BENLYSTA Solution for injection Ref.[6410] Active ingredients: Belimumab

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

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.

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. It is not necessary to administer two doses on the same 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

If a patient 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).

Special populations

Elderly

The efficacy and safety of Benlysta in the elderly has not been established. Data on patients ≥65 years are limited to <1.8% of the studied population. Therefore, the use of Benlysta in elderly patients is not recommended unless the benefits are expected to outweigh the risks. In case administration of Benlysta to elderly patients is deemed necessary, 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) has 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 each week; injections should never be given into areas where the skin is tender, bruised, red, or hard.

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).

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 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.

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 syringe or pre-filled pen can be stored at temperatures up to a maximum of 25°C for a period of up to 12 hours. The syringe or pen must be protected from light, and discarded if not used within the 12 hour period.

Pre-filled pen:

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.

Pre-filled syringe:

1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) and needle cap.
Available in pack of 1 pre-filled syringe and pack of 4 pre-filled syringes.

Not all pack sizes may be marketed.

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).

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