Entyvio vedolizumab for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to entyvio or any of its excipients. Highlights of prescribing information these highlights. This product information was approved at the time this auspar was published. Actemra is indicated for the treatment of giant cell arteritis gca in adult patients.
May 05, 2019 actemra package insert pdf learn about actemra treatment for rheumatoid arthritis, giant cell arteritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis. Adults with moderately to severely active rheumatoid arthritis ra after at least one other medicine called a disease modifying antirheumatic drug dmard has been used and did not work well. Subcutaneous injections for ra actemra tocilizumab. Other reported side effects include heart attack, stroke, brain bleed, pancreatitis, and interstitial lung disease. Actemra patient assistance genentech rheumatology access. Find instructions for actemra tocilizumab subcutaneous injections and helpful information on the actemra medication guide that should help you. Then i started actemra which dramatically reduced inflammation from 90% down to single digits. Our lawyers are handling actemra lawsuits in all 50 states. Technically, actemra is considered a biologic medication, and is therefore under different rules than most other medications. Actemra class action lawsuit actemra lawyers, attorneys. See the end of this medication guide for a complete list of ingredients in actemra. Roactemra, inntocilizumab european medicines agency europa. Source document contributed to documentcloud by jeffery delviscio stat.
Rheumatoid arthritis ra adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs dmards. Side effects of actemra tocilizumab injection, warnings, uses. Eular recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs. I could kneel again, take long walks, stand in line, etc.
Medication guide zoledronic acid injection what is the. The lawsuits allege that rochegenentech the manufacturer of actemra. The recommended dosage of actemra for adult patients given as a 60minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an. In the actemra iv monotherapy clinical study, the rate of serious infections was 3. Rheumatoid arthritis ra adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or. Actemra tocilizumab is used to treat rheumatoid arthritis and other autoimmune disorders. Actemra tocilizumab reduces the effects of a substance in the body that can cause inflammation. The prefilled syringe is a singledose needle that is manually injected. Medication guide zoledronic acid injection what is the most. This emedtv article explains this prescription medication in more detail, including how it works, how often it is injected, possible side effects, and more. In the actemraiv monotherapy clinical study, the rate of serious infections was 3.
The rate of serious infections in the 4 mgkg and 8 mgkg actemra plus dmard groups was 4. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and. Insert 1 daily at approximately the same time for 2 weeks, followed by 1 insert twice weekly, every three to four days for example, monday and thursday. Relevant identified uses of the substance or mixture and uses advised against use for intravenous infusion after dilution 1. Highlights of prescribing information these highlights do not include all the information needed to use actemra safely and effectively. Actemra tocilizumab is indicated for the treatment of giant cell arteritis gca in adult patients.
Dec 16, 2019 in general, the safety observed for actemra administered subcutaneously was consistent with the known safety profile of intravenous actemra, with the exception of isrs where a higher frequency was observed in actemra sc treated sjia patients compared to pjia patients and adult ra or gca patients see clinical trials experience in rheumatoid. Read the medication guide and instructions for use provided by your pharmacist before you start using tocilizumab and each time you get a refill. Higher than recommended doses or more frequent dosing of. This medication guide does not take the place of talking with your doctor about your medical condition or treatment. Actemra is used to treat moderate to severe rheumatoid arthritis in adults after at least one other medication did not work or has stopped working. The actpen is a prefilled, singledose, penlike autoinjector that keeps the needle tip shielded before the injection. Feb 02, 2019 brilinta can lead to fewer cv events for stemi patients compared to clopidogrel, allowing a growing support for brilinta ticagrelor package insert. Actemra sc is available in a prefilled syringe or actpen autoinjector. Tocilizumab is a recombinant humanied monoclonal antibody of the immunoglobulin s. Find out about the brilinta ticagrelor mechanism of action. Actemra tocilizumab injection, for intravenous infusion. Genentech rheumatology access solutions can help identify the most appropriate patient assistance option to help your patient get the actemra tocilizumab he or she needs. Product information for auspar actemra tocilizumab roche products pty ltd pm20120190533 final 6 february 2014.
Details of the supplier of the safety data sheet enquiries. If the quantity dose requested exceeds the maximum fda labeled dose, when specified, or to the safest studied dose per the manufacturers product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended. See full prescribing information for complete boxed warning. If symptoms of serotonin syndrome occur, discontinue aloxi and initiate supportive treatment. Hepatitis b virus reactivation and progressive multifocal leukoencephalopathy hepatitis b virus hbv reactivation can occur in patients receiving cd20directed cytolytic antibodies, including arzerra, in some cases resulting in fulminant hepatitis, hepatic failure, and death see warnings and precautions 5. Before you use actemra prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it. Tocilizumab subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis gca.
Aug 09, 2019 cimzia package insert pdf cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis. There are slight differences between the prefilled syringe and the actpen. Actemra subcutaneous formulation is not intended for. Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Aug 02, 2019 actemra tocilizumab reduces the effects of a substance in the body that can cause inflammation. These highlights do not include all the information needed to use actemra safely and effectively. Actemra subcutaneous formulation is not intended for intravenous. Infusionrelated reactions and hypersensitivity reactions including anaphylaxis have occurred. Patients should be informed of the increased risk of serotonin syndrome, especially if aloxi is used concomitantly with other serotonergic drugs see drug interactions 7, patient counseling information 17. Rheumatoid arthritis guides and tools actemra tocilizumab. The recommended dosage of actemra for adult patients given as a 60minute single intravenous drip infusion is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
Apr 16, 2020 actemra tocilizumab is an interleukin6 il6 receptor antagonist indicated for treatment of. Contraindications o actemra should not be administered to patients with known hypersensitivity to actemra. Actemra is a prescription medicine called an interleukin6 il6 receptor antagonist. Before you receive actemra, tell your healthcare provider about all of your medical conditions, including if you. Actemra actemra tocilizumab prefilled syringe read and follow the instructions for use that come with your actemra prefilled syringe before you start using it and each time you get a prescription refill. Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms.
Patient assistance options are available for eligible patients with commercial insurance, public insurance or no insurance. Highlights of prescribing information when administering with. Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain doserelated laboratory changes. Despite the reports of liver failure associated with actemra and warnings from health canada, the prescribing information for actemra in the u. In general, the safety observed for actemra administered subcutaneously was consistent with the known safety profile of intravenous actemra, with the exception of isrs where a higher frequency was observed in actemrasc treated sjia patients compared to pjia patients and adult ra or gca patients see clinical trials experience in rheumatoid. Talk to your doctor if you have any questions about reclast. If you are this type of patient, and switching from actemra iv to actemra for subcutaneous sc injection, you do not need to reapply for the program. See what others have said about actemra, including the effectiveness, ease of use and side effects. Serious infections leading to hospitalization or death including. Highlights of prescribing information extended treatment. Treatment with actemra was associated with a higher incidence of neutropenia.259 1313 985 1388 866 1251 894 629 701 1181 376 1412 881 1395 338 1289 1385 161 1159 767 1277 844 119 1226 1076 1542 812 1105 1305 778 1557 1164 1120 735 1266 160 1325 486 1106 1344 931 1198 626