THIOTEPA FOR INJECTION, BP 100 MG
THIOTEPA : 100 MG · DIN 02536870 · HIKMA CANADA LIMITED
Health Canada status: MARKETED
What is THIOTEPA FOR INJECTION, BP?
THIOTEPA FOR INJECTION, BP 100 MG contains THIOTEPA : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02536870, held by HIKMA CANADA LIMITED, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 27-Jun-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 THIOTEPA FOR INJECTION, BP used for?
In combination with other chemotherapy as part of a high-dose chemotherapy (HDCT) consolidation regimen followed by autologous stem cell transplantation (ASCT) for adults with CNS lymphoma.
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 | 02536870 |
|---|---|
| Brand name | THIOTEPA FOR INJECTION, BP |
| Generic / active ingredient | THIOTEPA : 100 MG |
| Manufacturer | HIKMA CANADA LIMITED |
| Strength | 100 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01AC01 THIOTEPA |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 27-Jun-2023 |
How is it administered?
185 mg/m2/day to 370 mg/m2/day IV as 1-2 daily infusions over 2-3 days prior to ASCT. Max cumulative dose 750 mg/m2. Administer via central catheter over 2-4 hours with a 0.2 μm in-line filter.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store and transport refrigerated (2°C to 8°C). Do not freeze. Reconstituted/diluted solutions have specific stability limits (refer to full monograph).
How is it supplied?
Type I clear glass vial with a dark blue flip-off aluminum seal and bromobutyl stopper. Pack size of 1 vial. Available in 15 mg and 100 mg strengths.
Contraindications
Hypersensitivity to thiotepa; pregnancy or breastfeeding; concomitant use with live virus or bacterial vaccines including yellow fever vaccine.
Warnings and precautions
Profound myelosuppression, cardiotoxicity, hepatotoxicity (including veno-occlusive disease), pulmonary toxicity, neurotoxicity, and renal toxicity. Secondary malignancies may occur.
What can be used instead?
Other Canadian products sharing ATC code L01AC01 THIOTEPA. 6 of 9 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 |
|---|---|---|---|---|---|
| TEPADINA | 100 MG | POWDER FOR SOLUTION | ADIENNE SA | MARKETED | DIN 02462702 |
| TEPADINA | 15 MG | POWDER FOR SOLUTION | ADIENNE SA | MARKETED | DIN 02462680 |
| THIOTEPA FOR INJECTION USP | 100 MG | POWDER FOR SOLUTION | STERIMAX INC | MARKETED | DIN 02526425 |
| THIOTEPA FOR INJECTION USP | 15 MG | POWDER FOR SOLUTION | STERIMAX INC | MARKETED | DIN 02526417 |
| THIOTEPA FOR INJECTION, BP | 15 MG | POWDER FOR SOLUTION | HIKMA CANADA LIMITED | MARKETED | DIN 02536862 |
| TEPADINA | 400 MG | POWDER FOR SOLUTION | ADIENNE SA | DORMANT | DIN 02523906 |
| THIO TEPA INJ 15MG/VIAL | 15 MG | POWDER FOR SOLUTION | LEDERLE CYANAMID CANADA INC. | CANCELLED POST MARKET | DIN 00237035 |
| THIOTEPA - (PWS 15 MG/VIAL) | 15 MG | POWDER FOR SOLUTION | WYETH CANADA | CANCELLED POST MARKET | DIN 02174391 |
Who else supplies THIOTEPA worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. THIOTEPA appears in 31 registered pack listings across 6 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.