BENLYSTA POWDER FOR SOLUTION FOR INFUSION 400MG [SIN14212P]

Product Info

BENLYSTA POWDER FOR SOLUTION FOR INFUSION 400MG

[SIN14212P]

Indications
BENLYSTA is indicated:

• As add-on therapy in adult patients 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 Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• In combination with background immunosuppressive therapies for treatment of active lupus nephritis in adult patients.

Dosage and Administration

Pharmaceutical form: Powder for concentrate for solution for infusion.

Lyophilised powder for intravenous infusion
BENLYSTA is administered intravenously by infusion, and must be reconstituted and diluted prior to administration (see Instructions for Use/Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

BENLYSTA treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. BENLYSTA infusions should be administered by a qualified healthcare professional trained to give infusion therapy. Administration of BENLYSTA may result in hypersensitivity reactions and infusion reactions. Therefore, BENLYSTA should be administered in an environment where resources for managing such reactions are immediately available.

BENLYSTA should be administered by a healthcare professional prepared to treat hypersensitivity reactions including anaphylaxis.

BENLYSTA should be infused over a 1-hour period.

BENLYSTA must not be administered as an intravenous push or bolus.

The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a potentially life-threatening adverse reaction (see Contraindications, Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients should be monitored during and for an appropriate period of time after administration of BENLYSTA (see Warnings and Precautions, Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

There are no or insufficient data available on the effects of BENLYSTA in patients with severe active central nervous system lupus.

The patient’s condition should be evaluated continuously.

Premedication for intravenous infusion

Premedication with an oral antihistamine, with or without an antipyretic, may be administered before the infusion of BENLYSTA (see Warnings and Precautions, Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults

Lyophilised powder for intravenous infusion

SLE

The recommended dosage regimen is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter. Discontinuation of treatment with BENLYSTA should be considered if there is no improvement in disease control after 6 months of treatment.

Lupus nephritis

The recommended dosage regimen is 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter.

Children

SLE

There is no relevant use of BENLYSTA in SLE patients less than 18 years of age.

Lupus nephritis

The safety and efficacy of BENLYSTA in children and adolescents aged below 18 years with severe active lupus nephritis have not been established. No data are available.

Special populations

Elderly (>65 years)

The efficacy and safety of BENLYSTA in the elderly has not been established. Data on patients >65 years are limited to <1.6% 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 Pharmacokinetics – Special patient populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 Pharmacokinetics – Special patient populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 Pharmacokinetics – Special patient populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

BENLYSTA is contraindicated in patients who have demonstrated anaphylaxis to BENLYSTA.