Benlysta 200 mg solution for injection in pre-filled pen – patient leaflet, side effects, dosage

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) 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.

1. 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 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. 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 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 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:

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.

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, 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

• 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 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.

62000000103360_A

Package leaflet: Information for the user

200 mg

solution for injection in pre-filled pen belimumab

English

62000000103360_A

Package leaflet: Information for the user

200 mg

solution for injection in pre-filled pen

belimumab English

6. Contents of the pack and other information

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

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.

©2026 GSK group of companies or its licensor.

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Page 1 of 2 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.

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

Inspection window

Gold needle guard

(needle inside)

Expiry date Ring cap

Grey stopper

Supplies you need for the injection

Benlysta pre-filled pen

Alcohol swab

(not included) Gauze pad or

cotton wool ball

(not included)

2 Prepare and inspect the

pre-filled pen

Allow to come to room temperature

➤ Leave the pen at room temperature

for 30 minutes. (Figure 4) Injecting cold Benlysta may take longer and may be uncomfortable.

Wait 30 minutes

Figure 4

✘ 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.

Benlysta solution

Figure 5

✘ 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.

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)

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 90° angle). Make sure the gold needle guard is flat on the skin.

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.

62000000103360_A 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)

➤ Holding the middle of the pre-filled

pen (near the inspection window), carefully take the pre-filled pen out of the tray. (Figure 2)

Check the expiry date

➤ Check the expiry date on the

pre-filled pen. (Figure 3)

Figure 3

✘ Do not use if the expiry date has

passed

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.

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

Purple indicator

first “click”

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)

Figure 12

Then wait until…

• 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.

Figure 1

Figure 2

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