RENFLEXIS
As listed in the register: RENFLEXIS
100 mg · powder for solution
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Infliximab
- Made by
- Samsung Bioepis Co., Ltd
- 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 (Renflexis). It describes the substance, not this exact product.
Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors.
Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-28
Safety of the active substance
From the US prescribing label for the same active substance (Renflexis). It describes the substance, not this exact product.
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning.
- The use of RENFLEXIS at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ].
- RENFLEXIS is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of RENFLEXIS or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness] [see Warnings and Precautions (5.7) and Adverse Reactions (6.1) ].
- RENFLEXIS doses >5 mg/kg in moderate or severe heart failure.
- ( 4 ) Previous severe hypersensitivity reaction to infliximab products or any inactive ingredients of RENFLEXIS or to any murine proteins.
Most common adverse reactions (>10%) – infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
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
SpainNo exact match for this strength and form
FranceNo 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 | Samsung Bioepis Co., Ltd |
|---|---|
| Active substance | Infliximab |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 100 mg |
| Form | powder for solution |
| Classification | L04AB02 · Cancer treatments and immune-system medicines |
| Route | intravenous |
| Dispensing (as stated by the register) | SCHEDULE D · PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02470373 |
| DPD drug code | 95936 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.