Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
Ebglyss is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg 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 lebrikizumab is 500 mg (two 250 mg injections) at both week 0 and week 2, followed by 250 mg administered subcutaneously every other week up to week 16.
Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment. Some patients with initial partial response may further improve with continued treatment every other week up to week 24.
Once clinical response is achieved, the recommended maintenance dose of lebrikizumab is 250 mg every fourth week.
Lebrikizumab can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) 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).
No dose adjustment is recommended for patients with renal or hepatic impairment (see section 5.2).
No dose adjustment for body weight is recommended (see section 5.2).
The safety and efficacy of lebrikizumab in children aged 6 months to <12 years or adolescents 12 to 17 years of age and weighing less than 40 kg have not yet been established. No data are available.
Subcutaneous use.
Lebrikizumab is administered by subcutaneous injection into the thigh or abdomen, except for 5 cm around the navel. If somebody else administers the injection, the upper arm can also be used.
For the initial 500 mg dose, two 250 mg injections should be administered consecutively in different injection sites.
It is recommended to rotate the injection site with each injection. Lebrikizumab should not be injected into skin that is tender, damaged or has bruises or scars.
A patient may self-inject lebrikizumab or the patient’s caregiver may administer lebrikizumab if their healthcare professional determines that this is appropriate. Proper training should be provided to patients and/or caregivers on the administration of lebrikizumab prior to use. Detailed instructions for use are included at the end of the package leaflet.
Single intravenous doses up to 10 mg/kg and multiple subcutaneous doses up to 500 mg have been administered to humans in clinical trials without dose-limiting toxicity. There is no specific treatment for lebrikizumab overdose. In the event of overdose, the patient should be monitored for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
Ebglyss 250 mg solution for injection in pre-filled syringe: 3 years.
Ebglyss 250 mg solution for injection in pre-filled pen: 2 years.
After removal from the refrigerator, Ebglyss must be used within 7 days (up to 30°C) or discarded. Once stored out of refrigeration, do not place back in the refrigerator.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
2 mL solution in a 2.25 mL Type-1 clear glass pre-filled syringe with small round flange, with a 27 gauge special thin wall x 12.7 mm stacked stainless steel needle, closed with a laminated bromobutyl elastomeric plunger and a rigid needle shield and assembled in a passive safety device.
Pack sizes:
1 pre-filled syringe
2 pre-filled syringes
multipack containing 3 (3 packs of 1) single-dose pre-filled syringes
multipack containing 4 (2 packs of 2) single-dose pre-filled syringes
multipack containing 5 (5 packs of 1) single-dose pre-filled syringes
multipack containing 6 (3 packs of 2) single-dose pre-filled syringes
2 mL solution in a 2.25 mL Type-1 clear glass syringe in a pre-filled pen with extra-small round flange, with a 27 gauge special thin wall x 8 mm stacked stainless steel needle, and closed with a laminated bromobutyl elastomeric plunger and a rigid needle shield.
Pack sizes:
1 pre-filled pen
2 pre-filled pens
multipack containing 3 (3 packs of 1) single-dose pre-filled pens
multipack containing 4 (2 packs of 2) single-dose pre-filled pens
multipack containing 5 (5 packs of 1) single-dose pre-filled pens
multipack containing 6 (3 packs of 2) single-dose pre-filled pens
Not all pack sizes may be marketed.
Detailed instructions for administration of Ebglyss in a pre-filled syringe or in a pre-filled pen are given at the end of the package leaflet.
The solution should be clear to opalescent, colourless to slightly yellow to slightly brown solution and free from visible particulates. If the solution is cloudy, discoloured or contains visible particulate matter, the solution should not be used.
After removing the 250 mg pre-filled syringe or pre-filled pen from the refrigerator, it should be allowed to reach room temperature by waiting for 45 min before injecting Ebglyss.
The pre-filled syringe or the pre-filled pen should not be exposed to heat or direct sunlight and should not be shaken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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