Teizeild

Teizeild should be administered by a healthcare professional with access to appropriate medical support to manage potential severe adverse reactions. Laboratory evaluation and vaccination prior to initiation • Prior to initiating Teizeild, a complete blood count and liver enzyme tests should be obtained.

4 for detailed guidance). 4). Additional doses of premedication should be administered if needed. Posology Teizeild should be administered by intravenous infusion (over a minimum of 30 minutes), using a body surface area (BSA)-based dosing, once daily for 14 consecutive days as follows: • Day 1: 65 micrograms/m2 • Day 2: 125 micrograms/m2 • Day 3: 250 micrograms/m2 • Day 4: 500 micrograms/m2 • Days 5 through 14: 1 030 micrograms/m2 Missed dose(s) If a planned Teizeild infusion is missed, dosing should be resumed by administering all remaining doses on consecutive days to complete the 14-day treatment course.

Treatment discontinuation Temporary treatment discontinuation may be required according to the severity of laboratory abnormalities. Based on clinical judgment, treatment should be paused if platelet count, neutrophil count, or haemoglobin level decreases significantly.

Dose interruption should not exceed 3 days. g. if dosing is missed on Days 4 and 5, dosing may restart at Day 6 with the dosing level specified for Day 4). 8. Special populations Elderly Clinical studies did not include elderly patients (65 years of age and older).

2). 2). 2). Paediatric population The safety and efficacy of Teizeild in children younger than 8 years of age have not been established. Method of administration Teizeild should be administered by intravenous infusion over a minimum of 30 minutes.

Two doses should not be administered on the same day. 6 and at the end of the package leaflet.

8. Special populations Elderly Clinical studies did not include elderly patients (65 years of age and older). 2). 2). 2). Paediatric population The safety and efficacy of Teizeild in children younger than 8 years of age have not been established.

Method of administration Teizeild should be administered by intravenous infusion over a minimum of 30 minutes. Two doses should not be administered on the same day. 6 and at the end of the package leaflet. 1. 8). CRS symptoms included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin.

8). 2). • liver enzymes and bilirubin should be monitored during treatment, more frequently within the first week. Treatment should be discontinued in patients who develop elevated ALT or AST more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.

• Symptoms of CRS should be treated with antipyretics, antihistamines and/or antiemetics. If severe CRS develops, temporarily pausing dosing for 1-2 days should be considered (and the remaining doses to complete the full 14-day course should be administered on consecutive days).

If CRS does not improve or if CRS recurs despite the pause, discontinuing treatment may be warranted. 8). Use of Teizeild is not recommended in patients with active serious infection or chronic infection other than localised skin infections.

Patients should be monitored for signs and symptoms of infection during and after treatment. If serious infection develops, appropriate treatment should be provided and Teizeild should be discontinued. Lymphopenia In clinical studies, 75% of patients treated with Teizeild developed lymphopenia.

8). White blood cell counts should be monitored during the treatment period. 8). Hypersensitivity reactions Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in patients treated with Teizeild.

8). CRS symptoms included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. 8). 2). • liver enzymes and bilirubin should be monitored during treatment, more frequently within the first week.

Treatment should be discontinued in patients who develop elevated ALT or AST more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN. • Symptoms of CRS should be treated with antipyretics, antihistamines and/or antiemetics.

If severe CRS develops, temporarily pausing dosing for 1-2 days should be considered (and the remaining doses to complete the full 14-day course should be administered on consecutive days). If CRS does not improve or if CRS recurs despite the pause, discontinuing treatment may be warranted.

8). Use of Teizeild is not recommended in patients with active serious infection or chronic infection other than localised skin infections. Patients should be monitored for signs and symptoms of infection during and after treatment. If serious infection develops, appropriate treatment should be provided and Teizeild should be discontinued.

Lymphopenia In clinical studies, 75% of patients treated with Teizeild developed lymphopenia. 8). White blood cell counts should be monitored during the treatment period. 8). Hypersensitivity reactions Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in patients treated with Teizeild.

8). If severe hypersensitivity reactions occur, Teizeild should be discontinued and treatment should be provided promptly. Vaccinations The safety of immunisation with live-attenuated vaccines in patients treated with Teizeild has not been studied.

Additionally, Teizeild may interfere with the immune response to vaccination and decrease vaccine efficacy. 2). • Inactivated or mRNA vaccinations are not recommended within the 2 weeks prior to treatment, during treatment, or up to 6 weeks after completion of treatment.

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