NEMLUVIO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN 30MG [SIN17206P]

Product Info

NEMLUVIO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN 30MG

[SIN17206P]

Indication

4.1 Therapeutic indications

Atopic dermatitis (AD)

Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in adult and adolescent patients ≥ 12 years old with body weight of at least 30 kg, who are inadequately controlled by topical therapies and are candidates for systemic therapy.

Prurigo nodularis (PN)

Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Dosing

4.2 Posology and method of administration

Posology

Atopic dermatitis (AD)

The recommended dosage of Nemluvio 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 of Nemluvio is 30 mg every 8 weeks (Q8W).

Concomitant Topical Therapies:

Use Nemluvio with TCS and/or TCI. TCI 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.

Prurigo nodularis (PN)

The recommended dose of Nemluvio 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 of Nemluvio 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 after 16 weeks of treatment for prurigo nodularis.

Missed dose

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Special populations

Elderly (≥ 65 years)
No dose adjustment is recommended for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic and Renal impairment
No dose adjustment is needed in patients with mild to moderate hepatic or renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No recommendation can be made in patients with severe hepatic or renal impairment due to lack of data.

Body weight
No dose adjustment for body weight is recommended for patients 12 years of age and older with atopic dermatitis (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For patients with prurigo nodularis and with body weight ≥ 90 kg, the 60 mg dose (two 30 mg injections) is recommended (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of Nemluvio in children with moderate-to-severe atopic dermatitis younger than 12 years old have not yet been established.

The safety and efficacy of Nemluvio have not been established in paediatric patients below the age of 18 years with prurigo nodularis.

Method of administration

Subcutaneous use.

Administer subcutaneous injection 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. Nemluvio should not be injected into skin that is tender, inflamed, swollen, damaged or has bruises, scars or open wounds.

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

Contraindications

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information