These highlights do not include all the information needed to use kevzara safely and effectively. Please see the full prescribing information, including boxed warning. Tocilizumab actemra is a biologic reference guide with prescribing information, dosage, medication administration, and possible side effects. These highlights do not include all the information needed to use actemra safely and effectively. Some of the dosage forms listed on this page may not apply to the brand name actemra. Actemra subcutaneous formulation is not intended for intravenous. Get to know actemra for giant cell arteritis gca actemra is the first prescription medicine approved by the fda to treat gca.
Covid19 and roactemra tocilizumab further information. Overview of covid19 and potential role of il6 and severe. Benlysta belimumab injection, for subcutaneous use initial u. Actemra can be used alone following discontinuation of glucocorticoids. Actemra roactemra was granted breakthrough therapy designation for ssc by the us food and drug administration fda in june 2015. Please see full prescribing information for more information. Actemra tocilizumab injection for intravenous infusion. Actemra tocilizumab is a recombinant humanized antihuman interleukin 6 il6 receptor monoclonal antibody of the immunoglobulin igg1. Highlights of prescribing information these highlights do not include all the information needed to use entyvio safely and effectively.
Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sjia patients in the tables below. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate. Actemra tocilizumab injection, for intravenous infusion. Actemra is an immunosuppressant biologic drug used to treat rheumatoid arthritis. Hepatitis b virus reactivation and progressive multifocal leukoencephalopathy hepatitis b virus hbv reactivation can occur in patients. Entyvio vedolizumab for injection, for intravenous use initial u. Highlights of prescribing information major surgery. Serious infections leading to hospitalization or death including tuberculosis tb, bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving. Substitution by any other biological medicinal product requires the consent of the prescribing. 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. Highlights of prescribing information these highlights. 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. Actemra sc billing codes genentech access solutions.
Benlysta belimumab for injection, for intravenous use. Clinical criteria policy information specific to the clinical appropriateness for the medication. Actemra actemra tocilizumab injection for intravenous use. Actemra is a medicine that affects your immune system. From when the fda first approved the drug in 2010 through february 2019, a total of 29,638 people had reported side effects when taking the drug, according to the analysis. A steroid taper is when a healthcare professional reduces an existing steroid dose over time. In the actemraiv monotherapy clinical study, the rate of serious infections was 3. Actemra sc formulation is not intended for intravenous. This material is provided for educational purposes only. Actemra side effects common and rare reactions to actemra. Actemra tocilizumab consumer medicine information cmi. Registration status and prescribing information of roche medicines may differ between countries.
Severe cytokine release syndrome after t cellreplete peripheral blood haploidentical donor transplantation is associated with poor survival and antiil6 therapy is safe and well tolerated. All patients treated with roactemra should be given the patient alert card. Call your doctor if you have a fever, chills, aches. This medicine is available only with a doctors prescription. Please see below for approved indications, as well as important safety information.
Actemra is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis ra who have had an inadequate response. Kymriah tisagenlecleucel suspension for intravenous infusion initial u. Actemra is not fdaapproved for use in treatment of covid19 pneumonia and the safety and effectiveness have not been established in these patients. There is no intent to promote any nonapproved product or indication. Risk of serious infections see full prescribing information for complete boxed warning. Il6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to antitumor necrosis factor biologicals. Serious infections and malignancies 1 indications and usage 1. Actemra is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis ra who have had an inadequate response to one or more diseasemodifying antirheumatic drugs dmards. Actemra tocilizumab injection prescribing information. For more important safety information, see full prescribing information and medication guide, including serious side effects.
Highlights of prescribing information actemra can be used. Please see below for ways actemra can be used, as well as important side effect information. Actemra tocilizumab is indicated for the treatment of giant cell arteritis gca in adult patients. This information is provided solely to enable physicians to make informed individual patient. The rate of serious infections in the 4 mgkg and 8 mgkg actemra plus dmard groups was 4. Elderly patients with dementiarelated psychosis treated with antipsychotic drugs are at an increased risk of death. It comes in an infusion or an injection, depending on what its treating. Patients less than 30 kg weight 10 mg per kg patients at or above 30 kg weight 8 mg per kg. When first prescribed, actemra is taken with a steroid taper. Please scroll down for important side effect information for actemra. Policy information specific to preferred medications section 2. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Actemra may also cause a perforation a hole or tear in your stomach or intestines. For additional safety information, please see the full prescribing information, including boxed warning.
Actemra tocilizumab injection, for intravenous or subcutaneous use. Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of ra, sjia, pjia or crs. Actemra information, side effects, warnings and recalls. Mothertobaby, a service of the organization of teratology information specialists 5034a thoroughbred lane brentwood, tennessee 37027 for administrative inquiries. See what others have said about actemra, including the effectiveness, ease of use and side effects. Alprolix is available as a lyophilized powder in singleuse vials containing nominally 250, 500, 2000, 3000, or 4000 international units iu. See full prescribing information for complete boxed warning.
You may get infections more easily, even serious or fatal infections. For additional safety information, please see the full prescribing information and medication guide. Actemra sc billing codes genentech access solutions author. Actemra actem ra tocilizumab injection for intravenous use actemra actem ra tocilizumab injection for subcutaneous use what is the most important information i should know about actemra. Actemra is a prescription medicine called an interleukin6 il6 receptor antagonist. Tocilizumab actemra is considered not medically necessary when used for patients who at initiation have an absolute neutrophil count anc below 2000mm 3, platelet count below 100,000mm 3, or who have alt. Kevzara sarilumab injection, for subcutaneous use initial u. Actemra tocilizumab is indicated for the treatment of chimeric antigen receptor car t cellinduced severe or lifethreatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Side effects of actemra tocilizumab injection, warnings, uses.
Actemra is indicated for the treatment of adult patients with moderately to severely. Actemra subcutaneous formulation is not intended for. Patients treated with tocilizumab are at increased risk for infections, some progressing to serious infections leading to. In the actemra iv monotherapy clinical study, the rate of serious infections was 3. Actemra should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. What is the most important information i should know about actemra. Actemra is used to treat moderate to severe rheumatoid arthritis ra in adults. Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain doserelated laboratory changes. This document contains confidential and proprietary information of cvscaremark and cannot be reproduced, distributed or printed without. Medical data company ehealthme publishes and routinely updates an analysis of fda reports involving actemra and gi perforation. If appropriate, the dose of concomitant mtx andor other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated. Highlights of prescribing information actemra subcutaneous.
Actemra actemra tocilizumab injection for subcutaneous use. This document contains side effect information about tocilizumab. Highlights of prescribing information these highlights do not include all the information needed to use kymriah safely and effectively. Actemra 80 mg 4 ml vial 5024205xx genentech actemra 200 mg10 ml vial 5024206xx genentech actemra 400 mg20 ml vial 5024207xx genentech actemra 162 mg0. Please see the full prescribing information, including boxed warning, for additional important safety. Actemra tocilizumab injection, for intravenous use injection, for subcutaneous use. Download or print coding information to help you complete payer forms for actemra for. Actemra subcutaneous formulation is not intended for intravenous administration. Actemra concentrated solution for intravenous iv infusion is a clear to. Roactemra 20 mgml concentrate for solution for infusion. Highlights of prescribing information total car these. Roche does not support, endorse or recommend the unapproved use of any roche medicine in your country. These highlights do not include all the information needed to use benlysta safely and effectively. Actemra is indicated for the treatment of giant cell arteritis gca in adult patients.
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