SIMPONI. Solution for Injection in a pre-filled syringe Solution for Injection in a pre-filled pen, SmartJect NEW ZEALAND DATA SHEET

Please download to get full document.

View again

of 16
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
Information Report
Category:

Religion & Spirituality

Published:

Views: 0 | Pages: 16

Extension: PDF | Download: 0

Share
Related documents
Description
SIMPONI Solution for Injection in a pre-filled syringe Solution for Injection in a pre-filled pen, SmartJect NEW ZEALAND DATA SHEET 1. PRODUCT NAME SIMPONI 50 mg Solution for Injection in a pre-filled
Transcript
SIMPONI Solution for Injection in a pre-filled syringe Solution for Injection in a pre-filled pen, SmartJect NEW ZEALAND DATA SHEET 1. PRODUCT NAME SIMPONI 50 mg Solution for Injection in a pre-filled syringe SIMPONI 50 mg Solution for Injection in a pre-filled pen, SmartJect SIMPONI 100 mg Solution for Injection in a pre-filled syringe SIMPONI 100 mg Solution for Injection in a pre-filled pen, SmartJect 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 ml single-use pre-filled syringe or pre-filled pen contains 50 mg of golimumab*. Each 1.0mL single-use pre-filled syringe or pre-filled pen contains 100mg of golimumab*. * Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology. Excipient(s) with known effect: Each pre-filled pen contains 20.5 mg sorbitol per 50 mg dose or 41 mg sorbitol per 100 mg dose. Each pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose or 41 mg sorbitol per 100 mg dose. For the full list of excipients, see section PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (injection), SmartJect The solution is clear to slightly opalescent, colourless to light yellow. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Rheumatoid arthritis (RA) SIMPONI, in combination with methotrexate (MTX), is indicated for: the treatment of active rheumatoid arthritis in adult patients when the response to DMARD therapy has been inadequate. the treatment of active rheumatoid arthritis in adult patients not previously treated with MTX. SIMPONI(171010)ADS Page 1 of 32 CCDS170630 SIMPONI has also been shown to reduce the rate of progression of joint damage as measured by X-ray, improve physical function and health related quality of life. SIMPONI can be used in patients previously treated with one or more TNF inhibitor(s). Psoriatic arthritis (PsA) SIMPONI, alone or in combination with MTX, is indicated for: The treatment of active psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has also been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray, improve physical function and health related quality of life. Ankylosing spondylitis (AS) SIMPONI is indicated for: The treatment of active ankylosing spondylitis in adult patients. SIMPONI has also been shown to improve physical function and health related quality of life. Ulcerative colitis (UC) SIMPONI is indicated for: The treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA) or who are intolerant to or have medical contraindications for such therapies. 4.2 Dose and method of administration SIMPONI treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or ulcerative colitis. After proper training in SC injection technique, patients may self-inject with SIMPONI if their physician determines that this is appropriate, with medical follow-up as necessary. Rheumatoid arthritis SIMPONI 50 mg given as a subcutaneous injection once a month, on the same date each month. Psoriatic arthritis SIMPONI 50 mg given as a subcutaneous injection once a month, on the same date each month. Ankylosing spondylitis SIMPONI 50 mg given as a subcutaneous injection once a month, on the same date each month. Ulcerative colitis SIMPONI 200 mg given as a subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 100 mg every 4 weeks, thereafter. During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. Available data suggest that clinical response is usually achieved within weeks of treatment (after 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period. SIMPONI(171010)ADS Page 2 of 32 CCDS170630 Special populations Elderly patients ( 65 years) No dosage adjustment is required in the elderly. Paediatric patients ( 18 years) SIMPONI is not recommended for use in children below age 18 due to a lack of data on efficacy and safety. Patients with impaired renal and/or hepatic function SIMPONI has not been studied in these patient populations. No dose recommendations can be made. 4.3 Contraindications Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4). Concurrent administration of SIMPONI with anakinra or abatacept (see section 4.4). Moderate or severe heart failure (NYHA class III/IV) (see section 4.4). Hypersensitivity to the active substance or to any of the excipients (see section 6.1). 4.4 Special warnings and precautions for use Infections Serious and sometimes fatal infections due to bacterial (including sepsis and pneumonia), mycobacterial, invasive fungal, viral, protozoal or other opportunistic pathogens have been reported in patients receiving TNF blocking agents, including SIMPONI. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most commonly reported with TNF-blockers. Patients have frequently presented with disseminated rather than localised disease, and were often taking concomitant immunosuppressants such as methotrexate (MTX) or corticosteroids. The concomitant use of a TNF-blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore, the concomitant use of SIMPONI and these biologic products is not recommended (see sections 4.3 and 4.5). Treatment with SIMPONI should not be initiated in patients with an active infection, including clinically important localised infections. The risks and benefits of treatment should be considered prior to initiating or continuing SIMPONI in patients: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have resided in or travelled to areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, or with underlying conditions that may predispose them to infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with SIMPONI. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. SIMPONI should be discontinued if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with SIMPONI should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored. SIMPONI(171010)ADS Page 3 of 32 CCDS170630 Invasive Fungal Infections For SIMPONI-treated patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy. Tuberculosis Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF-blockers, including SIMPONI. In addition, patients who have previously received treatment for latent or active tuberculosis have developed tuberculosis while receiving TNF-blockers, including SIMPONI. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be evaluated for tuberculosis risk factors (including close contact with a person with active tuberculosis) and tested for latent infection prior to initiating SIMPONI and periodically during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with SIMPONI. Anti-tuberculosis therapy should be considered prior to initiation of SIMPONI in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Tests for latent tuberculosis may yield false negative results, especially in patients who are immunocompromised or severely ill. Prior to initiating SIMPONI, treatment for latent tuberculosis should be considered in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis. The decision to initiate anti-tuberculosis therapy in these patients should only be made following consultation with a physician with expertise in the treatment of tuberculosis and taking into account both the risk for latent tuberculosis infection and the risks of anti-tuberculosis therapy. Cases of active tuberculosis have occurred in patients treated with SIMPONI during and after treatment for latent tuberculosis. Patients receiving SIMPONI should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infections. Tuberculosis should be strongly considered in patients who develop a new infection during SIMPONI treatment, especially in patients who have previously or recently travelled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis. In the controlled and uncontrolled portions of the Phase 2 RA and Phase 3 RA, PsA, and AS trials, the incidence of active tuberculosis was 0.23 and 0 per 100 patient-years in 2347 SIMPONI-treated patients and 674 placebo-treated patients, respectively. Cases of tuberculosis included pulmonary and extra pulmonary tuberculosis. The overwhelming majority of the tuberculosis cases occurred in countries with a high incidence rate of tuberculosis. Hepatitis B virus reactivation The use of TNF blockers including SIMPONI has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive). Patients should be tested for HBV infection before initiating treatment with immunosuppressants, including SIMPONI. For patients who test positive for hepatitis B surface antigen, consultation with a physician with expertise in the treatment of hepatitis B is recommended. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants. SIMPONI(171010)ADS Page 4 of 32 CCDS170630 Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. The risks and benefits of treatment should be considered prior to prescribing TNF-blockers, including SIMPONI, to patients who are carriers of HBV. Adequate data are not available on whether anti-viral therapy can reduce the risk of HBV reactivation in HBV carriers who are treated with TNF-blockers. Patients who are carriers of HBV and require treatment with TNF-blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, TNF-blockers should be stopped and antiviral therapy with appropriate supportive treatment should be initiated. The safety of resuming TNFblockers after HBV reactivation has been controlled is not known. Therefore, physicians should exercise caution when considering resumption of TNF-blockers in this situation and monitor patients closely. Malignancies The potential role of TNF-blocking therapy in the development of malignancies is not known. Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. Paediatric Malignancy Post-marketing cases of malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) who received TNF-blocking agents (initiation of therapy 18 years of age) to treat Juvenile Idiopathic Arthritis (JIA), Crohn s disease or other conditions. Approximately half the reports were lymphomas (Hodgkin s and non-hodgkin s lymphoma). The other cases represented a variety of different malignancies and included malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants, such as methotrexate, azathioprine or 6-mercaptopurine. The role of TNF blockers in the development of malignancies in children and adolescents remains unclear. Lymphoma In the controlled portions of clinical trials of all the TNF-blocking agents including SIMPONI, more cases of lymphoma have been observed among patients receiving anti-tnf treatment compared with control patients. During the SIMPONI Phase 2 and Phase 3 clinical trials in RA, PsA and AS, the incidence of lymphoma in SIMPONI-treated patients was higher than expected in the general population. Patients with rheumatoid arthritis and other chronic inflammatory diseases, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF-blocking therapy. Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Nearly all of these cases have occurred in patients with Crohn s disease or ulcerative colitis. The majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine (AZA) or 6- mercaptopurine (6 MP) concomitantly with a TNF-blocker at or prior to diagnosis. The potential risk with the combination of AZA or 6-MP and SIMPONI should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded. Leukaemia Cases of acute and chronic leukaemia have been reported with TNF-blocker use, including SIMPONI, in rheumatoid arthritis and other indications. Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukaemia. SIMPONI(171010)ADS Page 5 of 32 CCDS170630 Malignancies other than lymphoma In the controlled portions of the SIMPONI Phase 2 and Phase 3 clinical trials in RA, PsA, AS and UC, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the SIMPONI and the control groups. In an exploratory clinical trial evaluating the use of SIMPONI in patients with severe persistent asthma, more malignancies were reported in patients treated with SIMPONI compared with control patients (see section 4.8). The significance of this finding is unknown. In an exploratory clinical trial evaluating the use of another anti-tnf agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. All patients had a history of heavy smoking. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking. Colon Dysplasia/Carcinoma It is not known if SIMPONI treatment influences the risk of developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. In patients with newly diagnosed dysplasia treated with SIMPONI, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued. Skin cancers Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocking agents, including SIMPONI (see section 4.8). Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Congestive Heart Failure Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including SIMPONI. Some cases had a fatal outcome. Cases of CHF in patients with known cardiovascular risk factors have been observed with SIMPONI. In several exploratory trials of other TNF-blockers in the treatment of CHF, there were greater proportions of TNF-blocker treated patients who had CHF exacerbations requiring hospitalisation or increased mortality. SIMPONI has not been studied in patients with a history of CHF And SIMPONI should be used with caution in patients with CHF. If a decision is made to administer SIMPONI to patients with CHF, these patients should be closely monitored during therapy, and SIMPONI should be discontinued if new or worsening symptoms of CHF appear. Demyelinating disorders Use of TNF blocking agents, including SIMPONI, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis (MS) and peripheral demyelinating disorders, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of TNF-blockers, including SIMPONI, in patients with central or peripheral nervous system demyelinating disorders. Discontinuation of SIMPONI should be considered if these disorders develop. In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-tnf treatment should be carefully considered before initiation of SIMPONI therapy. SIMPONI(171010)ADS Page 6 of 32 CCDS170630 Autoimmunity Treatment with SIMPONI may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms of a lupus-like syndrome following treatment with golimumab, treatment should be discontinued (see section Antinuclear antibodies (ANA)/anti-double-stranded DNA (dsdna) antibodies). Haematological cytopaenias There have been post-marketing reports of pancytopaenia, leukopaenia, neutropaenia, agranulocytosis, aplastic anaemia, and thrombocytopaenia in patients receiving TNFblockers. Cytopaenias including pancytopaenia, have been infrequently reported with SIMPONI in clinical trials. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor). Discontinuation of SIMPONI therapy should be considered in patients with confirmed significant haematological abnormalities. Concurrent admini
Recommended
View more...
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks
SAVE OUR EARTH

We need your sign to support Project to invent "SMART AND CONTROLLABLE REFLECTIVE BALLOONS" to cover the Sun and Save Our Earth.

More details...

Sign Now!

We are very appreciated for your Prompt Action!

x