How should I store KESIMPTA Prefilled Syringe? Be sure to tell your doctor if you have a history of hepatitis B. Kesimpta (ofatumumab): Side effects, cost, dosage, and more There arent any herbs or supplements that have been specifically reported to interact with Kesimpta. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Avoid touching the syringe guard wings before use. These include the ones mentioned below. If the myelin sheath doesnt work properly, your brain cant communicate easily with the rest of your body. The CD19+ B-cell counts remained below LLN for approximately 97% of patients in Study 1 and 92% of patients in Study 2 from 12 weeks through 120 weeks while on KESIMPTA treatment. No decline in immunoglobulin G (IgG) was observed at the end of the study. All rights reserved. You also shouldnt get them for certain lengths of time before and after you use the medication. Kesimpta may be available through a mail-order pharmacy. Keep KESIMPTA in the original carton until ready for use to protect from light. Both forms contain 20 milligrams (mg) of Kesimpta in 0.4 milliliters (mL) of liquid solution. Our medical advisers say that, on balance, it's unlikely to increase the risk of COVID-19 infection or severe disease. Generic name: ofatumumab Kesimpta may not be right for you if you have certain medical conditions or other factors affecting your health. If needed, KESIMPTA may be stored for up to 7 days at room temperature, up to 86F (30C ). Kesimpta is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid . You shouldnt get live vaccines for 4 weeks before you start using Kesimpta and throughout your treatment with the drug. This is no matter how rare the side effect may be or whether theres a known link between the side effect and the medication. Each 20 mg/0.4 mL KESIMPTA Sensoready Pen or prefilled syringe delivers 0.4 mL of solution. The Food and Drug Administration (FDA) often requires a drugs prescribing information to include potential serious risks. Use KESIMPTA exactly as your healthcare provider tells you to use it. This helps the medication to begin working quickly. So if you get a non-live vaccine during your treatment, it may not work as well as usual. For more information, see the Kesimpta and pregnancy section above. In Study 1 and Study 2, a decrease in the mean level of IgM was observed in KESIMPTA-treated patients but was not associated with an increased risk of infections [see Warnings and Precautions (5.3)]. Ofatumumab does not share a common clearance pathway with chemical drugs that are metabolized by the cytochrome P450 system or other drug metabolizing enzymes. Kesimpta: Uses, Dosage, Side Effects, Warnings - Drugs.com If you have any questions about when to take your next dose, talk with your doctor or pharmacist. Administer by subcutaneous injection only. As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. No carcinogenicity studies have been conducted to assess the carcinogenic potential of ofatumumab. This Medication Guide has been approved by the U.S. Food and Drug Administration. Hold the syringe in place for the full 5 seconds. Looking for a partner as you take on the. (An immunoglobulin is a type of protein.). Prior to initiating KESIMPTA, perform Hepatitis B virus (HBV) screening. If you miss a dose of Kesimpta after your first 4 weeks of treatment, take it as soon as you remember, even if its almost time for your next dose. Its possible that hair loss can be a side effect of other medications used to treat MS. If you think youve used too much of this drug, call your doctor. Get All the Details. Its important to not shake or freeze Kesimpta. Why Parkinson's research is zooming in on the gut. Most frequently reported symptoms (2% or greater) included fever, headache, myalgia, chills, and fatigue. The following lists contain some of the key side effects that may occur while using Kesimpta. Immunosuppressants: Definition, Uses & Side Effects - Cleveland Clinic This Instructions for Use has been approved by the U.S. Food and Drug Administration. Symptoms observed included fever, headache, myalgia, chills, and fatigue, and were predominantly (99.8%) mild to moderate in severity. The mean time since MS diagnosis was 5.7 years and the median EDSS score at baseline was 3.0; 60% had been treated with a non-steroid therapy for MS. At baseline, the mean number of relapses in the previous year was 1 and the mean number of T1 GdE lesions on MRI scan was 1.5. KESIMPTA was associated with a decrease of 4.3% in mean IgG levels after 48 weeks of treatment and an increase of 2.2% after 96 weeks. However, you should still check with your doctor or pharmacist before using any of these products while taking Kesimpta. Its not known if Kesimpta is safe to use while pregnant. To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. In recent years, a number of novel and increasingly effective disease-modulatory therapies (DMTs) have been approve These cells are called B cells. The potential duration of B-cell depletion in infants exposed to ofatumumab in utero, and the impact of B-cell depletion on the safety and effectiveness of vaccines, are unknown. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, chilled, sweaty, itchy, or have a skin rash, headache . These starting doses are called loading doses and theyre meant to help start treating your symptoms quickly. Ofatumumab is produced in a murine NS0 cell line and consists of two IgG1 heavy chains and two kappa light chains with a molecular weight of approximately 146 kDa. can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out. Kesimpta is used to treat certain forms of multiple sclerosis (MS) in adults. This date is typically 1 year from the date they dispensed the medication. Kesimpta is an anti-CD20 monoclonal antibody that's approved to treat relapsing types of MS. Hydrochloric acid may have been added to adjust pH. Disability progression was defined as an increase in EDSS of at least 1.5, 1, or 0.5 points in patients with a baseline EDSS of 0, 1 to 5, or 5.5 or greater, respectively. Prescribing Information, Instructions for Use, and Medication Guide. Only remove the cap when you are ready to use the KESIMPTA Sensoready Pen. The drug comes in two forms: Your doctor can help determine which form is right for you. If you have any questions about which vaccines you may need or the best time to get a vaccine while you are using Kesimpta, talk with your doctor or pharmacist. List of 69 Multiple Sclerosis Medications Compared - Drugs.com The first injection of KESIMPTA should be performed under the guidance of a healthcare professional [see Warnings and Precautions (5.2)]. Delay KESIMPTA administration in patients with an active infection until the infection is resolved. Some side effects may occur during the injection or up to 24 hours later. KESIMPTATM(ofatumumab injection) is indicated for: the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features (see 14 CLINICAL TRIALS). Can diet and exercise reverse prediabetes? Last updated on Sep 1, 2022. Symptoms of multiple sclerosis (MS), the condition that Kesimpta is used to treat, may lead to weight changes. Click here for full Prescribing Information, including Medication Guide. PML didnt occur in clinical trials of people with MS who used Kesimpta. This article provides several useful tips on medication disposal. Look through the viewing window. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. For more information about using Kesimpta during pregnancy, see the Kesimpta and pregnancy section above. The manufacturer of Kesimpta doesnt have specific recommendations about birth control use in males* using the drug. There are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. How should I dispose of used KESIMPTA prefilled syringes? Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. A biosimilar form is a drug that has been shown to be just as safe and effective as the original biologic form. The precise mechanism by which ofatumumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Uses Warnings Before taking Side effects Interactions Dosage FAQ What is Kesimpta? To find out how often infections occurred in clinical studies, see the drugs prescribing information. Attention: Dispense with enclosed Medication Guide. The therapy is administered monthly via subcutaneous (under-the-skin) injections and it works by . Before using KESIMPTA, tell your healthcare provider about all of your medical conditions, including if you: What is the most important information I should know about KESIMPTA?, You should receive any required live or live-attenuated vaccines at least 4 weeks before you start treatment with KESIMPTA, Whenever possible, you should receive any non-live vaccines at least 2 weeks before you start treatment with KESIMPTA, Tell your healthcare provider about all the medicines you take. Note: Some of the drugs listed here are used off-label to treat these specific conditions. It's believed that Kesimpta works by decreasing the activity of your immune system. However, HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients being treated with ofatumumab for chronic lymphocytic leukemia (CLL) (at higher intravenous doses than the recommended dose in MS but for a shorter duration of treatment) and in patients treated with other anti-CD20 antibodies. The KESIMPTA Instructions for Use for each presentation contains more detailed instructions on the preparation of KESIMPTA. Do not rub the injection site. KESIMPTA is a CD20-directed cytolytic antibody 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. Introduction - Clinical Review Report: Ofatumumab (Kesimpta) - NCBI Instruct patients to inject the full amount of KESIMPTA according to the directions provided in the Instructions for Use. Symptoms may include difficulty walking or speaking, changes in personality, and facial drooping. If you have any questions about eating certain foods with Kesimpta, talk with your doctor. If you have any questions about the best birth control for you while youre using Kesimpta, talk with your doctor. If you have any questions about hepatitis B reactivation, talk with your doctor. Early, Researchers developed a groundbreaking vaccine for the Epstein-Barr virus (EBV), which is linked to a 32-fold higher risk of multiple sclerosis (MS). KESIMPTA has the potential for an increased risk of infections, including serious bacterial, fungal, and new or reactivated viral infections; some of these infections have been fatal in patients treated with other anti-CD20 antibodies.
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