ACH-TEMOZOLOMIDE 5 MG
TEMOZOLOMIDE : 5 MG · DIN 02438119 · ACCORD HEALTHCARE INC
Health Canada status: MARKETED
What is ACH-TEMOZOLOMIDE?
ACH-TEMOZOLOMIDE 5 MG contains TEMOZOLOMIDE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02438119, held by ACCORD HEALTHCARE INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 13-Jan-2016. 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 ACH-TEMOZOLOMIDE used for?
Treatment of adults with newly diagnosed glioblastoma multiforme (concomitant with radiotherapy then maintenance) or recurrent/progressive glioblastoma multiforme or anaplastic astrocytoma.
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 | 02438119 |
|---|---|
| Brand name | ACH-TEMOZOLOMIDE |
| Generic / active ingredient | TEMOZOLOMIDE : 5 MG |
| Manufacturer | ACCORD HEALTHCARE INC |
| Strength | 5 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L01AX03 TEMOZOLOMIDE |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 13-Jan-2016 |
| Original market date | 2016-01-13 00:00:00 |
How is it administered?
75 mg/m2 daily (concomitant with radiotherapy) or 150-200 mg/m2 for 5 days of a 28-day cycle (maintenance/recurrence). Administer in fasting state, 1 hour before meals.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store between 15°C and 30°C. Protect from moisture.
How is it supplied?
Unit dose sachets of 1 capsule (5 or 20 per box) and amber bottles of 5 capsules.
Contraindications
History of hypersensitivity to temozolomide or dacarbazine (DTIC); not recommended in patients with severe myelosuppression.
Warnings and precautions
Serious Warnings: Myelosuppression (neutropenia, thrombocytopenia, aplastic anemia) and hepatic injury/failure. Risk of Pneumocystis carinii pneumonia (PCP) and HBV reactivation.
What can be used instead?
Other Canadian products sharing ATC code L01AX03 TEMOZOLOMIDE. 25 of 39 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 |
|---|---|---|---|---|---|
| ACH-TEMOZOLOMIDE | 100 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | DIN 02389827 |
| ACH-TEMOZOLOMIDE | 140 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | DIN 02389835 |
| ACH-TEMOZOLOMIDE | 20 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | DIN 02389819 |
| ACH-TEMOZOLOMIDE | 250 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | DIN 02389851 |
| JAMP TEMOZOLOMIDE | 100 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02516810 |
| JAMP TEMOZOLOMIDE | 140 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02516829 |
| JAMP TEMOZOLOMIDE | 20 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02516802 |
| JAMP TEMOZOLOMIDE | 250 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02516845 |
| JAMP TEMOZOLOMIDE | 5 MG | CAPSULE | JAMP PHARMA CORPORATION | MARKETED | DIN 02516799 |
| TARO-TEMOZOLOMIDE | 100 MG | CAPSULE | TARO PHARMACEUTICALS INC | MARKETED | DIN 02443511 |
Who else supplies TEMOZOLOMIDE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TEMOZOLOMIDE appears in 315 registered pack listings across 14 markets, published on 11 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.