TOPOTECAN HYDROCHLORIDE FOR INJECTION 4 MG
TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 4 MG · DIN 02344009 · ACCORD HEALTHCARE INC
Health Canada status: APPROVED
What is TOPOTECAN HYDROCHLORIDE FOR INJECTION?
TOPOTECAN HYDROCHLORIDE FOR INJECTION 4 MG contains TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02344009, held by ACCORD HEALTHCARE INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as approved, status dated 06-Apr-2018. 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 TOPOTECAN HYDROCHLORIDE FOR INJECTION used for?
Metastatic carcinoma of the ovary after failure of initial or subsequent therapy; sensitive small cell lung cancer after failure of first line chemotherapy.
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 | 02344009 |
|---|---|
| Brand name | TOPOTECAN HYDROCHLORIDE FOR INJECTION |
| Generic / active ingredient | TOPOTECAN (TOPOTECAN HYDROCHLORIDE) : 4 MG |
| Manufacturer | ACCORD HEALTHCARE INC |
| Strength | 4 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01CE01 TOPOTECAN |
| AHFS class | 08:12.18 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 06-Apr-2018 |
How is it administered?
1.5 mg/m² by IV infusion over 30 minutes daily for 5 consecutive days of a 21-day course. Minimum 4 courses recommended. Dose adjustments required for neutropenia or renal impairment.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Reconstituted lyophilized product: store in refrigerator for up to 24 hours. Diluted solution: stable for up to 30 days at 20-25°C or 2-8°C.
How is it supplied?
4 mg / vial (lyophilized powder); 1 mg / mL (solution for injection). Vials are for single use.
Contraindications
History of hypersensitivity to topotecan or excipients; pregnancy or breast-feeding; severe bone marrow depression; severe renal impairment (CrCl < 20 mL/min).
Warnings and precautions
Bone marrow suppression (primarily neutropenia) is dose-limiting. Potentially fatal neutropenic colitis, gastrointestinal perforation, and interstitial lung disease reported.
Is TOPOTECAN in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by SANDOZ CANADA INCORPORATED, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
Check availability for TOPOTECAN HYDROCHLORIDE FOR INJECTION
What can be used instead?
Other Canadian products sharing ATC code L01CE01 TOPOTECAN. 4 of 14 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 |
|---|---|---|---|---|---|
| TEVA-TOPOTECAN | 4 MG | POWDER FOR SOLUTION | TEVA CANADA LIMITED | MARKETED | DIN 02441071 |
| TOPOTECAN HYDROCHLORIDE FOR INJECTION | 1 MG | SOLUTION | ACCORD HEALTHCARE INC | MARKETED | DIN 02396378 |
| TOPOTECAN HYDROCHLORIDE FOR INJECTION | 1 MG | SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02379422 |
| TOPOTECAN INJECTION | 1 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02390981 |
| HYCAMTIN | 4 MG | POWDER FOR SOLUTION | NOVARTIS PHARMACEUTICALS CANADA INC | CANCELLED POST MARKET | DIN 02231116 |
| MYLAN-TOPOTECAN HYDROCHLORIDE FOR INJECTION | 4 MG | POWDER FOR SOLUTION | MYLAN PHARMACEUTICALS ULC | CANCELLED PRE MARKET | DIN 02392798 |
| PMS-TOPOTECAN | 1 MG | POWDER FOR SOLUTION | PHARMASCIENCE INC | CANCELLED PRE MARKET | DIN 02406438 |
| PMS-TOPOTECAN | 4 MG | POWDER FOR SOLUTION | PHARMASCIENCE INC | CANCELLED POST MARKET | DIN 02406446 |
| TEVA-TOPOTECAN | 1 MG | POWDER FOR SOLUTION | TEVA CANADA LIMITED | APPROVED | DIN 02441063 |
| TOPOTECAN FOR INJECTION | 4 MG | POWDER FOR SOLUTION | FRESENIUS KABI CANADA LTD | CANCELLED POST MARKET | DIN 02346656 |
Who else supplies TOPOTECAN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TOPOTECAN appears in 29 registered pack listings across 8 markets, published on 8 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.