200 mg injection, in pre-filled pen 
belimumab

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours
  • If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In 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 packaging and other information 

1. What Benlysta is and what it is used for

Bone marrow as a subcutaneous injection  is a drug used to treat lupus(systemic lupus erythematosus, SLE ) in adults (18 years and older), whose disease is still

highly active despite standard treatment.

Lupus is a disease in which the immune system (the system that fights infection s) attacks your own cells and tissues you, and cause inflammation and tissue damage. It can affect almost any organ in the body and is believed to involve a type of white blood cell called a B cell s .

Benlysta contains belimumab ( a monoclonal antibody ). It reduces the number of B cells in the blood by blocking the function of BLyS, a protein that helps B cells live longer and is found in high levels in people with lupus.

You will receive Benlysta in addition to your usual treatment for lupus.

2. What you need to know before using 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 cautions

Talk to a doctor before using Benlysta:

  • if you have an ongoing or long-term infection or if you often get an infection . Your doctor will decide if you can get Benlysta.
  • if you are planning to be vaccinated or have received a vaccination within the last 30 days. Some types of vaccines should not be given just before or during treatment with Benlysta.
  • if your lupus affects your kidneys or 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 , a bone marrow transplant or a stem cell transplant
  • if you have had cancer .
  • Tell your doctor if any of these apply to you.

Depression and suicide

Depression, suicidal ideation and suicide attempts including suicide have been reported during treatment with Benlysta. Tell your doctor if you have had any of these conditions before. If at any time you experience new or worsening symptoms:

  • Contact a doctor immediately or see a hospital .

If you feel depressed or have thoughts of hurting yourself or committing suicide, it may help to tell a relative or close friend and ask them to read this leaflet. You can ask them to tell you if they are worried about any changes in your mood or behavior.

Pay attention to important symptoms

People taking drugs that affect the immune system may be at greater risk of developing 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 register Benlyst’s batch number. You should record this information in the event that you are asked about it in the future.

Children and young people

Do not give Benlysta as a subcutaneous injection to children or adolescents under 18 years of age.

Other medicines and Benlysta

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

In particular, you should tell your doctor if you are being treated with medicines that affect the immune system:

  • cyclophosphamide (a medicine used to treat certain cancers and autoimmune diseases)
  • any medicine that affects your B cells (used to treat cancer or inflammatory diseases).
  • Tell your doctor. Such drugs in combination with Benlysta can make your immune system less effective. This can increase your risk of a serious infection .

Pregnancy, breastfeeding, and fertility

Birth control in fertile women

  • Use an effective contraceptive while you are being treated with Benlysta and for at least 4 months after the last dose .

Pregnancy

Legs are usually not 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 may pass into breast milk. Your doctor will discuss with you if you should stop treatment with Benlysta while you are breast-feeding or if you should stop breast-feeding.

Driving and using machines

Benlysta can cause side effects that impair the ability to drive or use machines.

Important information about the contents of Benlysta

This medicine contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially ‘sodium-free’.

3. How to use Benlysta

How much to use

Adults (18 years and older)

The recommended dose is 200 mg (the entire contents of a pen ) once a week, injected under the skin on the same day each week.

If you want to change the dosing day

Take one dose on the new day (even if it is less than a week since the last dose ). Continue with the new weekly schedule from that day.

Injection of Benlysta

The doctor or nurse will show you or your caregiver how Benlysta is injected. Your doctor or nurse will be present when you inject the first dose of Benlysta with the pre-filled pen. Once you have learned to use the pen, your doctor or nurse may decide that you can give your injections yourself or that your caregiver can give them. Your doctor or nurse will also tell you what signs and symptoms you should be aware of when using Benlysta as severe allergic reactions may occur (see “ Allergic reactions” in section 4).

Bone marrow is injected under the skin of the abdomen or thighs.

Bone subcutaneous injection must not be given into a vein ( intravenously ).

Instructions on how to use the pre-filled pen are provided at the end of this leaflet.

If you use too much Benlysta 

If this happens, contact a doctor or nurse immediately who will monitor you for signs or symptoms of side effects and treat them if necessary. If possible, take the package or this leaflet with you.

If you forget to use Benlysta

Inject the missed dose as soon as you remember. Then continue according to your usual weekly schedule or start a new weekly schedule from the day you injected the missed dose . If you do not notice that you have missed a dose until it is time for your next dose , only inject the next dose according to plan. It is not necessary to inject two doses on the same day.

Discontinue 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.

Allergic reactions – seek medical attention immediately

Bone marrow can cause a reaction to injection or an allergic reaction ( hypersensitivity reaction ). Such side effects are common (may affect up to 1 in 10 people). They can sometimes be serious (uncommon, occurring in up to 1 in 100 users) and can be life-threatening. Such severe 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.

Tell 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
  • rash
  • itchy, raised bumps or hives.

In rare cases, less severe, delayed reactions to Benlysta may occur, usually 5 to 10 days after an injection . Such reactions may include a combination of symptoms such as rash, malaise, fatigue, muscle aches, headache and / or swelling of the face.

If you experience these symptoms, especially if you experience a combination of those symptoms:

  • Tell your doctor or nurse immediately.

Infection is

Leg ulcers can increase the risk of infection , including infection of the urinary tract and respiratory tract. These are very common and may occur in more than 1 in 10 users. Some infections can be serious and can cause death in rare cases.

If you get any of the following symptoms of infection:

  • fever and / or chills
  • cough, respiratory problems
  • diarrhea, vomiting
  • burning sensation when urinating, need to urinate frequently
  • hot, red or painful skin or sores on the body.
  • Tell your doctor or nurse immediately.

Depression and suicide

Depression, suicidal ideation and suicide attempts have been reported during treatment with Benlysta. Depression can occur in up to 1 in 10 users. Suicidal ideation and suicide attempts can occur in up to 1 in 100 users. If you feel depressed, have thoughts of harming yourself or other anxious thoughts, or if you are depressed and notice that you are feeling worse or developing new symptoms:

  • Contact a doctor immediately or see a hospital.

Increased risk of brain infection

Drugs that weaken the immune system, such as Benlysta, can increase the risk of developing a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).

Symptoms of PML are:

  • memory loss
  • problems with thinking
  • difficult to talk or walk
  • vision loss.
  • Tell your doctor immediately if you get any of these symptoms or similar symptoms that last for several days.

If you already had these symptoms before starting treatment with Benlysta:

  • Tell your doctor immediately if you notice any change in these symptoms.

Other possible side effects:

Very common side effects are

These can occur in more than 1 in 10 users:

  • bacterial infections ( see “Infections” above )
  • nausea, diarrhea.

Common side effects are

These can occur in up to 1 in 10 users:

  • elevated temperature or fever
  • low value for white blood cells (seen in blood samples)
  • infection of the nose, throat, or stomach
  • pain in hands or feet
  • migraine
  • reactions at the injection site, for example: rash, redness , itching or swelling of the skin where you have injected Benlysta.

Uncommon side effects are

These can occur in up to 1 in 100 users:

  • itchy, raised bumps (hives), rash.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C to 8 ° C).

Do not freeze.

Store in the original package. Sensitive to light.

A Benlysta prefilled injection pen can be stored at room temperature (up to 25 ° C) for more than 12 hours – so long as it is protected from light. After being removed from the refrigerator , the pen must be used within 12 hours or discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance 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 more information.

What the medicine looks like and contents of the pack

Benlysta supplied as 1 ml colorless to pale yellow solution in a pre-filled pen disposable.

Available in packs of 1 or 4 pre-filled pens in each pack and in multi-packs of 12 pre-filled pens (3 packs of 4 pre-filled pens).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

Glaxo Operations UK Ltd

Harmire Road

Barnard Castle

Durham County, DL12 8DT

UK

OR

GlaxoSmithKline Manufacturing SPA

Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma

Italy

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 (0) 10 85 52 00 Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals sa / nvBelgium / BelgiumTel: + 32 (0) 10 85 52 00
BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34 HungaryGlaxoSmithKline Kft.Tel .: + 36 1 225 5300
Czech RepublicGlaxoSmithKline sroTel: + 420 222 001 111cz.info@gsk.com MaltaGlaxoSmithKline (Malta) LimitedTel: + 356 21 238131
DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com The NetherlandsGlaxoSmithKline BVTel: + 31 (0) 33 2081100
GermanyGlaxoSmithKline GmbH & Co. KGTel .: + 49 (0) 89 36044 8701produkt.info@gsk.com NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00firmapost@gsk.no
EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com
GreeceGlaxoSmithKline AEBE Converter:Ηλ: + 30 210 68 82 100 PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000
SpainGlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com PortugalGlaxoSmithKline – Pharmaceutical Products, Lda. Tel: + 351 21 412 95 00FI.PT@gsk.com 
FranceGlaxoSmithKline LaboratoryTel .: + 33 (0) 1 39 17 84 44diam@gsk.com RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208
CroatiaGlaxoSmithKline dooTel: + 385 1 6051 999 SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com
IrelandGlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com
IcelandVistor hf. Phone: + 354 535 7000 Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com
ItalyGlaxoSmithKline SpATel: + 39 (0) 45 9218 111
ΚύπροςGlaxoSmithKline (Cyprus) Ltd:Ηλ: + 357 22 39 70 00gskcyprus@gsk.com United KingdomGlaxoSmithKline UK LtdTel: + 44 (0) 800 221441customercontactuk@gsk.com
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com
LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com

Muhammad Nadeem

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