PROGRAF 0.5 MG
TACROLIMUS : 0.5 MG · DIN 02243144 · ASTELLAS PHARMA CANADA INC
Health Canada status: MARKETED
What is PROGRAF?
PROGRAF 0.5 MG contains TACROLIMUS : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 02243144, held by ASTELLAS PHARMA CANADA INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 07-Nov-2005. 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 PROGRAF used for?
Prograf (tacrolimus) is indicated for: prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants; treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants. Prograf (tacrolimus immediate - release capsules, USP) is indicated for: treatment of active rheumatoid arthritis in adult patients for whom disease modifying anti - rheumatic drug (DMARD) therapy is ineffective or inappropriate.
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 | 02243144 |
|---|---|
| Brand name | PROGRAF |
| Generic / active ingredient | TACROLIMUS : 0.5 MG |
| Manufacturer | ASTELLAS PHARMA CANADA INC |
| Strength | 0.5 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L04AD02 TACROLIMUS |
| AHFS class | 90:28.28.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 07-Nov-2005 |
| Original market date | 2001-04-02 00:00:00 |
How is it administered?
Transplant: Oral 0.075-0.3 mg/kg/day in two divided doses; IV 0.01-0.05 mg/kg/day as continuous infusion. Rheumatoid Arthritis: 3 mg orally once daily. Titrate based on levels and response.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
The diluted solution for infusion should be stored at 15 - 25°C in glass or polyethylene containers and should be discarded after 24 hours.
How is it supplied?
100-count bottles or in blister packs of 100 capsules (10 capsules per card) for 0.5 mg, 1 mg, and 5 mg capsules; boxes of 10 ampoules for 5 mg/mL injection
Contraindications
Hypersensitivity to tacrolimus or any ingredient. Tacrolimus for injection is contraindicated in patients with hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil).
Warnings and precautions
Increased susceptibility to infection; potential development of lymphoma and skin cancer. Risk of anaphylaxis with IV formulation. Risk of neurotoxicity and nephrotoxicity.
What can be used instead?
Other Canadian products sharing ATC code L04AD02 TACROLIMUS. 21 of 31 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-TACROLIMUS | 0.5 MG | CAPSULE (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02454068 |
| ACH-TACROLIMUS | 1 MG | CAPSULE (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02456095 |
| ACH-TACROLIMUS | 5 MG | CAPSULE (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02456109 |
| ADVAGRAF | 0.5 MG | CAPSULE (EXTENDED RELEASE) | ASTELLAS PHARMA CANADA INC | MARKETED | DIN 02296462 |
| ADVAGRAF | 1 MG | CAPSULE (EXTENDED RELEASE) | ASTELLAS PHARMA CANADA INC | MARKETED | DIN 02296470 |
| ADVAGRAF | 3 MG | CAPSULE (EXTENDED RELEASE) | ASTELLAS PHARMA CANADA INC | MARKETED | DIN 02331667 |
| ADVAGRAF | 5 MG | CAPSULE (EXTENDED RELEASE) | ASTELLAS PHARMA CANADA INC | MARKETED | DIN 02296489 |
| ENVARSUS PA | 0.75 MG | TABLET (EXTENDED-RELEASE) | ENDO OPERATIONS LTD. | MARKETED | DIN 02485877 |
| ENVARSUS PA | 1 MG | TABLET (EXTENDED-RELEASE) | ENDO OPERATIONS LTD. | MARKETED | DIN 02485885 |
| ENVARSUS PA | 4 MG | TABLET (EXTENDED-RELEASE) | ENDO OPERATIONS LTD. | MARKETED | DIN 02485893 |
Who else supplies TACROLIMUS worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TACROLIMUS appears in 609 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.