TRUMENBA 60 MCG / 0.5 ML — DIN 02468751
NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY B : 60 MCG / 0.5 ML NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY A : 60 MCG / 0.5 ML · PFIZER CANADA ULC · SUSPENSION · wholesale supply in Canada
Health Canada status: MARKETED
What is TRUMENBA?
TRUMENBA 60 MCG / 0.5 ML contains NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY B : 60 MCG / 0.5 ML NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY A : 60 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02468751, held by PFIZER CANADA ULC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 31-Jan-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 TRUMENBA used for?
Trumenba is indicated for active immunization to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Meningococcal Vaccines in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
2 holders have a Canadian DIN containing Meningococcal Vaccines, across 3 DINs, of which 1 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| PFIZER CANADA ULC | 1 | 1 | TRUMENBA | Sourceable in Canada |
| GLAXOSMITHKLINE INC | 2 | 0 | MENJUGATE, MENJUGATE LIQUID | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 60 MCG / 0.5 ML |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | Trumenba is supplied in cartons of 1 and 10 single-dose prefilled syringes, without needles. The tip cap and rubber plunger of the syringe are not made with natural rubber latex. |
| Storage | Store in a refrigerator (2°C -8°C). Syringes should be stored in the refrigerator horizontally (laying flat on the shelf) to minimize the re-dispersion time. Do not freeze. Discard if the vaccine has been frozen. Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Keep out of reach and sight of children. Trumenba has been shown to be stable at temperatures of up to 25°C for 4 days. Cumulative multiple temperature excursions between 8°C and 25°C are permitted, as long as the total time does not exceed 4 days (96 hours). These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Meningococcal Vaccines |
|---|---|
| ATC code | J07AH |
| AHFS class | 80:12.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02468751 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2468751 |
| Brand name | TRUMENBA |
| Generic / active ingredient | NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY B : 60 MCG / 0.5 ML NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY A : 60 MCG / 0.5 ML |
| Market authorization holder | PFIZER CANADA ULC |
| Health Canada schedule | Schedule D |
| ATC code | J07AH |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J07AH |
| Current status | MARKETED |
| Status date | 31-Jan-2018 |
| Original market date | 2018-01-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Primary series: 2 doses: (0.5 mL each) administered at a 6-month interval. 3 doses: 2 doses (0.5 mL each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose. The choice of dosing schedule may depend on the risk of exposure and the subject's susceptibility to meningococcal serogroup B disease. Booster dose: A booster dose may be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease. Administration: For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm. The vaccine should be shaken vigorously to ensure that a homogeneous white suspension is obtained. Do not use the vaccine if it cannot be resuspended. The vaccine should be visually inspected for particulate matter and discoloration prior to administration. This product should not be used if particulate matter or discolouration is found. Separate injection sites and different syringes must be used if more than one vaccine is administered at the same time. There are no data available on the interchangeability of Trumenba with other meningococcal serogroup B vaccines to complete the vaccination series. Missed dose: If a dose of Trumenba is missed, individuals should contact their healthcare professionals for advice on appropriate series completion.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Trumenba is contraindicated in individuals who are hypersensitive to the active ingredient or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba. Procedures should be in place to avoid injury from fainting. Do not inject intravenously, intradermally, or subcutaneously. As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients. Driving and Operating Machinery: Trumenba has no or negligible influence on the ability to drive or use machines. However, some of the effects (see 8 ADVERSE REACTIONS) may temporarily affect the ability to drive or use machines. Hematologic: As with any intramuscular vaccine, Trumenba should be given with caution to individuals with thrombocytopenia or any coagulation disorder or to those receiving anticoagulant therapy, unless the potential benefit clearly outweighs the risk of administration. Immune: There are no data available for immunocompromised individuals, including those receiving immunosuppressant therapy. Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B even if they develop antibodies following vaccination with Trumenba.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
1 of 3 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| MENJUGATE | 10 MCG / 0.5 ML | POWDER FOR SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 02243820 |
| MENJUGATE LIQUID | 10 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | 02440709 |
2 · Same class — other molecules in ATC J07AH
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Meningococcus, A, C, Y, W-135, Tetraval. Purified Polysacc. Antigen Conjugated | MENACTRA · MENQUADFI · MENVEO | 3 | 2 | Yes |
| Meningococcus, A, C, Y, W-135, Tetraval. Purified Polysacc. Antigen | MENOMUNE-A/C/Y/W-135 · NIMENRIX | 4 | 1 | Yes |
| Meningococcal Vaccines | MENJUGATE · MENJUGATE LIQUID · TRUMENBA | 3 | 1 | Yes |
| Meningococcus C, Purified Polysaccharides Antigen Conjugated | MENINGITEC · NEISVAC-C | 2 | 1 | Yes |
| Meningococcus B, Multicomponent Vaccine | BEXSERO | 1 | 1 | Yes |
| Meningococcus, A, C, Bivalent Purified Polysacc. Antigen | MENCEVAX AC PWS 500MCG/VIAL · MENCEVAX AC PWS 50MCG/VIAL · MENCEVAX AC PWS INJ 2500MCG/VIAL · MENINGOCOCCAL POLYSACCHARIDE VACCINE GROUPS A & C | 4 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC J07A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J07AL | Pneumococcus, Purified Polysacc.antigen Conjugated · Pneumococcus, Purified Polysaccharides Antigen | 11 | 3 |
| J07AE | Cholera, Inactivated, Whole Cell · Cholera, Live Attenuated | 4 | 2 |
| J07AP | Typhoid, Inactivated, Whole Cell · Typhoid, Oral, Live Attenuated · Typhoid, Purified Polysaccharide Antigen | 5 | 2 |
| J07AJ | Pertussis, Inact., Whole Cell, Comb. With Toxoids · Pertussis, Inactivated, Whole Cell · Pertussis, Purified Antigen · Pertussis, Purified Antigen, Comb. With Toxoids | 7 | 1 |
| J07AM | Tetanus Toxoid · Tetanus Toxoid, Comb. With Diphtheria Toxoid | 7 | 1 |
| J07AX | Other Bacterial Vaccines | 4 | 1 |
| J07AG | Hemophilus Influenzae B Vaccines · Hemophilus Influenzae B, Combinations With Pertussis And Toxoids · Hemophilus Influenzae B, Combinations With Toxoids · Hemophilus Influenzae B, Purified Antig. Conjugated | 8 | 1 |
| J07AF | Diphtheria Toxoid | 4 | 0 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| ADACEL | PERTUSSIS TOXOID : 2.5 MCG / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 5 MCG / 0.5 ML DIPHTHERIA TOXOID : 2 LF / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML FIMBRIAE TYPES 2 AND 3 (FIM) : 5 MCG / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02240255 |
| DUKORAL | VIBRIO CHOLERAE INABA 48 CLASSICAL BIOTYPE, HEAT INACTIVATED : 31250000000 CELLS VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, FORMALIN INACTIVATED : 31250000000 CELLS VIBRIO CHOLERAE INABA 6973 EL TOR BIOTYPE, FORMALIN INACTIVATED : 31250000000 CELLS VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, HEAT INACTIVATED : 31250000000 CELLS RECOMBINANT CHOLERA TOXIN B SUBUNIT : 1 MG | VALNEVA SWEDEN AB | MARKETED | 02247208 |
| VAXCHORA | VIBRIO CHOLERAE, STRAIN CVD 103-HGR, LIVE : 2000000000 UNIT | BAVARIAN NORDIC AS | MARKETED | 02538164 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is TRUMENBA called?
Also recorded in Canada as: Meningococcal Group B Vaccine (recombinant, adsorbed) (GLOBAL), Meningococcal Group B Vaccine (rDNA, component, adsorbed) (UK).
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.