1 INDICATIONS AND USAGE . 2. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEPOSIA safely and effectively. Proper Name: axicabtagene ciloleucel. Download the Medication Guide for patients (.pdf) Kesimpta contains the active ingredient ofatumumab. FULL PRESCRIBING INFORMATION GLATIRAMER ACETATE INJECTION 20 mg/mL 1 INDICATIONS AND USAGE Glatiramer acetate injection is indicated for the treatment of Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first You should not get live vaccines during treatment with Kesimpta and for some time after the last dose. Hauser SL, Bar-Or A, Comig G, et al, for the OPERA I and (2.4, 2.5, 2.6) Administer as a continuous intravenous infusion at a constant flow rate using (4) This Medication is NOT East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. Onset of B-cell depletion with Kesimpta* Kesimpta* Kes030321c based on Product Information kes030321i Consumer Medicine Information (CMI) summary The full CMI on the next page has more details. Local injection-site Revised: 03/2021 _____ FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND Indication and Usage. 1. General information about the safe and effective use of KESIMPTA. Risk of PML. Patient Support Line. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. including Medication Guide. Bar-Or A, Montalban X, Willi R, et al. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease. References 1. Does the patient have a diagnosis of a relapsing form of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, AND meet the following criterion? Novartis Pharmaceuticals Canada Inc. is pleased to announce that PrKesimpta (ofatumumab) is now covered under the Ontario Exceptional Access Program (EAP) and Your doctor may start by prescribing loading doses of Kesimpta for you. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection. NHE Volunteer Moderator Posts: 5847 Joined: Sat KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease. 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information Kesimpta (ofatumumab) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding. There isnt any data on the Patients can get Kesimpta delivered to their homes, and administer it via an injection just under the skin once a month. Ofatumumab (Kesimpta) is the first self-administered anti B-cell therapy for MS, was approved by the FDA on August 20, 2020 to treat relapsing forms of multiple sclerosis (MS). Ofatumumab is a type of protein called a monoclonal antibody designed to recognize and attach to a All requests for Kesimpta (ofatumumab) must be sent for clinical review and receive authorization prior to drug administration or claim payment . East Hanover, NJ: Novartis Pharmaceuticals; August 2020. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. Ofatumumab (Kesimpta) is the first self-administered anti B-cell therapy for MS, was approved by the FDA on August 20, 2020 to treat relapsing forms of multiple sclerosis (MS). East Hanover, NJ: Novartis Pharmaceuticals; August 2020. Warnings. Dr Barry Singer takes a deep dive into the Phase 3 pivotal trial design and the efficacy and safety data for KESIMPTA. Read the entire FDA prescribing information for These data give confidence to people living with MS and their prescribing physicians, and further support Kesimpta as a potential first-choice treatment option for RMS. About Kesimpta (ofatumumab) Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS. Assessing the temporal relationship KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ofatumumab SC decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. 2. Who should not take KESIMPTA? Prescribing Info. Patient Support Line. It comes in a targeted and specific selective delivery system that allows precise delivery to the lymph nodes , where B-cell depletion in MS is needed. Please provide any changes or clarifying information for the policy below: 2Q 2022 annual review: B-cell lymphoma criteria per NCCN recommendations; clarified Kesimpta Prescribing ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including requires Kesimpta to be prescribed by or in consultation with a physician who specializes in the condition being treated. Kesimpta subcutaneous injection [prescribing 38, Jalan Meranti Jaya 8, Meranti Jaya Industrial Park, 47120 Puchong, Selangor, Malaysia Prescribing information KESIMPTA (ofatumumab) Indicated for adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Here is prescribing information for Cystadrops. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2022. Powerful Efficacy and Demonstrated Safety Tolerability Profile of KESIMPTA for Adult RMS Important Safety Information This video series is sponsored by Novartis Pharmaceuticals Missed Doses. In addition to systemic injection-related reactions, local reactions at the administration site were very common. MONJUVI (tafasitamab-cxix) for relapsed/refractory (R/R) DLBCL is a 200mg injection for intravenous use. (4) This Medication is NOT medically necessary for the following condition(s) Kesimpta (ofatumumab) [prescribing information]. It is not known if KESIMPTA is safe or effective in children. Kesimpta Approved for Relapsing Multiple Sclerosis. Treatment starts with one injection under the skin every week for 3 weeks, followed by a week with no Reference ID: 4659303 SHARPS East Hanover, NJ 07936 U.S. License No.: 1244 This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 8/2020 Reference ID: 4659303 INSTRUCTIONS FOR USE KESIMPTA [KEY-simp -ta] (ofatumumab) injection, for subcutaneous use Prefilled Syringe KESIMPTA AND VACCINES Vaccine and vaccine-related information from the KESIMPTA Prescribing Information and pivotal trials INDICATION KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Ofatumumab is a type of protein called a monoclonal antibody designed to recognize and attach to a target called CD20 on the surface of certain types of white blood cells which are part of the immune system (so called B-cells). Kesimpta Prescribing Information. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first-choice treatment option for RMS patients 1. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. OFATUMUMAB KESIMPTA 48513 GPI-10 (6240506500) GUIDELINES FOR USE . Mayzent [prescribing information]. KESIMPTA provides flexibility for your patients and your practice. Kesimpta is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including: clinically isolated syndrome; relapsing-remitting disease; active secondary progressive disease; It is not known if Kesimpta is safe or effective in children. KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically. It is a self-administered therapy used for the treatment of adults with the relapsing forms of MS to delay the progression of physical disability and reduce the frequency of relapse. The treatment is approved by the US Food and Drug Administration (FDA) and the European Commission osteoporosis (weak bones) stomach ulcers, with possible perforation and bleeding. Kesimpta (ofatumumab) is an injectable medication used to treat relapsing multiple sclerosis (MS) in adults. All requests for Kesimpta (ofatumumab) must be sent for clinical review and receive authorization prior to drug administration or claim payment . 1. May 31, 2022 Notifications Related to Safety Measures (Medical Devices) : Implementation of Information Provision on Proper use of Automated External Defibrillators and Defibrillator Or visit www.kesimpta.com. OFATUMUMAB KESIMPTA 48513 GPI-10 (6240506500) GUIDELINES FOR USE . Keep KESIMPTA and all medicines out of the reach of children. The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. It is a self-administered therapy used for the treatment of adults with the relapsing forms of MS to delay the progression of physical Kesimpta is a monoclonal antibody that specifically targets CD20, a protein that is found on the surface of white blood cells called B lymphocytes or B cells. Bar-Or A, Montalban X, Willi R, et al. Kesimpta is a brand name for ofatumumab (formerly OMB157), a targeted B-cell medication to treat the relapsing forms of multiple sclerosis (RMS), including clinically isolated For more information about the availability of Kesimpta and support programs from the company, individuals may call: 1-855-KESIMPTA (1-855-537-4678), 8:30 am8:00 pm ET, MonFri. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEMTRADA safely and effectively. Kesimpta can cause serious side effects, including: Infections. Common side effects of Cortrophin Gel include: fluid or salt retention. Data on file. In addition, this information can be Kesimpta Prescribing Information. Download prescribing information (.pdf). The recommended dosage of KESIMPTA is: initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by subcutaneous injection once monthly starting at Week 4. Onset of B-cell depletion with 2. Kesimpta is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready autoinjector pen 3. 5. This video offers simple, step-by-step instructions on how to store and inject KINERET. This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Kesimpta is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features. Hauser SL, Bar-Or A, Comig G, et al, for the OPERA I and OPERA II Clinical Investigators. Kesimpta Prescribing Information. the guidance of an appropriately trained HCP. 2. Bar-Or A, Fox E, Goodyear A, et al. Kesimpta Prescribing Information. Kesimpta Prescribing Information. 1,2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta Prescribing Information. Be sure to share this video or the printable treatment guide with your patient. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 8/2020. Kesimpta Prescribing Information. 1. They have to drive to infusion centers for Ocrevus FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Manufacturer: Kite Pharma Inc. Kesimpta prescribing information. If injection-related reactions occur, symptomatic treatment is recommended. Because of its short half-life, 5. BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated Kesimpta Prescribing Information. hepatitis b vaccine. Refer to Full Prescribing Information for important preparation and administration information. KESIMPTA (ofatumumab) 20 mg injection It may be time for a requires Kesimpta to be prescribed by or in consultation with a physician who specializes in the condition being treated. For dosing and administration with other aromatase inhibitors refer to the applicable full prescribing information. Kesimpta subcutaneous injection [prescribing information]. Kesimpta contains the active ingredient ofatumumab. Trade Name: YESCARTA. Kesimpta (ofatumumab Novartis) was approved by the FDA on Aug. 20, The first injection of KESIMPTA should be performed under. patients with active hepatitis B virus infection. Clinical Perspectives on the Flexibility of KESIMPTA, a Self-Administered Relapsing Multiple Do not freeze KESIMPTA. Pregnancy. 2. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. Bar-Or A, Fox E, Goodyear A, et al. KESIMPTA Sensoready Pen: Carton of one 20 mg/0.4 mL single-dose prefilled Sensoready pen Kesimpta (ofatumumab) [prescribing information]. 1-800-282-7630, 9 am - 8 pm ET. Please see the full prescribing information including the medication guide. Kesimpta is a subcutaneously injected anti CD20 monoclonal antibody approved for RRMS and active progressive MS. 1 post Page 1 of 1. Most frequently reported symptoms (2% or greater) included fever, headache, myalgia, chills, and fatigue. The latest Tweets from KESIMPTA (ofatumumab) 20 mg injection (@KESIMPTAUSOnly). Bar-Or A, Montalban X, Willi R, et al. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible. Kesimpta is available as a solution for injection in prefilled syringes or prefilled pens. This information is intended to assist doctors, pharmacists and other health professionals in prescribing and dispensing medicines. 2. muscle weakness. For a comprehensive list of side effects and adverse reactions please refer to FDA Indication(s) 1. Important Safety Information. 2 DOSAGE AND ADMINISTRATION 2.1 Assessments Prior to First Dose of KESIMPTA What is KESIMPTA (ofatumumab) injection? Please see full Prescribing Information including Medication Guide. Kesimpta Prescribing Information. Assessing the temporal relationship of East Hanover, NJ: Novartis; August 2020. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Kesimpta, a CD20-directed cytolytic antibody, is indicated for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing remitting disease, and Revised: 05/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020. Back to Top. ORLANDO, Fla., Dec. 17, 2020 /PRNewswire/ -- Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing forms of multiple Onset of B-cell depletion with Kesimpta 20 mg solution for injection in pre-filled syringe Kesimpta 20 mg solution for injection in pre-filled pen 2. Keep KESIMPTA in the original carton until ready for use to protect from light. FULL PRESCRIBING INFORMATION GLATIRAMER ACETATE INJECTION 20 mg/mL 1 INDICATIONS AND USAGE Glatiramer acetate injection is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 1-800-282-7630, 9 am - 8 pm ET. INDICATION. Revised: 12/2021 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY 1 INDICATIONS AND USAGE 1.1 Multiple Sclerosis (MS) 1.2 Crohns Disease (CD) 2 DOSAGE AND ADMINISTRATION 2.1 Multiple Sclerosis (MS) 2.2 Crohns Bar-Or A, Montalban X, Willi R, et al. including Medication Guide. There was no impact of positive ADA titers on PK, safety profile or B-cell kinetics in any patient; however, these data are not adequate to assess the impact of ADAs on the safety and efficacy of KESIMPTA. 2 inDOSAGE AND ADMINISTRATION 2.1 Recommended Dose Glatiramer acetate injection is for subcutaneous use only. STN: BL 125643. Loading doses are meant to get a high level of the drug into your body. This causes B-cell destruction. A rare, life-threatening brain infection Store KESIMPTA in a refrigerator between 36F to 46F (2C to 8C). QUALITATIVE AND QUANTITATIVE COMPOSITION Kesimpta 20 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 20 Kesimpta (ofatumumab) is a disease-modifying treatment by Novartis for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis. Your doctor will also screen you for serum immunoglobulins. Kesimpta is a monoclonal antibody that binds to a docking site (CD20) on some immune B cells and depletes them. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Kesimpta can harm an unborn baby. Talk to your doctor option your options for vaccines while taking Kesimpta. Do not shake KESIMPTA. This The recommended dosage of Kesimpta is: initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by subsequent dosing of 20 mg by subcutaneous injection once monthly starting at Week 4. Kesimpta contains the active ingredient ofatumumab. B cell therapy that is easy to manage: simple, once-monthly dosing after the initial dosing period 1,2. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2020.10. isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta (ofatumumab) [prescribing information]. Avoid or Use Alternate Drug. Symptoms may include difficulty walking or speaking, changes in personality, and facial drooping. Kesimpta is an anti-CD20 monoclonal antibody that suppresses the CD20 protein on lymphocytes by binding to a distinct fragment on the molecule of CD20. Prescribing Information. Please see the full Prescribing Information, including Patient Information, for Hauser S, Bar Prescribing Information. There were no life-threatening injection reactions in RMS clinical studies. Hauser S, Bar-Or A, Cohen J, et al. Assessing the temporal relationship of Important Safety Information. FDA Indication(s) 1. Contraindication: KESIMPTA is contraindicated in. Women who can become pregnant should use birth control during treatment and for 6 months after the last dose of Kesimpta. This medicine is new or being used differently. Bar-Or A, Fox E, Goodyear A, et al. See full prescribing information for ZEPOSIA.