Package leaflet: Information for the user

Benlysta 200 mg solution for injection in pre-filled pen

belimumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

What Benlysta is and what it is used for
What you need to know before using Benlysta
How to use Benlysta
Possible side effects
How to store Benlysta
Contents of the pack and other information
Step-by-step instructions for using the pre-filled pen

1. What Benlysta is and what it is used for

Benlysta for subcutaneous injection is a medicine used to treat lupus (systemic lupus
erythematosus, SLE) in adults (aged 18 years and older) and in children (aged 5 to less than 18 years and
with a body weight of at least 15 kg) whose disease remains highly active despite standard treatment.
Benlysta is also used, in combination with other medicines, to treat adults (aged 18 years and older) with active
lupus nephritis (kidney inflammation caused by lupus).
Lupus is a disease in which the immune system (the system that fights infections) attacks the body's own cells
and tissues, causing inflammation and organ damage. It can affect almost any organ in the body, and a type of
white blood cells called B cells is thought to be involved.
Benlysta contains belimumab (a monoclonal antibody). This reduces the number of B cells in the blood by
blocking the action of BLyS, a protein that helps B cells survive longer and which is present in high levels in
people with lupus.
You will receive both Benlysta and your usual lupus treatment.

2. What you need to know before using Benlysta

Do not use Benlysta:

if you are allergic to belimumab or to 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 using Benlysta:

if you currently have an infection or have had a long-term infection, or if you are prone to frequent infections. Your doctor will decide whether Benlysta can be given to you
if you are planning a vaccination or have been vaccinated within the last 30 days. Some types of vaccines should not be administered immediately before or during treatment with Benlysta
if lupus affects your nervous system
if you are HIV positive or have low levels of immunoglobulins
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 a tumour
if you have developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after using Benlysta.

➔ Inform your doctor if any of these situations apply to you.
Depression and suicide
There have been reports of depression, suicidal thoughts and suicide attempts, including completed suicides, during treatment with Benlysta. Inform your doctor if you have previously experienced any of these conditions. If at any time you notice the onset or worsening of symptoms:
➔ Contact your doctor or go to hospital immediately.
If you feel depressed or are thinking about harming yourself or committing suicide, it may be helpful to talk about this with a close family member or friend and ask them to read this leaflet. You may ask them to tell you if they are concerned about changes in your mood or behaviour.
Serious skin reactions
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment with Benlysta.
➔ Stop using Benlysta and contact a doctor immediately if you notice any of the symptoms described in section 4.
Be alert to important symptoms
People taking medicines that affect the immune system may be at increased 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 traceability of this medicine, you and the healthcare provider should record the batch number of Benlysta. You are advised to note down this information in case you are asked for it in the future.
Children and adolescents
Benlysta pre-filled pen for subcutaneous injection must not be used in children under 5 years of age or weighing less than 15 kg for the treatment of SLE.
Benlysta pre-filled pen for subcutaneous injection must not be used in children or adolescents under 18 years of age for the treatment of lupus nephritis.
Other medicines and Benlysta
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are being treated with medicines that affect the immune system, including any medicine that acts on B-cells (used to treat tumours or inflammatory diseases).
Combining these medicines with Benlysta may make the immune system less effective. This may increase the risk of a serious infection.
Pregnancy and breastfeeding
Contraception for women who could become pregnant

Use an effective method of contraception while being treated with Benlysta and for at least 4 months after the last dose.

Pregnancy
Benlysta is generally not recommended if you are pregnant.

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant. Your doctor will decide whether you can use Benlysta.
If you become pregnant during treatment with Benlysta, inform your doctor.

Breastfeeding
Inform your doctor if you are breastfeeding. Benlysta is likely to pass into breast milk. Your doctor will discuss with you whether you should stop treatment with Benlysta while breastfeeding or whether you should stop breastfeeding.
Driving and using machines
Benlysta may have side effects that could affect your ability to drive or operate machinery.
Benlysta contains polysorbate 80
This medicine contains 0.1 mg of polysorbate 80 per pre-filled pen. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have known allergies.
Benlysta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Benlysta

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Benlysta must be injected under the skin according to the schedule prescribed by your doctor.
Dosage
Systemic lupus erythematosus
Adults
The recommended dose is 200 mg (entire contents of one pen) once weekly.
Children and adolescents from 5 years of age
The recommended dose for children and adolescents from 5 years of age is based on body weight, as indicated below:

Body weight	Recommended dose
50 kg or more	200 mg (entire content of one pen) once weekly
30 kg to less than 50 kg	200 mg (entire content of one pen) every 10 days
15 kg to less than 30 kg	200 mg (entire content of one pen) every 2 weeks

Lupus nephritis
Adults only
The recommended dose may vary. Your doctor will prescribe the dose that is right for you, which is:

a 200 mg dose (entire contents of one pen) once weekly

a 400 mg dose (entire contents of two pens on the same day) once weekly for 4 weeks. After this, the recommended dose is 200 mg (entire contents of one pen) once weekly.

If you wish to change the day of administration
Take a dose on the new day (even if the time since the last dose is shorter than usual). Continue with the
new schedule from that day onward.
Benlysta injection
Your doctor or nurse will show you or your caregiver how to inject Benlysta. The first injection with the
Benlysta pre-filled pen must be given under the supervision of a doctor or nurse. Once you have been
instructed on how to use the pen, the doctor or nurse may decide that you or your caregiver can administer the
injection. Your doctor or nurse will also inform you about which signs and symptoms to watch for when using
Benlysta, as serious allergic reactions may occur (see “Allergic reactions” in section 4).
For children under 10 years of age, the Benlysta pre-filled pen must be administered by a doctor, nurse, or trained assistant.
Benlysta should be injected under the skin in the abdominal area (abdomen) or upper leg (thigh).
Subcutaneous injection of Benlysta must not be administered into a vein (intravenous administration).
Instructions for using the pre-filled pen are provided at the end of this leaflet.
If you use more Benlysta than you should
If this happens, contact your doctor or nurse immediately. They will monitor you for any signs or symptoms of adverse effects and treat them if necessary. If possible, show them the packaging or this leaflet.
If you forget to use Benlysta
Inject the missed dose as soon as you remember. Then continue with your usual weekly schedule, or start a new weekly schedule beginning on the day the missed dose was administered.
If you do not realize you have missed a dose until it is time for your next scheduled dose, administer only the next scheduled dose as planned.
Stopping treatment with Benlysta
Your doctor will decide whether you need to stop treatment with Benlysta.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop using Benlysta and contact a doctor immediately if you notice any of the following symptoms of a
serious skin reaction:

Reddish patches on the trunk; the patches are target-like or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). These side effects have been reported with an unknown frequency (cannot be estimated from available data).

Allergic reactions — seek immediate medical help
Benlysta may cause an injection-site reaction or an allergic reaction ( hypersensitivity ). These reactions are
common side effects (may affect up to 1 in 10 people). Occasionally (uncommon, may affect up to 1 in 100),
they may be severe and can be life-threatening. These serious reactions are most likely to occur on the day of
the first or second treatment with Benlysta, but may be delayed and occur several days later.
Contact your doctor or nurse immediately or go to the nearest hospital emergency department if you
experience any of the following symptoms of an allergic or injection-related reaction:

swelling of the face, lips, mouth, or tongue
wheezing, difficulty breathing, or shortness of breath
skin rash
itchy swellings or hives

Rarely, less severe adverse reactions may occur with Benlysta later, usually 5–10 days after injection. These
include symptoms such as rash, nausea, fatigue, muscle pain, headache, and facial swelling.
If you experience these symptoms, especially if two or more occur together:
➔ Inform your doctor or nurse.

Infections
Benlysta may make you more likely to get infections, including urinary and respiratory tract infections. These
are very common and may affect more than 1 in 10 people. Some infections may be severe and may result in
death, occurring uncommonly.
If you experience any of the following signs of infection:

fever and/or chills
cough, breathing problems
diarrhea, vomiting
burning sensation when passing urine; frequent urination
warm, red, or painful skin or sores on the body
➔ Contact your doctor or nurse immediately.

Depression and suicide
Cases of depression, suicidal thoughts, and suicide attempts have been reported during treatment with
Benlysta. Depression may affect up to 1 in 10 people, while suicidal thoughts and suicide attempts may affect
up to 1 in 100 people. If you feel depressed, think about harming yourself, have other distressing thoughts, or
if you are depressed and notice your condition worsening or new symptoms appearing:
➔ Contact your doctor or go to hospital immediately.

Increased risk of brain infection
Medicines that weaken the immune system, such as Benlysta, may increase your risk of developing a rare but
serious and potentially life-threatening brain infection called progressive multifocal leukoencephalopathy
(PML).
Symptoms of PML include:

memory loss
difficulty thinking
difficulty speaking or walking
loss of vision
➔ Contact your doctor immediately if you experience any of these symptoms or similar problems lasting for several days.

If you already had these symptoms before starting treatment with Benlysta:
➔ Contact 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 at the site where Benlysta was injected
itching, swellings (hives), skin rash
reduced number of white blood cells (visible in blood tests)
infection of the nose, throat, or stomach
pain in hands or feet
migraine
nausea, diarrhea

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. 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 stated on the label and the carton after "Exp". The expiry date refers to the last day of the month.
Store in a refrigerator (from 2 °C to 8 °C).
Do not freeze.
Keep in the original packaging to protect the medicine from light.
A single pre-filled Benlysta pen may be stored at room temperature (up to 25°C) for a maximum of 12 hours, provided it is protected from light. Once removed from the refrigerator, the pen must be used within 12 hours or discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Benlysta contains
The active substance is belimumab.
Each 1 mL pre-filled pen contains 200 mg of belimumab.
The excipients are arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80 (E 433), sodium chloride,
water for injections. See section 2 for further information on the content of polysorbate 80
and sodium.

Description of the appearance of Benlysta and contents of the pack
Benlysta is supplied as a solution ranging from colourless to pale yellow in a single-use 1 mL pre-filled pen.
Available in packs of 1 or 4 pre-filled pens per pack, and multiple packs containing
12 pre-filled pens (3 packs of 4 pre-filled pens).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma
Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline Trading Services Limited
Tél/Tel: + 32 (0)10 85 52 00 Tel: + 370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Trading Services Limited
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél.: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel:+ 385 800787089 Tel: + 40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000 Tel: + 386 80688869

Ísland Slovenská republika
Vistor ehf. GlaxoSmithKline Trading Services Limited
Sími: +354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Trading Services Limited
Tel: + 371 80205045

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Step-by-step instructions for using the pre-filled pen

Once weekly: for adults and for children aged 5 to less than 18 years and weighing 50 kg or more.
Every 10 days: for children aged 5 to less than 18 years and weighing between 30 kg and less than 50 kg.
Every 2 weeks: for children aged 5 to less than 18 years and weighing between 15 kg and less than 30 kg.

Read these sections first
Follow these instructions on how to correctly use the pre-filled pen. Failure to follow these instructions may affect the proper functioning of the pre-filled pen. You must also be trained on how to use the pre-filled pen.
Benlysta must be used exclusively under the skin (subcutaneously).

To improve traceability of this medicinal product, you and the healthcare provider should record the batch number of Benlysta. It is recommended that you note this information in case it is requested in the future.

Storage

Keep refrigerated until 30 minutes before use.
Keep in the outer carton to protect from light.
Keep out of the sight and reach of children.
Keep away from heat sources and direct sunlight.
Do not freeze. If the pen has been frozen, do not use it even if it has been thawed.
Do not use and do not return to the refrigerator if left at room temperature for more than 12 hours.

Warnings

The pre-filled pen must be used only once and then discarded.
Do not share the Benlysta pre-filled pen with other people.
Do not shake.
Do not use if dropped on a hard surface.
Do not remove the cap until shortly before injection.

Parts of the Benlysta pre-filled pen
Cap Inspection window

Technical diagram of a medical device with separated components showing a cap, a yellow connector, and a main body with a window

Golden needle shield Grey cap Expiry date
(internal needle)

Materials needed for injection

Elongated white medical device with a circular hole and a horizontal slit above two small white squares with a vapor cloud

Benlysta pre-filled pen
Alcohol swab Gauze or cotton ball
(not included) (not included)

1. Prepare and check the materials

Prepare the materials

Remove from the refrigerator a sealed tray containing a prefilled pen.
Return any remaining prefilled pens to the refrigerator.
Find a clean, well-lit, and comfortable surface, and gather the following supplies within easy reach:
- Benlysta prefilled pen
- Alcohol swabs ( not included in the package )
- Gauze or cotton ball ( not included in the package )
- Sealed container with lid for safe disposal of the pen ( not included in the package ).
Do not administer the injection if any of the listed supplies are missing.

Remove the prefilled pen

Peel back the film from the corner of the tray. ( Figure 1 )

Figure 1

Holding the center part of the prefilled pen (near the inspection window), carefully remove the prefilled pen from the tray. ( Figure 2 )

Figure 2

A hand holds horizontally a rectangular medical device with a dark circle on the left and a central elongated slit

Check the expiration date

Check the expiration date on the prefilled pen. ( Figure 3 )

Figure 3

Technical drawing of an elongated white medical device with a circular hole on the left and a central horizontal slit with an enlarged detail

Do not use after the expiration date.

2. Prepare and inspect the prefilled pen

Allow to reach room temperature

Leave the pen at room temperature for 30 minutes ( Figure 4 ). Injecting cold Benlysta may take longer and could be uncomfortable.

Figure 4

White timer with a dial showing 30 seconds and a yellow highlighted section on a black background with a golden horizontal stripe

Wait 30 minutes

Do not warm the pen in any other way. For example, do not heat in a microwave, in hot water, or in direct sunlight.
Do not remove the cap during this step.

Inspect the Benlysta solution

Look through the inspection window to check that the Benlysta solution is colorless to pale yellow. ( Figure 5 )
It is normal to see one or more air bubbles in the solution.

Figure 5
Benlysta solution

Black and white drawing of a hand holding a medical device with an arrow indicating a small dark oval window

Do not use if the solution is cloudy, discolored, or contains particles.

3. Choose and clean the injection site

Choose the injection site

Select an injection site (abdomen or thigh) as shown in Figure 6.

Figure 6

Stylized schematic of a human body with highlighted green areas on the

If 2 injections are needed to complete the dose, leave at least 5 cm (2 inches) between each injection site if the same general area is chosen.
Do not inject exactly at the same site each time. This is to avoid skin thickening.
Do not inject in areas where the skin is tender, bruised, red, or hardened.
Do not inject within 5 cm (2 inches) of the navel.

Clean the injection site

Wash your hands.
Clean the injection site by rubbing with an alcohol swab ( Figure 7 ). Allow the skin to air dry.

Figure 7

A hand applies a small adhesive patch to the skin surface of a human body on a black background

Do not touch this area before giving the injection.

4. Preparing for the injection

Remove the cap

Do not remove the cap until immediately before the injection.
Remove the cap by pulling or twisting it. The cap can be twisted either clockwise or counterclockwise. ( Figure 8 )

Figure 8

Two black hands assemble a medical device with a rotational motion indicated by a circular arrow and a black arrow pointing to the right

Do not reattach the cap onto the pen.

Position the pen

Hold the pen comfortably so that you can see the inspection window. This is important to ensure complete administration. ( Figure 9 )

Figure 9

A hand holds an injection pen vertically at 90 degrees to the surface of white skin on a black background

If necessary, prepare the injection site by pinching or stretching the skin.
Position the pen straight onto the injection site (at a 90° angle). Make sure the golden needle shield is flat against the skin.

5. Inject Benlysta and inspect

Start the injection

Firmly press the pen fully down onto the injection site and hold in place. (Figure 10)
This will insert the needle and start the injection.

Figure 10

A hand holds a gray and yellow medical device being pushed downward onto a white surface indicated by a purple arrow

You may hear a first "click" at the beginning of the injection. You will see the purple indicator start to move across the viewing window. (Figure 11)

Figure 11

A hand grips a rectangular medical device with a white speech bubble indicating a small purple section with internal horizontal lines

first "click"
purple indicator
Complete the injection

Continue to hold the pen pressed down until the purple indicator stops moving.
You may hear a second "click" a few seconds before the purple indicator stops moving. (Figure 12)

Figure 12

A hand holds a black medical device with a green indicator pointing toward a circular magnification of the illuminated component

Then wait until
the…
second "click"
…purple indicator
stops moving

The injection may take up to 15 seconds to complete.
When the injection is complete, lift the pen away from the injection site.

Inspect the injection site
A small amount of blood at the injection site may be present.

If needed, press a cotton ball or gauze pad against the injection site.
Do not rub the injection site.

6. Disposal of the used pen

Disposal of the used pen

Do not re-cap the pen.
Dispose of the used pen and cap in a puncture-resistant, tightly-closing container.
Ask your doctor or pharmacist for instructions on how to properly dispose of the used pen or the container for used pens.
Do not recycle or throw the used pen or the container for used pens into household waste.

Package leaflet: Information for the user

Benlysta 200 mg solution for injection in pre-filled syringe

belimumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

What Benlysta is and what it is used for
What you need to know before using Benlysta
How to use Benlysta
Possible side effects
How to store Benlysta
Contents of the pack and other information
Step-by-step instructions for using the pre-filled syringe

1. What Benlysta is and what it is used for

Benlysta for subcutaneous injection is a medicine used to treat lupus (systemic lupus erythematosus, SLE) in adults (aged 18 years and older) whose disease remains highly active despite standard treatment. Benlysta is also used, in combination with other medicines, to treat adults (aged 18 years and older) with active lupus nephritis (lupus-related kidney inflammation).
Lupus is a disease in which the immune system (the system that fights infections) attacks the body's own cells and tissues, causing inflammation and organ damage. It can affect almost any organ in the body, and it is believed that a type of white blood cells called B cells is involved.
Benlysta contains belimumab (a monoclonal antibody). This reduces the number of B cells in the blood by blocking the action of BLyS, a protein that helps B cells survive longer and which is present in high levels in people with lupus.
You will be given both Benlysta and your usual lupus treatment.

2. What you should know before using Benlysta

Do not use Benlysta:

if you are allergic to belimumab or to 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 using Benlysta

if you have an ongoing or chronic infection, or if you frequently get infections. Your doctor will decide whether Benlysta can be given to you
if you are planning a vaccination or have been vaccinated within the last 30 days. Some types of vaccines should not be administered immediately before or during treatment with Benlysta
if lupus affects your nervous system
if you are HIV positive or have low levels of immunoglobulins
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 a tumour
if you have developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after using Benlysta.

➔ Inform your doctor if any of these situations apply to you.
Depression and suicide
Cases of depression, suicidal thoughts, and suicide attempts, including suicide, have been reported during treatment with Benlysta. Inform your doctor if you have previously experienced any of these conditions. If at any time you notice the onset or worsening of symptoms:
➔ Contact your doctor or go to hospital immediately.
If you feel depressed or are thinking about harming yourself or committing suicide, it may be helpful to talk about this with a close family member or friend and ask them to read this leaflet. You may also ask them whether they are concerned about changes in your mood or behaviour.
Severe skin reactions
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment with Benlysta.
➔ Stop using Benlysta and contact a doctor immediately if you notice any of the symptoms described in section 4.
Be alert to important symptoms
People taking medicines that affect the immune system may be at increased risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).
➔ Read the information on “Increased risk of brain infection” in section 4 of this leaflet.
To improve traceability of this medicine, you and the healthcare provider should record the batch number of Benlysta. You are advised to keep a note of this information in case you are asked for it in the future.
Children and adolescents
Benlysta pre-filled syringe for subcutaneous injection must not be used in children or adolescents under 18 years of age.
Other medicines and Benlysta
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are being treated with medicines that affect the immune system, including any medicine acting on B-cells (used to treat tumours or inflammatory diseases).
Combining these medicines with Benlysta may make the immune system less effective. This may increase the risk of a serious infection.
Pregnancy and breastfeeding
Contraception for women who could become pregnant

Use an effective method of contraception during treatment with Benlysta and for at least 4 months after the last dose.

Pregnancy
Benlysta is not usually recommended if you are pregnant.

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant. Your doctor will decide whether you can use Benlysta.
If you become pregnant while being treated with Benlysta, inform your doctor.

Breastfeeding
Inform your doctor if you are breastfeeding. Benlysta is likely to pass into breast milk. Your doctor will discuss with you whether you should stop treatment with Benlysta while breastfeeding or whether you should stop breastfeeding.
Driving and using machines
Benlysta may have side effects that could affect your ability to drive or operate machinery.
Benlysta contains polysorbate 80
This medicine contains 0.1 mg of polysorbate 80 in each pre-filled syringe. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.
Benlysta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.