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Benlysta is a brand name for Belimumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Benlysta 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 (see section 5.1). Benlysta is indicated in combination with…
Verbatim from this product's EMA label. Tap a section to expand.
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 is given under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary.
4). A patient may self- inject, or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate. For patients under 10 years of age, Benlysta pre-filled pen must be administered by a healthcare professional or trained caregiver.
3 Posology SLE The patient’s condition should be evaluated continuously. Discontinuation of treatment with Benlysta is to be considered if there is no improvement in disease control after 6 months of treatment. Adults The recommended dose is 200 mg once weekly, administered subcutaneously.
2). 2). 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 Lupus nephritis Adults In patients initiating therapy with Benlysta for active lupus nephritis, the recommended dosage regimen is a 400 mg dose (two 200 mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter.
In patients continuing therapy with Benlysta for active lupus nephritis, the recommended dosage is 200 mg once weekly. Benlysta is to be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance.
The patient’s condition should be evaluated continuously. Missed doses 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.
Changing the scheduled dosing day 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.
2). Lupus nephritis If a patient with lupus nephritis is being transitioned from Benlysta intravenous administration to subcutaneous administration, it is recommended that the first dose of 200 mg subcutaneous injection be administered 1 to 2 weeks after the last intravenous dose.
Summary of the safety profile The safety of belimumab in patients with SLE has been evaluated in three pre-registration placebo-controlled intravenous studies and one subsequent regional placebo-controlled intravenous study, one placebo- controlled subcutaneous study, and two post-marketing placebo-controlled intravenous studies; the safety in patients with active lupus nephritis has been evaluated in one placebo-controlled intravenous study.
The data presented in the table below reflect exposure in 674 patients with SLE from the three pre- registration clinical studies and 470 patients in the subsequent placebo-controlled study administered Benlysta intravenously (10 mg/kg body weight over a 1-hour period on Days 0, 14, 28, and then every 28 days for up to 52 weeks), and 556 patients with SLE exposed to Benlysta subcutaneously (200 mg once weekly up to 52 weeks).
The safety data presented include data beyond Week 52 in some patients with SLE. The data reflect additional exposure in 224 patients with active lupus nephritis who received Benlysta 8 intravenously (10 mg/kg body weight for up to 104 weeks).
Data from post-marketing reports are also included. The majority of patients were also receiving one or more of the following concomitant treatments for SLE: corticosteroids, immunomodulatory medicinal products, anti-malarials, non-steroidal anti-inflammatory medicinal products.
Adverse reactions were reported in 84 % of Benlysta-treated patients and 87 % of placebo-treated patients. The most frequently reported adverse reaction (≥ 5 % of patients with SLE treated with Benlysta plus standard of care and at a rate ≥ 1 % greater than placebo) was nasopharyngitis.
The proportion of patients who discontinued treatment due to adverse reactions was 7 % for Benlysta-treated patients and 8 % for placebo-treated patients. The most frequently reported adverse reactions (> 5 % of patients with active lupus nephritis treated with Benlysta plus standard of care) were upper respiratory tract infection, urinary tract infection, and herpes zoster.
Traceability In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Benlysta has not been studied in the following patient groups and is not recommended in: • severe active central nervous system lupus • HIV 5 • a history of, or current, hepatitis B or C • hypogammaglobulinaemia (IgG < 400 mg/dL) or IgA deficiency (IgA < 10 mg/dL) • a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.
1). Caution needs to be exercised if Benlysta is co-administered with other B cell targeted therapy. Hypersensitivity Administration of subcutaneous or intravenous Benlysta may result in hypersensitivity reactions which can be severe, and fatal.
2). The risk of hypersensitivity reactions is greatest with the first two doses; however, the risk must be considered for every administration. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.
8). Patients must be advised that hypersensitivity reactions are possible, on the day of, or several days after administration, and be informed of potential signs and symptoms and the possibility of recurrence. Patients must be instructed to seek immediate medical attention if they experience any of these symptoms.
The package leaflet must be available to the patient. Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema. In intravenous clinical studies, serious infusion and hypersensitivity reactions included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
4). Infections The mechanism of action of belimumab could increase the risk for the development of infections in adults and children with lupus, including opportunistic infections, and younger children may be at increased risk. g. 8).
1.
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2). 1). Benlysta should be used with caution in the elderly. 2). 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.
2). Hepatic impairment No specific studies with Benlysta have been conducted in patients with hepatic impairment. 2). Paediatric population SLE The safety and efficacy of Benlysta subcutaneous administration in children under 5 years of age or less than 15 kg have not been established.
No data are available. Lupus nephritis The safety and efficacy of Benlysta subcutaneous administration in children and adolescents under 18 years of age have not been established. No data are available. Method of administration The pre-filled pen must be used for subcutaneous injection only.
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. 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).
9 % for placebo-treated patients. 4). Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency.
The frequency categories used are:
Very common 1/10 Common 1/100 to < 1/10 Uncommon 1/1000 to < 1/100 Rare 1/10 000 to < 1/1000 Not known cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The frequency given is the highest seen with either formulation. g. 4 ‘Infections’ for further information. 2 ‘Hypersensitivity reactions’ covers a group of terms, including anaphylaxis, and can manifest as a range of symptoms including hypotension, angioedema, urticaria or other rash, pruritus, and dyspnoea.
‘Infusion or injection-related systemic reactions’ covers a group of terms and can manifest as a range of symptoms including bradycardia, myalgia, headache, rash, urticaria, pyrexia, hypotension, hypertension, dizziness, and arthralgia.
Due to overlap in signs and symptoms, it is not possible to distinguish between hypersensitivity reactions and infusion or injection-related systemic reactions in all cases. 3 Applies to subcutaneous formulation only. Description of selected adverse reactions Data presented below are pooled from the three pre-registration intravenous clinical studies (10 mg/kg body weight intravenous dose only) and the subcutaneous clinical study.
‘Infections’ and ‘Psychiatric disorders’ also include data from a post-marketing study. 10 Infusion or injection-related systemic reactions and hypersensitivity: Infusion or injection-related systemic reactions and hypersensitivity were generally observed on the day of administration, but acute hypersensitivity reactions may also occur several days after dosing.
Patients with a history of multiple drug allergies or significant hypersensitivity reactions may be at increased risk. 3 %, respectively, requiring permanent treatment discontinuation. The incidence of post-injection systemic reactions and hypersensitivity reactions occurring within 3 days of subcutaneous administration was 7 % in the group receiving Benlysta and 9 % in the group receiving placebo.
Clinically significant hypersensitivity reactions associated with Benlysta administered subcutaneously and requiring permanent […]
Pneumococcal vaccination should be considered before initiating Benlysta treatment. Benlysta must not be initiated in patients with active serious infections (including serious chronic infections). Physicians need to exercise caution and carefully assess if the benefits are expected to outweigh the risks when considering the use of Benlysta in patients with a history of recurrent infection.
Physicians need to advise patients to contact their health care provider if they develop symptoms of an infection. Patients who develop an infection while undergoing treatment with Benlysta must be monitored closely and careful consideration given to interrupting immunosuppressant therapy including Benlysta until the infection is resolved.
The risk of using Benlysta in patients with active or latent tuberculosis is unknown. 8). Physicians should assess the risk of depression and suicide considering the patient’s medical history and current psychiatric status before treatment with Benlysta and continue to monitor patients during treatment.
Physicians must advise patients (and caregivers where appropriate) to contact their health care provider about new or worsening psychiatric symptoms. In patients who experience such symptoms, treatment discontinuation is to be considered.
6 Severe cutaneous adverse reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with Benlysta treatment. Patients should be advised of the signs and symptoms of SJS and TEN and monitored closely for skin reactions.
If signs and symptoms suggestive of these reactions appear, Benlysta should be withdrawn immediately, and an alternative treatment should be considered. If the patient has developed SJS or TEN with the use of Benlysta, treatment with Benlysta must not be restarted in this patient at any time.
Progressive multifocal leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has been reported with Benlysta treatment for SLE. , cognitive, neurological or psychiatric symptoms or signs). Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML must be considered as clinically indicated.
If PML is suspected, immunosuppressant therapy, including Benlysta, must be suspended until PML has been excluded. If PML is confirmed, immunosuppressant therapy, including Benlysta, must be discontinued. Immunisation Live vaccines should not be given for 30 days before, or concurrently with Benlysta, as clinical safety has not been established.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Benlysta. Because of its mechanism of […]