Simponi golimumab clinical trials information for hcps. Medication guide simponi simponee golimumab injection, for subcutaneous use what is the most important information i should know about simponi. Serious infections leading to hospitalization or death including tuberculosis tb, bacterial sepsis, invasive fungal such as histoplasmosis, and other opportunistic infections have occurred in patients receiving simponi aria 5. Rheumatologist benefits investigation and prescription form. Simponi golimumab injection, solution for subcutaneous use. Medication policies are developed to help ensure safe, effective and appropriate use of selected. Highlights of prescribing information these highlights do not. Highlights of prescribing information these highlights do not include all the information needed to use simponi golimumab safely and effectively. Simponi aria simponee ahreeuh golimumab injection, for intravenous use what is the most important information i should know about simponi aria. Janssen link enables eligible patients to receive simponi at no cost until they receive coverage. Please read the full prescribing information and medication guide for simponi aria and discuss any questions you have with your.
Simponi treatment andor other types of biologic and nonbiologic treatments. Monitor all patients for active tb during treatment, even if initial. Simponi uses a histidine buffer, which allows for a formulation ph of approximately 5. I authorize janssen carepath to act on my behalf for the limited purposes of transmitting this prescription to the appropriate pharmacy designated by me, the patient, or the patients plan. Simponi golimumab rheumatoid arthritis health information. Simponi golimumab risk evaluation and mitigation strategy rems. Simponi is administered by 50mg subcutaneous sc injection once a month.
See program requirements below and on previous page. The relationship between these in vitro findings and clinical safety and efficacy has not been established. Highlights of prescribing information mesalamineinduced. See full prescribing information for complete boxed warning. Adverse reactions reported in at least 2% of patients taking otezla, that occurred at a frequency at least 1% higher than that observed in. The prescribing information included here may not be appropriate for use outside the united states and its territories. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis tb and histoplasmosis. Simponi aria can lower the ability of your immune system to fight infections. In the phase 23 trials in uc evaluating simponi treated patients, no new adverse drug reactions were identified, and the frequency of adverse drug reactions was similar to the safety profile observed in patients with ra, psa, and as. In addition to presenting an overview of ra, psa, and as, this clinical monograph for simponi aria includes clinical trial information, the recommended dosage and administration, efficacy and safety, and information about the distribution network for simponi aria. Otezla dosage should be reduced in patients with severe renal impairment creatinine clearance less than 30 mlmin. These highlights do not include all the information needed to use kevzara safely and effectively. Please see the full prescribing information and medication guide for simponi aria.
Golimumab simponi, simponi aria is a tumor necrosis tnf. These highlights do not include all the information needed to use mavenclad safely and effectively. Simponi aria official prescribing information for healthcare professionals. Serious infections leading to hospitalization or death including tuberculosis. Benlysta belimumab for injection, for intravenous use. Sep 30, 2019 see full prescribing information for complete boxed warning.
Asacol hd mesalamine delayedrelease tablets, for oral use. Simponi aria fda prescribing information, side effects. There has been a therapeutic failureinadequate response with methotrexate alone, or b. We will give you information on your insurance coverage, potential outofpocket costs, and treatment support, and identify options that may help make your treatment more affordable. Simponi is a medicine that affects your immune system. These highlights do not include all the information needed to use humira safely and effectively. Risk of serious infections see full prescribing information for complete boxed warning. Golimumab binds to both soluble and transmembrane bioactive forms of tnf.
Moderately to severely active rheumatoid arthritis when. Based on the information in this report, no specific safety concerns in patients with ra, psa, or as treated with simponi relativ e to those patients treated with a nonbiologic medication were noted. For detailed information on lupron depot, click on a link below. Simponi patient support janssen carepath for simponi. Remeron mirtazapine tablets, for oral use remeronsoltab mirtazapine orally disintegrating tablets initial u. Simponi aria fda prescribing information, side effects and uses. Highlights of prescribing information these highlights do not include all the information needed to use simponi safely and effectively. Simponi, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis. Boxed warning, serious infections 9201 i dosage and. Download prescribing information pi for otezla otezla.
Simponi induction dosage regimen is 200mg sc injection at week 0, followed by 100 mg at week 2, and then 100 mg maintenance therapy every 4 weeks. Humira adalimumab injection, for subcutaneous use initial u. Rheumatologist benefits investigation and prescription. Please see the full prescribing information and medication guide for simponi. Patients treated with simponi are at increased risk for developing serious infections that. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The most common side effects of simponi aria include. See fiiii prescribing information for complete boxed warning. They offer a guide to coverage and are not intended to dictate to providers how to. Medication policies are developed to help ensure safe, effective and appropriate use of selected medications.
Simponi is used to treat moderately to severely active rheumatoid arthritis ra in adults, in combination with methotrexate. These highlights do not include all the information needed to use asacol hd safely and effectively. Full prescribing information 1 indications and usage avonex is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Simponi aria is a medicine that affects your immune system. The simponi aria dosage regimen is 2 mg per kg given as an intravenous infusion over 30. Serious infections and malignancies 1 indications and usage 1. See full prescribing information for complete boxed warning serious infections leading to hospitalization or death. Serious infections leading to hospitalization or death including tuberculosis tb, bacterial sepsis, invasive fungal such as histoplasmosis, and other opportunistic infections have occurred in patients receiving simponi 5.
Kevzara sarilumab injection, for subcutaneous use initial u. Enbrel etanercept for subcutaneous injection prescribing information. Simponi is a human immunoglobulin g1 igg1 monoclonal antibody manufactured by janssen biotech, inc. Highlights of prescribing information these highlights do not include all the information needed to use remeronremeronsoltab safely and effectively. Official consumer website for remicade infliximab remicade. Orencia abatacept lyophilized powder for intravenous infusion prescribing information. There is insufficient information regarding the concomitant use of golimumab with. Golimumab simponi, simponi aria arizona complete health. Provide the medication guide to your patients and encourage. Simponi aria golimumab patient site homepage simponi. These highlights do not include all the information needed to use benlysta safely and effectively. Benlysta belimumab injection, for subcutaneous use initial u.
Patients were randomised to receive placebon150, simponi 50 mg n147, or simponi 100 mg n148. Patient medication guide full prescribing information dosing. Medicinal product subject to restricted medical prescription see annex i. Simponi can lower your ability to fight infections. Product information for auspar simponi golimumab rmc janssencilag pm20021511 date of finalisation 19 may 2014. In the controlled phase of trial ra, the rate of infusions associated with an infusion reaction was reported in 1. Simponi should be discontinued if a patient develops a. Once you and your doctor have decided that simponi is right for you, janssen carepath will help you find the resources you may need to get started and stay on track. This information is intended for the use of patients and caregivers in the united states and puerto rico only.
Results of the current safety evaluation are consistent with reports of. When golimumab simponi aria is covered golimumab simponi aria may be medically necessary for treatment of adult patients with. Simponi aria golimumab patient site homepage simponi aria. Updated references to include simponi prescribing information. Simponi can lower the ability of your immune system to fight infections. Prescription information if requesting benefits investigation only.
Medication guide simponi aria simponee ahreeuh golimumab injection, for intravenous use what is the most important information i should know about simponi aria. Simponi aria golimumab injection, for intravenous use. Serious infections and malignancy see full prescribing information for complete boxed warning. For patients with rheumatoid arthritis ra, simponi should be given in combination with methotrexate and for patients with psoriatic arthritis psa or ankylosing spondylitis as. The prescribing information included here may not be appropriate for use outside the united states and puerto rico. By providing your information and information about your patient on this form, you are requesting the services described on this form. Golimumab is an antibody with humanderived antibody variable and constant regions. See full prescribing information for remeronremeronsoltab. Serious infections leading to hospitalization or death including tuberculosis tb, bacterial sepsis, invasive fungal such as histoplasmosis, and other opportunistic infections have occurred in patients receiving simponi aria. Simponi aria, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. This product information was approved at the time this auspar was published. Simponi golimumab injection, for subcutaneous use initial u. Simponi, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
1460 392 689 727 355 1393 1011 1459 750 584 119 1054 697 1070 760 435 800 1062 1299 640 123 102 1078 1486 20 780 615 1437 272 1490 924 424 1406 1293 504 973 891 255 347 1347 1281