Benlysta
belimumab
Benlysta 200 mg solution for injection in pre-filled pen belimumab
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What Benlysta is and what it is used for
What you need to know before you use Benlysta
How Benlysta is used
Possible side effects
How to store Benlysta
Contents of the pack and other information
Step-by-step instructions for using the pre-filled pen
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.
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.
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.
Tell your doctor if any of these may apply to you.
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.
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.
Do not give Benlysta as a subcutaneous injection to children or adolescents younger than 18 years of age.
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.
Benlysta can have side effects which may make you less able to drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free’.
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 should be injected under your skin on the same day each week.
Systemic lupus erythematosus (SLE)
Lupus nephritis
a dose of 200 mg (complete contents of one pen) once a week.
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.
Take a dose on the new day (even if it is less than a week since your last dose). Continue with the new weekly schedule from that day.
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).
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 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.
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.
Your doctor will decide if you need to stop using Benlysta.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
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.
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.
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.
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).
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.
These may affect more than 1 in 10 people:
bacterial infections (see ‘Infections’ above)
feeling sick, diarrhoea.
These may affect up to 1 in 10 people:
high temperature or fever
low white blood cell count (can be seen in blood tests)
nose, throat or stomach infection
pain in hands or feet
migraine
injection site reactions, for example: rash, redness, itching or swelling of the skin where you have injected Benlysta.
These may affect up to 1 in 100 people:
itchy, bumpy rash (hives), skin rash.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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, sodium chloride, water for injections. See ‘Important information about the contents of Benlysta’ in section 2 for further information.
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 (Ireland) Limited
12 Riverwalk
Citywest Business Campus Dublin 24
Ireland
GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana, 90
43056 San Polo di Torrile Parma
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tél/Tel: + 32 (0) 10 85 52 00
GlaxoSmithKline (Ireland) Limited
Teл.: + 359 80018205
GlaxoSmithKline (Ireland) Limited Tel.: + 36 80088309
GlaxoSmithKline (Ireland) Limited Tel: + 356 80065004
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701
GlaxoSmithKline (Ireland) Limited Tel: + 372 8002640
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
GlaxoSmithKline – Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44
GlaxoSmithKline (Ireland) Limited Tel: + 40 800672524
GlaxoSmithKline (Ireland) Limited Tel:+ 385 800787089
GlaxoSmithKline (Ireland) Limited Tel: + 386 80688869
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741111
GlaxoSmithKline (Ireland) Limited
Τηλ: + 357 80070017
GlaxoSmithKline (Ireland) Limited Tel: + 371 80205045
GlaxoSmithKline (Ireland) Limited Tel: + 370 80000334
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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 should also 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.
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.
The pre-filled pen should be used only once and then discarded.
(not included) Gauze pad or cotton wool ball
(not included)
Remove one sealed tray containing a pre-filled pen from 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).
Peel back the film of the tray and remove the pre-filled pen.
Check the expiry date on the pre-filled pen. (Figure 1)
Figure 1
Exp: Month – Year
Exp: Month – Year
Leave the pen at room temperature for 30 minutes. (Figure 2) Injecting cold Benlysta may take longer and may be uncomfortable.
Figure 2
•Do not remove the ring cap during this step.
Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour. (Figure 3)
It is normal to see one or more air bubbles in the solution.
Figure 3
Choose an injection site (abdomen or thigh) as seen in Figure 4.
Figure 4
If you need 2 injections to complete your dose, leave at least 5 cm (2 inches) between each injection if using the same site.
Wash your hands.
Clean the injection site by wiping it with an alcohol swab (Figure 5). Allow the skin to air dry.
Figure 5
Remove the ring cap by pulling or twisting it off. The ring cap may be twisted off either clockwise or anti-clockwise. (Figure 6)
Figure 6
Hold the pen comfortably so that you can view the inspection window. This is important so that you can confirm a complete dose. (Figure 7)
Figure 7
If needed, firm the injection site by pulling or stretching the skin.
Position the pen straight over the injection site (at a 90o angle). Make sure the gold needle guard is flat on the skin.
Firmly press the pen all the way down onto the injection site and hold in place. (Figure 8)
This will insert the needle and start the injection.
Figure 8
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 9)
Figure 9
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 10)
Figure 10
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.
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.
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.