Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis.
The recommended dose of tralokinumab for adult patients is an initial dose of 600 mg (four 150 mg injections) followed by 300 mg (two 150 mg injections) administered every other week as subcutaneous injection.
At prescriber’s discretion, every fourth week dosing may be considered for patients who achieve clear or almost clear skin after 16 weeks of treatment. The probability of maintaining clear or almost clear skin may be lower with every fourth week dosing (see section 5.1).
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve further with continued treatment every other week beyond 16 weeks.
Tralokinumab can be used with or without topical corticosteroids. The use of topical corticosteroids, when appropriate, may provide an additional effect to the overall efficacy of tralokinumab (see section 5.1). Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.
If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.
No dose adjustment is recommended for elderly patients (see section 5.2). Limited data is available in patients >75 years of age.
No dose adjustment is needed in patients with renal impairment. Very limited data are available in patients with severe renal impairment (see section 5.2).
No dose adjustment is needed in patients with hepatic impairment. Very limited data are available in patients with moderate or severe hepatic impairment (see section 5.2).
For patients with high body weight (>100 kg), who achieve clear or almost clear skin after 16 weeks of treatment, reducing the dosage to every fourth week might not be appropriate (see section 5.2).
The safety and efficacy of tralokinumab in children below the age of 18 years have not yet been established. No data are available.
Subcutaneous use.
The pre-filled syringe should be not shaken. After removing the pre-filled syringes from the refrigerator, they should be allowed to reach room temperature by waiting for 30 minutes before injecting.
Tralokinumab is administered by subcutaneous injection into the thigh or abdomen, except the 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used.
For the initial 600 mg dose, four 150 mg tralokinumab injections should be administered consecutively in different injection sites.
It is recommended to rotate the injection site with each dose. Tralokinumab should not be injected into skin that is tender, damaged or has bruises or scars.
A patient may self-inject tralokinumab or the patient’s caregiver may administer tralokinumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the administration of tralokinumab prior to use. Detailed instructions for use are included at the end of the package leaflet.
There is no specific treatment for tralokinumab overdose. In clinical studies with tralokinumab, single intravenous doses of up to 30 mg/kg and multiple subcutaneous doses of 600 mg every 2 weeks for 12 weeks were found to be well tolerated.
3 years.
If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days, within its shelf-life, without being refrigerated again during this period. Do not store above 25°C. If the carton needs to be removed permanently from refrigerator, the date of removal may be recorded on the carton. After removal from the refrigerator, Adtralza must be used within 14 days or discarded.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
1 mL (150 mg) solution in a siliconised type-1 clear glass pre-filled syringe with 27 gauge ½ inch thin wall stainless steel staked needle, elastomer plunger stopper extended finger flange and needle guard.
Pack size:
Not all pack sizes may be marketed.
The solution should be clear to opalescent, colourless to pale yellow. If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used. Do not use if the pre-filled syringe is damaged or has been dropped on a hard surface.
After removing the pre-filled syringes from the refrigerator, they should be allowed to reach room temperature by waiting for 30 minutes before injecting Adtralza.
Adtralza is sterile. Discard any unused product remaining in the pre-filled syringe.
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