Full prescribing information. FULL PRESCRIBING INFORMATION .

Full prescribing information EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use Initial U. • Do not administer OPSYNVI to a pregnant female because it may cause fetal harm (4. Approval: 2004 . BENLYSTA (belimumab) for injection, for intravenous use BENLYSTA (belimumab) injection, for subcutaneous use Initial U. 2 Renal Cell Carcinoma Dec 14, 2021 · See full prescribing information for Cleviprex. In patients with early breast cancer, treatment with KISQALI should continue for 3 years or until disease recurrence or unacceptable toxicity Jun 18, 2024 · See full prescribing information for complete boxed warning. encourage patients to LAZCLUZE™ (lazertinib) tablets, for oral use Initial U. 1 Heart Failure CAROSPIR is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. It may not be copied, in whole or in part, without the expressed written permission of McNeil See full prescribing information for ZAVZPRET. 1) • Patients started on therapy should be monitored closely (5. Apply a thin layer of EUCRISA twice daily to affected areas. See full prescribing information for EMGALITY. 3) May 21, 2021 · See full prescribing information for RYBREVANT. SUNOSI (solriamfetol) tablets, for oral use, [controlled substance schedule pending] Initial U. See full prescribing information for AVASTIN. 3) • Take VENCLEXTA tablets orally once daily with a meal and water. CARVYKTI® (ciltacabtagene autoleucel) suspension for intravenous infusion Initial U. WARNING: SERIOUS LIVER INJURY Mar 24, 2020 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5. 2 Important Nov 5, 2024 · These highlights do not include all the information needed to use MOUNJARO safely and effectively. COBENFY™ (xanomeline and trospium chloride) capsules, for oral use Initial U. ZOLGENSMA ® (onasemnogene abeparvovec -xioi) suspension, for intravenous infusion. 2 DOSAGE AND ADMINISTRATION 2. Evaluate cardiac function prior to and during Jun 21, 2024 · See 17 for PATIENT COUNSELING INFORMATION. • Increased risk of suicidal ideation in children or adolescents (5. 8 Jul 15, 2021 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. OPZELURA is a prescription medicine used on the skin (topical) for: short-term and non-continuous treatment of mild to moderate . FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged . See full prescribing information for TAGRISSO TAGRISSO® (osimertinib) tablets, for oral use Initial U. TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use. • Jun 15, 2020 · FULL PRESCRIBING INFORMATION . 1 Important Dosage and Administration Instructions 2. Revised: 5/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. See full prescribing information for NERLYNX. Approval: 2023. 3) See full prescribing information for complete boxed warning. Dec 23, 2024 · 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. (3) Dec 6, 2024 · See full prescribing information for complete boxed warning. Revised: 07/2024. Oct 25, 2017 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEPPRA safely and effectively. Approval: 2024 severity. 005% is indicated for the reduction of elevated intraocular pressure (IOP) in HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEURONTINsafely and effectively. 1 Recommended Dosage and Administration . Approval: 2023 See full prescribing information for VELSIPITY. TM (budesonide oral suspension) Initial U. Do not administer BREYANZI to patients with active infection or Oct 1, 2024 · See full prescribing information for INVEGASUSTENNA. Aug 1, 2024 · See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. 1 Important Dosing Information 2. 6 years and older with severe asthma, and with Apr 23, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CARVYKTI safely and effectively. TM. Approval: 2022 WARNING: RISK OF HEART FAILURE See full prescribing information for complete 4 days ago · • See full prescribing information for dosage recommendations in patients with renal impairment. 3) • Hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made. May 26, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EMGALITY safely and effectively. Approval: 2011 ----- These highlights do not include all the information needed to use BOSULIF safely and effectively. Anaphylaxis has . 1 INDICATIONS AND USAGE. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO Nov 25, 2024 · FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . See full prescribing information for KEYTRUDA. Approval: 2017 _____ RECENT MAJOR CHANGES _____ Feb 27, 2020 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . 1 Urothelial Carcinoma TECENTRIQ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD­ Jun 7, 2021 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. 1 Recommended Dosage 2. See full prescribing information for IMFINZI. 1). • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Oct 18, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DUPIXENT safely and effectively. NEURONTIN® (gabapentin) capsules,for oral use NEURONTIN® (gabapentin) tablets,for oral use NEURONTIN® (gabapentin) oral solution Initial U. Approval: 2024 -----INDICATIONS AND USAGE -----COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, indicated for the treatment of schizophrenia in adults. WAINUA™ (eplontersen) injection, for subcutaneous use. 2, 16) -----DOSAGE FORMS AND STRENGTHS----- • AMTAGVI is a cell suspension for Oct 23, 2024 · See full prescribing information for WAINUA. Approval: 1999 -----RECENT MAJOR CHANGES----- Nov 15, 2024 · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Dec 15, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRENESSITY safely and effectively. 1 INDICATIONS AND USAGE SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. Warnings and Precautions, Infections . 4) Jan 8, 2019 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 3 days ago · Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. Approval: experiencing Grade 4 liver Jan 11, 2025 · These highlights do not include all the information needed to use TRODELVY safely and effectively. RETACRIT™ (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO -FETAL TOXICITY • Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. 1 Large B-cell Lymphoma YESCARTA is indicated for the treatment of: • Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of Dec 12, 2024 · Sections or subsections omitted from the Full Prescribing Information are not listed _____ Page 2 of 17 . 06/2024 . See full prescribing information for SUNOSI. See full prescribing information for LAZCLUZE. 1) May 3, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAMZYOS safely and effectively. KEYTRUDA ® (pembrolizumab) injection, for intravenous use Initial U. 0 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0. Monoclonal antibodies directed against aggregated forms of beta amyloid, including LEQEMBI, can cause amyloid related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIAE) - Jan 11, 2025 · * Sections or subsections omitted from the full prescribing information are not listed. This prescribing information is the exclusive property of McNeil Consumer Healthcare, division of Johnson & Johnson Inc . ABILIFY ® (aripiprazole) Tablets, for oral use ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® See full prescribing information for complete boxed warning. 4) • Closely monitor glucose when switching to LANTUS and during initial weeks thereafter. 2 Posterior Segment Uveitis 1. tract disease (LRTD) caused by respiratory syncytial virus Oct 25, 2024 · See full prescribing information for ORLYNVAH. Do not chew, crush, or break tablets. • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. INDICATIONS AND USAGE . FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 3 Instructions for Use . RYBREVANT ® (amivantamab-vmjw) injection, for intravenous use Initial U. CRENESSITY™ (crinecerfont) capsules, for oral use CRENESSITY™ (crinecerfont) oral solution Initial U. This indication is approved under accelerated approval based on overall response rate and 3 days ago · FULL PRESCRIBING INFORMATION . Jul 25, 2017 · HIGHLIGHTS OF PRESCRIBING INFORMATION. Approval: 1997 . Approval: 2012 Nov 8, 2013 · FULL PRESCRIBING INFORMATION . See full prescribing information for ENHERTU. 1 Dosing Information ONPATTRO should be administered by a healthcare professional. MOUNJARO® (tirzepatide) Injection, for subcutaneous use Initial U. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Aug 22, 2024 · See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 1, 2. Approval: 2019-----RECENT MAJOR CHANGES----- 2 days ago · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. ( 2. BOSULIF ® (bosutinib) tablets, for oral use BOSULIF ® (bosutinib) capsules, for oral use Initial U. Approval: 2021 Oct 22, 2020 · FULL PRESCRIBING INFORMATION . Jan 6, 2025 · 2 STELARA® (ustekinumab) STELARA® (ustekinumab) FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Do not administer ABECMA Feb 7, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEYTRUDA safely and effectively. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY safely and effectively. Approval: [pending controlled substance scheduling] Jun 14, 2024 · FULL PRESCRIBING INFORMATION WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES • Cytokine Release Syndrome (CRS), including life-threatening Dec 21, 2017 · These highlights do not include all the information needed to use PRISTIQ safely and effectively. 8) • Provide prophylaxis for tumor lysis syndrome. Approval: 2001 -----INDICATIONS AND USAGE----- Sep 17, 2024 · Refer to the Full Prescribing Information for the recommended dosage of the aromatase inhibitor. Approval: 2018 Apr 5, 2024 · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. See the full prescribing information for dosage adjustments by indication for patients receiving CYP2C19 and/or CYP3A4 inhibitors; in patients with moderate or severe renal impairment or moderate hepatic impairment; and patients with Jun 7, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYTELO safely and effectively. These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. EOHILIA. 2 Administration 3 DOSAGE FORMS FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 2 DOSAGE AND ADMINISTRATION For topical use only. INDICATIONS AND USAGE AJOVY is a calcitonin gene -related peptide antagonist indicated for Mar 20, 2019 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SUNOSI™ safely and effectively. KEYTRUDA (pembrolizumab) injection, for intravenous use -----­ Indications and Usage, Small Cell Lung Cancer – Accelerated full prescribing information 1 INDICATIONS AND USAGE NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14) ] . Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. 3) • Withhold FARXIGA for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. 2. The recommended starting dosage is 5 mg twice a day (10 mg/day) by mouth. Important Safety Information. Approval: 2015 -----INDICATIONS AND USAGE----- See full prescribing information for complete boxed warning Do not substitute KADCYLA for or with trastuzumab. Reactions (6. Revised: 6/2024 FULL PRESCRIBING INFORMATION: CONTENTS ⃰ 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. • Females of reproductive potential: exclude pregnancy before start of treatment, monthly during treatment, and 1 month after stopping treatment. These highlights do not include all the information needed to use TAGRISSO safely and . Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been . 2 DOSAGE AND ADMINISTRATION . Approval: 2020 Feb 8, 2013 · These highlights do not include all the information needed to use POMALYST safely and effectively. These highlights do not include all the information needed to use DOVATO safely and effectively. See full prescribing information for RYBREVANT. that may lead to hospitalization or death [see Warnings and Precautions (5. 1 . Approval: 1997 WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, Aug 19, 2024 · 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. Anaphylaxis has occurred Nov 18, 2024 · See full prescribing information for complete boxed warning. Jun 2, 2023 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UBRELVY safely and effectively. Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). 2, 2. 1 Differentiated Thyroid Cancer LENVIMA is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Approval: 2019 . 2 NTRK Gene Fusion-Positive Solid Tumors 2 DOSAGE AND ADMINISTRATION 2. 1 Asthma. DOSAGE AND ADMINISTRATION . INDICATIONS AND USAGE. NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. WARNING: SERIOUS INFECTIONS and MALIGNANCY . 1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous See full prescribing information for complete boxed warning. 1 Plaque Psoriasis TREMFYA is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or 5 days ago · Refer to Table 1 of the full prescribing information for specific dosing guidelines based on body weight. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. NERLYNX (neratinib) tablets, for oral use. of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. 3 Diabetic Macular Edema 2 DOSAGE AND ADMINISTRATION 2. OPDIVO® (nivolumab) injection, for intravenous use Initial U. 1)] Most patients who developed these infections Jun 21, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. S. See full prescribing information for TRODELVY. See full prescribing information for KYBELLA. Cleviprex (clevidipine) injectable emulsion, for intravenous use Initial U. 2 Administration See full prescribing information for complete boxed warning • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. FOSAMAX. See full prescribing information for RETACRIT. effectively. EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. KEPPRA (levetiracetam) injection, for intravenous use Initial U. These highlights do not include all the information needed to use IMFINZI ° safely and effectively. Approval: 2024 -----INDICATIONS AND USAGE-----ORLYNVAH a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the 4 days ago · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Mar 24, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use GLEEVEC safely and effectively. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U. • Monitor hepatic function prior to and during treatment [see Warnings and Precautions (5. Approval: 2018 . WARNING: GASTROINTESTINAL PERFORATIONS, SURGERY Jun 16, 2022 · • See Full Prescribing Information for recommended VENCLEXTA dosages. Cardiomyopathy: HERCEPTIN HYLECTA can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. 2 Important Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 6 ADVERSE REACTIONS Sep 28, 2023 · See Full Prescribing Information for additional dosage modifications. Patients treated with REMICADE® are at increased risk for developing serious infections . Approval: 2023----- INDICATIONS AND USAGE -----WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment . Mar 24, 2015 · See full prescribing information for complete boxed warning. WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE • Cases of acute liver failure with fatal outcomes have been reported. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. Approval: 2015 -----RECENT MAJOR CHANGES----- Dec 15, 2024 · See full prescribing information for complete boxed warning. Interrupt or slow the rate of infusion in patients with mild or Nov 13, 2024 · The USPI is divided into Highlights of Prescribing Information, Table of Contents, and the Full Prescribing Information (FPI); and is often followed by Patient Information. _____ FULL PRESCRIBING INFORMATION . Select patients for therapy based on an FDA- Dec 23, 2020 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. Approval: 2014 -----Indications and Usage (1) 09/2024 Dosage and Administration (2) 09/2024 Nov 11, 2024 · 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. WEGOVY (semaglutide) injection, for subcutaneous use . ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. 1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory . See full prescribing information for ABRYSVO. ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use Initial U. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving May 17, 2024 · See 17 for PATIENT COUNSELING INFORMATION. See full prescribing information for WEGOVY. See full prescribing information for PRISTIQ. ZAVZPRET™ (zavegepant) nasal spray Initial U. Withhold NERLYNX in patients experiencing Grade 3 liver . Oct 3, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION. Feb 22, 2024 · See full prescribing information for complete boxed warning. 9) DOSAGE FORMS AND STRENGTHS. EMBRYO-FETAL TOXICITY • Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. See full prescribing information for MOUNJARO. See full prescribing information for NEURONTIN. 1 ROS1-Positive Non-Small Cell Lung Cancer 1. GLEEVEC ® (imatinib mesylate) tablets, for oral use . 1 Plaque Psoriasis SKYRIZI® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1)]. AJOVY (fremanezumab-vfrm) injection, for subcutaneous use Initial U. Feb 12, 2024 · See full prescribing information for EOHILIA. . 1. See full prescribing information for SOLIRIS. Approval: 2006 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. 1) and Adverse . 1 General Dosing Information 2. See full prescribing information for VYVGART HYTRULO. POMALYST ® (pomalidomide) capsules, for oral use Initial US Approval: 2013 . 4Patient Selection 2. 1 8. ORLYNVAH. Limitations of Use • YORVIPATH was not studied for acute post-surgical hypoparathyroidism. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. See full prescribing information for CARVYKTI. XTANDI ® is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC). Approval: 2008-----INDICATIONS AND USAGE-----Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. full prescribing information: contents* full prescribing information warning: patients co-infected with hepatitis b virus (hbv) and human immunodeficiency virus (hiv-1): emergence of lamivudine-resistant hbv and exacerbations of hbv 1 indications and usage 2 dosage and Sep 19, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. 1 INDICATIONS AND USAGE . Monitor hepatic function prior to initiation and prior to each dose. 1) Hepatotoxicity, liver failure and death have occurred in KADCYLA-treated patients. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . Dosage and Administration, Recommended Dosage . Acute serious liver injury and elevated Dec 20, 2019 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENHERTU safely and effectively. 1 INDICATIONS AND USAGE MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 Sep 14, 2018 · See full prescribing information for AJOVY. Dec 2, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABILIFY safely and effectively. DOSAGE AND ADMINISTRATION. See full prescribing Dec 23, 2024 · The FDALabel Database is a web-based application used to perform customizable searches of over 150,000 human prescription, biological, over-the-counter (OTC), and animal May 7, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION . VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. (RYTELO (imetelstat) for injection, for intravenous use. Approval: 2020. See full prescribing information for CRENESSITY. 1 Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) TAGRISSO is indicated as adjuvant therapy after tumor resection in Jul 1, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADAKVEO safely and effectively. 1 Retinal Vein Occlusion 1. RYBREVANT (amivantamab-vmjw) injection, for intravenous use Initial U. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of Feb 16, 2024 · • See Full Prescribing Information for instructions on receipt, preparation, and administration of AMTAGVI (2. 1 Dosing Information . Echocardiogram assessments of LVEF are required prior to and during Aug 19, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Dec 27, 2018 · FULL PRESCRIBING INFORMATION . See full prescribing information for ABILIFY. See full prescribing information for CAMZYOS. 1 INDICATIONS AND USAGE Retin-A Micro ® is a retinoid indicated for topical application in the treatment of acne vulgaris. Initial U. 1 Atopic Dermatitis DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately Oct 30, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KYBELLA safely and effectively. 3 DOSAGE FORMS AND STRENGTHS . See full prescribing information for TAGRISSO. Approval: 2021 -----INDICATIONS AND USAGE-----RYBREVANT is a bispecific EGF receptor-directed and MET receptor- directed antibody indicated for the treatment of adult patients with locally Mar 4, 2024 · FULL PRESCRIBING INFORMATION OPDUALAG ™ (nivolumab and relatlimab-rmbw) 1 INDICATIONS AND USAGE OPDUALAG™ (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. revised: 4/2024 . See full prescribing information for GLEEVEC. 2) See full prescribing information for instructions on preparation and administration. If the product has a HIGHLIGHTS OF PRESCRIBING INFORMATION. The recommended dose of XTANDI is 160 mg (four 40 mg capsules) administered orally once daily. 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 Mar 1, 2021 · HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use REPATHA ® safely and effectively. 2 . 3 Vaccination Schedule for Individuals 6 Weeks Through 15 Months of Age 2. Approval: 2024. 1 Overactive Bladder in Adults GEMTESA® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. postmenopausal women, FOSAMAX increases bone mass and reduces the incidence of fractures, Sep 18, 2024 · These highlights do not include all the information needed to use KEYTRUDA safely and effectively. FULL PRESCRIBING INFORMATION. FULL PRESCRIBING INFORMATION . Jun 7, 2021 · FULL PRESCRIBING INFORMATION . 4, 5. Approval: 2014-----RECENT MAJOR CHANGES----- Oct 15, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 2 Psoriatic Arthritis Aug 12, 2024 · Sections or subsections omitted from the full prescribing information are not listed. Apr 11, 2023 · 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. See full prescribing information for RITUXAN. 1, 8. TAGRISSO ® (osimertinib) tablets, for oral use Initial U. These highlights do not include all the information needed to use SOLIRIS safely and effectively. 4 Catch-Up Vaccination Schedule for Unvaccinated Individuals 7 Months Through 17 Years of Age Aug 21, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LAZCLUZE •safely and effectively. These highlights do not include all the information needed to use NERLYNX safely and effectively. SOLIRIS ® (eculizumab) injection, for intravenous use . indicated. 5. AVASTIN (bevacizumab) injection, for intravenous use Initial U. SERIOUS INFECTIONS . 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 Jul 26, 2024 · FULL PRESCRIBING INFORMATION. Indications and Usage. 8, 2. These highlights do not include all the information needed to use BENLYSTA safely and effectively. 2 Administration 2. Jun 12, 2024 · See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE IYUZEH™ (latanoprost ophthalmic solution) 0. XTANDI can be Aug 13, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE NEMLUVIO is indicated for the treatment of adults with prurigo nodularis. INDICATIONS AND USAGE - EOHILIA is a corticosteroid indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic Jul 26, 2024 · FULL PRESCRIBING INFORMATION . Revised: 06/2024 . Delay or dose reduce as recommended. Approval: 2022 WARNING: CYTOKINE RELEASE SYNDROME, Dec 16, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION. 1 Dosing Information SPINRAZA is administered intrathecally by, or under the direction of, healthcare professionals Oct 15, 2021 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Dec 17, 2024 · The Full Prescribing Information includes a summary of the essential scientific information for the healthcare professional for the safe and effective use of the medicine (see Table C for a 6 days ago · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for complete boxed warning Mar 1, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYBREVANT safely and effectively. Approval: 2019 RECENT MAJOR CHANGES Contraindications (4) 2/2023 Jun 6, 2023 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORIAHNN safely and effectively. KYBELLA® (deoxycholic acid) injection, for subcutaneous use Initial U. Limitations of Use NURTEC ODT is not indicated for the preventive treatment of migraine. ADAKVEO® (crizanlizumab-tmca) injection, for intravenous use Initial U. See full prescribing information for UBRELVY. ZUNVEYL is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. See dosage, administration, warnings, 4 days ago · DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to Nov 25, 2024 · See full prescribing information. 1 Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer THYROGEN® is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) Sep 20, 2024 · See full prescribing information for recommended dosage in patients with an eGFR ≥15 to < 50 mL/minute. 1 Plaque Psoriasis (PsO) STELARA® is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for These highlights do not include all the information needed to use ABRYSVO safely and effectively. See full prescribing information for RYTELO. Apr 27, 2020 · FULL PRESCRIBING INFORMATION . 1 Dose and Schedule . See full prescribing information for ORIAHNN. 1 . Revised: 9/2023 _____ FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. 1 Early Breast Cancer VERZENIO® (abemaciclib) is indicated: • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant Jun 21, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION . ENHERTU ® (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U. Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 4) DOSAGE FORMS AND STRENGTHS May 7, 2024 · see 17 for patient counseling information and fda-. See full prescribing information for ADAKVEO. Continued approval for this indication may 1 day ago · 3djh ri &ohdq wkh wrs ri wkh yldo zlwk dq dofrkro zlsh vhh )ljxuh )ljxuh 8vh dvhswlf whfkqltxh wr fduu\ rxw vwhsv ± 5hpryh wkh jdxjh [ ò lqfk plfurq Sections or subsections omitted from the full prescribing information are not listed. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM [see Clinical Studies (14)]. ZEPZELCA is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Dec 19, 2022 · See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. If lenalidomide is used during pregnancy, it may cause birth Aug 21, 2019 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . Patients receiving concomitant XELODA and oral coumarin-derivative anticoagulants such as warfarin and phe nprocoumo n should have their anticoagulant response (INR or Apr 5, 2024 · FULL PRESCRIBING INFORMATION . 4 Dosage Oct 24, 2024 · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Approval: 2008 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. reported to occur after administration of Xolair. VELSIPITY™ (etrasimod) tablets, for oral use Initial U. 1 Vaccination Prior to Treatment Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to Feb 17, 2024 · FULL PRESCRIBING INFORMATION. 1 Advanced Renal Cell Carcinoma Jan 6, 2025 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STELARA® safely and effectively. Jul 7, 2016 · See full prescribing information for complete boxed warning. Approval: 2018 Jan 9, 2024 · • See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes (2. RECENT MAJOR CHANGES. REPATHA (evolocumab) injection, for subcutaneous use . Approval: 2023 -----INDICATIONS AND USAGE----- MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye May 15, 2018 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RETACRIT •safely and effectively. COMIRNATY® (COVID-19 Vaccine, mRNA)suspension for injection, for intramuscular use 2024-2025Formula Initial U. 2 Dosing 2. Approval: 2024 INDICATIONS AND USAGE RYTELO is an Nov 20, 2024 · See full prescribing information for COBENFY. 1) • No suicides occurred in clinical trials (5. 1) • Infusion-Related Reactions: Discontinue for severe and life-threatening infusion-related reactions. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete Jul 21, 2021 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. May 15, 2020 · full prescribing information 1 INDICATIONS AND USAGE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CUTAQUIG safely and effectively. Oct 8, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OPDIVO safely and effectively. 4)----- DOSAGE FORMS AND STRENGTHS Dec 23, 2024 · Prescribing information for approved human prescription drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the product. INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension, for intramuscular use Initial U. Jan 10, 2025 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Approval: 2007 . WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM . • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested Oct 30, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION. 1 Hypercalcemia of Malignancy Zometa is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3. ABRYSVO ® (Respiratory Syncytial Virus Vaccine) for injection, for intramuscular use Initial U. Approval: 2021 -----RECENT MAJOR CHANGES----- Apr 28, 2022 · FULL PRESCRIBING INFORMATION. See full prescribing information Jul 30, 2021 · SAPHNELO is a type I interferon receptor antagonist for the treatment of moderate to severe systemic lupus erythematosus (SLE). 3, 5. 3) and how to change to LANTUS from other insulins (2. See full prescribing information for COMIRNATY. Institute dose See 17 for PATIENT COUNSELING INFORMATION. (2. Approval: 1993 Dec 1, 2020 · See full prescribing information for complete boxed warning. WARNING: RISK OF HEART FAILURE . 2 Preparation and Administration . TYLENOL ® Regular Strength (DIN 00559393) Acetaminophen Tablet s USP 325 mg . 1 Dosing and Administration Information . See full prescribing information for POMALYST. Sep 16, 2023 · for PATIENT COUNSELING INFORMATION . RITUXAN® (rituximab) injection, for intravenous use Initial U. VEKLURY is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. See full prescribing information for BOSULIF. Dosage . 3 Recommended Concomitant Medications 2. Approval: 2015----- RECENT MAJOR CHANGES ----- May 26, 2023 · See full prescribing information for MIEBO. 1 Treatment of Osteoporosis in Postmenopausal Women. UBRELVY®(ubrogepant) tablets, for oral use Initial U. 1, 5. Sep 14, 2024 · 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. PRISTIQ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U. Apr 5, 2018 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RITUXAN safely and effectively. TM (sulopenem etzadroxil and probenecid) tablets, for oral use Initial U. See full prescribing information for DUPIXENT. is indicated for the treatment of osteoporosis in postmenopausal womenIn . Anaphylaxis has occurred Jan 6, 2023 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE LEQEMBI is indicated for the treatment of Alzheimer’s disease. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age May 25, 2023 · 3 FULL PRESCRIBING INFORMATION WARNING: SIGNIFICANT DRUG INTERACTIONS WITH PAXLOVID • PAXLOVID includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal Jan 7, 2022 · See full prescribing information for complete boxed warning. See full prescribing information for REPATHA. See More . MIEBO™ (perfluorohexyloctane ophthalmic solution), for topical ophthalmic use Initial U. 3) -----DOSAGE FORMS AND STRENGTHS----- Capsules: 47 mg, 62 mg, 93 mg and 124 mg of arimoclomol. See full prescribing information for OPDIVO. CAMZYOS® (mavacamten) capsules for oral use Initial U. Approval: 2015-----RECENT MAJOR CHANGES----- Jun 13, 2018 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVASTIN safely and effectively . JYNNEOS is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who Dec 27, 2024 · FULL PRESCRIBING INFORMATION OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) 1 INDICATIONS AND USAGE 1. for JYNNEOS. Jun 10, 2024 · 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. See full prescribing information for ZOLGENSMA. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. See full prescribing information for KEPPRA . 2 Recommended Dosage 2. 1 Preparation 2. Revised: 06/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. See full prescribing information for BENLYSTA. ADUHELM is indicated for the treatment of Alzheimer’s disease. See full prescribing 5 days ago · PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Approval: 2023 Jan 8, 2025 · 3 FULL PRESCRIBING INFORMATION WARNING: HEPATOTOXICITY • Severe and sometimes fatal hepatotoxicity has occurred in clinical trials [see Warnings and Precautions (5. dixioz oxbg ictqe ieasm vocxzx stqtw reh jhcy llcmb dzedcg