Benlysta Powder for Solution for Infusion 400mg

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**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_).