BENLYSTA 120 mg Порошок Для Раствора Для Внутривенного Введения

Наталья Бессолицына

Наталья Бессолицына — врач-ревматолог высшей категории. Проводит онлайн-консультации по диагностике, лечению и сопровождению пациентов с заболеваниями суставов и системными болезнями соединительной ткани. В работе опирается на международные клинические рекомендации и методы доказательной медицины.

С какими симптомами и диагнозами можно обратиться:

Боли в суставах — острая, хроническая, рецидивирующая боль.
Артриты: ревматоидный артрит, псориатический артрит, полиартрит, подагрический артрит.
Артрозы: остеоартроз, коксартроз, гонартроз, узелковый полиостеоартроз.
Плечелопаточный периартрит и спондилоартриты.
Хронические воспалительные заболевания позвоночника — болезнь Бехтерева.
Системные аутоиммунные заболевания: системная красная волчанка, склеродермия, системные васкулиты.
Остеопороз и нарушение плотности костей.

Наталья Бессолицына помогает разобраться в причинах болей, назначает необходимые обследования и подбирает индивидуальное лечение с учётом состояния пациента, образа жизни и риска прогрессирования болезни. Основной акцент — на раннюю диагностику, профилактику осложнений и улучшение качества жизни.

Онлайн-формат позволяет получить квалифицированную ревматологическую помощь независимо от региона проживания.

Записаться на онлайн-консультацию

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Инструкция по применению BENLYSTA

Содержание инструкции

Benlysta 200 mg injectable solution in pre-filled pen
Benlysta 200 mg injectable solution in pre-filled syringe
Benlysta 120 mg powder for concentrate for solution for infusion, 400 mg powder for concentrate for solution for infusion

Benlysta 200 mg injectable solution in pre-filled pen

belimumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced during
the use of this medicine. See the end of section 4 for information on how to report adverse
effects.

Read this leaflet carefully before using this medicine as 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 others, even if they have the same symptoms as you, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Benlysta and what is it used for

Benlysta for subcutaneous injection is a medicine used to treat lupus(systemic lupus
erythematosus, SLE) in adults (aged 18 years and over) and in children (from 5 to less than 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 (aged 18 years and over) with active lupus nephritis (kidney inflammation related to 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
every organ in the body and is believed to involve a type of white blood cell, called B cells.
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 live longer and which is present in
high amounts in people with lupus.
You will be given both Benlysta and your usual lupus treatment.

2. What you need to know before you use Benlysta

Do not use Benlysta:

if you are allergicto belimumab or to any of the other ingredients of this medicine ( listed in section 6)

➔ Check with your doctorif this applies to you.

Warnings and precautions
Talk to your doctor before using Benlysta:

if you have a current or long-standing infectionor are frequently prone to infections. Your doctor will decide whether Benlysta can be given to you
if you are planning a vaccinationor have been vaccinated in the last 30 days. Certain types of vaccines should not be given immediately before or during treatment with Benlysta
if lupus affects your nervous system
if you are HIV positiveor have low levels of immunoglobulins
if you have, or have had, hepatitis B or C
if you have had an organ transplantor a bone marrowor stem cell transplant
if you have had cancer
if you have developed a severe skin rashor skin peeling, blistersand/or mouth soresafter using Benlysta.

➔ Tell your doctorif any of these situations apply to you.

Depression and suicide
Reports of depression, suicidal thoughts and suicide attempts, including suicide, have been reported during
treatment with Benlysta. Tell your doctor if you have previously experienced these conditions. If at
any time you experience the onset or worsening of symptoms:
➔ See your doctor or go to hospital immediately.
If you feel depressed or think about harming yourself or committing suicide, it may be helpful to talk to a close
relative or friend and ask them to read this leaflet. You can ask them to tell you if they are concerned about
changes in your mood or behavior.

Severe skin reactions
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment
with Benlysta.
➔ Stop using Benlysta and see a doctor immediately if you notice any of the
symptoms described in section 4.
Pay attention 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.
In order to improve the traceability of this medicine, you and the healthcare professional must record the batch
number of Benlysta. It is recommended that you make a note of this information in case it is requested in
the future.

Children and adolescents
Benlysta pre-filled pen as a subcutaneous injection should 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 as a subcutaneous injection should not be used in children or
adolescents under 18 years of age for the treatment of lupus nephritis.

Other medicines and Benlysta
Tell your doctorif you are taking, have recently taken or might take any other medicines.
In particular, tell 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 cancers 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 effective contraceptionwhile 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, suspect you might be pregnant or are planning to become pregnant. The doctor will decide whether you can use Benlysta.
If you become pregnantwhile being treated with Benlysta, tell your doctor.

Breastfeeding
Tell your doctor if you are breastfeeding.Benlysta is likely to pass into breast
milk. The doctor will discuss with you whether you should stop treatment with Benlysta while breastfeeding or
stop breastfeeding.

Driving and using machines
Benlysta may have side effects that can reduce your ability to drive or operate
machinery.

Benlysta contains polysorbate 80
This medicine contains 0.1 mg of polysorbate 80 in each pre-filled pen. Polysorbates can
cause allergic reactions. Tell 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, that is to say essentially ‘sodium-free’.

3. How to use Benlysta

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Benlysta must be injected under the skin following the schedule prescribed by your doctor.

How much to use
Systemic lupus erythematosus

Adults
The recommended dose is 200 mg (entire content of a pen) once a week.

Children and adolescents 5 years of age and older
The recommended dose for children and adolescents 5 years of age and older is based on body weight, as indicated
below:

Lupus nephritis

Adults only

The recommended dose may vary. Your doctor will prescribe the right dose for you, which is:

a dose of 200 mg (entire content of a pen) once a week

a dose of 400 mg (entire content of two pens in one day) once a week for 4 weeks. After this, the recommended dose is 200 mg (entire content of a pen) once a week.

If you want 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.

Benlysta injection
Your doctor or nurse will show you or someone assisting you how to inject Benlysta. The first injection with
Benlysta pre-filled pen will be under the supervision of your doctor or nurse. Once you have been
instructed on how to use the pen, your doctor or nurse may decide that you or someone assisting you can
administer the injection. Your doctor or nurse will also inform you of any signs and symptoms you should pay
attention to when using Benlysta, as serious allergic reactions may occur (see “ Reactions

allergic” in section 4).
For children under 10 years of age, the Benlysta pre-filled pen must be injected by a doctor,
a nurse or a trained assistant.
Benlysta should be injected under the skin in the abdominal area (abdomen) or the upper part of the leg (thigh).
The subcutaneous injection of Benlysta must not be injected into a vein ( intravenously).
Instructions for use of 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, who will monitor you for
any signs or symptoms of side effects and treat them if necessary. If possible, show them the
package or this leaflet.

Body weight	Recommended dose
50 kg or more	r 200 mg (entire content of a pen) once a week
from 30 kg to less than 50 kg	a 200 mg (entire content of a pen) once every 10 days
from 15 kg to less than 30 kg	F 200 mg (entire content of a pen) once every 2 weeks

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 the time of the next dose, administer only that next dose
as scheduled.

Discontinuation of Benlysta treatment
Your doctor will decide if 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.
manifest them.

Stop using Benlysta and contact your doctor immediatelyif you notice any of the following symptoms of a
severe skin reaction:

reddish patches on the trunk, the patches are target-like or circular spots, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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 attention
Benlysta can cause an injection reaction or an allergic reaction ( hypersensitivity). These reactions are
common side effects (may affect up to 1 in 10 people). They can occasionally (not
common, may affect up to 1 in 100) be serious and life-threatening.
These serious reactions are more likely to occur on the day of the first or second treatment with
Benlysta, but may be delayed and occur several days later.

Immediately inform your doctor or nurse or go to the nearest hospital emergency roomif 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 bumps or hives

Rarely, less serious adverse reactions may occur with Benlysta even later, usually 5-
10 days after the injection. These include symptoms such as rash, nausea, fatigue, muscle
pain, headache and facial swelling.

If you experience these symptoms, especially if you experience two or more together:
➔ Tell your doctor or nurse.
Infections
Benlysta may make you more likely to get infections, including urinary tract and
respiratory infections. These are very common and can affect more than 1 in 10 people. Some infections can
be serious and can cause death with uncommon frequency.

If you experience any of the following symptoms 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. ➔ Tell your doctor or nurse immediately.

Depression and suicide
Reports of depression, suicidal thoughts and suicide attempts have been reported during treatment with
Benlysta. Depression may affect up to 1 in 10 people, suicidal thoughts and suicide attempts
may affect up to 1 in 100 people. If you feel depressed, think about harming yourself, or have other distressing thoughts
or if you are depressed and notice that you are feeling worse or new symptoms appear:
➔ See your doctor or go to the hospital immediately.
Increased risk of brain infection
Medicines that weaken the immune system, such as Benlysta, can put you at greater risk of
contracting a rare, serious and life-threatening brain infection called progressive multifocal
leukoencephalopathy(PML).

Symptomsof PML include:

memory loss,
difficulty thinking,
difficulty speaking or walking,
loss of vision ➔ Tell your doctor immediatelyif you experience any of these symptoms or similar problems that have lasted for several days.

If you already had these symptoms before starting treatment with Benlysta:
➔ Tell your doctor immediatelyif you notice any change in these symptoms.

Other possible side effects
Very common side effects
These can affect more than 1 in 10 people:

bacterial infections ( see “Infections”, above)

Common side effects
These can affect up to 1 in 10 people:

high temperature or fever
reactions at the injection site, for example: rash, redness, itching or swelling of the skin where Benlysta was injected
itching, bumps (hives), rash
decreased number of white blood cells (visible from blood tests)
infection of the nose, throat or stomach
pain in the hands or feet
migraine
nausea, diarrhea

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported 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 which is stated on the label and the package 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.
Store in the original package to protect the medicine from light.
A single pre-filled pen of Benlysta can 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This 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 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 Benlysta and contents of the pack
Benlysta is supplied as a colourless to pale yellow solution in a 1 mL single-use pre-filled pen.
Available in packs of 1 or 4 pre-filled pens in each carton and multi-packs comprising
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 on this medicinal product, contact the local representative of the Marketing Authorisation
Holder:

Lietuva
GlaxoSmithKline Trading Services Limited
Tel: + 370 80000334

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0)10 85 52 00

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

България
GlaxoSmithKline Trading Services Limited
Тел.: + 359 80018205

Magyarország
GlaxoSmithKline Trading Services Limited
Tel.: + 36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Trading Services Limited
Tel: + 356 80065004

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

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GlaxoSmithKline Trading Services Limited
Tel: + 372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
GlaxoSmithKline Trading Services Limited
Tel:+ 385 800787089

France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
[email protected]

România
GlaxoSmithKline Trading Services Limited
Tel: + 40 800672524

Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000

Slovenija
GlaxoSmithKline Trading Services Limited
Tel: + 386 80688869

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
GlaxoSmithKline Trading Services Limited
Tel: + 421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: + 357 80070017

Sverige
GlaxoSmithKline AB
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
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Step-by-step instructions for using the pre-filled pen
Once a week:for adults and for children aged 5 to less than 18 years and weighing 50 kg or
more.

Once every 10 days:for children aged 5 to less than 18 years and weighing between 30 kg and less than
50 kg.

Once 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 use the pre-filled pen correctly. Failure to follow these
instructions may affect the proper functioning of the pre-filled pen. You should also be instructed on
how to use the pre-filled pen.
Benlysta must be used exclusively under the skin( subcutaneously)
In order to improve the traceability of this medicinal product, you and the healthcare professional must record the lot
number of Benlysta. It is recommended that you make a note of this information in case it is requested in
the future.

Storage

Keep refrigerated until 30 minutes before use.
Keep in the carton to protect from light.
Keep out of the sight and reach of children.
Keep away from heat and direct sunlight.
Do notfreeze. If the pen has been frozen, do notuse it even if it has been thawed.
Do notuse and do notreturn 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 notshare Benlysta pre-filled pen with other people.
Do notshake.
Do notuse if dropped on a hard surface.
Do notremove the cap until just before the injection.

Parts of Benlysta pre-filled pen
CapInspection window
Materials you need for the injection

Grey auto-injector device with a yellow button and a transparent window to view the dosage

Gold needle guardGrey capExpiry date
(inner needle)

Benlysta pre-filled pen
Alcohol swab

(not included)

Gauze or cotton ball

(not included)

1. Prepare and check the materials

Prepare the materials

Remove a sealed tray containing a pre-filled pen from the refrigerator.
Return any remaining pre-filled pens to the refrigerator.
Find a clean, well-lit, and comfortable surface and have the following materials readily available:
Benlysta pre-filled pen
alcohol swabs ( not included in the package)
gauze or cotton ball ( not included in the package)
a container with a tight-fitting lid for disposing of the pen ( not included in the package).
Do notadminister the injection if you do not have all the listed supplies.

Remove the pre-filled pen

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

Figure 1

Hand pressing the release button on a rectangular gray device with a transparent window

Holding the central part of the pre-filled pen (near the inspection window), carefully remove the pre-filled pen from the tray. ( Figure 2)

Figure 2

Hand holding a rectangular gray device with a purple viewing window and a circular button

Check the expiration date

Check the expiration date on the pre-filled pen. ( Figure 3)

Figure 3

White injectable pen with purple button and detailed enlargement of

Do notuse after the expiration date.

2. Prepare and inspect the pre-filled pen

Allow to reach room temperature

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

Figure 4

White stopwatch with a red hand indicating 30 seconds on a yellow and black background

Wait 30 minutes

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

Inspect the Benlysta solution

Look in the inspection window to check that the Benlysta solution is from colourless to a light yellow colour. ( Figure 5)

Figure 5

It is normal to see one or more air bubbles in the solution.

Benlysta solution

Grey injectable pen with purple button and arrow indicating pressure with the finger

Do notuse if the solution is cloudy, with colour changes or contains particles.

3. Choose and clean the injection site

Choose the injection site

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

Figure 6

Stylized human body with green areas highlighting regions of abdominal and hip fat accumulation

If 2 injections are needed to complete the dose, leave at least 5 cm (2 inches) between each injection site if the same site is chosen.
Do notinject exactly in the same site each time. This is to avoid skin hardening.
Do notinject in areas where the skin is sensitive, bruised, red, or hardened.
Do notinject within 5 cm (2 inches) of the navel.

Clean the injection site

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

Figure 7

Hand applying an adhesive bandage to the fair skin of an arm or thigh with a gentle motion

Do nottouch this area before administering the injection.

4. Preparing for the injection

Remove the cap

Do notremove the cap until immediately before the injection.
Remove the cap by pulling or rotating it. The cap can be rotated both clockwise and counterclockwise. ( Figure 8)

Figure 8

Black medical device with blue button and green and white arrows indicating rotation and pushing with blue hands

Do notreplace the cap on the pen.

Position the pen

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

Figure 9

Gray auto-injector device held in hand with 90-degree angle applied to the light skin of the arm

If necessary, tighten the injection site by pulling or stretching the skin.
Position the pen straight onto the injection site (at a 90-degree angle). Make sure the golden needle guard is flat against the skin.

5. Inject Benlysta and inspect

Start the injection

Press the pen firmly and completely into the injection site and hold in place. ( Figure 10)
This will insert the needle and begin the injection.

Figure 10

Grey auto-injector device held in hand with yellow needle penetrating the skin indicated by a purple arrow

You may feel a first “click” at the beginning of the injection. You will see the purple indicator start to move along the inspection window. ( Figure 11)

Figure 11

Hand holding a rectangular grey medical device with a purple window and an arrow indicating the point of application

first “click”
purple indicator
Complete the injection

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

Figure 12

Hand holding a green auto-injector device with visible needle and arrow indicating the injection point on the skin

Then wait until
when…
second “click”
… the 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
A small amount of blood may be present at the injection site.

If necessary, press a cotton ball or gauze on the injection site.
Do notrub the injection site.

6. Disposal of the used pen

Disposal of the used pen

Do notreplace the cap on the pen.
Dispose of the used pen and cap in a container with a tight-fitting lid.
Ask your doctor or pharmacist for instructions on how to properly dispose of the used pen or the pen container.
Do notrecycle or dispose of the used pen, or the pen container, in household waste.

Benlysta 200 mg injectable solution in pre-filled syringe

belimumab

Read this leaflet carefully before using this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is Benlysta and what is it used for

Benlysta for subcutaneous injection is a medicine used to treat lupus(systemic lupus
erythematosus, SLE) in adults (aged 18 years or older) whose disease is still highly active
despite standard treatment. Benlysta is also used, in combination with other medicines, to treat
adults (aged 18 years or older) with active lupus nephritis (kidney inflammation related to 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
every organ in the body and is believed to involve a type of white blood cell, called B cells.
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 live longer and which is present in
high amounts in people with lupus.
You will be given both Benlysta and your usual treatment for lupus.

2. What you need to know before you use Benlysta

Do not use Benlysta:

if you are allergicto belimumab or to any of the other ingredients of this medicine ( listed insection 6)

➔ Check with your doctorif this applies to you.

Warnings and precautions
Talk to your doctor before using Benlysta

if you have a current or long-standing infectionor are frequently prone to infections. Your doctor will decide if Benlysta can be given to you
if you are planning a vaccinationor have been vaccinated in the last 30 days. Certain types of vaccines should not be given immediately before or during treatment with Benlysta
if lupus affects your nervous system
if you are HIVpositiveor have low levels of immunoglobulins
if you have, or have had, hepatitis B or C
if you have had an organ transplantor a bone marrowor stem cell transplant
if you have had cancer
if you have developed a severe skin rashor skin peeling, blistersand/or mouth ulcersafter using Benlysta.

➔ Tell your doctorif any of these situations apply to you.

Depression and suicide
There have been reports of depression, thoughts of suicide and suicide attempts, including suicide, during
treatment with Benlysta. Tell your doctor if you have previously experienced these conditions. If at
any time you experience the onset or worsening of symptoms:
➔ See your doctor or go to hospital immediately.
If you feel depressed or think about harming yourself or committing suicide, it may be helpful to talk to a close
relative or friend and ask them to read this leaflet. You can ask them to tell you if they are concerned about
changes in your mood or behavior.

Severe skin reactions
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment
with Benlysta.
➔ Stop using Benlysta and see a doctor immediately if you notice any of the
symptoms described in section 4.
Pay attention 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 in “Increased risk of brain infection” in section 4 of
this leaflet.
In order to improve the traceability of this medicine, you and the healthcare professional must record the batch
number of Benlysta. It is recommended that you make a note of this information in case it is requested in
the future.

Children and adolescents
Benlysta pre-filled syringe as a subcutaneous injection should not be used in children or
adolescents under the age of 18 years.

Other medicines and Benlysta
Tell your doctorif you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are being treated with medicines that have effects on the immune system
including any medicine that acts on B cells (used to treat cancers 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 effective contraceptionwhile 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, suspect you might be pregnant or are planning to become pregnant. The doctor will decide if you can use Benlysta.
If you become pregnantduring treatment with Benlysta, tell your doctor.

Breastfeeding
Tell your doctor if you are breastfeeding.Benlysta is likely to pass into breast
milk. The doctor will discuss with you whether to stop treatment with Benlysta while breastfeeding or to stop
breastfeeding.

Driving and using machines
Benlysta may have side effects that can reduce 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 can
cause allergic reactions. Tell your doctor if you have known allergies.

Benlysta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to use Benlysta

How much to use
Adults (age 18 years or older)

Systemic lupus erythematosus
The recommended dose is 200 mg (entire 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:

a dose of 200 mg (entire contents of one syringe) once a week

a dose of 400 mg (entire contents of two syringes in one day) once a week for 4 weeks. After this, the recommended dose is 200 mg (entire contents of one syringe) once a week.

If you want to change the day of administration
Take a dose on the new day (even if less than a week has passed since your last dose). Continue
with the new weekly schedule from that day.

Benlysta injection
Your doctor or nurse will show you or someone assisting you how to inject Benlysta. The first injection with
Benlysta in a prefilled syringe will be under the supervision of your doctor or nurse. Once you have been
instructed on how to use the syringe, your doctor or nurse may decide that you or someone assisting you can
administer the injection. Your doctor or nurse will also inform you about which signs and symptoms you should pay
attention to when using Benlysta, as serious allergic reactions may occur (see “ Reactions

allergic” in section 4).
Benlysta should be injected under the skin in the abdominal area (abdomen) or in the upper part of the leg (thigh).
The subcutaneous injection of Benlysta must not be injected into a vein ( intravenously).
Instructions for using the prefilled syringe are provided at the end of 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 the time of the next dose, administer only that next dose
as planned.

Stopping treatment with Benlysta
Your doctor will decide if 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.
manifest.

Stop using Benlysta and contact your doctor immediatelyif you notice any of the following symptoms of a
severe skin reaction:

reddish patches on the trunk, the patches are target-like or circular spots, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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).

Immediately inform your doctor or nurse or go to the nearest hospital emergency room 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 bumps or hives

If you experience these symptoms, especially if you experience two or more together:
➔ Tell your doctor or nurse.
Infections
Benlysta may make you more likely to get infections, including urinary tract and
respiratory infections. These are very common and may affect more than 1 in 10 people. Some infections may
be serious and can cause death with uncommon frequency.

If you experience any of the following symptoms of infection:

fever and/or chills
cough, breathing problems
diarrhea, vomiting
burning sensation when passing urine; frequent urination
skin that is warm, red or painful or sores on the 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 may affect up to 1 in 10 people, suicidal thoughts and suicide attempts
may affect up to 1 in 100 people. If you feel depressed, think about harming yourself or have other distressing thoughts
or if you are depressed and notice you are feeling worse or new symptoms appear:
➔ See your doctor or go to hospital immediately.
Increased risk of brain infection
Medicines that weaken the immune system, such as Benlysta, may put you at increased risk of
contracting a rare but serious and life-threatening brain infection called progressive multifocal
leukoencephalopathy(PML).

Symptomsof PML include:

memory loss,
difficulty thinking,
difficulty speaking or walking,
loss of vision ➔ Tell your doctor immediatelyif you experience any of these symptoms or similar problems that have lasted for several days.

If you already had these symptoms before starting treatment with Benlysta:
➔ Tell your doctor immediatelyif you notice any change 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, such as: rash, redness, itching or swelling of the skin where Benlysta was injected
itching, bumps (hives), rash
decreased number of white blood cells (visible from blood tests)
infection of the nose, throat or stomach
pain in the hands or feet
migraine
nausea, diarrhea

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the label and the packaging box after Expiry.
The expiry date refers to the last day of the month.
Store in a refrigerator (from 2 °C to 8 °C).
Do not freeze.
Store in the original packaging to protect the medicine from light.
A single pre-filled syringe of Benlysta can 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 syringe must be used within
12 hours or discarded.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Benlysta contains
The active substance is belimumab.
Each 1 mL pre-filled syringe 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 Benlysta and contents of the pack
Benlysta is supplied as a colourless to pale yellow solution in a 1 mL 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.