MENACTRA

Abbreviated Prescribing Information

See local prescribing information for full details prior to prescribing

TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

MENACTRA solution for injection is available in single-dose vial (0.5 ml), containing

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide conjugated to diphtheria toxoid protein. The other ingredients are sodium chloride, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic. The vaccine contains no preservative and must be stored at 2oC to 8oC (do not freeze).

THERAPEUTIC INDICATION

This vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitides serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age.

Menactra vaccine is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by N meningitidis serogroup B.

POSOLOGY AND METHOD OF ADMINISTRATION

Menactra is administered as a single 0.5 mL injection by the intramuscular route, preferably in the anterolateral thigh or deltoid region depending on the recipient's age and muscle mass.

Primary vaccination:

In children 9 through 23 months of age who travel or living in endemic areas. Menactra is given as a 2- dose series at least three months apart. Individuals 2 through 55 years of age receive a single dose.

Do not administer this product intravenously, subcutaneously, or intradermally. The need for, or timing of, a booster dose of Menactra vaccine has not yet been determined. Parenteral drug products should be inspected visually for container integrity, particulate matter, and discoloration prior to administration, whenever solution and container permit.

CONTRAINDICATIONS

Hypersensitivity/severe allergic reaction (eg, anaphylaxis)
Guillain-Barré Syndrome
Febrile or Acute Disease
Pregnancy

SPECIAL WARNING AND SPECIAL PRECAUTIONS FOR USE:

Guillain-Barré Syndrome. The use of Menactra vaccination could be a potential for an increased risk of Guillain-Barré Syndrome. The decision to give Menactra should take into account the potential benefits and risks.
Preventing and Managing Allergic Vaccine Reactions. Review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to prevent allergic vaccine reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Thrombocytopenia or Bleeding Disorders. Menactra vaccine has not been evaluated in persons with thrombocytopenia or bleeding disorders. As with any other vaccine administered intramuscularly, the vaccine risk versus benefit for persons at risk of hemorrhage following intramuscular injection must be evaluated.
Altered Immunocompetence
Reduced Immune Response. Some individuals receiving immunosuppressant therapy may have reduced immune responses to Menactra.
Complement Deficiency. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, even if they develop antibodies following vaccination with Menactra.
Limitations of Vaccine Effectiveness. Menactra vaccine may not protect all recipients against vaccine serogroups.
Syncope. Syncope (fainting) has been reported following vaccination with Menactra. Procedures should be in place to prevent falling injury and manage syncopal reactions.

INTERACTIONS

Menactra vaccine was concomitantly administered with Typhoid Vi Polysaccharide Vaccine for adults 18 to 55 years, and with Tetanus and Diphtheria Toxoid Adsorbed Vaccine (Td) for adults 11 to 17 years.
In children younger than 2 years of age, Menactra vaccine was co-administered with one or more of the following vaccines: PCV7, MMR, V, MMRV, HepA, or Hib vaccine .
When Menactra was administered concomitantly with PCV, antibody responses to 3 of the 7 serotypes in PCV and to serogroup W-135 of Menactra did not meet the non-inferiority criteria. Given the high antibody response rates to all PCV serotypes when assessed by either ELISA or OPA, and considering that >81% of subjects achieved SBA-HC antibody titers ≥1:8 for all 4 serogroups of Menactra, it is unlikely that there will be any impact on the clinical efficacy of either of these vaccines when administered concomitantly.
Menactra vaccine must not be mixed with other vaccine in the same syringe and given at separate injection sites.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids may reduce the immune response to vaccines.

PREGNANCY AND LACTATION

This vaccine should be given to pregnant women only if clearly needed, especially the risk is clearly identified needed, such as during an outbreak or prior to necessary travel to an endemic area, and only following an assessment involving the healthcare professional and patient of the risks and benefits.

Careful consideration should be taken before Menactra vaccine is administered to a nursing mother.

UNDESIRABLE EFFECTS

Children 9 Through 23 Months of Age

The safety of Menactra was evaluated in four clinical studies that enrolled 3721 participants who received Menactra at 9 and 12 months of age. At 12 months of age these children also received one or more other recommended vaccines [Measles, Mumps, Rubella and Varicella Virus Vaccine Live (MMRV) or Measles, Mumps, and Rubella Virus Vaccine (MMR) and Varicella Virus Vaccine Live (V) each manufactured by Merck & Co., Inc., Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PCV7), Hepatitis A Vaccine (HepA)].

Individuals 2 Through 55 Years of Age

The safety of Menactra vaccine was evaluated in eight clinical studies that enrolled 10,057 participants aged 2–55 years who received Menactra vaccine and 5266 participants who received Menomune – A/C/Y/W-135 vaccine. The three primary safety studies were randomized, active-controlled trials that enrolled participants 2–10 years of age (Menactra vaccine, N=1713; Menomune – A/C/Y/W-135 vaccine, N=1519), 11–18 years of age (Menactra vaccine, N=2270; Menomune – A/C/Y/W-135 vaccine, N=972), and 18–55 years of age (Menactra vaccine, N=1384; Menomune – A/C/Y/W-135 vaccine, N=1170), respectively.

Safety Evaluation

Participants were monitored after each vaccination for 20 or 30 minutes for immediate reactions, depending on the study. Solicited injection site and systemic reactions were recorded in a diary card for 7 consecutive days after each vaccination. Participants were monitored for 28 days (30 days for infants and toddlers) for unsolicited adverse events and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, and serious adverse events (SAEs).

Unsolicited adverse event information was obtained either by telephone interview or at an interim clinic visit. Information regarding adverse events that occurred in the 6-month post vaccination time period was obtained via a scripted telephone interview

Serious Adverse Events in All Safety Studies

Serious adverse events (SAEs) were reported during a 6-month time period following vaccinations in individuals 9 months through 55 years of age. In children who received Menactra vaccine at 9 months and at 12 months of age, SAEs occurred at a rate of 2.0% - 2.5%. In participants who received one or more childhood vaccine(s) (without co-administration of Menactra vaccine) at 12 months of age, SAEs occurred at a rate of 1.6% - 3.6%, depending on the number and type of vaccines received. In children 2–10 years of age, SAEs occurred at a rate of 0.6% following Menactra vaccine and at a rate of 0.7% following Menomune – A/C/Y/W-135 vaccine. In adolescents 11 through 18 years of age and adults 18 through 55 years of age, SAEs occurred at a rate of 1.0% following Menactra vaccine and at a rate of 1.3% following Menomune – A/C/Y/W-135 vaccine.

Solicited Adverse Events in the Primary Safety Studies

In children 9 months and 23 months of age were injection site tenderness and irritability. In 2–10 years were injection site pain, irritability, diarrhea, drowsiness, and anorexia we also common. In adolescents ages 11–18 years and adults ages 18–55 years were injection site pain, headache, and fatigue.

Adverse Events in Concomitant Vaccine Studies

Solicited Injection Site and Systemic Reactions When Given With Other Pediatric Vaccines

Tenderness, redness, and swelling at the Menactra vaccine injection site and at the concomitant vaccine injection sites. Irritability was the most frequent systemic reaction.

Solicited Injection Site and Systemic Reactions When Given With Tetanus and Diphtheria Toxoid Adsorbed Vaccine (Td)

Injection site pain, headache, fatigue

Solicited Injection Site and Systemic Reactions When Given With Typhoid Vi Polysaccharide Vaccine

Headache and fatigue

Post-Marketing Experience

Blood and lymphatic system disorders - Lymphadenopathy, Immune system disorders - Hypersensitivity reactions such as anaphylaxis/anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, Nervous system disorders - Guillain-Barre syndrome, paresthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis, Musculoskeletal and connective tissue disorders – Myalgia, General disorders and administrative site conditions – Large injection site reactions, extensive swelling of the injected limb (may be associated with erythema, warmth, tenderness or pain at injection site).

Presentation: Box, 1 vial @ 0.5 mL (single dose) (DKI1616500343A1)

Box, 5 vials @ 0.5 mL dose) (DKI1616500343A1)

Date of revision: 02 January 2021 (based on BPOM approval 23 December 2020)

This information is intended for Health Care Professional only. See local product information for full details information