Tocilizumab may also cause a perforation a hole or tear in your stomach or intestines. It is supplied as a nonpyrogenic, sterile lyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg and 30 mg of thiotepa. In the metaanalysis, all 19 gca patients treated with tocilizumab achieved disease remission. We evaluated the effect of a 52week treatment with tocilizumab by subcutaneous injection tczsc among biologicnaive japanese house workers hws and paid workers pws with ra in. The actpen is a prefilled, singledose, penlike autoinjector that keeps the needle tip shielded before the injection, allowing you to inject by holding down a button. Contraindications o actemra should not be administered to patients with known hypersensitivity to actemra.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for actimmune tocilizumab. Actemra subcutaneous formulation is not intended for intravenous. Integrated safety in tocilizumab clinical trials arthritis. If tocilizumab is transferred into human milk, effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to tocilizumab are unknown. Tocilizumab actemra is a recombinant humanized igg1. Common side effects include headaches, infections, and high blood pressure.
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. For patients weighing tocilizumab during a dosing interval at steady state varies between 10. To receive updates about the status of this trial, please subscribe to our global als clinical trial database. Of 155 patients who were receiving corticosteroids at. Tocilizumab in systemic juvenile idiopathic arthritis in a realworld. Before using this medicine, let your healthcare provider know if you have any health conditions, such as diabetes, cancer, or high cholesterol.
Tocilizumab is a recombinant humanied monoclonal antibody of the immunoglobulin s. Actemra tocilizumab dose, indications, adverse effects. Remove the needle cap immediately before injection, and gently pinch a cleaned area of skin. These results add to the body of evidence showing the efficacy of tcz as.
The recommended dose of actemra for adult patients with gca is 162 mg given once every week as a. Patients using actemra for subcutaneous administration should be instructed to inject the full amount in the syringe 0. Remarkably, prednisone dosage could be reduced within 12 weeks to a. Tocilizumab binds to soluble il6r in a dosedependent manner and saturates the receptor at approximately 0. Tocilizumab tcz is registered for clinical use both as iv. Highlights of prescribing information these highlights do not. This includes information you learn in documentaries, websites, interviews and package inserts.
Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate. Patients who experience grade 2 or higher neurologic toxicities should be monitored with continuous. For more important safety information, see full prescribing information and medication guide, including serious side effects. Together, these two options should give you and your healthcare provider a choice in how you take actemra. Roactemra 20 mgml concentrate for solution for infusion. Apr 17, 2017 a basic convention of writing is to cite sources from which you gathered information. Patients were randomized into 1 of 2 treatment groups. Tocilizumab roactemra, in combination with methotrexate, is recommended as an option for the treatment of rheumatoid arthritis in adults if. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and. Actemra may be used as monotherapy or concomitantly with methotrexate or other nonbiologic dmards as an intravenous infusion or as a subcutaneous injection. Tocilizumab is administered by intravenous infusions at 8 mg. After sc administration, tocilizumab absorption was most rapid from.
These highlights do not include all the information needed to use actemra safely and effectively. Aug 03, 2010 tocilizumab is the first interleukin6 receptor inhibitor. Phase 3 trial confirms superiority of tocilizumab to steroids. Pdf pharmacokinetic and pharmacodynamic analysis of. Whichever treatment method option you prefer, your actemra is the same. Not known whether tocilizumab is distributed into milk. As a result, inflammation and its consequences in the joints are reduced, and the progressive destruction of the joints is slowed or prevented. Risk of serious infections see full prescribing information for complete boxed warning. For instructions on dilution of the medicinal product before administration, see section 6. There were only 3 rcts and none of which involved tocilizumab.
Actemra subcutaneous formulation is not intended for. Tocilizumab in early progressive rheumatoid arthritis. Before you start treatment with tocilizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. For people having tocilizumab every four weeks as a drip into a vein, the dose is based on body weight so each persons dose may be different. Withdraw the amount of actemra for intravenous infusion from the vial s and add slowly into the 0. Actimmune tocilizumab stops il6 interleukin6, a protein that revs up the immune system, from working.
Economic evaluation of tocilizumab monotherapy compared to. For patients weighing tocilizumab is an interleukin6 il6 receptor antagonist indicated for treatment of. Highlights of prescribing information these highlights do. Objectives the efficacy of tocilizumab tcz, an antiinterleukin6 receptor antibody. Ensure that 2 doses of tocilizumab are available prior to infusion of yescarta. Tocilizumab, an antiil6 receptor antibody, to treat covid19related. Up to 11 days at iv dosage of 4 mgkg every 4 weeks. Physicochemical and biological characterization of the proposed. Regulatory approval for a biosimilar product relies on the. The fully diluted actemra solutions for infusion using 0. The mean daily dosage continued to decrease gradually thereafter, to 0. Mean changes in genantmodified sharp scores were small.
Global molecular effects of tocilizumab therapy in rheumatoid. After iv dosing, tocilizumab undergoes biphasic elimination from the circulation. Tocilizumab was approved by australias therapeutic goods administration on 27 may 2009 and was listed on the pharmaceutical benefits scheme from 1 august 2010. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to. There was cs dose reduction for all patients and total discontinuation of steroids in 9 47% patients. Original ucla clinical trial published report full text pdf als forum discussion. The infusion normally takes one hour and is followed by a period of observation for at least one hour to make sure you dont have any side effects. Please see below for ways actemra can be used, as well as important side effect information. To mix the solution, gently invert the bag to avoid foaming. Tocilizumab is given as a drip infusion into the vein. Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sjia patients.
The drug is a whole antibody designed specifically to target il6 receptor fig. Tocilizumab is efficacious and generally well tolerated in a wide range of. Find the actemra tocilizumab dosing calculator that can quickly assess and help prescribe actemra dosing for rheumatoid arthritis treatment. Advertisements on this site do not constitute a guarantee or endorsement by the journal, association, or publisher of the quality or value of such product or of the. You may get infections more easily, even serious or fatal infections. It belongs to a group of drugs called dmards diseasemodifying antirheumatic drug. Actemra tocilizumab was the first ra treatment to directly block the action of a protein in your body called interleukin6 il6. The molecular formula of the drug is c 6428 h 9976 n 1720 o 2018 s 42, cas number.
Tocilizumab tcz is a humanized monoclonal antibody that inhibits the interleukin6 receptor. Patients from these randomized trials could receive tocilizumab treatment in openlabel extension trials. For people having tocilizumab as an injection under the skin, the dose is usually 162mg one prefilled syringe. The recommended dosage for actemra sc is the same in both the prefilled syringe and the actpen. The efficacy and safety of tocilizumab in patients with rheumatoid arthritis have been evaluated in a comprehensive phase 3 program. Do not inject into skin that is tender, damaged, or has bruises or scars. Apr 09, 2020 conversely, the modified crs treatment guidance cited in zuma1 suggested considering tocilizumab treatment of crs starting at lee grade 2, resulting in 45% of enrolled patients receiving at least 1 tocilizumab dose supplemental data. Seventeen patients were randomized to receive tcz intravenously at a dosage of 8. Monitor patients for signs and symptoms of neurologic toxicities table 2. Tocilizumab is a drug used to treat the symptoms of rheumatoid arthritis and juvenile idiopathic arthritis. The isoelectric point pi and charge variants were analyzed using chrom perfect analysis software. Dec 16, 2019 how is tocilizumab given actemra, actemra actpen. Dosing schedule for ra treatment actemra tocilizumab.
The package insert recommends that lipid levels be checked 48 weeks after initiating tcz, and every 6 months thereafter 26, 31, 3336. Package insert thiotepa for injection, usp description thiotepa for injection is an ethyleniminetype compound. The giacta trial is a multicenter, randomized, doubleblind, and placebocontrolled study designed to test the ability of tocilizumab tcz, an interleukin il6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis gca. In new zealand, tocilizumab was approved for distribution in july 2009, 26 and pharmac approved subsidising it with special authority restrictions on 1 july 20 for systemic juvenile. Following the onset of rheumatoid arthritis ra, patients experience a functional decline caused by various joint symptoms which affects their activities of daily living and can lead to reduced work productivity. See full safety and boxed warnings for more information. The als therapy development institute will continue to monitor this clinical trial.
Tcz was first approved in 2005 as an orphan drug in japan for the treatment of. Its safety and efficacy were demonstrated in three large phase iii trials, for use in combination with mtx in patients with ra with inadequate response to traditional dmards 12, , 14. Clinical, radiographic and immunogenic effects after 1 year of. Using a dartlike motion, insert the needle at a 45degree or 90degree angle. Slowly add actemra for intravenous infusion from each vial into the infusion bag or bottle. Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Actemra tocilizumab injection, for intravenous infusion. Tocilizumab also competitively inhibits il6 binding to soluble il6r.
The product contains no preservative and is intended for single use only. Controlled studies in pregnant women show no evidence of fetal risk. Tocilizumab binds to il6 in the body and thereby blocks the effects of il6. Here, the longterm safety profile of tocilizumab, using pooled data from all of these trials, is reported. This product information was approved at the time this auspar was published. Roactemra, inntocilizumab european medicines agency europa. There were no ischemic cardiac disorders or events associated with tcz treatment during these trials. Thiotepa is a synthetic product with antitumor activity.
Dosing calculator for ra treatment actemra tocilizumab. Design of the tocilizumab in giant cell arteritis trial. Design of the tocilizumab in giant cell arteritis trial the harvard community has made this article openly available. Subcutaneous injections for ra actemra tocilizumab. Serious infections leading to hospitalization or death including. Highlights of prescribing information total car these.
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. Its used whenever you are sharing an idea or information that is not original to you. Effect of subcutaneous tocilizumab treatment on work. Release the pinched skin, and gently push the plunger all the way down to inject the full amount in the prefilled syringe 0. Product information for auspar actemra tocilizumab roche products pty ltd pm20120190533 final 6 february 2014. Actimmune tocilizumab lowers inflammation, relieves symptoms, and prevents the disease from getting worse. Actemra is a prescription medicine called an interleukin6 il6 receptor antagonist.
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