REZUROCK 200 MG — DIN 02526115
BELUMOSUDIL (BELUMOSUDIL MESYLATE) : 200 MG · SANOFI-AVENTIS CANADA INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is REZUROCK?
REZUROCK 200 MG contains BELUMOSUDIL (BELUMOSUDIL MESYLATE) : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02526115, held by SANOFI-AVENTIS CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 08-Mar-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is REZUROCK used for?
REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. Efficacy in patients with chronic GVHD was based on objective response rate and duration of response in a single-arm study.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 200 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | REZUROCK is available as 200 mg pale yellow, oblong tablets, debossed with “KDM” on one side and "200" on the other side. Each tablet contains 200 mg belumosudil (equivalent to 242.5 mg belumosudil mesylate). REZUROCK is packaged in 60 cc high density polyethylene (HDPE) bottles each containing 30 tablets. |
| Storage | Store at room temperature, 15°C to 30°C. Store in the original container only to protect from moisture. Replace cap securely each time after opening. Do not discard desiccant. Keep this and all medicines out of the reach and view of children. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Belumosudil |
|---|---|
| ATC code | L04AA48 |
| AHFS class | 92:92.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02526115 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2526115 |
| Brand name | REZUROCK |
| Generic / active ingredient | BELUMOSUDIL (BELUMOSUDIL MESYLATE) : 200 MG |
| Market authorization holder | SANOFI-AVENTIS CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | L04AA48 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L04AA |
| Current status | MARKETED |
| Status date | 08-Mar-2023 |
| Original market date | 2023-03-08 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
The recommended dose of REZUROCK is 200 mg given orally once daily, with food, at approximately the same time each day. Treatment should continue until progression of chronic GVHD that requires a new systemic therapy or occurrence of unacceptable toxicity. Swallow REZUROCK tablets whole. Do not cut, crush, or chew tablets. Take REZUROCK with a meal at approximately the same time each day. If a dose is missed, it should be taken as soon as possible on the same day, and the regular daily dose schedule resumed the next day. Do not take extra doses to make up for the missed dose. Dosage modifications for adverse reactions are provided in Table 1. For Grade 3 ALT or AST (> 5 to 20 x ULN) or Grade 2 bilirubin (> 1.5 to 3 x ULN) hepatotoxicity, hold REZUROCK until recovery to ≤ Grade 1, then resume at the recommended dose. For Grade 4 ALT or AST (> 20 x ULN) or Grade >3 bilirubin (> 3 x ULN) hepatotoxicity, permanently discontinue REZUROCK. For other Grade 3 adverse reactions, hold REZUROCK until recovery to ≤ Grade 1, then resume at the recommended dose level. For other Grade 4 adverse reactions, permanently discontinue REZUROCK.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
REZUROCK is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Hypertension: Occurred in 21% of patients (Grade 3-4 in 6%). Optimize blood pressure prior to initiating REZUROCK. Monitor blood pressure monthly and/or as clinically indicated. Withhold or permanently discontinue based on severity. Hypotension: Potential risk. Occurred in 4.8% of patients (Grade ≥ 3 in 2.4%). Optimize blood pressure prior to initiating REZUROCK. Monitor blood pressure monthly and/or as clinically indicated. Withhold or permanently discontinue based on severity. Diarrhea: Occurred in 32.5% of patients (Grade ≥ 3 in 5%). A fatal adverse reaction was reported in one patient with severe nausea, vomiting, diarrhea and multi-organ failure. Administer fluid and electrolyte replacement and antidiarrheal medications as needed. Withhold or permanently discontinue based on severity. Cytopenias (lymphocyte count decreased, white blood cell count decreased, neutrophil count decreased, platelet count decreased, anemia): Patients should have complete blood counts monitored monthly. Withhold or permanently discontinue based on severity. Hemorrhage: Grade ≥ 3 hemorrhagic events occurred in 5% of patients. Withhold or permanently discontinue based on severity. Hepatic: Hepatotoxicity events occurred. LFT elevations were frequently reported. Monitor liver function prior to starting REZUROCK, then monthly or as clinically indicated. Withhold or permanently discontinue based on severity. Infection: Occurred in 53% of patients (Grade 3 or 4 in 16%). Monitor for fever, neutropenia, and infection, and initiate appropriate anti-infective therapy. Withhold or permanently discontinue based on severity. Photosensitivity: REZUROCK absorbs UV light and shows affinity for melanin. Patients should be advised that skin reactions due to phototoxicity could potentially occur.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC L04AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Mycophenolic Acid | ACCEL-MYCOPHENOLATE MOFETIL CAPSULES · ACCEL-MYCOPHENOLATE MOFETIL TABLETS · ACH-MYCOPHENOLATE · AG-MYCOPHENOLATE · +21 more | 41 | 24 | Yes |
| Apremilast | APO-APREMILAST · APO-APREMILAST TABLETS · AURO-APREMILAST · GLN-APREMILAST · +7 more | 22 | 11 | Yes |
| Abatacept | ORENCIA | 3 | 2 | Yes |
| Antilymphocyte Immunoglobulin (Horse) | ATGAM · ATGAM STERILE SOLUTION IV 50MG/ML | 2 | 1 | Yes |
| Cladribine | MAVENCLAD | 1 | 1 | Yes |
| Efgartigimod Alfa | VYVGART | 1 | 1 | Yes |
| Belumosudil | REZUROCK | 1 | 1 | Yes |
| Antithymocyte Immunoglobulin (Rabbit) | THYMOGLOBULIN | 1 | 1 | Yes |
| Alefacept | AMEVIVE | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L04A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L04AX | Azathioprine · Dimethyl Fumarate · Lenalidomide · Methotrexate · Other Immunosuppressants · +3 more | 191 | 124 |
| L04AC | Anakinra · Basiliximab · Bimekizumab · Brodalumab · Canakinumab · +13 more | 85 | 75 |
| L04AB | Adalimumab · Certolizumab Pegol · Etanercept · Golimumab · Infliximab | 71 | 55 |
| L04AD | Ciclosporin · Tacrolimus | 49 | 30 |
| L04AK | Leflunomide · Teriflunomide | 44 | 25 |
| L04AH | Everolimus · Sirolimus | 36 | 23 |
| L04AF | Baricitinib · Deucravacitinib · Ritlecitinib · Tofacitinib · Upadacitinib | 23 | 19 |
| L04AG | Alemtuzumab · Anifrolumab · Belimumab · Efalizumab · Inebilizumab · +7 more | 20 | 15 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is REZUROCK called?
Also recorded in Canada as: BELUMOSUDIL (GLOBAL), BELUMOSUDIL (US).
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.