Actemra subcutaneous formulation is not intended for. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. Using a dartlike motion, insert the needle at a 45degree or 90degree angle. Patient assistance options are available for eligible patients with commercial insurance, public insurance or no insurance. Since actimmune tocilizumab calms down your immune system, it raises your risk of serious or possibly lifethreatening infections, including tb tuberculosis. The actpen is a prefilled, singledose, penlike autoinjector that keeps the needle tip shielded before the injection. The efficacy of subcutaneous actemra in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of the established efficacy of intravenous actemra in polyarticular jia patients and subcutaneous actemra in patients with ra see clinical pharmacology 12. This was followed by eu and us approvals in january 2009 and january 2010, respectively. See full prescribing information for complete boxed warning. While it may prove somewhat effective in combating giantcell arthritis, a new study indicates that the side effects of actemra resulted in adverse health problems for. How to inject actemra tocilizumab use of this site. 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 a recombinant humanied monoclonal antibody of the immunoglobulin s. The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. Together, these two options should give you and your healthcare provider a choice in how you take actemra. All information contained within the johns hopkins arthritis center website is intended for educational purposes only. Rochechugai, known as roactemra in europe, is a firstinclass humanized interleukin6 receptor monoclonal antibody. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or broken. Parts of your actemra prefilled syringe see figure a. Get emergency medical help if you have signs of an allergic reaction. General dosing information it is recommended that actemra not be initiated in patients with an absolute neutrophil count anc below 2000 per mm 3, platelet count below 100,000 per mm 3, or who have alt or ast above 1. Do not inject into skin that is tender, damaged, or has bruises or scars.
Side effects of actemra injection affected 15% of subjects. You can get it as a shot or an infusion, but it may not be the best choice if you have liver problems. The rate of serious infections in the 4 mgkg and 8 mgkg actemra plus dmard groups was 4. 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. Fda approves actemra tocilizumab for giant cell arteritis. Approximately 100 centers will enroll 250 patients with active disease. Physicians and other health care professionals are encouraged to consult other sources and confirm the information contained within this site. 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. This emedtv article explains this prescription medication in more detail, including how it works, how often it is injected, possible side effects, and more. Slowly add actemra for intravenous infusion from each vial into the infusion bag or bottle. 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.
Actemra class action lawsuit actemra lawyers, attorneys. Highlights of prescribing information these highlights do. Actemra lawsuit information sanders phillips grossman. Actemra tocilizumab injection side effects, images, uses. This product information was approved at the time this auspar was published. If you are on the infusion, you will have this medicine at a center where nurses will place a needle in your vein and give you the medicine through it. A dose of 162 mg given once every other week as a subcutaneous injection, in. The actemra is helping but when i first started it wasnot helping as muchafter 4 doses we doubled the dose and it helps morei know ra is so discouraging cuz if you cant find a med that works the joint damage continuesi hope to at least be able to function for a few more years. To mix the solution, gently invert the bag to avoid foaming. In one study of tocilizumab, responses were seen in four of. It is a kind of medicine called a monoclonal antibody. Actemra tocilizumab injection, for intravenous or subcutaneous use. Level i codes and descriptors ed by the american medical associations current.
I love to knit, sew, and help in the gardeni dont pace. Tocilizumab is given as an injection once a week or as an iv infusion once a month. Actemra fda prescribing information, side effects and uses. There are slight differences between the prefilled syringe and the actpen. Actemra tocilizumab side effects, dosage, interactions. Cdec final recommendation tocilizumab actemra ncbi. Serious infections leading to hospitalization or death including. A healthcare provider will give you this type of injection. In the current prescribing information, tcz initiation is not. Actemra is the brand name of the prescription medicine tocilizumab, which is used to treat adults with rheumatoid arthritis a condition in which the body attacks its own joints the drug is.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to. For instructions on dilution of the medicinal product before administration, see section 6. Before you use actemra prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it. Exclusion criteria na required medical information rheumatoid arthritis ra initial. Roactemra, inntocilizumab european medicines agency europa.
Release the pinched skin, and gently push the plunger all the way down to inject the full amount in the prefilled syringe 0. The rate of infection in ra patients treated with tocilizumab in clinical practice is higher. This new indication provides the first fdaapproved therapy, specific to this type of vasculitis, according to a press release from the agency. Whichever treatment method option you prefer, your actemra is the same. Subcutaneous injections for ra actemra tocilizumab. In the actemraiv monotherapy clinical study, the rate of serious infections was 3. Design of the tocilizumab in giant cell arteritis trial. The prefilled syringe is a singledose needle that is manually injected. Learn how to store and discard medical supplies safely. A small proportion of tocilizumabtreated ra patients in clinical trials.
Actemra subcutaneous formulation is not intended for intravenous administration. Eular recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs. Before you start treatment with tocilizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections. Actemra can be used alone following discontinuation of glucocorticoids. Actemra iv s medications actemra 200 mg10 ml vial, actemra 400 mg20 ml vial, actemra 80 mg4 ml vial covered uses all medically accepted indications not otherwise excluded from part d. Tocilizumab is an antiil6 receptor antibody that has been used in the treatment of steroidrefractory gvhd. The product monograph recommends the following dosage regimen for the sc.
Actimmune tocilizumab effectively relieves pain and prevents joint damage. The codes are divided into two levels, or groups, as described below. Yet hundreds of patients taking actemra have died from such problems, and many more have suffered harm. Actemra patient assistance genentech rheumatology access. Effect of tocilizumab on neutrophils in adult patients with rheumatoid. Actemra is a prescription medicine called an interleukin6 il6 receptor antagonist. 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. The comparative cost of tocilizumab sc with tocilizumab iv will depend on the. 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. Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sjia patients. The recommended dose of actemra for adult patients with gca is 162 mg given once every week as a. Do not remove the needle cap until you are ready to inject actemra. Actemra tocilizumab dose, indications, adverse effects.
Actemra sc is available in a prefilled syringe or actpen autoinjector. I could kneel again, take long walks, stand in line, etc. As explained in this emedtv article, tocilizumab is used for treating three different kinds of arthritis. Risk of infections in rheumatoid arthritis patients treated with. Actemra is a biologic medication synthesized in the laboratory. Intravenous actemra was first approved for rheumatoid arthritis ra in japan in april 2008. In the actemra iv monotherapy clinical study, the rate of serious infections was 3. Tocilizumab may also cause a perforation a hole or tear in your stomach or intestines. Contraindications o actemra should not be administered to patients with known hypersensitivity to actemra. Tcz was first approved in 2005 as an orphan drug in japan for the treatment of. Then i started actemra which dramatically reduced inflammation from 90% down to single digits. Rheumatoid arthritis guides and tools actemra tocilizumab. You may get infections more easily, even serious or fatal infections. J3262 hcpcs code tocilizumab injection hcpcs registry.
Sanders phillips grossman actemra litigation attorneys are representing clients nationwide in a lawsuit against the drug manufacturer, rochegenentech, for failure to warn the medical community and public about the risks of heart attack, heart failure, stroke, pancreatitis, lung disease, gastrointestinal perforation and death in patients when taking actemra for rheumatoid arthritis ra or. Remove the needle cap immediately before injection, and gently pinch a cleaned area of skin. The food and drug administration fda has expanded the approved use of subcutaneous actemra tocilizumab to treat adults with giant cell arteritis. Risk of serious infections see full prescribing information for complete boxed warning. This article further describes the uses of this prescription drug, including its use in children. Product information for auspar actemra tocilizumab roche products pty ltd pm20120190533 final 6 february 2014. These forms replace the statement of medical necessity smn and the patient authorization and notice of request for transmission of health information to genentech. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate. See what others have said about actemra, including the effectiveness, ease of use and side effects. Other reported side effects include heart attack, stroke, brain bleed, pancreatitis, and interstitial lung disease. Antibodies are substances in the body that help the immune system fight disease. The lawsuits allege that rochegenentech the manufacturer of actemra. Side effects of actemra tocilizumab injection, warnings. 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.
665 1120 304 1011 903 51 452 419 784 284 920 545 583 338 72 1226 1214 935 243 264 1506 1024 1568 930 1595 1067 329 1394 106 1107 1275 700 149 317 761 880 1212