BENLYSTA 120 mg. 1 Vial
Benlysta is a drug that is used for treatment of lupus (systemic lupus erythematosus, SLE) in adults (aged 18 years and above) in which the disease is highly active, regardless of the use of conventional therapy.
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 believed to involve a type of white blood cells called B cells.
Benlysta contains belimumab (mAb). Belimumab 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 elevated in people with lupus.
Benlysta will be given to you along with your usual treatment for lupus.
2. What you need to know before you are given Benlysta?
You should not apply Benlysta:
• if you are allergic to belimumab or any of the other ingredients of this medicine (listed in section 6)
Ask your doctor if this may apply to you
Take special care with Benlysta:
Talk to your doctor before taking Benlysta:
• If you have an infection for a long time or often get infections. Your doctor will decide whether you should apply Benlysta.
if planning to get vaccinated or have recently had a vaccination (within the last 30 days). Certain types of vaccines should be administered before or during treatment with Benlysta
• if your lupus affects your kidneys or nervous system;
• if you have HIV or low immunoglobulin levels;
• if you have or have had hepatitis B or C;
• if you have had an organ transplant, bone marrow transplant or stem cell transplant;
• if you have cancer.
Tell your doctor if any of the above applies to you.
Other medicines and Benlysta
Tell your doctor if you are being treated with cyclophosphamide (a medicine that affects your immune system and is used to treat some cancers and autoimmune disorders) or a medicine that affects your B cells (used to treat cancer or inflammatory diseases). The combination of these medications with Benlysta may reduce the effectiveness of your immune system. This may increase the risk of serious infection.
Tell your doctor if you are taking, have recently taken or taking other medicines, including medicines obtained without a prescription.
Pregnancy and lactation
Benlysta is not usually recommended if you are pregnant
• Tell your doctor if you are pregnant, think you may be pregnant or planning a pregnancy. Your doctor will decide whether you should apply Benlysta.
• Use an effective method of contraception while being treated with Benlysta and for at least 4 months after the last dose.
• If you become pregnant while being treated with Benlysta, tell your doctor. If you are breastfeeding
• Tell your doctor if you are breastfeeding. Probably Benlysta can pass into breast milk. Your doctor will discuss with you whether you should stop treatment with Benlysta, while breast-feeding, or have to stop breast-feeding while receiving treatment with Benlysta.
Driving and using machines
There is no known effect of Benlysta on ability to drive and use machines.
Benlysta contains less than 23 mg of sodium in each dose and therefore is essentially sodium.
3. How is Benlysta?
Nurse or doctor will give you Benlysta system into a vein (intravenous infusion) that must elapse for one hour.
Your doctor will decide the correct dose depending on your body weight. The recommended dose is 10 mg per kilogram of body weight.
Usually given Benlysta on the first day of treatment and then after 14 and 28 days. After this period, Benlysta is usually administered once every 4 weeks.
Medicines given before the infusion
Your doctor may decide to give you medicines which help to reduce any infusion reactions before you are given Benlysta. This may include the type of medicines called antihistamines and drugs for prevention of temperature rise. You will be checked closely and if you do have any reactions these will be treated.
Stopping treatment with Benlysta
Your doctor will decide if you should stop use of Benlysta.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions and infusion reactions
Benlysta can cause a reaction to the infusion or an allergic reaction (hypersensitivity reaction). These effects may affect 1 to 10 in 100 patients and can sometimes be severe and life threatening. The probability of these events to occur is greatest in the day or one day after the first or second embodiment of Benlysta.
If any of the following symptoms of hypersensitivity or infusion reaction, tell your doctor or nurse, or go to the emergency room of the nearest hospital:
• swelling of the face, lips, mouth or tongue
• wheezing, trouble breathing or shortness of breath
• raised itchy rash or hives Very common side effects
These may affect more than 1 in 10 people:
• bacterial infections, such as infections of the breast and bladder
• nausea, diarrhea
Common side effects
These may affect up to 1 in 10 people:
• fever or fever
• low number of white blood cells
• infection of the nose, throat or stomach
• pain in the hands or feet
• insomnia, depression
Uncommon side effects
These may affect up to 1 in 100 people:
• severe allergic reactions, sometimes with swelling of face or mouth, making breathing difficult
• swelling of the face, lips and tongue
• raised, itchy bumps or hives
Tell your doctor or nurse if you experience any of these symptoms.
If you get any side effects, contact your doctor. This includes any possible effects not listed in this leaflet.
5. How to store Benlysta?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date 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 - 8 ° C).
Do not freeze.
Store in the original package in order to protect from light.
Any unused product or waste material should be disposed of in accordance with local requirements.
6. Contents of the pack and other information
• The active ingredient is belimumab.
Each 5 ml vial contains 120 mg belimumab. Each 20 ml vial contains 400 mg belimumab.
• The other ingredients are citric acid (E330), sodium citrate (E331), sucrose and polysorbate 80
Benlysta looks like and contents of the pack?
Benlysta is a white to off-white powder for solution for infusion in a glass vial with a latex-free, silicone rubber stopper and aluminum flip-off seal.
Each pack contains 1 vial.