Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (see sections 4.2 and 5.1).
Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. It is recommended that the first subcutaneous injection of Benlysta is given under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary. The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4). A patient may self- inject, or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate.
For patients under 10 years of age, Benlysta pre-filled pen must be administered by a healthcare professional or trained caregiver.
The patient's condition should be evaluated continuously. Discontinuation of treatment with Benlysta is to be considered if there is no improvement in disease control after 6 months of treatment.
The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight (see section 5.2).
The recommended subcutaneous dose is based on weight (see sections 5.1 and 5.2).
| Body weight | Recommended dose |
|---|---|
| ≥50 kg | 200 mg once weekly |
| 30 to <50 kg | 200 mg every 10 days |
| 15 to <30 kg | 200 mg every 2 weeks |
In patients initiating therapy with Benlysta for active lupus nephritis, the recommended dosage regimen is a 400 mg dose (two 200 mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter. In patients continuing therapy with Benlysta for active lupus nephritis, the recommended dosage is 200 mg once weekly. Benlysta is to be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. The patient's condition should be evaluated continuously.
If a dose is missed, it is recommended to be administered as soon as possible. Thereafter, patients can resume dosing on their usual day of administration, or start a new schedule from the day that the missed dose was administered.
If patients wish to change their scheduled dosing day, a new dose can be given on the newly preferred day of the week. Thereafter the patient can continue with the new schedule from that day, even if the dosing interval may be temporarily less than usual.
If a patient with SLE is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection must be administered 1 to 4 weeks after the last intravenous dose (see section 5.2).
If a patient with lupus nephritis is being transitioned from Benlysta intravenous administration to subcutaneous administration, it is recommended that the first dose of 200 mg subcutaneous injection be administered 1 to 2 weeks after the last intravenous dose. This transition can occur any time after the patient completes the first 2 intravenous doses (see section 5.2).
Data on patients ≥65 years are limited (see section 5.1). Benlysta should be used with caution in the elderly. Dose adjustment is not required (see section 5.2).
Belimumab has been studied in a limited number of SLE patients with renal impairment. On the basis of the available information, dose adjustment is not required in patients with mild, moderate or severe renal impairment. Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2).
No specific studies with Benlysta have been conducted in patients with hepatic impairment. Patients with hepatic impairment are unlikely to require dose adjustment (see section 5.2).
SLE:
The safety and efficacy of Benlysta subcutaneous administration in children under 5 years of age or less than 15 kg have not been established. No data are available.
Lupus nephritis:
The safety and efficacy of Benlysta subcutaneous administration in children and adolescents under 18 years of age have not been established. No data are available.
The pre-filled pen must be used for subcutaneous injection only. The recommended injection sites are the abdomen or thigh. When injecting in the same region, patients must be advised to use a different injection site for each injection; injections must not be given into areas where the skin is tender, bruised, red, or hard. When a 400 mg dose is administered at the same site, it is recommended that the 2 individual 200 mg injections are administered at least 5 cm (approximately 2 inches) apart.
Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen are provided at the end of the package leaflet (see Step-by-step instructions).
There is limited clinical experience with overdose of Benlysta. Adverse reactions reported in association with cases of overdose have been consistent with those expected for belimumab.
Two doses up to 20 mg/kg body weight administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg body weight.
In the case of inadvertent overdose, patients should be carefully observed and supportive care administered, as appropriate.
3 years.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original carton in order to protect from light.
A single Benlysta pre-filled pen can be stored at temperatures up to a maximum of 25°C for a period of up to 12 hours. The pre-filled pen must be protected from light, and discarded if not used within the 12 hour period.
1 mL solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Available in packs of 1 or 4 pre-filled pens and multipack containing 12 single-dose pre-filled pens (3 packs of 4 pre-filled pens).
Not all pack sizes may be marketed.
Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen are provided at the end of the package leaflet (see Step-by-step instructions).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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