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Prescribing Information

Medication Guide

Healthcare Provider Letter

Safety Data Sheets

Alecensa® (alectinib)

Healthcare Provider Letters:

Important Drug Warning - December 2021

Safety Data Sheets:

ALECENSA(R) Capsules 150 mg

Avastin® (bevacizumab)

Healthcare Provider Letters:

Important Drug Warning - August 2024 Important Drug Warning: Necrotizing Fasciitis - Apr 2013 Warning for Counterfeit Product Labeled as Avastin in the United States Feb 2012 Important Change to Avastin® label for treatment of metastatic breast cancer - Nov 2011 Important New Safety Information in Women Receiving AVASTIN - Oct 2011 Intraocular Inflammatory Reactions - Dec 2008 Microangiopathic Hemolytic Anemia (MAHA) - July 2008 Tracheoesophageal (TE) Fistula - April 2007 Cases of RPLS in Patients Receiving AVASTIN - Sept 2006 VEGF antibodies for the treatment of retinopathy of prematurity - Aug 2006

Safety Data Sheets:

AVASTIN(R) Vials (100 mg) AVASTIN(R) Vials (400 mg)

Columvi™ (glofitamab-gxbm)

Safety Data Sheets:

COLUMVI(TM) 2.5 mg/2.5 ml COLUMVI(TM) 10 mg/10 ml

Cotellic® (cobimetinib)

Safety Data Sheets:

COTELLIC Tablets (20 mg)

Erivedge® (vismodegib)

Healthcare Provider Letters:

Important Drug Warning - November 2016 Serious Risk with Use of Erivedge (vismodegib) Capsules: Premature Epiphyseal Fusion - June 2016 Extension of Pregnancy Prevention Duration for Women of Childbearing Potential and Waiting Periods for Blood Donations and Lactation in Patients taking ERIVEDGE (vismodegib) capsule - February 2016

Safety Data Sheets:

ERIVEDGE(R) Capsules 150 mg

Gazyva® (obinutuzumab)

Healthcare Provider Letters:

Gazyva TM (obinutuzumab) Important Drug Warning: Thrombocytopenia - Feb 2014

Safety Data Sheets:

GAZYVA(R) Vials (1,000 mg/40 ml)

Herceptin® (trastuzumab)

Healthcare Provider Letters:

440mg Vials and Herceptin BWFI Diluent - June 2008 Updated Cardiotoxicity Information - Aug 2005 Fatal Embryo-Fetal Toxicity due to Herceptin Exposure During Pregnancy

Safety Data Sheets:

HERCEPTIN® Vials (150 mg)

Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk)

Safety Data Sheets:

HERCEPTIN HYLECTA Vials (600 mg/5 ml)

Itovebi™ (inavolisib)

Safety Data Sheets:

Itovebi(TM) Tablets (3 mg) Itovebi(TM) Tablets (9 mg)

Kadcyla® (ado-trastuzumab emtansine)

Healthcare Provider Letters:

Kadcyla Important Safety Warning: Hemorrhage, Nov 2013 KADCYLA (ado-trastuzumab emtansine) error on the carton - May 2013

Safety Data Sheets:

KADCYLA(R) Lyophilized Powder in Vials (100 mg) KADCYLA(R) Lyophilized Powder in Vials (160 mg) KADCYLA(R) Solution

Lunsumio™ (mosunetuzumab-axgb)

Healthcare Provider Letters:

Important Drug Warning - August 2024

Safety Data Sheets:

LUNSUMIO(TM) Vials (30 mg/30 ml) LUNSUMIO(TM) Vials (1 mg/ml)

Perjeta® (pertuzumab)

Safety Data Sheets:

PERJETA(R) (420 mg)

Phesgo® (pertuzumab, trastuzumab, and hyaluronidase-zzxf)

Safety Data Sheets:

PHESGO™ (pertuzumab, trastuzumab & hyaluronidase-zzxf) Injection (60 mg/ml, 60 mg/ml) PHESGO™ (pertuzumab, trastuzumab & hyaluronidase-zzxf) Injection (80 mg/ml, 40 mg/ml)

Polivy® (polatuzumab vedotin-piiq)

Safety Data Sheets:

POLIVY(R) Vials (30 mg & 140 mg)

Rituxan® (rituximab [Oncology])

Healthcare Provider Letters:

Rituxan® (rituximab) Label: Hepatitis B Reactivation, October 2013 Important Drug Warning: Updated Safety Information - Dec 2006 Important Drug Warning: New Safety Information - Sept 2008 Important Drug Warning: Updated Safety Information - Oct 2009

Safety Data Sheets:

RITUXAN(R) Vials (100 mg/10 ml) RITUXAN(R) Vials (500 mg/50 ml)

Rituxan Hycela® (rituximab and hyaluronidase human)

Safety Data Sheets:

Rituxan Hycela (TM) Vials (1600 mg) Rituxan Hycela (TM) Vials (1400 mg)

Rozlytrek® (entrectinib)

Safety Data Sheets:

ROZLYTREK(R) Oral Pellets (50 mg) ROZLYTREK(TM) Capsules (100 mg) ROZLYTREK(TM) Capsules (200 mg)

Tarceva® (erlotinib)

Healthcare Provider Letters:

Important Prescribing Information - October 2016 Important Correction of Drug Information - June 2016

Safety Data Sheets:

TARCEVA(R) Tablets (25 mg) TARCEVA(R) Tablets (100 mg) TARCEVA(R) Tablets (150 mg)

Tecentriq® (atezolizumab)

Healthcare Provider Letters:

Important Drug Warning - August 2024 Important Prescribing Information - November 2022 Important Prescribing Information - August 2021 Important Prescribing Information - May 2021 Important Prescribing Information - March 2021 Follow Up Important Prescribing Information - March 2021 Important Drug Warning - August 2018 Important Prescribing Information - June 2018 Important Drug Warning - July 2017

Safety Data Sheets:

TECENTRIQ® Vials (840 mg/14 ml) TECENTRIQ® Vials (1,200 mg/20 ml)

Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs)

Safety Data Sheets:

TECENTRIQ Hybreza™ Vials 1,875 mg/15 ml

Venclexta® (venetoclax)

Safety Data Sheets:

VENCLEXTA(R) Tablets (10, 50 and 100 mg)

Xeloda® (capecitabine)

Safety Data Sheets:

XELODA(R) Tablets (150 mg) XELODA(R) Tablets (500 mg)

Zelboraf® (vemurafenib)

Healthcare Provider Letters:

Important Drug Warning - June 2017 Important Drug Warning - March 2014 Important Drug Warning - August 2013

Safety Data Sheets:

ZELBORAF(R) F.C. Tablets (240 mg)

Actemra® (tocilizumab)

Healthcare Provider Letters:

Important Drug Warning - November 2024 Important Prescribing Information - Temporary Supply Shortage Actemra 20 mg/mL Concentrate for Solution for Infusion (IV) September 2021 Apr 2020 - Shipping short-dated Actemra (tocilizumab) 400 mg/20 mL vial for IV with dark blue cap Important Drug Warning - 2019 IMPORTANT SAFETY INFORMATION Regarding ACTEMRA® (tocilizumab) REMS, October 2013 Actemra for RA and SJIA - June 2011 Actemra for RA and SJIA - Oct 2012

Safety Data Sheets:

ACTEMRA(R) SC Autoinjector (162 mg/0.9 ml) ACTEMRA(R) Sterile Concentrate for Injection (80 mg) ACTEMRA(R) SC Prefilled Syringes (162 mg/0.9 ml) ACTEMRA(R) Sterile Concentrate for Injection (200 mg) ACTEMRA(R) Sterile Concentrate for Injection (400 mg)

Esbriet® (pirfenidone)

Healthcare Provider Letters:

Important Drug Warning - August 2019

Safety Data Sheets:

Esbriet ® F.C. Tablets (267 mg) Esbriet ® F.C. Tablets (801 mg) Esbriet ® Capsules (267 mg)

Lucentis® (ranibizumab injection)

Healthcare Provider Letters:

New Warnings and Precautions: Retinal Vasculitis with or without Occlusion – March 2024 Counterfeit Product - November 2018 Important Drug Notification: Intraocular Inﬂammatory Reactions After Intravitreal Injection - Dec 2008 SAILOR with AMD - Jan 2007 Safety Risk with Intravitreal Use of VEGF - Aug 2006

Safety Data Sheets:

LUCENTIS(R) Prefilled Syringe (0.5 mg/0.05 ml) LUCENTIS(R) Prefilled Syringe (0.3 mg/0.05 ml)

Rituxan® (rituximab [Immunology])

Healthcare Provider Letters:

Rituxan® (rituximab) Label: Hepatitis B Reactivation, October 2013 Rituxan and PML - Oct 2009 Rituxan and RA - Sept 2008 Rituxan and the treatment of SLE - Dec 2006

Safety Data Sheets:

RITUXAN(R) Vials (100 mg/10 ml) RITUXAN(R) Vials (500 mg/50 ml)

Susvimo™ (ranibizumab injection)

Healthcare Provider Letters:

Important Prescribing Information - October 2022

Safety Data Sheets:

SUSVIMO 10MG/0.1ML VIAL

Vabysmo® (faricimab-svoa)

Healthcare Provider Letters:

Important Drug Warning – November 2023

Safety Data Sheets:

VABYSMO 12% aqueous solution

Xolair® (omalizumab)

Healthcare Provider Letters:

June 2021 - Important Prescribing Information April 2020 - Important Prescribing Information: Self-administration during the COVID-19 pandemic

Safety Data Sheets:

XOLAIR(R) PFS (300mg/2ml) XOLAIR(R) PFS (150 mg) XOLAIR(R) PFS (75 mg) XOLAIR(R) Vials (150 mg)

Nutropin AQ® ((somatropin) injection for subcutaneous use)

Safety Data Sheets:

NUTROPINAQ(R) NuSpin (5 mg/2 ml) NUTROPINAQ(R) Pen Cartridge and NuSpin (10 mg/2 ml) NUTROPINAQ(R) Pen Cartridge and NuSpin (20 mg/2 ml)

Activase® (alteplase)

Healthcare Provider Letters:

Important Prescribing Information - November 2024 Stopper Dislodgement - How to reduce the risk of stopper dislodgement and leakage when using 100-mg vials

Safety Data Sheets:

ACTIVASE(R) Vials (50 mg) ACTIVASE(R) Vials (100 mg)

Enspryng® (satralizumab-mwge)

Safety Data Sheets:

ENSPRYNG™ SC (120 mg/ml)

Evrysdi® (risdiplam)

Healthcare Provider Letters:

Information Regarding Potential Leakage of Evrysdi (risdiplam) 0.75 mg/mL NDC 50242-175-07 Solution from Bottles Delivered to Patients

Safety Data Sheets:

EVRYSDI® (Risdiplam) 0.75 mg/ml EVRYSDI® Powder for Oral Solution (60 mg)

Ocrevus® (ocrelizumab)

Safety Data Sheets:

OCREVUS® Vials (300 mg/10 ml)

Ocrevus Zunovo™ (ocrelizumab and hyaluronidase-ocsq)

Safety Data Sheets:

OCREVUS ZUNOVO™ Vials 920 mg/23ml

CellCept® (mycophenolate mofetil)

Healthcare Provider Letters:

Correction of labeling provided with CellCept® Intravenous and CellCept® Oral Suspension - May 2015 Important Changes in the CellCept® Prescribing Information - June 2008 Mycophenolate REMS (Risk Evaluation and Mitigation Strategy) - 2012 Reports of Pure Red Cell Aplasia - Aug 2009 Pregnancy Notice - 2010 Pharmacists: Important New Dispensing Information - Jan 2009 Introduction of a CellCept Medication Guide - Jan 2009 Important Changes in the CellCept® Prescribing Information - Oct 2007

Safety Data Sheets:

CELLCEPT(R) Capsules (250 mg) CELLCEPT(R) Film Coated Tablets (500 mg) CELLCEPT(R) Oral Suspension CELLCEPT(R) Lyophilized Vials (500 mg) CELLCEPT(R) Powder for Oral Suspension

Pegasys® (peginterferon alfa-2a)

Safety Data Sheets:

PEGASYS(R) Vials (180 mcg/ml) PEGASYS(R) Prefilled Syringe (180 mcg/0.5 ml) PEGASYS ProClick(TM) Autoinjector (180 mcg/0.5 ml)

Pulmozyme® (dornase alfa)

Safety Data Sheets:

Pulmozyme(R) Inhalation Solution (2.5 mg)

Tamiflu® (oseltamivir phosphate)

Healthcare Provider Letters:

Tamiflu Dear Pharmacist Letter Removal of Dosing Dispenser-Aug 2013 Important Prescribing Information for Patients Under 1 - Jan 2013

Safety Data Sheets:

TAMIFLU(R) Capsules (30 mg) TAMIFLU(R) Capsules (45 mg) TAMIFLU(R) Capsules (75 mg) TAMIFLU(R) Suspension (6 mg/ml) TAMIFLU(R) Powder for Oral Suspension (30 mg/5ml)

Valcyte® (valganciclovir hydrochloride)

Healthcare Provider Letters:

Important Prescribing Information - July 2021

Safety Data Sheets:

VALCYTE(R) Powder for Oral Solution (50 mg/ml) VALCYTE(R) F.C. Tablets (450 mg)

Xofluza® (baloxavir marboxil)

Healthcare Provider Letters:

Important Prescribing Information - October 2019

Safety Data Sheets:

XOFLUZA(TM) Granules for Oral Suspension XOFLUZA(TM) Reconstituted Oral Suspension (2 mg/ml) XOFLUZA(TM) Tablets (40 mg)

Actemra® (TOCILIZUMAB [authorized for Emergency Use])

Cathflo Activase® (alteplase)

Healthcare Provider Letters:

Important Drug Warning - May 2024 Important Drug Information: New rubber stoppers now available - Dec 2014 Important Drug Information: Filtering Instructions for Pharmacists - Mar 2013

Safety Data Sheets:

CATHFLO ACTIVASE(R) Vials (2 mg)

Floodlight™ (MS)

Fuzeon® (enfuvirtide)

Safety Data Sheets:

FUZEON(R) Lyophilized Vials (90 mg)

Hemlibra® (emicizumab-kxwh)

Safety Data Sheets:

HEMLIBRA™ (30 mg/1.0 ml) HEMLIBRA™ (60 mg/0.4 ml) HEMLIBRA™ (105 mg/0.7 ml) HEMLIBRA™ (150 mg/1.0 ml) HEMLIBRA™ (12 mg/0.4 ml) HEMLIBRA™ (300 mg/2.0 ml)

PiaSky® (crovalimab-akkz)

Safety Data Sheets:

PIASKY® (340 mg/2 ml)

TNKase® (tenecteplase)

Healthcare Provider Letters:

Recall of Triad Group Alcohol Prep Products Due to Potential Microbial Contamination - Jan 2011

Safety Data Sheets:

TNKase(R) Lyophilized Powder (50 mg)

Valium® (diazepam)

Healthcare Provider Letters:

Serious risks with use of KLONOPIN® and/or VALIUM® - Feb 2021 Important Drug Warning - January 2017

Safety Data Sheets:

VALIUM(R) Tablets (2 mg) VALIUM(R) Tablets (5 mg) VALIUM(R) Tablets (10 mg)

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