Active Ingredient: Belimumab
Belimumab 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.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
200 - 200 mg
From 200 To 200 mg once every 7 day(s)
The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight.
The patient’s condition should be evaluated continuously. Discontinuation of treatment with belimumab 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.
If a patient is being transitioned from belimumab intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose.
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.
Intravenous
10 - 10 mg per kg of body weight
From 10 To 10 mg per kg of body weight once every 14 day(s)
Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of belimumab.
The recommended dose regimen is 10 mg/kg belimumab on Days 0, 14 and 28, and at 4-week intervals thereafter. The patient’s condition should be evaluated continuously. Discontinuation of treatment with belimumab should be considered if there is no improvement in disease control after 6 months of treatment.
If a patient is being transitioned from belimumab intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose.
Belimumab should be infused over a 1-hour period.
Belimumab must not be administered as an intravenous bolus.
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