NEMLUVIO Powder and solvent for solution for injection Ref.[114712] Active ingredients: Nemolizumab

Treatment with nemolizumab should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of conditions for which nemolizumab is indicated.

Posology

Atopic dermatitis (AD)

The recommended dose is:

• An initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W)
• After 16 weeks of treatment, for patients who achieve clinical response, the recommended maintenance dose is 30 mg every 8 weeks (Q8W)

Nemolizumab 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. Any use of topical therapies should be tapered and subsequently discontinued when the disease has sufficiently improved.

Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis. Some patients with initial partial response may further improve with continued treatment beyond 16 weeks. Once clinical response is achieved, the recommended maintenance dose of nemolizumab is 30 mg every 8 weeks.

Prurigo nodularis (PN)

The recommended dose for patients weighing <90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks (Q4W).

The recommended dose for patients weighing ≥90 kg is an initial dose of 60 mg dose (two 30 mg injections), followed by 60 mg given every 4 weeks (Q4W).

Consideration should be given to discontinuing treatment in patients who have shown no response on pruritus after 16 weeks of treatment for prurigo nodularis.

Missed dose

If a dose is missed, it should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.

Special populations

Elderly (≥65 years)

No dose adjustment is recommended for elderly patients (see section 5.2).

Hepatic and renal impairment

No dose adjustment is needed in patients with hepatic or renal impairment (see section 5.2).

Paediatric population

Atopic dermatitis:

The safety and efficacy of nemolizumab in children less than 12 years of age and body weight <30 kg have not yet been established. No data are available.

Prurigo nodularis:

The safety and efficacy of nemolizumab in children less than 18 years of age have not been established. No data are available.

Method of administration

Subcutaneous use.

The subcutaneous injection should be administered into the front upper thighs or abdomen avoiding the 5 cm area around the navel. Injection into the upper arm should only be performed by a caregiver or healthcare professional.

For subsequent doses, it is recommended to rotate the injection site with each dose. Nemolizumab should not be injected into skin that is tender, inflamed, swollen, damaged or has bruises, scars or open wounds.

Nemolizumab is intended for use under the guidance of a healthcare professional. A patient may self-inject nemolizumab or the patient’s caregiver may administer nemolizumab if their healthcare professional determines that this is appropriate. Prior to first injection, patients and/or caregivers should be given proper training on the preparation and administration of nemolizumab according to the instructions for use at the end of the package leaflet.

There is no specific treatment for nemolizumab overdose. In the event of overdose, the patient should be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment should be instituted immediately.

Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen:

30 months.

Nemluvio 30 mg powder and solvent for solution for injection in pre-filled syringe:

3 years.

Once reconstitution steps are completed, Nemluvio must be used within 4 hours or discarded.

If necessary, the carton containing the pre-filled pen or pre-filled syringe can be removed from the refrigerator and kept at room temperature (up to 25°C) for a single period up to 90 days. The date of removal from the refrigerator shall be recorded in the space provided on the outer carton. Do not use Nemluvio if the expiry date has passed or if left out of the refrigerator for more than 90 days (whichever is earlier).

Store in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original carton in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen:

Single-use dual-chamber borosilicate glass type 1 cartridge in an auto-injector, with a stainless steel staked needle.

Pack size: 1 pre-filled pen, multipack containing 2 (2 packs of 1) pre-filled pens, multipack containing 3 (3 packs of 1) pre-filled pens.

Nemluvio 30 mg powder and solvent for solution for injection in pre-filled syringe:

Single-use dual-chamber pre-filled syringe in a borosilicate glass type 1, co-packaged with a 27G needle (stainless steel) with safety shield.

Pack size: 1 pre-filled syringe

Not all pack sizes may be marketed.

Comprehensive instructions for the administration of Nemluvio in a pre-filled pen or in a pre-filled syringe are given at the end of the package leaflet.

Nemluvio must be removed from the refrigerator for 30-45 min before reconstitution.

Inspect Nemluvio visually prior to reconstitution. Do not use if powder is not white, or if liquid is cloudy, or particulate matter is visible. Prior to administration, check that the solution is clear and colourless to slightly yellow and does not contain particles.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.