Benlysta斑麗達

Benlysta Dosage/Direction for Use

belimumab

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Powder for concentrate for solution for infusion: 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 severe or life-threatening hypersensitivity reactions and infusion reactions. Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered. Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see Precautions and Adverse Reactions). Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available. Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction.
Patients treated with Benlysta should be made aware of the potential risk of severe or life-threatening hypersensitivity and the potential for delayed onset or recurrence of symptoms. The package leaflet should be provided to the patient each time Benlysta is administered (see Precautions).
Posology: Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta (see Precautions).
The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter. The patient's condition should be evaluated continuously. Discontinuation of treatment with Benlysta should be considered if there is no improvement in disease control after 6 months of treatment.
Solution for injection: Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. It is recommended that the first subcutaneous injection of Benlysta should be under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary. The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see Precautions). A patient may self-inject or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate.
Posology: The recommended dose is 200 mg once weekly, administered subcutaneously. Dosing is not based on weight (see Pharmacology: Pharmacokinetics under Actions).
The patient's condition should be evaluated continuously. Discontinuation of treatment with Benlysta 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.
Transition from intravenous to subcutaneous administration: If a patient is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose (see Pharmacology: Pharmacokinetics under Actions).
Special populations: Elderly: Powder for concentrate for solution for infusion: The efficacy and safety of Benlysta in the elderly has not been established. Data on patients ≥65 years are limited to <1.8% 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 Pharmacology: Pharmacokinetics under Actions).
Solution for injection: The efficacy and safety of Benlysta in the elderly has not been established. Data on patients ≥65 years are limited to <1.8% 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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Powder for concentrate for solution for infusion: The recommended dose regimen for children aged 5 years and older is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter. The safety and efficacy of Benlysta in children aged below 5 years has not been established. No data are available.
Solution for injection: The safety and efficacy of Benlysta in children and adolescents (< 18 years of age) has not been established. No data are available.
Method of administration: Powder for concentrate for solution for infusion: Benlysta is administered intravenously by infusion, and must be reconstituted and diluted before administration. For instructions on reconstitution, dilution, and storage of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
Benlysta should be infused over a 1-hour period.
Benlysta 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 (see Precautions and Adverse Reactions).
Solution for injection: The pre-filled pen should be used for subcutaneous injection only. 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.
Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen are provided at the end of the package leaflet (see Step-by-step instructions).
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