Benlysta 400 mg 1 vial (Refrigerator)

Product Description:

• 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.

Depression:

• 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.

Pregnancy:

• 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.
• Breastfeeding
• 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".

Ingredients:

• 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.