STIVARGA
As listed in the register: STIVARGA
40 mg · tablet
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Regorafenib
- Made by
- Bayer Inc
- 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 (Stivarga). It describes the substance, not this exact product.
Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, metastasis and tumor immunity.
In in vitro biochemical or cellular assays, regorafenib or its major human active metabolites M-2 and M-5 inhibited the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAF V600E, SAPK2, PTK5, Abl and CSF1R at concentrations of regorafenib that have been achieved clinically.
Regorafenib is metabolized by CYP3A4 and UGT1A9.
Approximately 71% of a radiolabeled dose was excreted in feces (47% as parent compound, 24% as metabolites) and 19% of the dose was excreted in urine (17% as glucuronides) within 12 days after administration of a radiolabeled oral solution at a dose of 120 mg.
In a food-effect study, 24 healthy men received a single 160 mg dose of STIVARGA on three separate occasions: under a fasted state, with a high-fat meal and with a low-fat meal.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-02-09
Safety of the active substance
From the US prescribing label for the same active substance (Stivarga). It describes the substance, not this exact product.
WARNING: HEPATOTOXICITY.
The most common adverse reactions (≥20%) are pain (including gastrointestinal and abdominal pain), HFSR, asthenia/fatigue, diarrhea, decreased appetite/food intake, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, weight loss, rash, and nausea.
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
European UnionNo exact match for this strength and form
Spain1 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Bayer Inc |
|---|---|
| Active substance | Regorafenib |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 40 mg |
| Form | tablet |
| Classification | L01EX05 · Cancer treatments and immune-system medicines |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02403390 |
| DPD drug code | 88820 |
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.