Posology : מינונים

4.2    Posology and method of administration

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 should be 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.

Posology

SLE
The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight (see section 5.2).

The patient’s condition should be evaluated continuously. Discontinuation of treatment with Benlysta should be considered if there is no improvement in disease control after 6 months of treatment.

Lupus nephritis
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 should 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.

Missed doses

If a dose is missed, it should be administered as soon as possible. Thereafter, patients can resume dosing on their usual day of administration, or start a new weekly schedule from the day that the missed dose was administered.

Changing the weekly dosing day

If patients wish to change their weekly dosing day, a new dose can be given on the newly preferred day of the week. Thereafter the patient should continue with the new weekly schedule from that day, even if the dosing interval may be temporarily less than a week.

Transition from intravenous to subcutaneous administration

SLE
If a patient with SLE is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose (see section 5.2).

Lupus nephritis
If a patient with lupus nephritis is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first dose of 200 mg subcutaneous injection should be administered 1 to 2 weeks after the last intravenous dose. This transition should occur any time after the patient completes the first 2 intravenous doses (see section 5.2).

Special populations

Elderly
The efficacy and safety of Benlysta in the elderly has not been established. 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).

Renal impairment
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).

Hepatic impairment
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).

Paediatric population
The safety and efficacy of Benlysta subcutaneous administration in children and adolescents (< 18 years of age) have not been established. No data are available.

Method of administration

The pre-filled pen or pre-filled syringe should be used for subcutaneous injection only. The recommended injection sites are the abdomen or thigh. When injecting in the same region, patients should be advised to use a different injection site for each injection; injections should never 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 or pre-filled syringe are provided at the end of the package leaflet (see Step-by-step instructions).