Anaphylaxis
Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.
Medicine information BENLYSTA 120mg powder for concentrate for solution for infusion
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.
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 120mg
- Substance:
- belimumab
- Date of latest medicines list:
- 01-10-2026
- Product code:
- W57242001
- Strength:
- 120mg
- Pharmaceutical form:
- powder for concentrate for solution for infusion
- Quantity:
- 1
- Product type:
- Original
- Price:
- 765.26 RON
- Prescription status:
- S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.
Pharmaceutical forms available for belimumab
Strengths available for belimumab
- 120mg
- 200mg
- 400mg
Official documents
The SmPC text is not displayed because a match to this medicine, strength and pharmaceutical form has not been confirmed.
The correspondence between the document and the displayed text is unconfirmed.
- Source institution
- EMA
- Document language
- English
- Source record: first published
- 09/08/2011
- Source record: last updated
- 08/09/2026
Warnings:
Additional monitoring
This medicine is subject to additional monitoring.
Breastfeeding warning
Use during breastfeeding only on medical advice.
Pregnancy warning
Use during pregnancy only on medical advice.
Reimbursement lists for BENLYSTA 120mg GlaxoSmithKline
G17 (C1) - Major collagenosis (systemic lupus erythematosus, scleroderma)
- Price
- 765.26 RON
- Copayment
- 765.26 RON
- Patient payment
- 0.00 RON