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:

• Always use this medicine exactly as your doctor or pharmacist has told you. 


• Contact a doctor or pharmacist if you are unsure.


• Benlysta should be injected under the skin on the same day each week.


• The pre-filled pen should only be used once, then thrown away.


• The Benlysta pre-filled pen must not be shared with another person.

Inspect the injection site:

• There may be a small amount of blood at the injection site.


• If needed, press a cotton ball or gauze on the injection site


• Do not rub the injection site.

Adults (18 years or older):
Systemic lupus erythematosus (SLE):

• The recommended dose is 200 mg (total contents of one pen) once a week.

Lupus nephritis:
Recommended dose may vary . Your doctor will prescribe the right dose for you. This will be:

• A dose of 200 mg (total content of a pen) once a week.

Or

• A dose of 400 mg (total content of two pens on the same day) once a week for 4 weeks. Thereafter, the recommended dose is 200 mg (total content of one pen) once a week.

If you want to change the dosing day:

• Take a dose on the new day (even if it's been less than a week since your last dose).


• Continue with the new weekly plan from this day.

How To Inject Benlysta:

• A nurse or doctor will show you or your carer how to inject Benlysta. 


• Your first injection with Benlysta pre-filled pen should be guided by your doctor or nurse. 


• After you have been trained to use the pen, your doctor or nurse may decide that you can inject yourself, or that your carer can give it to you.


• Your doctor or nurse should also explain which signs and symptoms you need to watch out for when using Benlysta, because serious allergic reactions can occur.


• You must inject Benlysta under the skin in the stomach area ( abdomen ) or upper leg (thigh).


• Benlysta for injection under the skin ( subcutaneously ) must not be injected into a blood vessel ( intravenously ).
  Instructions for using the pre-filled pen are provided at the back of this leaflet.

If you take too much Benlysta:

• If this happens, contact your doctor or nurse immediately, who will monitor you for signs or symptoms of side effects and treat these symptoms if necessary. 


• If possible, show them the carton or this leaflet.

If you have forgotten to take Benlysta:

• Inject the missed dose as soon as you remember.


• Continue with your normal 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 already time for the next dose, you should only inject the next dose as planned.

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' in section 4 of this leaflet.


• 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 pre-filled pen of 1 ml contains 200 mg of belimumab.

What Benlysta looks like and the contents of the package:

• Benlysta is supplied as a 1 ml colorless to slightly yellow solution in a pre-filled pen for single use.


• Step-by-step instructions for using the pre-filled pen Once a week


• Follow these instructions for proper use of the pre-filled pen.


• The function of the pre-filled pen may be affected if these instructions are not followed. 


• You will also receive training in using the pre-filled pen.


• Belysta should only be used under the skin ( subcutaneously ).


• 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.

Product Details:

• Brand: Benlysta
• Product Form: pre-filled subcutaneous injection