Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Benlysta 200 mg solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Belimumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Benlysta as a subcutaneous injection is a medicine used to treat lupus (systemic lupus erythematosus, SLE) in adults (18 years of age and older) and children (5 to under 18 years of age and weighing at least 15 kg) whose disease is still highly active despite standard treatment. Benlysta is also used in combination with other medicines to treat adults (18 years of age and older) with active lupus nephritis (lupus-related kidney inflammation). Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage. It can affect almost any organ in the body, and is thought to involve a type of white blood cells called B cells. Benlysta contains belimumab (a monoclonal antibody). It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in people with lupus. You will be given Benlysta as well as your usual treatment for lupus. 2.
What you need to know before you take it
e Benlysta
Do not use Benlysta •
if you are allergic to belimumab or any of the other ingredients of this medicine (listed in section 6).
Check with your doctor if this may apply to you.
1
Warnings and precautions Talk to your doctor before you use Benlysta: • • • • • • • •
if you have a current or long-term infection or if you often get infections. Your doctor will decide if you can be given Benlysta if you are planning to have a vaccination or have had a vaccination within the last 30 days. Some vaccines should not be given just before or during treatment with Benlysta if your lupus affects your nervous system if you are HIV positive or have low immunoglobulin levels if you have, or have had, hepatitis B or C if you have had an organ transplant, or a bone marrow or stem cell transplant if you have had cancer if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using Benlysta.
Tell your doctor if any of these may apply to you.
Depression and suicide There have been reports of depression, suicidal thoughts, and suicide attempts including suicide during treatment with Benlysta. Tell your doctor if you have a history of these conditions. If you experience new or worsening symptoms at any time:
Contact your doctor or go to a hospital straight away.
If you feel depressed or have thoughts of harming yourself or committing suicide, you may find it helpful to tell a relative or close friend and ask them to read this leaflet. You might ask them to tell you if they are worried about changes in your mood or behaviour. Severe skin reactions Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with Benlysta treatment. Stop using Benlysta and seek medical attention immediately if you notice any of the symptoms described in section 4. Look out for important symptoms People taking medicines that affect their immune system may be more at risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). Read the information 'Increased risk of brain infection' in section 4 of this leaflet. To improve the traceability of this medicine, you and your healthcare provider should record the Benlysta lot number. It is recommended that you make a note of this information in case you are asked for it in the future. Children and adolescents Benlysta pre-filled pen as a subcutaneous injection is not intended to be used in children younger than 5 years of age or less than 15 kg for the treatment of SLE. Benlysta pre-filled pen as a subcutaneous injection is not intended to be used in children or adolescents younger than 18 years of age for the treatment of lupus nephritis. Other medicines and Benlysta Tell your doctor if you are taking any other medicines, if you have recently taken or might take any other medicines.
2
In particular tell your doctor if you are being treated with medicines that affect your immune system, including any medicine that affects your B cells (to treat cancer or inflammatory diseases). Using such medicines in combination with Benlysta may make your immune system less effective. This could increase your risk of a serious infection. Pregnancy and breast-feeding Contraception for women who could become pregnant •
Use an effective method of contraception while you are being treated with Benlysta and for at least 4 months after the last dose.
Pregnancy Benlysta is not usually recommended if you are pregnant. • •
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will decide if you can use Benlysta. If you become pregnant while being treated with Benlysta, tell your doctor.
Breast-feeding Tell your doctor if you are breast-feeding. It is likely that Benlysta can pass into breast milk. Your doctor will discuss with you whether you should stop treatment with Benlysta while you are breast-feeding, or if you should stop breast-feeding. Driving and using machines Benlysta can have side effects which may make you less able to drive or use machines. Benlysta contains polysorbate 80 This medicine contains 0.1 mg of polysorbate 80 in each pre-filled pen. Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies. Benlysta contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially 'sodium-free'. 3.
How to take it
Always use this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure. Benlysta must be injected under your skin following the schedule prescribed to you by your doctor. How much to use Systemic lupus erythematosus Adults The recommended dose is 200 mg (complete contents of one pen) once a week. Children and adolescents 5 years and older The recommended dose for children and adolescents 5 years and older is based on weight as shown below:
3
Body weight
Recommended dose
50 kg or more
200 mg (complete contents of one pen) once a week
30 kg to less than 50 kg
200 mg (complete contents of one pen) once every 10 days
15 kg to less than 30 kg
200 mg (complete contents of one pen) once every 2 weeks
Lupus nephritis Adults only The recommended dose may vary. Your doctor will prescribe the right dose for you, which is either: •
a dose of 200 mg (complete contents of one pen) once a week.
or •
a dose of 400 mg (complete contents of two pens in one day) once a week for 4 weeks. After this, the recommended dose is 200 mg (complete contents of one pen) once a week.
If you wish to change your dosing day Take a dose on the new day (even if the time since your last dose is less than usual). Continue with the new schedule from that day. Injecting Benlysta Your doctor or nurse will show you or your caregiver how to inject Benlysta. Your first injection with the Benlysta pre-filled pen will be supervised by your doctor or nurse. After you have been trained on how to use the pen, your doctor or nurse may decide that you can give yourself the injection, or your caregiver can give it to you. Your doctor or nurse will also tell you what signs and symptoms to look out for when using Benlysta, because serious allergic reactions can occur (see 'Allergic reactions' in section 4). For children under 10 years of age, the Benlysta pre-filled pen must be injected by a doctor, nurse, or trained caregiver. You inject Benlysta under your skin in your stomach area (abdomen) or upper leg (thigh). Benlysta subcutaneous injection must not be injected into a vein (intravenously). Instructions for using the pre-filled pen are given at the end of this leaflet. If you use more Benlysta than you should If this happens, immediately contact your doctor or nurse, who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary. If possible show them the pack, or this leaflet. If you forget to use Benlysta Inject the missed dose as soon as you remember. Then continue with your normal weekly schedule as usual or start a new weekly schedule starting from the day you inject the missed dose. If you do not notice that you have missed a dose until it is already time for your next dose, then just inject this next dose as planned. Stopping treatment with Benlysta Your doctor will decide if you need to stop using Benlysta. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. 4
Stop using Benlysta and seek medical attention immediately if you notice any of the following symptoms of a severe skin reaction: • reddish patches on the trunk, the patches are target-like macules or circular, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis). These
Possible side effects
have been reported with unknown frequency (cannot be estimated from the available data). Allergic reactions – get medical help immediately Benlysta can cause a reaction to the injection, or an allergic (hypersensitivity) reaction. These are common side effects (may affect up to 1 in 10 people). They can occasionally be severe (uncommon, affecting up to 1 in 100 people), and could be life-threatening. These severe reactions are more likely to happen on the day of your first or second treatment with Benlysta, but can be delayed and occur several days afterwards. Tell your doctor or nurse immediately, or go to the Emergency department of your nearest hospital, if you get any of the following symptoms of an allergic or injection-related reaction: • swelling of the face, lips, mouth or tongue • wheezing, difficulty in breathing or shortness of breath • rash • itchy raised bumps or hives. Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an injection. They include symptoms such as rash, feeling sick, tiredness, muscle aches, headache, or facial swelling. If you experience these symptoms, particularly if you get two or more of them together: Tell your doctor or nurse. Infections Benlysta can make you more likely to get infections, including infection of the urinary tract and airways. These are very common and may affect more than 1 in 10 people. Some infections can be severe and can uncommonly cause death. If you get any of the following symptoms of an infection: • fever and/or chills • cough, breathing problems • diarrhoea, vomiting • burning sensation while passing urine; urinating often • warm, red or painful skin or sores on your body. Tell your doctor or nurse immediately. Depression and suicide There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Benlysta. Depression can affect up to 1 in 10 people, suicidal thoughts and suicide attempts can affect up to 1 in 100 people. If you feel depressed, have thoughts about harming yourself or other distressing thoughts, or if you are depressed and notice that you feel worse or develop new symptoms:
Contact your doctor or go to a hospital straight away.
Increased risk of brain infection Medicines that weaken your immune system, such as Benlysta, may put you at higher risk of getting a rare but serious and life-threatening brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML include: • memory loss • trouble in thinking • difficulty with talking or walking 5
•
loss of vision. Tell your doctor immediately if you have any of these symptoms, or similar problems that have lasted over several days.
If you already had these symptoms before you started treatment with Benlysta: Tell your doctor immediately if you notice any changes in these symptoms. Other possible side effects: Very common side effects These may affect more than 1 in 10 people: • bacterial infections (see 'Infections' above). Common side effects These may affect up to 1 in 10 people: • high temperature or fever • injection site reactions, for example: rash, redness, itching or swelling of the skin where you have injected Benlysta • itchy, bumpy rash (hives), skin rash • low white blood cell count (can be seen in blood tests) • nose, throat or stomach infection • pain in hands or feet • migraine • feeling sick, diarrhoea Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Benlysta
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C to 8 °C). Do not freeze. Store in the original package in order to protect from light. A single Benlysta pre-filled pen can be stored at room temperature (up to 25°C) for a maximum of 12 hours
- as long as it is protected from light. Once removed from the refrigerator, the pen must be used within 12 hours or discarded. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
6
What Benlysta contains The active ingredient is belimumab. Each 1 mL pre-filled pen contains 200 mg belimumab. The other ingredients are arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80 (E 433), sodium chloride, water for injection. See section 2 for further information on polysorbate 80 and sodium content. What Benlysta looks like and contents of the pack Benlysta is supplied as a 1 mL colourless to slightly yellow solution in a single use pre-filled pen. Available in packs of 1 or 4 pre-filled pens in each pack and multipacks comprising 12 pre-filled pens (3 packs of 4 pre-filled pens). Not all pack sizes may be marketed. Marketing Authorisation Holder GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer Glaxo Operations UK Ltd Harmire Road Barnard Castle County Durham, DL12 8DT United Kingdom OR GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, 90 43056 San Polo di Torrile Parma Italy Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product name – Benlysta 200 mg solution for injection in pre-filled pen Reference number – 19494/0271 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in January 2026 Trade marks are owned by or licensed to the GSK group of companies. 7
© 2026 GSK group of companies or its licensor <—————————————————————————————————————————–
8
Step-by-step instructions for using the pre-filled pen Once weekly: for adults, and for children 5 to under 18 years of age and weighing 50 kg or more. Once every 10 days: for children 5 to under 18 years of age and weighing 30 kg to less than 50 kg. Once every 2 weeks: for children 5 to under 18 years of age and weighing 15 kg to less than 30 kg. Read These Sections First Follow these instructions on how to use the pre-filled pen correctly. Failure to follow these instructions may affect proper function of the pre-filled pen. You will also need to receive training on how to use the pre-filled pen. Benlysta is for use under the skin only (subcutaneous). To improve the traceability of this medicine, you and your healthcare provider should record the Benlysta lot number. It is recommended that you make a note of this information in case you are asked for it in the future. Storage •
Keep refrigerated until 30 minutes before use.
•
Keep in the carton in order to protect from light.
•
Keep out of the sight and reach of children.
•
Keep away from heat and sunlight.
•
Do not freeze. If the pen has been frozen, do not use the pen even if it is thawed.
•
Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours.
Warnings •
The pre-filled pen must only be used once and then discarded.
•
Do not share your Benlysta pre-filled pen with another person.
•
Do not shake.
•
Do not use if dropped onto a hard surface.
•
Do not remove the ring cap until just before the injection.
Benlysta pre-filled pen parts Ring cap
Inspection window 9
EXP: Month – Year
Gold needle guard (needle inside)
Grey stopper
Expiry date
Supplies you need for the injection
Benlysta pre-filled pen
Alcohol swab (not included)
Gauze pad or cotton wool ball (not included)
1. Gather and check supplies Gather supplies •
Remove one sealed tray containing a pre-filled pen from the refrigerator.
•
Place any remaining pre-filled pens back into the refrigerator.
•
Find a comfortable, well-lit and clean surface and place the following supplies within reach:
•
•
Benlysta pre-filled pen
•
alcohol swab (not included in the pack)
•
gauze pad or cotton wool ball (not included in the pack)
•
container with a tight-fitting lid for pen disposal (not included in the pack).
Do not perform the injection if you do not have all the supplies listed.
Take out the pre-filled pen •
Peel back the film from the corner of the tray. (Figure 1) 10
Figure 1
EXP: Month – Year
•
Holding the middle of the pre-filled pen (near the inspection window), carefully take the pre-filled pen out of the tray. (Figure 2) Figure 2
EXP:
Check the expiry date •
Check the expiry date on the pre-filled pen. (Figure 3)
Figure 3
Exp: Month – Year
Exp: Month – Year
•
Do not use if the expiry date has passed
2. Prepare and inspect the pre-filled pen Allow to come to room temperature
11
•
Leave the pen at room temperature for 30 minutes. (Figure 4) Injecting cold Benlysta may take longer and may be uncomfortable.
Figure 4
Wait 30 minutes
min
•
Do not warm the pen in any other way. For example, do not warm it in a microwave oven, hot water or direct sunlight.
•
Do not remove the ring cap during this step.
Inspect the Benlysta solution •
Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour. (Figure 5)
•
It is normal to see one or more air bubbles in the solution.
Figure 5 Benlysta solution
•
Do not use if the solution looks cloudy, discoloured or has particles.
3. Choose and clean the injection site Choose the injection site •
Choose an injection site (abdomen or thigh) as seen in Figure 6.
12
Figure 6
• • • •
If you need 2 injections to complete your dose, leave at least 5 cm (2 inches) between each injection if using the same site. Do not inject into the exact same site each time. This is to avoid the skin becoming hardened. Do not inject in areas where the skin is tender, bruised, red or hard. Do not inject within 5 cm (2 inches) of the navel (belly button).
Clean the injection site • •
Wash your hands. Clean the injection site by wiping it with an alcohol swab (Figure 7). Allow the skin to air dry.
Figure 7
•
Do not touch this area again before giving the injection.
4. Prepare for the injection Remove the ring cap •
Do not remove the ring cap until immediately before the injection.
•
Remove the ring cap by pulling or twisting it off. The ring cap may be twisted off either clockwise or anti-clockwise. (Figure 8)
13
Figure 8
•
Do not put the ring cap back onto the pen.
Position the pen •
Hold the pen comfortably so that you can view the inspection window. This is important so that you can confirm a complete dose. (Figure 9)
Figure 9
•
If needed, firm the injection site by pulling or stretching the skin.
•
Position the pen straight over the injection site (at a 90o angle). Make sure the gold needle guard is flat on the skin.
5. Inject Benlysta and Inspect Start the injection •
Firmly press the pen all the way down onto the injection site and hold in place. (Figure 10)
•
This will insert the needle and start the injection.
14
Figure 10
•
You may hear a first "click" at the start of the injection. You will see the purple indicator start to move through the inspection window. (Figure 11)
Figure 11
first "click"
Purple indicator
Complete the injection •
Continue to hold the pen down until the purple indicator has stopped moving. You may hear a second "click" a few seconds before the purple indicator stops moving. (Figure 12)
15
Figure 12
second "click"
Then wait until…
… purple indicator stops moving
•
The injection may take up to 15 seconds to complete.
•
When the injection is complete, lift the pen from the injection site.
Inspect the injection site There may be a small amount of blood at the injection site. • •
If needed, press a cotton ball or gauze pad on the injection site. Do not rub the injection site
6. Dispose of used pen Dispose of the used pen •
Do not put the ring cap back onto the pen.
•
Dispose of the used pen and ring cap in a container with a tight-fitting lid.
•
Ask your doctor or pharmacist for instructions on how to properly dispose of a used pen or container of used pens.
•
Do not recycle or throw the used pen, or the container of used pens, in household waste.
16
Frequently asked questions about Benlysta 200 mg solution for injection in pre-filled pen
How do I take Benlysta 200 mg solution for injection in pre-filled pen?
Benlysta 200 mg solution for injection in pre-filled pen comes as injection containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Benlysta 200 mg solution for injection in pre-filled pen?
The active substance in Benlysta 200 mg solution for injection in pre-filled pen is belimumab.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Benlysta 200 mg solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Benlysta 200 mg solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: belimumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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 background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (see sections 4.2 and 5.1).
4.2. Posology and method of administration
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. The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4). 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.
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. Dosing is not based on weight (see section 5.2).
Children and adolescents (aged 5 to less than 18 years)
The recommended subcutaneous dose is based on weight (see sections 5.1 and 5.2).
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.
Transition from intravenous to subcutaneous administration
SLE
If a patient with SLE is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection must be administered 1 to 4 weeks after the last intravenous dose (see section 5.2).
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. This transition can occur any time after the patient completes the first 2 intravenous doses (see section 5.2).
Special populations
Elderly
Data on patients ≥ 65 years are limited (see section 5.1). Benlysta should be used with caution in the elderly. Dose adjustment is not required (see section 5.2).
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. Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2).
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 section 5.2).
Paediatric population
SLE
The safety and efficacy of Benlysta subcutaneous administration in children under 5 years of age or less than 15kg 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).
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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
• 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.
Concomitant use with B cell targeted therapy
Available data do not support the co-administration of rituximab with Benlysta in patients with SLE (see section 5.1). 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. In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered (see section 4.2). 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. Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.2 and 4.8).
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. Please refer to the Summary of Product Characteristics for Benlysta powder for concentrate for solution for infusion (section 4.4).
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. In controlled clinical studies, the incidence of serious infections was similar across the Benlysta and placebo groups; however, fatal infections (e.g. pneumonia and sepsis) occurred more frequently in patients receiving Benlysta compared with placebo (see section 4.8). 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.
Depression and suicidality
In controlled clinical intravenous and subcutaneous studies, psychiatric disorders (depression, suicidal ideation and behaviour including suicides) have been reported more frequently in patients receiving Benlysta (see section 4.8). 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.
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. Physicians must be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., 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 belimumab, 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 action, belimumab may interfere with the response to immunisations. However, in a small study evaluating the response to a 23-valent pneumococcal vaccine, overall immune responses to the different serotypes were similar in SLE patients receiving Benlysta compared with those receiving standard immunosuppressive treatment at the time of vaccination. There are insufficient data to draw conclusions regarding response to other vaccines.
Limited data suggest that Benlysta does not significantly affect the ability to maintain a protective immune response to immunisations received prior to administration of Benlysta. In a substudy, a small group of patients who had previously received either tetanus, pneumococcal or influenza vaccinations were found to maintain protective titres after treatment with Benlysta.
Malignancies and lymphoproliferative disorders
Immunomodulatory medicinal products, including Benlysta, may increase the risk of malignancy. Caution is advised when considering Benlysta therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. Patients with malignant neoplasm within the last 5 years have not been studied, with the exception of those with basal or squamous cell cancers of the skin, or cancer of the uterine cervix, that has been fully excised or adequately treated.
Polysorbate 80 content
This medicinal product contains polysorbate 80 (see section 2), which may cause allergic reactions.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No in vivo interaction studies have been performed. The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation. It is not known if belimumab could be an indirect modulator of such cytokines. A risk for indirect reduction of CYP activity by belimumab cannot be excluded. On initiation or discontinuation of belimumab, therapeutic monitoring is to be considered for patients being treated with CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.
Pregnancy
There are a limited amount of data from the use of Benlysta in pregnant women. Post-marketing data from a prospective pregnancy registry have collected pregnancy information in women exposed to belimumab. Due to the small sample size achieved, no definitive conclusions from this registry can be made regarding a potential risk of birth defects following exposure to belimumab.
Besides an expected pharmacological effect i.e. reduction of B cells, animal studies in monkeys do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.
Breast-feeding
It is unknown whether Benlysta is excreted in human milk or is absorbed systemically after ingestion. However, belimumab was detected in the milk from female monkeys administered 150 mg/kg body weight every 2 weeks.
Because maternal antibodies (IgG) are excreted in breast milk, it is recommended that a decision is made on whether to discontinue breast-feeding or to discontinue Benlysta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data on the effects of belimumab on human fertility. Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. No detrimental effects on such activities are predicted from the pharmacology of belimumab. It is recommended that the clinical status of the subject and the adverse reaction profile of Benlysta be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
4.8. Undesirable effects
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 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. The proportion of patients who discontinued treatment due to adverse reactions was 12.9 % for Benlysta-treated patients and 12.9 % for placebo-treated patients.
Severe cutaneous adverse reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with Benlysta treatment (see section 4.4).
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
Common
Uncommon
Rare
Not known
≥ 1/10
≥ 1/100 to < 1/10
≥ 1/1000 to < 1/100
≥ 1/10 000 to < 1/1000
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.
System organ class
Frequency
Adverse reactions
Infections and infestations1
Very common
Bacterial infections, e.g. bronchitis, urinary tract infection
Common
Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper respiratory tract infection
Blood and lymphatic system disorders
Common
Leucopenia
Immune system disorders
Common
Hypersensitivity reactions2
Uncommon
Anaphylactic reaction
Rare
Delayed-type, non-acute hypersensitivity reactions
Psychiatric disorders
Common
Depression
Uncommon
Suicidal behaviour, suicidal ideation
Nervous system disorders
Common
Migraine
Gastrointestinal disorders
Common
Diarrhoea, nausea
Skin and subcutaneous tissue disorders
Common
Injection site reactions3, urticaria, rash
Uncommon
Angioedema
Not known
Stevens-Johnson syndrome, toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders
Common
Pain in extremity
General disorders and administration site conditions
Common
Infusion or injection-related systemic reactions2, pyrexia
1 See 'Description of selected adverse reactions' and section 4.4 '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.
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.
The incidence of infusion reactions and hypersensitivity reactions after intravenous administration occurring within 3 days of an infusion was 12 % in the group receiving Benlysta and 10 % in the group receiving placebo, with 1.2 % and 0.3 %, 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 treatment discontinuation were reported in 0.2 % of patients receiving Benlysta and in no patients receiving placebo.
Infections: The overall incidence of infections in intravenous and subcutaneous pre-registration SLE studies was 63 % in both groups receiving Benlysta or placebo. Infections occurring in at least 3 % of patients receiving Benlysta and at least 1 % more frequently than patients receiving placebo were viral upper respiratory tract infection, bronchitis, and urinary tract infection bacterial. Serious infections occurred in 5 % of patients in both groups receiving Benlysta or placebo; serious opportunistic infections accounted for 0.4 % and 0 % of these, respectively. Infections leading to discontinuation of treatment occurred in 0.7 % of patients receiving Benlysta and 1.5 % of patients receiving placebo. Some infections were severe or fatal.
For information on infections observed in paediatric patients with SLE see Paediatric population section below.
In the lupus nephritis study, patients were receiving a background of standard therapy (see section 5.1) and the overall incidence of infections was 82 % in patients receiving Benlysta compared with 76 % in patients receiving placebo. Serious infections occurred in 13.8 % of patients receiving Benlysta and in 17.0 % of patients receiving placebo. Fatal infections occurred in 0.9 % (2/224) of patients receiving Benlysta and in 0.9 % (2/224) of patients receiving placebo.
In a randomised, double-blind, 52-week, post-marketing safety SLE study (BEL115467) which assessed mortality and specific adverse events in adults, serious infections occurred in 3.7 % of patients receiving Benlysta (10 mg/kg body weight intravenously) vs. 4.1 % of patients receiving placebo. However, fatal infections (e.g. pneumonia and sepsis) occurred in 0.45 % (9/2002) of Benlysta-treated patients vs. 0.15 % (3/2001) of patients receiving placebo, while the incidence of all-cause mortality was 0.50 % (10/2002) vs. 0.40 % (8/2001), respectively. Most fatal infections were observed during the first 20 weeks of treatment with Benlysta.
Psychiatric disorders: In the pre-registration intravenous SLE clinical studies, serious psychiatric events were reported in 1.2 % (8/674) of patients receiving Benlysta 10 mg/kg body weight and 0.4 % (3/675) of patients receiving placebo. Serious depression was reported in 0.6 % (4/674) of patients receiving Benlysta 10 mg/kg body weight and 0.3 % (2/675) of patients receiving placebo. There were two suicides in Benlysta-treated patients (including one receiving Benlysta 1 mg/kg body weight).
In a post-marketing SLE study, serious psychiatric events were reported in 1.0 % (20/2002) of patients receiving Benlysta and 0.3 % (6/2001) of patients receiving placebo. Serious depression was reported in 0.3 % (7/2002) of patients receiving Benlysta and < 0.1 % (1/2001) of patients receiving placebo. The overall incidence of serious suicidal ideation or behaviour or self-injury without suicidal intent was 0.7 % (15/2002) in patients receiving Benlysta and 0.2 % (5/2001) in the placebo group. No suicide was reported in either group.
The intravenous SLE studies above did not exclude patients with a history of psychiatric disorders.
In the subcutaneous SLE clinical study, which excluded patients with a history of psychiatric disorders, serious psychiatric events were reported in 0.2 % (1/556) of patients receiving Benlysta and in no patients receiving placebo. There were no serious depression‑related events or suicides reported in either group.
Leucopenia: The incidence of leucopenia reported in patients with SLE as an adverse event was 3 % in the group receiving Benlysta and 2 % in the group receiving placebo.
Injection site reactions: In the subcutaneous SLE study, the frequency of injection site reactions was 6.1 % (34/556) and 2.5 % (7/280) for patients receiving Benlysta and placebo, respectively. These injection site reactions (most commonly pain, erythema, hematoma, pruritus and induration) were mild to moderate in severity. The majority did not necessitate drug discontinuation.
Paediatric population
The adverse reaction profile in paediatric patients is based on one subcutaneous study and one intravenous study.
In a 52-week open-label study in which 25 paediatric patients (10 to 17 years of age) with SLE received subcutaneous Benlysta at a comparable exposure to adults (200 mg at a set dosing interval based on body weight, on a background of concomitant treatments), the safety profile in paediatric patients receiving Benlysta subcutaneously was consistent with the known safety profile for belimumab.
In a 52-week placebo-controlled study in which 53 patients (6 to 17 years of age) with SLE received Benlysta (10 mg/kg body weight intravenously on Days 0, 14, 28, and then every 28 days, on a background of concomitant treatments), no new safety signals were observed in the paediatric population 12 years of age and above (n = 43). Safety data in children younger than 12 years of age (n = 10) are limited.
Infections
5- to 11-year-old group: infections were reported in 8/10 patients receiving Benlysta intravenously and 3/3 patients receiving placebo, and serious infections were reported in 1/10 patients receiving Benlysta intravenously and 2/3 patients receiving placebo (see section 4.4).
12- to 17-year-old group: infections were reported in 22/43 patients receiving Benlysta intravenously and 25/37 patients receiving placebo, and serious infections were reported in 3/43 patients receiving Benlysta intravenously and 3/37 patients receiving placebo. In the open-label extension phase there was one fatal infection in a patient receiving Benlysta intravenously.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is limited clinical experience with overdose of Benlysta. Adverse reactions reported in association with cases of overdose have been consistent with those expected for belimumab.
Two doses up to 20 mg/kg body weight administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg body weight.
In the case of inadvertent overdose, patients should be carefully observed and supportive care administered, as appropriate.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- BENLYSTA prescriptionBELIMUMABUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- BenlystaBelimumabum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Benlysta 200 mg solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.