The treatment options presented in the tables below have been deemed to be appropriate by clinical experts for the treatment of patients with sjia. Highlights of prescribing information these highlights do not include all the information needed to use kevzara safely and effectively. Do not administer canakinumab to members with active tb infection. Policy history date action september 2011 annual editorial and reference update september 2012 annual editorial and reference update june 20 annual editorial and reference update a new fda indication was approved for active systemic juvenile. The recommended starting dose of ilaris for caps patients is.
Highlights of prescribing information vosevi is not. Highlights of prescribing information these highlights do not. Chronic inflammation is associated with an increased risk of several diseases, including cancer. Erbitux can cause serious and fatal infusion reactions. Lachmann, hj, konepaut, i, kuemmerledeschner, jb, et al.
Department of biotechnology, bharthidasan university, tn, india. Medical necessity criteria page 48 indication dose systemic juvenile idiopathic arthritis weight is greater than or equal to 7. Ilaris canakinumab rationale for inclusion in pa program. Ilaris canakinumab dosing, indications, interactions. Dec 18, 2018 ilaris canakinumab for subcutaneous injection.
The formation of cyp450 enzymes may be altered by increased concentrations of cytokines during chronic inflammation. To evaluate the safety of canakinumab treatment in patients with the schnitzler syndrome. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. Ilaris canakinumab prior auth criteria proprietary information.
Applies to all blue shield of california medicare part d plans diagnoses considered for coverage. In the study, 85 of 109 canakinumabnaive patients 78%. What is the most important information i should know about ilaris. Comparators are not restricted to drugs, but may be devices or procedures. Highlights of prescribing information these highlights do not include all the information needed to use dupixent safely and effectively. Product titles in highlights of prescribing information. Restricted access do not disseminate or copy without approval. Added that continued therapy may be approved despite inadequate response if request is for a dose increase. Do not start, stop, or change the dose of any drug without checking with your doctor.
Medicare part d coverage criteria ilaris canakinumab plan limitations. Added examples of positive response for all indications. Ilaris canakinumab for injection, for subcutaneous use fda. Medicare part d coverage criteria ilaris canakinumab. This leaflet is part iii of a threepart product monograph published. If there is latent disease, tb treatment must be started before initiation of treatment. It is expressed in a murine sp20ag14 cell line and comprised of two 447or 448 residue heavy chains and two 214residue light chains, with a molecular mass. Ilaris is supplied in a sterile, singleuse, colorless, 6 ml glass vial containing 150 of canakinumab as a white, preservativefree, lyophilized powder. Vectibix solution is colorless and may contain a small amount of visible translucenttowhite, amorphous, proteinaceous particles. Aminophylline injection aminophylline dihydrate dose. Please see full prescribing information, including serious side effects, and the medication guide. Novartis faces an uphill battle turning niche drug. Canakinumab page 4 of 7 a severe autoinflammatory disease, driven by innate immunity by means of proinflammatory cytokines such as interleukin 1. Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
Ilaris package insert fdaapproved indication and dosage. Product titles in highlights of prescribing information consistent with requirements under 21 cfr 201. Ilaris can lower the ability of your immune system to fight infections. Dailymed ilaris canakinumab injection, powder, lyophilized. Novartis canakinumab acz885 reduced cardiovascular risk by 25% in subgroup of cantos phase iii trial participants nov, 2017 subgroup of patients had a 25% reduction in major adverse cardiovascular events when treated with canakinumab in a new analysis of phase iii cantos trial presented at the american heart association scientific sessions. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Updated formulation section in background to 150 mg powder vs 180 mg powder, and modified to be more. Manual guidelines prior authorization will be required for all current and future dose forms available. All fdaapproved indications not otherwise excluded from part d coverage criteria. These highlights do not include all the information needed to use ilaris safely and effectively. Ilaris canakinumab injection, powder, lyophilized, for solution ilaris canakinumab injection, solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they will be specified as such.
The indications below including fdaapproved indications and compendial uses are. Ilaris canakinumab injection, powder, lyophilized, for solution ilaris canakinumab injection, solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they. Jul 21, 2019 ancobon prescribing information pdf package insert flucytosine ancobon is a the appropriate approved prescribing information should be consulted. Novartis canakinumab acz885 reduced cardiovascular risk by. Ilaris canakinumab injection for subcutaneous use initial u. Read below for details on accessing ilaris, information about copay assistance, and to learn about the ilaris home health nurse service. Ilaris is used to treat familial mediterranean fever fmf in adult and.
Added approval criteria for tumor necrosis factor receptor associated periodic syndrome, hyperimmunoglobulin d syndromemevalonate kinase deficiency, and familial mediterranean fever per updated package labeling. The ilaris support program offers a full range of services to assist in managing ilaris therapy. Novartis pharmaceuticals corporation, december 2016. Nov 22, 2010 to evaluate if canakinumab 300mg every 8 weeks can maintain clinical remission in those patients who required canakinumab 150 mg additional dose on day 7 and achieved clinical remission at day 14. Draft pa criteria page 1 of 5 initial approval date. Ilaris canakinumab for injection, for subcutaneous use ilaris canakinumab injection, for subcutaneous use initial u.
For nonus residents full prescribing information patient medication. Cryopyrinassociated periodic syndromes caps in patients 4 years of age and older, including. Ilaris canakinumab is covered under the medical benefit when used within the following guidelines. Capsule, mg edl solution for injection, g in ml edl. Highlights of prescribing information these highlights do not include all the information needed to use zinplavasafely and effectively. Moderate if canakinumab is initiated or discontinued in a patient taking aminophylline, monitor theophylline concentrations. Do not administer vectibix as an intravenous push or bolus. The active substance in ilaris, canakinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a messenger molecule or cytokine in the body called interleukin. Patients should be informed of the signs and symptoms of allergic and other adverse drug. A complex tumor microenvironment created and maintained by a range of cell types promotes tumor growth, angiogenesis, and metastasis.
Ilaris canakinumab is a prescription medicine injected by your healthcare provider just below the skin subcutaneous used to treat. Xgeva includes the same active ingredient denosumab found in prolia. Tell all of your health care providers that you take canakinumab. What are some things i need to know or do while i take canakinumab. The 2012 american college of rheumatology acr guidelines for the management of gout indicate that an interleukin1 il1 inhibitor such as anakinra 100 mg subcutaneously daily for 3 consecutive days or canakinumab 150 mg subcutaneously is an option for severe acute gouty arthritis attacks that are refractory to other medications. Dec 23, 2019 you must check to make sure that it is safe for you to take canakinumab with all of your drugs and health problems. Ilaris canakinumab for injection, for subcutaneous use. Canakinumab is also in phase i clinical trials as a possible treatment for chronic obstructive pulmonary disease, gout, and coronary artery disease the cantos trial. Lachmann hj, konepaut i, kuemmerledeschner jb, et al. Canakinumab reduces incidents of lung cancer and associated. Comparators may be recommended appropriate practice, versus actual practice.
Existing product reimbursement agreements are not reflected in the table and as such may not. Ilaris is indicated for the treatment of active systemic juvenile idiopathic arthritis sjia in patients aged 2 years and older. Highlights of prescribing information these highlights do. Benefit policy manual, chapter 15, 50 drugs and biologicals. Sep 14, 2019 cryopyrinassociated periodic syndromes caps the recommended dose of ilaris is 150 mg for caps patients with body weight greater than 40 kg. Ilaris is indicated for the treatment of familial mediterranean fever fmf. For caps patients with body weight greater than or equal to 15 kg and less than or equal to 40 kg, the recommended dose is 2 mgkg. Review article current pediatric research 2017 volume 21, issue 4. Physician package insert kineret anakinra page 6 of 11 amgen thousand oaks insert provides information about the product and its use, it is not intended to take the place of regular discussions between the patient and healthcare provider.
Highlights of prescribing information these highlights do not include all the information needed to use ilaris safely and effectively. If a treating physician disagrees with hmsacvss determination as to medical necessity in a given case, the physician may request that hmsa reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. This messenger is involved in causing inflammation and is found in high levels in patients with periodic fever syndromes, still. This messenger is involved in causing inflammation and is found in high levels in patients with periodic fever syndromes, stills disease and gouty arthritis. Excluded from part d if meets coverage criteria under part b. Kineret is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis ra, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs dmards. Canakinumab was being developed by novartis for the treatment of rheumatoid arthritis, but this trial was completed in october 2009. Any unused product or waste material should be disposed of in accordance with local requirements. Inflammasomes, multicomplex cytosolic proteins, generate much of this inflammation, including the activation of the cytokine interleukin il1 inflammation. October 9, 2019 criteria for prior authorization adult rheumatoid arthritis agents billing code type for drug coverage and provider type information, see the kmap reference codes webpage. Familial cold autoinflammatory syndrome fcas mucklewells syndrome mws. Use of canakinumab in the cryopyrinassociated periodic syndrome. Highlights of prescribing information zinplavasafely and.
Ilaris canakinumab commercial medical benefit drug policy. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. Prior authorization criteria ilaris canakinumab note. Preparation visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Composition and packaging section of the product monograph. Highlights of prescribing information these highlights do not include all the information needed to use orencia safely and effectively. Prior authorization protocol arcalyst rilonacept, ilaris. Creactive protein crp, serum amyloid a saa levels, disease activity, andor skin rash were used to assess response to therapy.
Highlights of prescribing information an initial dose. Medication guide ilaris ilahrus canakinumab for injection, for subcutaneous use injection, for subcutaneous use what is the most important information i should know about ilaris. The european medicines agency decided that kinerets benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone. Ilaris canakinumab in the schnitzler syndrome full text.
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