What is MENVEO?

MENVEO 47 MCG / 0.5 ML contains CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN : 47 MCG / 0.5 ML MENINGOCOCCAL GROUP W-135 OLIGOSACCHARIDE : 5 MCG / 0.5 ML MENINGOCOCCAL GROUP A OLIGOSACCHARIDE : 10 MCG / 0.5 ML MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE : 5 MCG / 0.5 ML MENINGOCOCCAL GROUP C OLIGOSACCHARIDE : 5 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02347393, held by GLAXOSMITHKLINE INC, supplied as POWDER FOR SOLUTION ; SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 27-Mar-2017. 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 MENVEO used for?

MENVEO is indicated for active immunization of individuals 2 months through 55 years of age to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

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?

There are two presentations available, a two-vial lyophilized powder/liquid presentation and a single-vial liquid presentation. For the lyophilized powder/liquid presentation, the contents of the vials must be combined to form MENVEO prior to administration (4.3 Reconstitution). The liquid presentation does not require reconstitution before use. Infants from 2 to 6 months of age: Primary vaccination schedule is 3 doses (0.5 mL each), given with an interval of at least 2 months; followed by a fourth dose during the second year of life (at 12-16 months). Infants and toddlers from 7 to 23 months of age: Primary vaccination schedule is 2 doses (0.5 mL each). The second dose should be administered in the second year of life and at least two months after the first dose. Individuals from 2 years of age and older: Primary vaccination schedule is a single dose (0.5 mL). Booster: The need for, and timing of, a booster dose of MENVEO has not yet been determined. Reconstitution: MENVEO Powder and solution for injection (Lyophilized Powder/Liquid presentation) only: MENVEO must be prepared for administration by reconstituting the lyophilized MenA conjugate component with the liquid MenCWY conjugate component. Using a graduated syringe, withdraw the entire contents of the vial of MenCWY liquid conjugate component and inject into the MenA lyophilized conjugate component vial. Invert and shake the vial vigorously. Using a needle of suitable gauge and length for the vaccination, withdraw 0.5mL of reconstituted product. Following reconstitution, the vaccine is a clear, colourless solution, free from visible foreign particles. In the event that any foreign particulate matter and/or variation of physical aspect is observed, discard the vaccine. The reconstituted vaccine should be used immediately. Any unused product or waste material should be disposed in accordance with local requirements for disposal of biohazardous waste. Administration: Prior to injection, change the needle for one suitable for withdrawal of the vaccine for administration. Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose. Ensure that no air bubbles are present in the syringe before injecting the vaccine. Parenteral drug products should be inspected for container integrity, particulate matter and discoloration before administration. The vaccine is to be administered as a single 0.5 mL intramuscular injection, preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle (upper arm) in children, adolescents and adults. Do not administer the vaccine intravenously, subcutaneously or intradermally. Separate injection sites must be used if more than one vaccine is being administered at the same time.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store refrigerated, away from the freezer compartment, at 2°C to 8°C. Vaccine must be maintained at 2°C to 8°C during transport. Do not use MENVEO after the expiry date which is stated on the carton. ALL contents must be discarded on reaching the outer carton expiry date. For the lyophilized powder/liquid formulation, the vaccine consists of one lyophilized powder vial and one liquid vial. Each of the two components may carry a different expiry date. The reconstituted vaccine should be used immediately, but may be held at or below 25°C for up to 8 hours. Do not freeze. Frozen/previously frozen product should not be used. Protect from light.

How is it supplied?

MENVEO Powder and solution for injection (Lyophilized Powder/Liquid presentation): Pack sizes of 1 dose (2 vials) per package and/or 10 doses (20 vials) per package. MENVEO (Liquid) Solution for injection (Liquid presentation): Pack sizes of 1 dose (1 vial) per package and/or 10 doses (10 vials) per package.

Contraindications

Known hypersensitivity to any component of MENVEO, including CRM197 or other diphtheria-containing vaccines, or a life-threatening reaction after previous administration of a vaccine containing similar components is a contraindication to vaccine administration. MENVEO should not be administered to subjects with a known history of Guillain-Barré Syndrome.

Warnings and precautions

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting. As with all injectable pediatric vaccines, the potential risk of apnea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. As for all vaccines, the date of vaccine administration, the lot number and the manufacturer of the vaccine administered should be recorded in the patient's immunization record. MENVEO should be administered via intramuscular injection. Care should be taken to avoid injecting MENVEO vaccine subcutaneously or intravenously. An unused sterile syringe and needle should be used for each patient to prevent transmission of blood-borne infectious agents from person to person. Needles should not be recapped and should be disposed of according to guidelines for management of biohazardous waste. As with other vaccines, MENVEO should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection is not a contraindication. As with any vaccine, a protective immune response may not be elicited in all vaccinees. MENVEO will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine. Exercise caution when driving or operating a vehicle or potentially dangerous machinery. MENVEO has not been evaluated in persons with thrombocytopenia or bleeding disorders. Because of the risk of hematoma, MENVEO should not be administered to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons receiving anticoagulant therapy, unless the potential benefit outweighs the risk of administration. NACI has published recommendations for the immunization of people with haemophilia and other bleeding disorders. Immunocompromised patients may have an inadequate response to the vaccination, resulting in lack of protection. The immune response to MENVEO vaccine administered to immunosuppressed persons has not been studied. Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y even following vaccination with MENVEO.

What can be used instead?

Other Canadian products sharing ATC code J07AH08 MENINGOCOCCUS, A, C, Y, W-135, TETRAVAL. PURIFIED POLYSACC. ANTIGEN CONJUGATED. 2 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.