BENLYSTA
As listed in the register: BENLYSTA 400 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION
400 mg (80 mg/kg) belimumab · polvo para concentrado para solución para perfusión
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Belimumab
- Made by
- Glaxosmithkline (Ireland) Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (BENLYSTA). It describes the substance, not this exact product.
BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells.
BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-21
Safety of the active substance
From the US prescribing label for the same active substance (BENLYSTA). It describes the substance, not this exact product.
- BENLYSTA is contraindicated in patients with a prior history of:.
- Anaphylaxis with belimumab [see Warnings and Precautions ( 5.2 )]..
- Stevens-Johnson syndrome or toxic epidermal necrolysis with belimumab [see Warnings and Precautions ( 5.3 )].
- Previous anaphylaxis, Stevens‑Johnson syndrome, or toxic epidermal necrolysis as a reaction to belimumab.
The most common serious adverse events were serious infections (6% and 5.2% in the groups receiving BENLYSTA and placebo plus standard therapy, respectively), some of which were fatal.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Glaxosmithkline (Ireland) Limited |
|---|---|
| Active substance | Belimumab |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 400 mg (80 mg/kg) belimumab |
| Form | polvo para concentrado para solución para perfusión |
| Classification | L04AG04 · Cancer treatments and immune-system medicines |
| Route | vía intravenosa |
| Marketed | Yes, according to the register |
| Name in the register | BENLYSTA 400 mg POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION |
| Nº Registro | 11700002 |
Source: CIMA — Centro de Información online de Medicamentos · 2026-09-30 · not reviewed by a clinician
Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA. Reuse terms: Aviso legal AEMPS.
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- polvo para concentrado para solución para perfusión2 products
- 120 mg (80 mg/kg) belimumab
- 400 mg (80 mg/kg) belimumab
- solución inyectable en pluma precargada1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.