Patient leaflet - Benlysta 200 mg solution for injection in Pre-filled syringe
1. What Benlysta is and what it is used 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) 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 use 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.
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 syringe as a subcutaneous injection is not intended to be used in children or adolescents younger than 18 years of age.
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.
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 syringe. Polysorbates may cause allergic reactions. Tell your doctor if you have 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 Benlysta is used
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 on the same day each week.
How much to use
Adults (18 years of age and older)
Systemic lupus erythematosus
The recommended dose is 200 mg (complete contents of one syringe) once a week.
Lupus nephritis
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 syringe) once a week.
or
- a dose of 400 mg (complete contents of two syringes in one day) once a week for 4 weeks. After this, the recommended dose is 200 mg (complete contents of one syringe) once a week.
If you wish to change your dosing day
Take a dose on the new day (even if it is less than a week since your last dose). Continue with the new weekly 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 syringe will be supervised by your doctor or nurse. After you have been trained on how to use the syringe, 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).
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 syringe 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.
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 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, can 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
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 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 syringe 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 syringe 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
What Benlysta contains
The active ingredient is belimumab.
Each 1 mL pre-filled syringe 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 syringe with a needle cap.
Available in packs of 1 or 4 pre-filled syringes in each pack.
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
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Product name – Benlysta 200 mg solution for injection in pre-filled syringe
Reference number – 19494/0319
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in January 2026
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© 2026 GSK group of companies or its licensor
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Step-by-step instructions for using the pre-filled syringe
Once-Weekly: for adults only
Read These Sections First
Follow these instructions on how to use the pre-filled syringe correctly. Failure to follow these instructions may affect proper function of the pre-filled syringe. You will also need to receive training on how to use the pre-filled syringe.
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 pre-filled syringe has been frozen, do not use the pre-filled syringe 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 syringe must only be used once and then discarded.
- Do not share your Benlysta pre-filled syringe with another person.
- Do not shake.
- Do not use if dropped onto a hard surface.
- Do not remove the needle cap until just before the injection.
Benlysta pre-filled syringe parts
Supplies you need for the injection
Before use
Needle cap
Needle Body Plunger
Inspection window
Finger grips
After use — needle is covered by needle guard
Needle guard activated
Benlysta pre-filled syringe
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 syringe from the refrigerator.
- Place any remaining pre-filled syringes back into the refrigerator.
Find a comfortable, well-lit and clean surface and place the following supplies within reach:
- Benlysta pre-filled syringe
- 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 syringe disposal (not included in the pack).
- Do not perform the injection if you do not have all the supplies listed.
Take out the syringe
- Peel back the film from the corner of the tray. (Figure 1)
Figure 1
- Holding the middle of the pre-filled syringe (near the inspection window), carefully take the pre-filled syringe out of the tray. (Figure 2)
Figure 2
Check the expiry date
- Check the expiry date on the pre-filled syringe. (Figure 3)
Figure 3
- Do not use if the expiry date has passed.
- Prepare and inspect the pre-filled syringe
Allow to come to room temperature
- Leave the syringe at room temperature for 30 minutes. (Figure 4) Injecting cold Benlysta may take longer and may be uncomfortable.
Figure 4
- Do not warm the syringe in any other way. For example, do not warm it in a microwave oven, hot water or direct sunlight.
- Do not remove the needle 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.
Exp: Month – Year
Exp: Month – Year
Wait 30 minutes min
Figure 5
- Do not use if the solution looks cloudy, discoloured or has particles.
- Choose and clean the injection site
Choose the injection site
- Choose an injection site (abdomen or thigh) as seen in Figure 6.
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).
Benlysta solution 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.
- Prepare for the injection
Remove the needle cap
- Do not remove the needle cap until immediately before the injection.
- Hold the pre-filled syringe by the body, and with the needle facing away from you. (Figure 8a)
- Remove the needle cap by pulling it straight off. (Figure 8b)
Figure 8
- You may see a drop of liquid at the end of the needle. This is normal.
- Do not let the needle touch any surface.
a
b
- Do not expel any air bubbles from the syringe.
- Do not put the needle cap back onto the syringe.
- Inject Benlysta and Inspect
Insert the needle
- Hold the syringe in one hand.
- Use your free hand to gently pinch the skin around the injection site. (Figure 9)
- Insert the entire needle into the pinched area of the skin at a slight angle (45°), using a dart-like motion.
Figure 9
- After the needle is completely inserted, release the pinched skin.
Complete the injection
- Push the plunger all the way down until all of the solution is injected. (Figure 10)
Figure 10
Keeping hold of the syringe, slowly move your thumb back, allowing the plunger to rise up
(Figure 11). The needle will automatically rise up into the needle guard.
Push the plunger all the way down
Figure 11
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.
- Dispose of used syringe
Dispose of the used syringe
- Dispose of the used syringe and needle cap in a container with a tight-fitting lid.
- Ask your doctor or pharmacist for instructions on how to properly dispose of a used syringe or container of used syringes.
Do not recycle or throw the used syringe, or the container of used syringes in household waste.
Slowly move your thumb back