Cyltezo

Cyltezo treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cyltezo is indicated. 4). Patients treated with Cyltezo should be given the patient alert card.

After proper training in injection technique, patients may self-inject with Cyltezo if their physician determines that it is appropriate and with medical follow-up as necessary. , corticosteroids and/or immunomodulatory agents) should be optimised.

Posology Rheumatoid arthritis The recommended dose of Cyltezo 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 Cyltezo.

Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Cyltezo. 1. In monotherapy, some patients who experience a decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.

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. Medicinal product no longer authorised 5 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 Cyltezo 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 Cyltezo 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.

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 Cyltezo 40 mg every other week may benefit from an increase in dosage 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 dosage may subsequently be reduced to 40 mg every other week. Hidradenitis suppurativa The recommended Cyltezo 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 Cyltezo 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 Cyltezo.

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 Cyltezo 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), 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 Cyltezo and signs and symptoms of disease recur, Cyltezo may be re- administered. Medicinal product no longer authorised 6 During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Some patients who experience decrease in their response to Cyltezo 40 mg every other week may benefit from an increase in dosage to 40 mg Cyltezo 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 Cyltezo induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given […]

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.

Serious adverse reactions have been reported for adalimumab. TNF-antagonists, such as adalimumab 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 postmarketing experience.

They are displayed by system organ class and frequency in Table 6 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The highest frequency seen among the various indications has been included. g. optic neuritis, Guillain-Barré syndrome)1) Eye disorders Common Uncommon Visual impairment, conjunctivitis, blepharitis, eye swelling DiplopiaMedicinal product no longer authorised 19 System Organ Class Frequency Adverse Reaction Ear and labyrinth disorders Common Uncommon Vertigo Deafness, tinnitus Cardiac disorders* Common Uncommon Rare Tachycardia Myocardial infarction1), arrhythmia, congestive heart failure Cardiac arrest Vascular disorders Common Uncommon Hypertension, flushing, haematoma Aortic aneurysm, vascular arterial occlusion, thrombophlebitis Respiratory, thoracic and mediastinal disorders* Common Uncommon Rare Asthma, dyspnoea, cough Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1) […]

Traceability In order to improve 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 Cyltezo. Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.

Treatment with Cyltezo 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 Cyltezo should be considered prior to initiating therapy (see Other opportunistic infections).

Patients who develop a new infection while undergoing treatment with Cyltezo should be monitored closely and undergo a complete diagnostic evaluation. Administration of Cyltezo 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 Cyltezo 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.

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 Cyltezo, 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 alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.

3). Medicinal product no longer authorised 11 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 Cyltezo, and in accordance with local recommendations.

Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Cyltezo 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.

, persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Cyltezo. 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 Cyltezo 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 Cyltezo. 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 Cyltezo should be closely monitored for signs and symptoms of active HBV infection […]

4). 4).