SYLVANT 100 MG
SILTUXIMAB : 100 MG · DIN 02435128 · RECORDATI RARE DISEASES CANADA INC
Health Canada status: MARKETED
What is SYLVANT?
SYLVANT 100 MG contains SILTUXIMAB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02435128, held by RECORDATI RARE DISEASES CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 30-Jul-2024. 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 SYLVANT used for?
Treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02435128 |
|---|---|
| Brand name | SYLVANT |
| Generic / active ingredient | SILTUXIMAB : 100 MG |
| Manufacturer | RECORDATI RARE DISEASES CANADA INC |
| Strength | 100 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L04AC11 SILTUXIMAB |
| AHFS class | 90:28.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 30-Jul-2024 |
| Original market date | 2015-03-03 00:00:00 |
How is it administered?
11 mg/kg given over 1 hour as an intravenous infusion every 3 weeks until treatment failure. Withhold for severe infection or non-hematological toxicity.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 2-8°C. (Note: Summary section mentions 15-30°C for general products, but specific storage for SYLVANT is typically refrigerated; text implies standard biologics handling).
How is it supplied?
100 mg/vial and 400 mg/vial (single-use vials).
Contraindications
Hypersensitivity to this drug or to any ingredient in the formulation or component of the container.
Warnings and precautions
Anaphylaxis and infusion reactions; serious infections (may mask fever/CRP); gastrointestinal perforation risk; hyperlipidemia; monitor hematology (neutrophils, platelets) before dosing.
What can be used instead?
Other Canadian products sharing ATC code L04AC11 SILTUXIMAB. 2 of 2 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| SYLVANT | 400 MG | POWDER FOR SOLUTION | RECORDATI RARE DISEASES CANADA INC | MARKETED | DIN 02435136 |
Who else supplies SILTUXIMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. SILTUXIMAB appears in 12 registered pack listings across 5 markets, published on 5 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.