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Benlysta

Benlysta 200 Mg Auto-Injector S.C (Refrigerator)

3,531.99 SAR
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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.
Read More
  • Manufacturer: Benlysta
  • Product form: pre-filled subcutaneous injection
  • Ingredients: belimumab
  • Product function: Immuno-suppressant