These partners have agreed to distribute only products purchased directly from genentech and not to distribute actemra iv through secondary channels. Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3296 for at least one year. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. This drug will likely be quite expensive and you may want to consider using. Actemra tocilizumab is an interleukin6 il6 receptor antagonist indicated for treatment of. Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Actemra, a monoclonal antibody, is a prescriptionbased drug used to help treat cytokine release syndrome, giant cell arteritis, juvenile idiopathic arthritis and rheumatoid arthritis. Actemra has been linked to serious side effects including heart attack, heart failure, stroke, pancreatitis, lung disease, gastrointestinal perforation, and more. Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively. The actemra copay card program provides drug copay assistance for outofpocket costs of actemra only when actemra iv or actemra subcutaneous sc injection is prescribed for an approved use.
Actemra tocilizumab is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Interleukin 6 il6 is a cytokine that plays an important role in immune response and is implicated in the. Actemra may also cause a perforation a hole or tear in your stomach or intestines. How can i find out which part d drug plans cover the prescription drugs i take. Actemra is an antibody that binds to a specific set of receptors known as interleukin6 il6 receptors in the body.
If you have questions, call the optumrx call center for nevada. Customers can purchase actemra iv through authorized specialty distributors and wholesalers that have made a commitment to product integrity. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. The prefilled syringe is a singledose needle that is manually injected.
Actemra is a biologic medication synthesized in the laboratory. Youll need to provide the exact name of your drugs, plus the dosage and. Learn more about medicare prescription drug plans and savings with goodrx. Actemra solution for injection drug information, side. Prior authorization request optumrx actemra tocilizumab. Actemra tocilizumab dosing, indications, interactions. It is a kind of medicine called a monoclonal antibody. Whichever treatment method option you prefer, your actemra is the same. See what are the possible side effects with actemra. See full safety and boxed warnings for more information. Prescribing information rheumatoid arthritis resources for patients and practices. Actemra tocilizumab side effects, dosage, interactions. Source document contributed to documentcloud by jeffery delviscio stat.
See full prescribing information including boxed warning on serious infections. Sanders phillips grossman actemra litigation attorneys are representing clients nationwide in a lawsuit against the drug manufacturer, rochegenentech. Find patient medical information for actemra intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Find valuable actemra tocilizumab ra education information, including ra patient brochure, prescription guide, dosing calculator and dosing guide. Highlights of prescribing information actemra can be used. Actemra may indirectly stimulate these cyp enzymes. Identification of the substancemixture and of the companyundertaking 1. This action prevents the interleukin6 which is a natural inflammatory protein from binding to the receptor, thereby reducing the symptoms of rheumatoid arthritis and juvenile idiopathic arthritis. 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. Pancreatitis is very rare, so that number is alarming. Actemra is supplied as 80 mg4 ml ndc 50242501, 200 mg10 ml ndc 50242601, and 400 mg20 ml ndc 50242701 individually packaged 20 mgml singledose vials for further dilution prior to intravenous infusion. Actemra sc formulation is not intended for intravenous. Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
Prior authorization request nevada medicaid optumrx. Side effects of actemra tocilizumab injection, warnings. Tocilizumab binds to il6 in the body and thereby blocks the effects of il6. Actemra tocilizumab injection for intravenous infusion. Subcutaneous injections for ra actemra tocilizumab. For additional safety information, please see the full prescribing information, including boxed warning. Actemra tocilizumab is indicated for the treatment of giant cell arteritis gca in adult patients. Rituxan immunology and actemra copay card program login. These highlights do not include all the information needed to use actemra safely and effectively. Click ok if you are a health care professional or specialty pharmacy representative. Actemra specialty pharmacy clinical policy bulletins. Roactemra, inntocilizumab european medicines agency europa. Actemra tocilizumab injection is a preservativefree, sterile clear, colorless to pale yellow solution.
Coverage for high cost specialty drugs for rheumatoid arthritis in. Roni shye, pharmd bcgp bcacp, is a licensed pharmacist in the states of florida, ohio, and pennsylvania. Stat noted that actemra can increase cholesterol levels, a known risk factor for pancreatitis. This policy refers only to actemra tocilizumab injection for intravenous infusion for the treatment of rheumatoid. Roactemra 20 mgml concentrate for solution for infusion. For more important safety information, see full prescribing information and medication guide, including serious side effects.
Actemra fep fax form revised 112020 send completed form to. The cost of actemra, as with most prescriptions, greatly depend on the dosage, your health insurance plan and the pharmacy you choose. Tocilizumab actemra is a humanized interleukin6 il6 receptorinhibiting monoclonal antibody that is approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults who have had. Detailed information on this medicinal product is available on the website of the. Actemra may be used alone or in combination with methotrexate.
In one study of tocilizumab, responses were seen in four of. The fda sent an email on june, 2019 about drug safetyrelated labeling changes srlc which alerted us to a revised version of the actemra prescribing information document used in the us. It is recommended that patients use the information presented as a part of a broader decisionmaking process. 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.
Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Highlights of prescribing information these highlights do not include all the information needed to use actemra safely and effectively. Therefore, these drugs are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is. For example, the prescribing information for humira and remicade include warnings for interstitial lung disease. Tell your healthcare provider if you have ever had any type of cancer. See full prescribing information for complete boxed warning.
You may get infections more easily, even serious or fatal infections. A drug list, or formulary, is a list of prescription drugs covered by your plan. 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. Serious infections leading to hospitalization or death including tuberculosis tb, bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving. Actemra medicare coverage and copay details goodrx. Actemra lawsuit information sanders phillips grossman. For more important safety information, see full prescribing information and. Read the entire fda prescribing information for actemra tocilizumab injection. Actemra fda prescribing information, side effects and uses. Tocilizumab actemra is currently listed on the aetna formulary exclusions list. Home blog new report discusses deaths related to actemra.
These forms replace the statement of medical necessity smn and the patient authorization and notice of request for transmission of health information to genentech. Medicare advantage prescription drug plans were more likely to cover. Tocilizumab, also known as atlizumab, is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis ra and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. Relevant identified uses of the substance or mixture and uses advised against. Find valuable actemra tocilizumab information, including an actemra dosing calculator, ra patient brochure, actemra prescription guide and more. Actemra subcutaneous formulation is not intended for. Dose interruptions of tocilizumab for the following laboratory abnormalities are. Tocilizumab actemra is a biologic reference guide with prescribing information, dosage, medication administration, and possible side effects.
Actemra was specially formulated to bind to human interleukin6 il6 receptors and block the. The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. It is a humanized monoclonal antibody against the interleukin6 receptor il6r. Detailed information on this medicinal product is available on the website of the european. This action prevents the interleukin6 which is a natural inflammatory protein from binding to the receptor, thereby reducing the symptoms of rheumatoid arthritis. Rheumatoid arthritis guides and tools actemra tocilizumab. Actemra lawsuit information heart problems, stroke. Specialty pharmacy clinical policy bulletins aetna nonmedicare prescription drug plan. Highlights of prescribing information actemra subcutaneous. 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. Please see below for ways actemra can be used, as well as important side effect information.
Actemra distribution genentech rheumatology access solutions. New report discusses deaths related to actemra goodrx. See what others have said about actemra, including the effectiveness, ease of use and side effects. The information from these initial studies was used to warn doctors about the side effects of using or prescribing.
Antibodies are substances in the body that help the immune system fight disease. Our actemra tocilizumab side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Note that actemra iv is not approved for use in giant cell arteritis gca patients. The all exposure population includes all patients in registration studies who received at least one dose of actemra.
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