TRUMENBA 60 MCG / 0.5 ML

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.

Product details and regulatory record

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.

How is it stored and handled?

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.

How is it supplied?

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.

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?

Other Canadian products sharing ATC code J07AH MENINGOCOCCAL VACCINES. 1 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.

Who else supplies MENINGOCOCCAL VACCINES worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. MENINGOCOCCAL VACCINES appears in 12 registered pack listings across 3 markets, published on 3 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.