Benlysta Dosage/Direction for Use

BENLYSTA is administered intravenously by infusion, and must be reconstituted and diluted prior to administration (see Use and Handling under Cautions for Usage).
BENLYSTA treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE.
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, Precautions).
Patients should be monitored during and for an appropriate period of time after administration of BENLYSTA (see Precautions, Adverse Reactions).
Premedication for patients with allergies: Premedication with an oral antihistamine, with or without an antipyretic, may be administered before the infusion of BENLYSTA (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions and Precautions).
Adults: 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.
In patients with active lupus nephritis, BENLYSTA should be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance.
Children: SLE: BENLYSTA has not been studied in patients less than 18 years of age. There are no data on the safety and efficacy of BENLYSTA in this age group.
Lupus nephritis: The safety and efficacy of BENLYSTA in children and adolescents aged below 18 years have not been studied, therefore, BENLYSTA is not recommended for use in children and adolescents with active lupus nephritis.
Elderly: 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 patient is deemed necessary, dose adjustment is not required (see Pharmacology: Pharmacokinetics: Special Patient Groups under Actions).
Renal impairment: No formal studies of BENLYSTA have been performed in patients with renal impairment.
BENLYSTA has been studied in a limited number of SLE patients with renal impairment. Dosage adjustment is not required in patients with renal impairment (see Pharmacology: Pharmacokinetics: Special Patient Groups under Actions).
Hepatic impairment: No formal studies of BENLYSTA have been performed in patients with hepatic impairment. However, patients with hepatic impairment are unlikely to require dose modification (see Pharmacology: Pharmacokinetics: Special Patient Groups under Actions).