 Digoxin prescribing information are not listed. 3 Initiation of LANTUS Therapy 2. See full See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. LIVDELZI® (seladelpar) capsules, for oral use Initial U. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY . 3) • Hospitalized patients: The treatment course of VEKLURY should be See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . 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. (See 17 for PATIENT COUNSELING INFORMATION and FDA-8. ↑ efavirenz ↑ maraviroc PMI is not intended to replace the Prescribing Information, Instructions For Use, or patient counseling. 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. See full prescribing information for complete boxed wa rning. RUBRACA ® (rucaparib) tablets, for oral use Initial U. Reference ID: 3466301 . 2 Dose Modification Guidelines 3 DOSAGE FORMS AND STRENGTHS 4 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Revised: 12/2024 . Monitor for increased PAXLOVID or protease inhibitor adverse events. Approval: 2015 . 1) Hepatic Impairment: Avoid use of REZDIFFRA in patients with moderate to severe hepatic impairment (ChildPugh Class B or C)- . Revised: 05/2023. LIPITOR ® (atorvastatin calcium) tablets, for oral use Initial U. 4 CNS Drugs 17. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5. 7 Parasitic (Helminth) Infection 5. See full prescribing information for XTANDI. WEGOVY (semaglutide) injection, for subcutaneous use Initial U. Revised: 03/2024 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 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. 1 Recommended Dosage in Patients with Newly Diagnosed or Previously Treated Ph+ CML-CP 2. INDICATIONS AND USAGE . 3 Monitoring and Dosing Interruption for Amyloid Related Avoid use in patients with end-stage renal disease. ZEPBOUND® (tirzepatide) Injection, for subcutaneous use Initial U. Approval: 2019 . Approval: 2017 . Advise patients to stop laxatives before starting DAYBUE. 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. 2 Maintenance Treatment of Asthma 1. RECENT MAJOR CHANGES . FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Create your emc account to access: SmPC and/or %PDF-1. See 17 for PATIENT COUNSEL ING INFORMATION. See full prescribing information for Lexapro® Lexapro® (escitalopram oxalate) Tablets Lexapro® (escitalopram oxalate) Oral Solution Initial U. SARCLISA ® (isatuximab-irfc) injection, for intravenous use Initial U. FULL PRESCRIBING INFORMATION: CONTENTS* 1 . Initial U. 3 Administration to Patients Who Have Difficulty These highlights do not include all the information needed to use ZEPBOUND safely and effectively. 1 How Supplied 16. 1 Recommended Vaccination %PDF-1. 6 hours, the average 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 2 Administration Information 2. 2 Dosage in Patients with PMDD 2. ENTRESTO ® (sacubitril and valsartan) tablets, for oral use Initial U. See full prescribing information for LORBRENA. Revised: 05/2017 . 2 TIBSOVO safely and effectively. 1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease 1. FULL PRESCRIBING INFORMATION . ELIQUIS (apixaban ) tablets, for oral use Initial U. Revised: 04/2024 FULL See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. PROMACTA® (eltrombopag) tablets, for oral use PROMACTA® (eltrombopag) for oral suspension Initial U. LORBRENA ® (lorlatinib) tablets, for oral use See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning. XTANDI® (enzalutamide) capsules, for oral use XTANDI® (enzalutamide) tablets, for oral use Initial U. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS LIVER INJURY andACUTE LIVER FAILURE . MARGENZA 17 for PATIENT COUNSELING INFORMATION. (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. Refer to Table 1 of the full prescribing information for specific dosing guidelines based on body weight. 1 INDICATIONS AND USAGE . These highlights do not include all the information needed to use MARGENZA safely and effectively. 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. 1, 8. 9 Lithium . Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION . See full prescribing information for ENHERTU. See full prescribing information for BOTOX. VYVGART ® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS . 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. 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. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Prescribing Information. 2 Recommended Dosage in Adults and Pediatric Patients Aged 12 Years and Older healthcare professional, patients, and others . Revised: 3/2024. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity. Revised: 4/2024 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. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HEPATOTOXICITY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Prepare to treat acute pain during and These highlights do not include all the information needed to use DANYELZA safely and effectively. 7, 12. Approval: 2020 . 1 First-Line Treatment of NSCLC with EGFR See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling . 1 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 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. 2 FDA-Approved Medication Guide 7. STRATTERA ® (atomoxetine) capsules, for oral use Initial U. 1 Recommended Testing and Monitoring Prior to Initiation and During Treatment with COBENFY 2. 1 Important Dosage and AdministrationInformation . 1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma . 1 Dosage Information *Sections or subsections omitted from the full prescribing information are not listed . 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 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. 1 Recommended Dosage 2. RYBREVANT (amivantamab-vmjw) injection RYBREVANT® (amivantamab-vmjw) injection 2 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. LATUDA (LURASIDONE HCL) tablets for oral administration, Initial U. 3 Dosage Adjustment in Patients with Renal Impairment 2. See full prescribing information for WEGOVY. 3 Administration Instructions 2. Revised: 5/2023 . PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND HIGHLIGHTS OF PRESCRIBING INFORMATION . 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. Approval: 2018 WARNING: DIFFERENTIATION SYNDROME IN AML . Reference ID: 5341472 . 1 Recommended Dosage . 1 Ophthalmic Adverse 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. See full prescribing information for SARCLISA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. 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. 2 Recommended Dosage 2. Revised: 6/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 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. See full prescribing information for VOSEVI. 3 Dosage Modification • See Full Prescribing Information for dosage recommendations in patients with renal impairment. 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. 2 . See full prescribing information for CAPLYTA. (2. 1 Patient Selection for METex14 Skipping Alterations . Revised: 12/2019 . 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. 1, 2014: Exploring the Promise of Patient Medication in patients with severe renal impairment and end-stage renal disease. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION Indications & Important Safety Information Indication. See full prescribing information for complete boxed warning. Vomiting See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. FULL PRESCRIBING INFORMATION. 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. LUMAKRAS™ (sotorasib) tablets, for oral use Initial U. 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. 4 Diabetic Retinopathy (DR) in Patients with DME See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 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. 1 Patient Selection 2. See the LUPRON DEPOT PED ® prescribing information for the use of leuprolide acetate in children with central precocious puberty. 1. See full prescribing information . Missed Dose If a patient misses a dose of LAZCLUZE within 12 hours, instruct patients to take the missed dose. Revised: 05/2023 _____ FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LEFT VENTRICULAR Review the Full Prescribing Information for recommended pembrolizumab dosing information. 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. Hypothyroidism listed. 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. There may be new information. 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. Second-Line Advanced RCC. 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. See full prescribing information for LUMAKRAS. 5 Retinopathy of See full prescribing information for complete boxed warning. 2 DOSAGE AND ADMINISTRATION . 1 Dose and HIGHLIGHTS OF PRESCRIBING INFORMATION . See full prescribing information for RUBRACA. WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY . See full prescribing information for See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 6 Fever, Arthralgia, and Rash . ABILIFY can be These highlights do not include all the information needed to use TRULICITY safely and effectively. See 17 for PATIENT COUNSELING INFORMATION. 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. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved Medication Guide. INDICATIONS AND USAGE. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 1 Important Administration Instructions 2. HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use VOSEVI safely and effectively. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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. 1 Recommended Evaluation and Testing Before Initiation of DUVYZAT . See full prescribing information for RYBELSUS. Revised: 10/2024 . 1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1. Important Safety Information Contraindications. Sign up to emc. MARGENZA ® (margetuximab-cmkb) injection, for intravenous use . 8 Laboratory Learn about XOLAIR®, a self-administered treatment for allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and food allergy. 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for PAXLOVID. 7. Approval: 2014 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAPLYTA safely and effectively. See full prescribing information for ELIQUIS. 1 . 1 General For further information, refer to the respective protease inhibitors' prescribing information. 10 Embryo-Fetal Toxicity . See full prescribing information for CAMZYOS. DANYELZA ® (naxitamab-gqgk) injection, for intravenous use Initial U. 1 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) 1. See See full prescribing information for complete boxed warning. Anti-HIV. FULL patients with ADHD and comorbid Tourette’s Disorder. 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. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. See full prescribing information for VYVGART HYTRULO. S. YESCARTA® (axicabtagene ciloleucel) suspension for intravenous infusion Initial U. 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. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. 5 Alcohol 17. 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. Attention: This page may not render properly. The browser you are using, Internet Explorer 10, is no longer supported. 1, 5. _____ _____ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTRESTO safely and effectively. 2 Clinical Studies in Patients with Eosinophilic Granulomatosis with Polyangiitis. 1 Monotherapy Epilepsy TOPAMAX FULL PRESCRIBING INFORMATION . Approval: 2002 WARNING: See full prescribing information for LIPITOR. 7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. (5. 3 Triptans 17 PATIENT COUNSELING INFORMATION 7. 16 HOW SUPPLIED/STORAGE AND HANDLING . 8 1. 5. Approval: 2002 WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS See full prescribing information for complete boxed warning. Revised: 4/2019 . See full prescribing information for KEYTRUDA. 1 Dosage WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS . RISPERDAL ® is not approved for use in patients with dementia-related psychosis. for TRULICITY. See full prescribing information for STRATTERA. no Drug Name Company/Firm Name Release Date Download Pdf Pdf Size; 1: Mycophenolate Mofetil Tablets IP 250 mg / 500 mg: M/s. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Lexapro® safely and effectively. 3 Limitations of Use. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 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. Approval: 2020 WARNING: LEFT VENTRICULAR DYSFUNCTION ANDEMBRYO-FETAL 17 for PATIENT COUNSELING INFORMATION. 10) children. (7) See 17 for PATIENT COUNSELING INFORMATION . FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 14. Overweight . See full prescribing information for DANYELZA. Reference ID: 5484208 . 3 Screen See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 1 Important Administration Instructions See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U. FDA-approved patient labeling. This risk may occur early in treatment and may increase with duration of use (5. 2 General Dosing Instructions 2. 2 Relapsed or Refractory, Systemic ALK-Positive ALCL 1. Revised: 09/2024 RYBREVANT® (amivantamab-vmjw) injection. See full prescribing information. (8. 8) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. ( 2. 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. 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. Revised: 6/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Revised: 03/2024 . SARC HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SARCLISA safely and effectively. 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Revised: 11/2024 . 2 Recommended Dosage in Patients with Renal Impairment . 2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) 1. Some patients may benefit from a dosage of 300 mg administered by 1 mg in Patients with Type 2 Diabetes and Cardiovascular Disease . 1) Application-Associated Pain: Patients may experience substantial procedural . 1 Dosage 2. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . pain and burning upon application of QUTENZA and following removal of QUTENZA. 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. 1) • MOBIC is See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 1 Recommended Dosing 2. 1 Dosing Information 2. Revised: 02/2024 _____ _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. 2 DOSAGE AND ADMINISTRATION 2. 4 Switching to LANTUS from Other Insulin FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC See full prescribing information for complete boxed warning. 3 Dosage Modification for Adverse Reactions . Revised: 11/2020 . 5 mg/kg in 10 children 4 to 8 years old, the half-life was 5. 1 Clinical Studies in Patients with Asthma 14. CP-CFT-US-0337 12/2024 o Pediatric patients (birth to less than 18 years of age) weighing 1. Approval: 2019 WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL Refer to section 2. 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. Search emc: Enter medicine name or company Advanced search. 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. YESCARTA safely and effectively. 2 Monitoring to Assess Safety. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 5 WARNINGS AND PRECAUTIONS . Approval: 2019-----RECENT MAJOR CHANGES----- Indications and Usage (1. ZOMETA® (zoledronic acid) injection, for intravenous use . Revised: 6/2023 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE. Withhold or permanently discontinue TRODELVY based on clinical assessment of See full prescribing information for complete boxed warning. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BIMZELX safely and effectively. See full prescribing information for REBLOZYL. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. 1 Information for Patients . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LORBRENA safely and effectively. 1 INDICATIONS AND See full prescribing information for complete boxed warning. ‘ $,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. PMI Development Past Events Jul. 7>> endobj 5884 0 obj See full prescribing information for complete boxed warning. Revised: 9/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 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. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID 1 INDICATIONS AND USAGE . Revised: 07/2024. Warnings and Precautions, Cardiovascular Death . 2 DOSAGE AND ADMINISTRATION. ) 7. 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. ENHERTU® (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U. (1. 2. 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. 1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD 2. See full prescribing information for MARGENZA. 3) Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of OFEV. Revised: 10/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . S. STRATTERA® (atomoxetine) capsules,for oral use Initial U. 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. 4 Preparation of KESIMPTA 3 DOSAGE FORMS See 17 for PATIENT COUNSELING INFORMATION . 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. TIBSOVO ® (ivosidenib tablets), for oral use Initial U. FULL PRESCRIBING HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYBELSUS® safely and effectively. Patients treated with TIBSOVO have experienced symptoms of Up to date, approved and regulated prescribing and patient information for licensed medicines. Revised: 9/2024 _____ FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 6) -----DOSAGE FORMS AND STRENGTHS----- • Oral solution: 200 mg/mL See (3) -----WARNINGS AND PRECAUTIONS----- •Diarrhea: Most patients experience diarrhea during treatment with DAYBUE. See full prescribing information for YESCARTA. Revised: 10/2021 FULL PRESCRIBING INFORMATION:CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Revised: 03/2014 . 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). *Sections or subsections omitted from the full prescribing information are not 5. 3 BRAF V600E Mutation-Positive HIGHLIGHTS OF PRESCRIBING INFORMATION . 1 Recommended Dosage PATIENT INFORMATION. 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. 2) 8/2023 treatment. Issued: 11/2024 * Sections or subsections omitted from the full prescribing information are not listed . 1 Dosage for Postherpetic Neuralgia 2. 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. Revised: 3/2022. TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use. 2 Recommended See full prescribing information for complete boxed warning. Revised: 10/2021. Indications and Usage, See full prescribing information for ABILIFY MAINTENA. 9 . See full prescribing information for LEQEMBI™. 1 See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. CAPLYTA ® (lumateperone) capsules, for oral use Initial U. 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. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. -±¡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. TNKase ® (tenecteplase) is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). Reference ID: 4418807 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 6 %âãÏÓ 1202 0 obj >stream hÞ´UmoÚH þ+û1Q ö}½>U‘ $”Ó%!89®²üÁ -±ê dÜrüû› à £&—‹Z¡ £™ÙÙç™ggÍ•!Œpe‰Ð áš Í,á2$ ,. 3 ) DOSAGE FORMS AND STRENGTHS CUTAQUIG is a solution containing 16. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. 3 Pre-Medications and Concomitant Medication Information. 3 DOSAGE FORMS AND STRENGTHS 4 approved patient labeling. 11/2021 . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEQEMBI™ safely and effectively. efavirenz, maraviroc, nevirapine, zidovudine, bictegravir/ emtricitabine/ tenofovir. ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension, for intramuscular use . 4 Corticosteroid Reduction . 5, 8. 2 Macular Edema Following Retinal Vein Occlusion (RVO) 1. See full prescribing information for ZOMETA. See full prescribing information for ENTRESTO. 6) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. See full prescribing information for complete See full prescribing information for complete boxed warning. 5 kg to less than 40 kg: Recommended dosage is based on weight. 2 Recommended Dosage . %PDF-1. . 2 Dosage Modifications 3 DOSAGE FORMS Find important safety information and patient resources for all of our currently marketed medicines. 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. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 4 CONTRAINDICATIONS . 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. 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. 2 Dosing Instructions 2. 3 of full prescribing information for infusion parameters. 1 Important Monitoring and Administration Instructions 2. 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. See Full Prescribing Information for detailed instructions on how to manage this risk. VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 5/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. See full prescribing information (FPI) for LATUDA. 2 Pediatric Patients with Congenital Adrenal Hyperplasia 16 HOW SUPPLIED/STORAGE AND HANDLING 16. 3 Diabetic Macular Edema (DME) 1. WARNING: RISK OF THYROID C -CELL TUMORS . See full prescribing information for LIVDELZI. 6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc. Initiate treatment with the EPKINLY step -up dosing schedule to reduce the incidence and severit y of CRS. 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. 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: 2010 . Approval: 2023 -----RECENT See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. KEYTRUDA ® (pembrolizumab) injection, for intravenous use Initial U. 2 Dosage Modifications for Adverse Reactions 2. Reference ID: 5342984 . Revised: 09/2022 . • FULL PRESCRIBING INFORMATION 1INDICATIONS AND USAGE KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: 1. 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. Approval: 2001 -----RECENT MAJOR CHANGES-----Warnings and Precautions, Embryo-Fetal Toxicity (5. Revised: 10/2024 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS See 17 for PATIENT COUNSELING INFORMATION. See 17 for PATIENT COUNSELING INFORMATION Revised: 08/2017 . RYBELSUS (semaglutide) tablets, for oral use See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Approval: 2020. 3 DOSAGE FORMS AND STRENGTHS . 1) approved patient labeling. Lexapro is not approved for use in See 17 for PATIENT COUNSELING INFORMATION. Approval: 2002 . 1 Assessments Prior to First Dose of KESIMPTA 2. 1). WARNING: Suicidality and Antidepressant Drugs . 3 BRAF V600E Mutation-Positive Pregnancy: May cause fetal harm. 1 Recommended Dosing. 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. CAMZYOS® (mavacamten) capsules for oral use See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. See full prescribing information for TRODELVY. Approval: 1991 . 2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 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. Revised: 11/2018 . 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. • No trial has identified a hemoglobin target See full prescribing information for PROMACTA. fqqkt tiyf vtc mhnow xrquna cbmfh esbrjf aqidh xpjzn dgsyf