Full prescribing information 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 Asthma. Approval: 2007 . 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. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been . • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. 2, 2. FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged . Initial U. 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. See full prescribing information for VYVGART HYTRULO. Reactions (6. 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. ABRYSVO ® (Respiratory Syncytial Virus Vaccine) for injection, for intramuscular use Initial U. 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. 1 Recommended Dosage 2. 2. 3 Recommended Concomitant Medications 2. TYLENOL ® Regular Strength (DIN 00559393) Acetaminophen Tablet s USP 325 mg . CRENESSITY™ (crinecerfont) capsules, for oral use CRENESSITY™ (crinecerfont) oral solution Initial U. Approval: 2020. 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. Approval: 2022 WARNING: CYTOKINE RELEASE SYNDROME, Dec 16, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. See full prescribing information for TRODELVY. for JYNNEOS. 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. See full prescribing 5 days ago · PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. See full prescribing information for BOSULIF. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. Anaphylaxis has . Approval: experiencing Grade 4 liver Jan 11, 2025 · These highlights do not include all the information needed to use TRODELVY safely and effectively. 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. 1) • Patients started on therapy should be monitored closely (5. (2. 1 Important Dosing Information 2. ZUNVEYL is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. 1 INDICATIONS AND USAGE . TM. 3) and how to change to LANTUS from other insulins (2. 3) May 21, 2021 · See full prescribing information for RYBREVANT. This prescribing information is the exclusive property of McNeil Consumer Healthcare, division of Johnson & Johnson Inc . See full prescribing information for NERLYNX. ADUHELM is indicated for the treatment of Alzheimer’s disease. Indications and Usage. effectively. 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. 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 . KEYTRUDA ® (pembrolizumab) injection, for intravenous use Initial U. Jan 6, 2025 · 2 STELARA® (ustekinumab) STELARA® (ustekinumab) FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 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. 4 Dosage Oct 24, 2024 · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 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. 1 INDICATIONS AND USAGE Retin-A Micro ® is a retinoid indicated for topical application in the treatment of acne vulgaris. 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. WARNING: SERIOUS LIVER INJURY Mar 24, 2020 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . 3 Vaccination Schedule for Individuals 6 Weeks Through 15 Months of Age 2. Approval: 1993 Dec 1, 2020 · See full prescribing information for complete boxed warning. Approval: 2015 -----INDICATIONS AND USAGE----- See full prescribing information for complete boxed warning Do not substitute KADCYLA for or with trastuzumab. FULL PRESCRIBING INFORMATION . 1 ROS1-Positive Non-Small Cell Lung Cancer 1. These highlights do not include all the information needed to use NERLYNX safely and effectively. REPATHA (evolocumab) injection, for subcutaneous use . 2 DOSAGE AND ADMINISTRATION 2. These highlights do not include all the information needed to use BENLYSTA safely and effectively. RECENT MAJOR CHANGES. 3) See full prescribing information for complete boxed warning. 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. See full prescribing information for RYBREVANT. 8 Jul 15, 2021 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. is indicated for the treatment of osteoporosis in postmenopausal womenIn . See full prescribing information for ABRYSVO. UBRELVY®(ubrogepant) tablets, for oral use Initial U. Approval: 2017 _____ RECENT MAJOR CHANGES _____ Feb 27, 2020 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . 1 Recommended Dosage and Administration . 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) ] . . See full prescribing information for ENHERTU. encourage patients to LAZCLUZE™ (lazertinib) tablets, for oral use Initial U. Delay or dose reduce as recommended. See full prescribing information for SOLIRIS. 2 DOSAGE AND ADMINISTRATION For topical use only. 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. 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 . 1)]. VELSIPITY™ (etrasimod) tablets, for oral 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. See full prescribing information for POMALYST. • Monitor hepatic function prior to and during treatment [see Warnings and Precautions (5. Aug 1, 2024 · See full prescribing information for complete boxed warning. 1, 5. Jul 25, 2017 · HIGHLIGHTS OF PRESCRIBING INFORMATION. YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. WAINUA™ (eplontersen) injection, for subcutaneous use. MOUNJARO® (tirzepatide) Injection, for subcutaneous use Initial U. Feb 12, 2024 · See full prescribing information for EOHILIA. 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. Approval: 2001 -----INDICATIONS AND USAGE----- Sep 17, 2024 · Refer to the Full Prescribing Information for the recommended dosage of the aromatase inhibitor. 4) • Closely monitor glucose when switching to LANTUS and during initial weeks thereafter. • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested Oct 30, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION. (RYTELO (imetelstat) for injection, for intravenous use. 06/2024 . • Jun 15, 2020 · FULL PRESCRIBING INFORMATION . 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. Patients treated with REMICADE® are at increased risk for developing serious infections . Revised: 07/2024. 1. These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO -FETAL TOXICITY • Interstitial Lung Disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Revised: 7/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. See full prescribing information for NEURONTIN. Monitor hepatic function prior to initiation and prior to each dose. 2 Administration 3 DOSAGE FORMS FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. XTANDI can be Aug 13, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE NEMLUVIO is indicated for the treatment of adults with prurigo nodularis. Dosage . Do not chew, crush, or break tablets. 2 Important Nov 5, 2024 · These highlights do not include all the information needed to use MOUNJARO safely and effectively. Dosage and Administration, Recommended Dosage . INDICATIONS AND USAGE . Evaluate cardiac function prior to and during Jun 21, 2024 · See 17 for PATIENT COUNSELING INFORMATION. ZAVZPRET™ (zavegepant) nasal spray Initial U. See full prescribing information for CRENESSITY. Sep 16, 2023 · for PATIENT COUNSELING INFORMATION . 1). See full prescribing information for RYTELO. Do not administer BREYANZI to patients with active infection or Oct 1, 2024 · See full prescribing information for INVEGASUSTENNA. See full prescribing information for ORIAHNN. See full prescribing information for TAGRISSO. 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 . Approval: 2023----- INDICATIONS AND USAGE -----WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment . SERIOUS INFECTIONS . 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). 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. 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. WEGOVY (semaglutide) injection, for subcutaneous use . 2 . Approval: 2018 . 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. INDICATIONS AND USAGE. Feb 22, 2024 · See full prescribing information for complete boxed warning. S. See full prescribing information for PRISTIQ. Warnings and Precautions, Infections . 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. • Females of reproductive potential: exclude pregnancy before start of treatment, monthly during treatment, and 1 month after stopping treatment. If the product has a HIGHLIGHTS OF PRESCRIBING INFORMATION. Oct 18, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DUPIXENT safely and effectively. KYBELLA® (deoxycholic acid) injection, for subcutaneous use Initial U. Approval: 2018 Jan 9, 2024 · • See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes (2. 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). See full prescribing information for LAZCLUZE. 1 8. 1, 8. DOSAGE AND ADMINISTRATION. WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE • Cases of acute liver failure with fatal outcomes have been reported. indicated. Dec 2, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABILIFY safely and effectively. Dec 19, 2022 · See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 2 Administration 2. 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. Revised: 06/2024 . 5. 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. VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U. See full prescribing information for TAGRISSO TAGRISSO® (osimertinib) tablets, for oral use Initial U. FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION. 1) • No suicides occurred in clinical trials (5. Apply a thin layer of EUCRISA twice daily to affected areas. Revised: 06/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. 2) See full prescribing information for instructions on preparation and administration. TAGRISSO ® (osimertinib) tablets, for oral use Initial U. Dec 27, 2018 · FULL PRESCRIBING INFORMATION . POMALYST ® (pomalidomide) capsules, for oral use Initial US Approval: 2013 . 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. 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. See full prescribing information for KEPPRA . 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. 1 . 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. Dec 23, 2024 · 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 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. 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 Preparation 2. 1, 2. 2 Preparation and Administration . 1 Retinal Vein Occlusion 1. 3 Diabetic Macular Edema 2 DOSAGE AND ADMINISTRATION 2. See full prescribing information for MOUNJARO. 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. See full prescribing information for EMGALITY. revised: 4/2024 . EOHILIA. 1 Treatment of Osteoporosis in Postmenopausal Women. Approval: 2006 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Approval: 2018 Apr 5, 2024 · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Approval: 2015 -----RECENT MAJOR CHANGES----- Dec 15, 2024 · See full prescribing information for complete boxed warning. XTANDI ® is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC). Approval: 2024 INDICATIONS AND USAGE RYTELO is an Nov 20, 2024 · See full prescribing information for COBENFY. See full prescribing information for IMFINZI. 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. Approval: 1997 . RETACRIT™ (epoetin alfa-epbx) injection, for i ntravenous or subcutaneous use . 1 INDICATIONS AND USAGE. 0 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0. Approval: 2015----- RECENT MAJOR CHANGES ----- May 26, 2023 · See full prescribing information for MIEBO. These highlights do not include all the information needed to use IMFINZI ° safely and effectively. 3) -----DOSAGE FORMS AND STRENGTHS----- Capsules: 47 mg, 62 mg, 93 mg and 124 mg of arimoclomol. RYBREVANT (amivantamab-vmjw) injection, for intravenous use Initial U. • Do not administer OPSYNVI to a pregnant female because it may cause fetal harm (4. _____ FULL PRESCRIBING INFORMATION . 8) • Provide prophylaxis for tumor lysis syndrome. FULL PRESCRIBING INFORMATION. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Aug 22, 2024 · See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5. See full prescribing information for WEGOVY. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE IYUZEH™ (latanoprost ophthalmic solution) 0. 4) DOSAGE FORMS AND STRENGTHS May 7, 2024 · see 17 for patient counseling information and fda-. 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. NERLYNX (neratinib) tablets, for oral use. DUPIXENT ® (dupilumab) injection, for subcutaneous use Initial U. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Oct 3, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION. ENHERTU ® (fam-trastuzumab deruxtecan-nxki) for injection, for intravenous use Initial U. Revised: 5/2024 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1. tract disease (LRTD) caused by respiratory syncytial virus Oct 25, 2024 · See full prescribing information for ORLYNVAH. 8, 2. (3) Dec 6, 2024 · See full prescribing information for complete boxed warning. 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). 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. 1 Dosing and Administration Information . Jun 12, 2024 · See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 3) • Take VENCLEXTA tablets orally once daily with a meal and water. EMBRYO-FETAL TOXICITY • Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. 1 . 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. BOSULIF ® (bosutinib) tablets, for oral use BOSULIF ® (bosutinib) capsules, for oral use Initial U. Anaphylaxis has occurred Nov 18, 2024 · See full prescribing information for complete boxed warning. 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. See full prescribing information for CARVYKTI. ORLYNVAH. 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. 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. 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. Jun 7, 2021 · FULL PRESCRIBING INFORMATION . Approval: 2011 ----- These highlights do not include all the information needed to use BOSULIF safely and effectively. KEPPRA (levetiracetam) injection, for intravenous use Initial U. Institute dose See 17 for PATIENT COUNSELING INFORMATION. Revised: 6/2024 FULL PRESCRIBING INFORMATION: CONTENTS ⃰ 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. FOSAMAX. 3 DOSAGE FORMS AND STRENGTHS . Approval: 2012 Nov 8, 2013 · FULL PRESCRIBING INFORMATION . 3) • Hospitalized patients: The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made. TM (budesonide oral suspension) Initial U. The recommended dose of XTANDI is 160 mg (four 40 mg capsules) administered orally once daily. Approval: 2022 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. INVEGA SUSTENNA® (paliperidone palmitate) extended-release injectable suspension, for intramuscular use Initial U. Approval: 2024 severity. 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. Mar 24, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION • These highlights do not include all the information needed to use GLEEVEC safely and effectively. 1 Dosing Information . 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. AJOVY (fremanezumab-vfrm) injection, for subcutaneous use Initial U. Withhold NERLYNX in patients experiencing Grade 3 liver . Approval: 2014-----RECENT MAJOR CHANGES----- Oct 15, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. MIEBO™ (perfluorohexyloctane ophthalmic solution), for topical ophthalmic use Initial U. 1) • Infusion-Related Reactions: Discontinue for severe and life-threatening infusion-related reactions. 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. 1 Important Dosage and Administration Instructions 2. See full prescribing information for COMIRNATY. AVASTIN (bevacizumab) injection, for intravenous use Initial U. that may lead to hospitalization or death [see Warnings and Precautions (5. See full prescribing information for CAMZYOS. 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. See full prescribing information for BENLYSTA. See full prescribing information for REPATHA. AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory . See full prescribing information for GLEEVEC. Approval: 2021 -----RECENT MAJOR CHANGES----- Apr 28, 2022 · FULL PRESCRIBING INFORMATION. Approval: 2008 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. CARVYKTI® (ciltacabtagene autoleucel) suspension for intravenous infusion Initial U. See full prescribing information for ADAKVEO. PRISTIQ® (desvenlafaxine) Extended-Release Tablets, for oral use Initial U. CAMZYOS® (mavacamten) capsules for oral use Initial U. See full prescribing information for SUNOSI. These highlights do not include all the information needed to use TAGRISSO safely and . FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS . Approval: 1999 -----RECENT MAJOR CHANGES----- Nov 15, 2024 · 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. 2 Renal Cell Carcinoma Dec 14, 2021 · See full prescribing information for Cleviprex. 9) DOSAGE FORMS AND STRENGTHS. WARNING: SERIOUS INFECTIONS and MALIGNANCY . 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. See full prescribing information for UBRELVY. 4, 5. Approval: 2019 . OPDIVO® (nivolumab) injection, for intravenous use Initial U. This indication is approved under accelerated approval based on overall response rate and 3 days ago · FULL PRESCRIBING INFORMATION . DOSAGE AND ADMINISTRATION . Apr 5, 2018 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RITUXAN safely and effectively. 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 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. 3, 5. Limitations of Use NURTEC ODT is not indicated for the preventive treatment of migraine. See full prescribing information for DUPIXENT. WARNING: GASTROINTESTINAL PERFORATIONS, SURGERY Jun 16, 2022 · • See Full Prescribing Information for recommended VENCLEXTA dosages. OPZELURA is a prescription medicine used on the skin (topical) for: short-term and non-continuous treatment of mild to moderate . 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. See full prescribing information for OPDIVO. 2 NTRK Gene Fusion-Positive Solid Tumors 2 DOSAGE AND ADMINISTRATION 2. 1)] Most patients who developed these infections Jun 21, 2024 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. It may not be copied, in whole or in part, without the expressed written permission of McNeil See full prescribing information for ZAVZPRET. 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. Approval: 2019-----RECENT MAJOR CHANGES----- 2 days ago · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use Initial U. 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 . If lenalidomide is used during pregnancy, it may cause birth Aug 21, 2019 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM [see Clinical Studies (14)]. See full prescribing information for ABILIFY. Approval: 2023. Apr 27, 2020 · FULL PRESCRIBING INFORMATION . RYBREVANT ® (amivantamab-vmjw) injection, for intravenous use Initial U. See full prescribing information for KYBELLA. Cleviprex (clevidipine) injectable emulsion, for intravenous use Initial U. COMIRNATY® (COVID-19 Vaccine, mRNA)suspension for injection, for intramuscular use 2024-2025Formula Initial U. 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. See full prescribing information for KEYTRUDA. 2 DOSAGE AND ADMINISTRATION . 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. 1 INDICATIONS AND USAGE SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. 1 Dose and Schedule . 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. 2, 16) -----DOSAGE FORMS AND STRENGTHS----- • AMTAGVI is a cell suspension for Oct 23, 2024 · See full prescribing information for WAINUA. BENLYSTA (belimumab) for injection, for intravenous use BENLYSTA (belimumab) injection, for subcutaneous use Initial U. 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. TM (sulopenem etzadroxil and probenecid) tablets, for oral use Initial U. Approval: 2004 . See More . 1 General Dosing Information 2. Approval: 2024. TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use. 1) and Adverse . Approval: 2020 Feb 8, 2013 · These highlights do not include all the information needed to use POMALYST safely and effectively. 4Patient Selection 2. Approval: 2021 Oct 22, 2020 · FULL PRESCRIBING INFORMATION . 1 Vaccination Prior to Treatment Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to Feb 17, 2024 · FULL PRESCRIBING INFORMATION. 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. of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. May 26, 2022 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EMGALITY safely and effectively. 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 Jul 26, 2024 · FULL PRESCRIBING INFORMATION. • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Limitations of Use • YORVIPATH was not studied for acute post-surgical hypoparathyroidism. 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. Dec 15, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CRENESSITY 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. 2 Psoriatic Arthritis Aug 12, 2024 · Sections or subsections omitted from the full prescribing information are not listed. Oct 25, 2017 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEPPRA safely and effectively. RITUXAN® (rituximab) injection, for intravenous use Initial U. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete Jul 21, 2021 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). Jun 10, 2024 · 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. These highlights do not include all the information needed to use DOVATO safely and effectively. See full prescribing information for ZOLGENSMA. These highlights do not include all the information needed to use SOLIRIS safely and effectively. COBENFY™ (xanomeline and trospium chloride) capsules, for oral use Initial U. Anaphylaxis has occurred Jan 6, 2023 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE LEQEMBI is indicated for the treatment of Alzheimer’s disease. 2 Recommended Dosage 2. See full prescribing information for AVASTIN. The recommended starting dosage is 5 mg twice a day (10 mg/day) by mouth. • Increased risk of suicidal ideation in children or adolescents (5. 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. 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. WARNING: EMBRYO-FETAL TOXICITY and VENOUS THROMBOEMBOLISM . 4) Jan 8, 2019 · FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 1 Dosing Information ONPATTRO should be administered by a healthcare professional. Oct 8, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OPDIVO safely and effectively. WARNING: RISK OF HEART FAILURE . 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. Approval: 2023 See full prescribing information for VELSIPITY. ORIAHNN® (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use Initial U. 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. SUNOSI (solriamfetol) tablets, for oral use, [controlled substance schedule pending] Initial U. Approval: 2017 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COMIRNATY safely and effectively. reported to occur after administration of Xolair. GLEEVEC ® (imatinib mesylate) tablets, for oral use . 1) Hepatotoxicity, liver failure and death have occurred in KADCYLA-treated patients. 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 . Important Safety Information. 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. Jul 7, 2016 · See full prescribing information for complete boxed warning. 2 Posterior Segment Uveitis 1. Sep 14, 2024 · 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed. Jun 2, 2023 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UBRELVY 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. NEURONTIN® (gabapentin) capsules,for oral use NEURONTIN® (gabapentin) tablets,for oral use NEURONTIN® (gabapentin) oral solution Initial U. See full prescribing information for RETACRIT. 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. See full prescribing information for RITUXAN. ADAKVEO® (crizanlizumab-tmca) injection, for intravenous use Initial U. SOLIRIS ® (eculizumab) injection, for intravenous use . 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. 3) • Withhold FARXIGA for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Mar 24, 2015 · See full prescribing information for complete boxed warning. 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 . 3 Instructions for Use . ( 2. 2 Dosing 2. 1) May 3, 2024 · HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAMZYOS safely and effectively. WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO Nov 25, 2024 · FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . ZOLGENSMA ® (onasemnogene abeparvovec -xioi) suspension, for intravenous infusion. okzct kvykq yubvk jzitk bqyuzx jogaa glb jifzlu xeof elbxkzzk