Leaflet BENLYSTA 200mg solution for injection in pre-filled syringe
Indicated for: systemic lupus erythematosus
Route of administration: injectable
Substance: belimumab (monoclonal antibody)
ATC: L04AA26 (Antineoplastic and immunomodulating agents | Immunosuppressants | Selective immunosuppressants)
Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.
This medicine is subject to additional monitoring.
Use during breastfeeding only on medical advice.
Use during pregnancy only on medical advice.
Belimumab is a biological medicine used in patients with active systemic lupus erythematosus despite standard treatment, and in selected cases of active lupus nephritis. It is a monoclonal antibody that blocks a protein called BLyS/BAFF, which is involved in the survival of B lymphocytes. By doing this, it may reduce disease activity and flares.
It is given by intravenous infusion or subcutaneous injection, depending on the prescribed form. Treatment is decided by a rheumatologist or nephrologist and is used together with other lupus medicines, not as emergency treatment for severe flares. The effect develops gradually, and patients should keep recommended visits and blood tests.
Side effects may include respiratory infections, nausea, diarrhoea, fever, injection-site pain, headache, insomnia or infusion reactions. Severe allergic reactions can occur, including several hours after administration. Because it affects the immune system, it may increase the risk of some infections and requires caution in patients with active infection.
Contact a doctor urgently if breathing difficulty, facial swelling, severe rash, persistent fever, significant cough, pain when urinating, worsening depression or thoughts of self-harm occur. Tell the doctor about vaccines, pregnancy, breastfeeding, chronic infections and all immunosuppressants used. Live vaccines are usually avoided during treatment.
General data about BENLYSTA 200mg
- Substance: belimumab
- Date of latest medicines list: 01-02-2018
- Product code: W64070001
- Concentration: 200mg
- Pharmaceutical form: solution for injection in pre-filled syringe
- Quantity: 1
- Product type: Original
- Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.
Pharmaceutical forms available for belimumab
Concentrations available for belimumab
- 120mg
- 200mg
- 400mg