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Amgevita is a brand name for Adalimumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis AMGEVITA in combination with methotrexate, is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate. • the treatment of severe, active and…
Verbatim from this product's EMA label. Tap a section to expand.
AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated. 4). Patients treated with AMGEVITA should be given the Patient Reminder Card.
After proper training in injection technique, patients may self-inject with AMGEVITA if their physician determines that it is appropriate and with medical follow-up as necessary. g. corticosteroids and/or immunomodulatory agents) should be optimised.
Posology Rheumatoid arthritis The recommended dose of AMGEVITA for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with AMGEVITA.
5 Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA. 1. In monotherapy, some patients who experience a decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg adalimumab every week or 80 mg every other week.
Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. Dose interruption There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption. Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis The recommended dose of AMGEVITA for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period. Psoriasis The recommended dose of AMGEVITA for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Summary of the safety profile Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more. These trials included rheumatoid arthritis patients with short term and long- standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis- related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period. 4% for control treated patients. The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
17 Serious adverse reactions have been reported for adalimumab. TNF-antagonists, such as AMGEVITA affect the immune system and their use may affect the body’s defence against infection and cancer. Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Paediatric population In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials and on post- marketing experience and are displayed by system organ class and frequency in table 7 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients taking TNF-antagonists are more susceptible to serious infections.
Impaired lung function may increase the risk for developing infections. Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with AMGEVITA. Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.
Treatment with AMGEVITA should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with AMGEVITA should be considered prior to initiating therapy (see Other opportunistic infections).
11 Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation. Administration of AMGEVITA should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Physicians should exercise caution when considering the use of AMGEVITA in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Serious infections Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
1. 4). 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period. Beyond 16 weeks, patients with inadequate response to AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg every week or 80 mg every other week.
1). If adequate response is achieved with 40 mg every week or 80 mg every other week, the dose may subsequently be reduced to 40 mg every other week. Hidradenitis suppurativa The recommended AMGEVITA dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Two weeks later (day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day). Antibiotics may be continued during treatment with AMGEVITA if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with AMGEVITA.
6 Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. 1). 1). Crohn’s disease The recommended AMGEVITA induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 80 mg at week 0 followed by 40 mg at week 2.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped AMGEVITA and signs and symptoms of disease recur, AMGEVITA may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. Some patients who experience decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg AMGEVITA every week or 80 mg every other week.
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12. Continued therapy should be carefully reconsidered in a patient not responding within this time period. Ulcerative colitis The recommended AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day […]
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The highest frequency seen among the various indications has been included. 8. Table 7. g. optic neuritis, Guillain-Barré syndrome)1) Eye disorders Common Visual impairment, Conjunctivitis, Blepharitis, Eye swelling Uncommon Diplopia Ear and labyrinth disorders Common Vertigo Uncommon Deafness, Tinnitus 19 System organ class Frequency Adverse reaction Cardiac disorders* Common Tachycardia Uncommon Myocardial infarction1), Arrhythmia, Congestive heart failure Rare Cardiac arrest Vascular disorders Common Hypertension, Flushing, Haematoma Uncommon Aortic aneurysm, Vascular arterial occlusion, Thrombophlebitis Respiratory, thoracic and mediastinal disorders* Common Asthma, Dyspnoea, Cough Uncommon Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis, Pleural effusion1) Rare Pulmonary fibrosis1) Gastrointestinal disorders Very common Abdominal pain, Nausea and vomiting […]
Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported. Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
e. disseminated) tuberculosis. Before initiation of therapy with AMGEVITA, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy.
e. tuberculin skin test and chest x-ray) should be performed in all patients (local recommendations may apply). It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
3). In all situations described below, the benefit/risk balance of therapy should be very carefully considered. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of AMGEVITA, and in accordance with local recommendations.
Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of AMGEVITA in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with AMGEVITA. 12 Other opportunistic infections Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
These infections have not consistently been recognised in patients taking TNF- antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes. For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of AMGEVITA should be promptly discontinued.
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections. e. surface antigen positive). Some cases have had a fatal outcome.
Patients should be tested for HBV infection before initiating treatment with AMGEVITA. For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Carriers of HBV who require treatment with AMGEVITA should be closely monitored for signs and symptoms of active HBV infection throughout […]