OPFOLDA 65 MG
MIGLUSTAT : 65 MG · DIN 02556812 · AMICUS THERAPEUTICS CANADA INC.
Health Canada status: MARKETED
What is OPFOLDA?
OPFOLDA 65 MG contains MIGLUSTAT : 65 MG. It is listed in the Health Canada Drug Product Database under DIN 02556812, held by AMICUS THERAPEUTICS CANADA INC., supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 05-Dec-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 OPFOLDA used for?
Enzyme stabilizer in combination with POMBILITI (cipaglucosidase alfa) for the treatment of adult patients with late-onset Pompe disease weighing >=40 kg.
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 | 02556812 |
|---|---|
| Brand name | OPFOLDA |
| Generic / active ingredient | MIGLUSTAT : 65 MG |
| Manufacturer | AMICUS THERAPEUTICS CANADA INC. |
| Strength | 65 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A16AX06 MIGLUSTAT |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 05-Dec-2025 |
How is it administered?
Taken orally every other week, 1-3 hours before cipaglucosidase alfa infusion. Fast 2 hours before and after. Dose: 260 mg (>=50 kg) or 195 mg (40 to <50 kg).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in the provided text (refer to section 11 which is listed in TOC but content not fully provided).
How is it supplied?
40 cc HDPE bottles containing 4 or 24 capsules.
Contraindications
Hypersensitivity to miglustat; women who are or may become pregnant; patients with a contraindication to cipaglucosidase alfa.
Warnings and precautions
Must be used with cipaglucosidase alfa. Risk of embryo-fetal harm and impaired fertility. Caution when driving due to potential dizziness or somnolence.
What can be used instead?
Other Canadian products sharing ATC code A16AX06 MIGLUSTAT. 3 of 3 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 |
|---|---|---|---|---|---|
| SANDOZ MIGLUSTAT | 100 MG | CAPSULE | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02456257 |
| ZAVESCA | 100 MG | CAPSULE | JANSSEN INC | MARKETED | DIN 02250519 |
Who else supplies MIGLUSTAT worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MIGLUSTAT appears in 24 registered pack listings across 9 markets, published on 9 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.