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