Benlysta 120 mg 1 vial (Refrigerator)
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- Benlysta as a subcutaneous injection is a medicine used to treat lupus (systemic lupus erythematosus, SLE) in adults (over 18 years) where disease activity remains high despite standard treatment.
- Benlysta is also used in combination with other medicines to treat adults with active lupus nephritis (lupus-related kidney inflammation).
- Lupus is a disease in which the immune system (the system that fights infections ) 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 cell 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. BLys is a protein that helps B cells live longer and is found in high levels in people with lupus .
- You will be given Benlysta in addition to your usual treatment for lupus.
How To Use:
- A nurse or doctor will give you Benlysta by infusion into a vein ( intravenous infusion) over one hour.
Adults and children (5 years or older):
- Your doctor will decide what dose you need depending on your body weight.
- The recommended dose is 10 mg per kilogram (kg) of body weight.
- You are usually given Benlysta on the first day of treatment, and then 14 and 28 days later.
- After this, Benlysta is usually given once every 4 weeks.
Medicines given before an infusion:
- Your doctor may give you medicines that can help reduce infusion reactions before you receive Benlysta.
- These may include a type of medicine called an antihistamine and a medicine to prevent fever .
- You will be followed up closely, and if you have any reactions these will be treated.
End treatment with Benlysta:
- Your doctor will decide whether you need to stop treatment with Benlysta.
How To Store:
- Store in the refrigerator up to 30 minutes before use.
- Store in the carton to protect from light.
- Keep out of reach of children.
- Do not freeze.
- Should not be used if it has been at room temperature for more than 12 hours.
- Do not toast.
- Do not use if dropped on a hard surface.
Warnings And Precautions:
Do not use Benlysta:
- If you are allergic (hypersensitive) to belimumab or any of the other ingredients of this medicine.
- Talk to your doctor if this applies to you.
Talk to your doctor before using Benlysta:
- If you have an ongoing or long-term infection or if you often get infections .
- Your doctor will decide whether you can be treated with Benlysta.
- If you plan to be vaccinated or have recently been vaccinated (within the last 30 days).
- Certain types of vaccines must not be given immediately before or during treatment with Benlysta.
- If your lupus affects your nervous system.
- If you have or have had hepatitis b or c.
- If you have had an organ transplant , or a bone marrow transplant or stem cell transplant.
- If you have had cancer.
- Talk to your doctor if any of this applies 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 had these disorders before.
If at any time you experience new or worsening symptoms:
- Contact your doctor or see a hospital immediately.
- If you feel depressed or have thoughts of self-harm or suicide, it may be helpful to confide in a relative or close friend and ask him/her to read this leaflet. You can ask if he/she is concerned about changes in your mood or behavior.
Be alert for important symptoms:
- People taking drugs that affect their immune system may be at greater risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).
- Read the information 'Increased risk of brain infection'.
- To improve the traceability of this medicine, you and your healthcare staff should register the lot number for Benlysta.
- It is recommended to note this information in case you are asked about it later.
- Children and youth
- Benlysta as a subcutaneous injection must not be given to children or adolescents under 18 years of age.
Other medicines and Benlysta:
- Talk to your doctor if you use, have recently used or plan to use other medicines.
- Consult your doctor if you are being treated with medicines that affect the immune system, including any medicine that affects B cells (used to treat cancer or inflammatory diseases).
- A combination of such medicines and Benlysta can make your immune system less effective. This can increase the risk of a serious infection .
- Pregnancy and breastfeeding contraceptive in women who may become pregnant
- Use a safe method of contraception while being treated with Benlysta and for at least 4 months after the last dose.
- Benlysta is not normally recommended if you are pregnant .
- Talk to your doctor if you are pregnant, think you may be pregnant or plan to become pregnant. Your doctor will decide if you can use Benlysta.
- Talk to your doctor if you become pregnant while being treated with Benlysta.
- Talk to your doctor if you are breastfeeding.
- It is likely that Benlysta can pass into breast milk.
- Your doctor will discuss with you whether you need to stop treatment with Benlysta while you are breast-feeding, or whether you need to stop breast-feeding.
Driving and using machines:
- Benlysta may have side effects that may affect your ability to drive or use machines.
- Important information about the contents of Benlysta
- Benlysta contains less than 1 mmol sodium (23 mg) per dose, and is virtually "sodium-free".
- The active substance is belimumab.
- Each 5 ml vial contains 120 mg of belimumab.
- Each 20 ml vial contains 400 mg of belimumab.
- After reconstitution, the solution contains 80 mg of belimumab per ml.
What Benlysta looks like and the contents of the package:
- Benlysta is supplied as a white to off-white powder to concentrate for infusion, solution in a vial with a silicone-based rubber stopper with an aluminum seal.
- There is 1 vial in each carton.
120 mg vial:
- The vial of 120 mg Benlysta for single use must be reconstituted with 1.5 ml water for injections to obtain a total concentration of 80 mg/ml belimumab.
400 mg vial:
- The single-use vial of 400 mg Benlysta must be reconstituted with 4.8 ml water for injections to obtain a total concentration of 80 mg/ml belimumab.
- Manufacturer: Benlysta
- Product form: Vials
- Ingredients: belimumab
- Product function: Immuno-suppressant