Active Ingredient: Belimumab
Belimumab is indicated as add-on therapy in patients aged 5 years and older 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:
For:
Subcutaneous, 200 milligrams belimumab, once weekly.
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.
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 with SLE 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.
Data on patients ≥65 years are limited. Belimumab should be used with caution in the elderly. Dose adjustment is not required.
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 for each injection; injections should never be given into areas where the skin is tender, bruised, red, or hard. When a 400 mg dose is administered at the same site, it is recommended that the 2 individual 200 mg injections are administered at least 5 cm (approximately 2 inches) apart.
For:
In case that patient age in years is ≥ 5
Intravenous, 10 milligrams belimumab per kilogram of body weight, one dose, over the duration of 7 days. Afterwards, intravenous, 10 milligrams belimumab per kilogram of body weight, one dose, over the duration of 14 days. Afterwards, intravenous, 10 milligrams belimumab per kilogram of body weight, one dose, over the duration of 4 weeks.
Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of belimumab.
In patients with SLE, the recommended belimumab dose regimen is 10 mg/kg body weight on Days 0, 14 and 28, and at 4-week intervals thereafter. The patient's condition should be evaluated continuously.
The safety and efficacy of belimumab intravenous administration in children under 5 years of age have not been established. No data are available.
In patients with SLE, discontinuation of treatment with belimumab should be considered if there is no improvement in disease control after 6 months of treatment.
If a patient with SLE 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.
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.
For:
Regimen A, in case that patient age in years is ≥ 5 and patient weight is ≥ 50 kg
Subcutaneous, 200 milligrams belimumab, once weekly.
Regimen B, in case that patient age in years is ≥ 5 and patient weight is ≥ 30 kg and patient weight is < 50 kg
Subcutaneous, 200 milligrams belimumab, once every 10 days.
Regimen C, in case that patient age in years is ≥ 5 and patient weight is ≥ 15 kg and patient weight is < 30 kg
Subcutaneous, 200 milligrams belimumab, once every 2 weeks.
The patient's condition should be evaluated continuously. Discontinuation of treatment with belimumab is to be considered if there is no improvement in disease control after 6 months of treatment.
The recommended subcutaneous dose is based on weight.
| Body weight | Recommended dose |
|---|---|
| ≥50 kg | 200 mg once weekly |
| 30 to <50 kg | 200 mg every 10 days |
| 15 to <30 kg | 200 mg every 2 weeks |
The safety and efficacy of belimumab subcutaneous administration in children under 5 years of age or less than 15 kg have not been established. No data are available.
If a dose is missed, it is recommended to be administered as soon as possible. Thereafter, patients can resume dosing on their usual day of administration, or start a new schedule from the day that the missed dose was administered.
If patients wish to change their scheduled dosing day, a new dose can be given on the newly preferred day of the week. Thereafter the patient can continue with the new schedule from that day, even if the dosing interval may be temporarily less than usual.
The recommended injection sites are the abdomen or thigh. When injecting in the same region, patients must be advised to use a different injection site for each injection; injections must not be given into areas where the skin is tender, bruised, red, or hard. When a 400 mg dose is administered at the same site, it is recommended that the 2 individual 200 mg injections are administered at least 5 cm (approximately 2 inches) apart.
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