NITISINONE TABLETS 5 MG
NITISINONE : 5 MG · DIN 02458624 · CYCLE PHARMACEUTICALS LTD.
Health Canada status: CANCELLED POST MARKET
What is NITISINONE TABLETS?
NITISINONE TABLETS 5 MG contains NITISINONE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02458624, held by CYCLE PHARMACEUTICALS LTD., supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 31-Oct-2025. 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 NITISINONE TABLETS used for?
Treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
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 | 02458624 |
|---|---|
| Brand name | NITISINONE TABLETS |
| Generic / active ingredient | NITISINONE : 5 MG |
| Manufacturer | CYCLE PHARMACEUTICALS LTD. |
| Strength | 5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A16AX04 NITISINONE |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 31-Oct-2025 |
How is it administered?
Initial dose: 1 mg/kg/day divided in 2 doses. Titrate to 1.5-2 mg/kg/day based on succinylacetone levels. Administer with or without food. Tablets can be disintegrated in water or crushed.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refer to section 11), but suspension in syringe is stable for 24 hours at room temperature.
How is it supplied?
High-density polyethylene (HDPE) square bottles with child-resistant caps. Each bottle contains 60 tablets.
Contraindications
Hypersensitivity to nitisinone or any ingredient in the formulation; breast-feeding women.
Warnings and precautions
Risk of elevated plasma tyrosine (maintain <500 μmol/L); leukopenia and thrombocytopenia; risk of hepatic neoplasms/liver failure; ocular symptoms (perform slit-lamp exam).
What can be used instead?
Other Canadian products sharing ATC code A16AX04 NITISINONE. 8 of 12 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 |
|---|---|---|---|---|---|
| MDK-NITISINONE | 10 MG | CAPSULE | MENDELIKABS INC | MARKETED | DIN 02457733 |
| MDK-NITISINONE | 2 MG | CAPSULE | MENDELIKABS INC | MARKETED | DIN 02457717 |
| MDK-NITISINONE | 5 MG | CAPSULE | MENDELIKABS INC | MARKETED | DIN 02457725 |
| ORFADIN | 10 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459728 |
| ORFADIN | 2 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459698 |
| ORFADIN | 20 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459736 |
| ORFADIN | 4 MG | SUSPENSION | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02469693 |
| ORFADIN | 5 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459701 |
| MDK-NITISINONE | 20 MG | CAPSULE | MENDELIKABS INC | DORMANT | DIN 02470055 |
| NITISINONE TABLETS | 10 MG | TABLET | CYCLE PHARMACEUTICALS LTD. | CANCELLED POST MARKET | DIN 02458632 |
Who else supplies NITISINONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NITISINONE appears in 51 registered pack listings across 6 markets, published on 6 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.