Menomune A/C/Y/W-135

Meningococcal Vaccines, All Types

 
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
If a meningococcal vaccine has been previously given, question the patient, parent, or guardian about any symptoms or signs of an adverse reaction.
Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1—800—822—7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.
Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

Visually inspect parenteral products for particulate matter and discoloration prior to administration. When reconstituted, meningococcal vaccine is clear and colorless.
Do not mix meningococcal vaccine with any other vaccine or product in the same syringe.

Reconstitution (Menomune):
Using a sterile syringe suitable to ensure accurate measurements, withdrawal the supplied diluent (0.6 ml for single-dose vial or 6 ml for multidose vial).
Inject diluent into vial containing lyophilized vaccine.
Swirl vial until the vaccine has completely dissolved. The resulting solution should be clear and colorless.
Storage of reconstituted vaccine:
Single-dose vial: Administer immediately after reconstitution.
Multidose vial: Store at 2—8 degrees C (35—46 degrees F) for up to 35 days after reconstitution; do not freeze.
 
Subcutaneous injection:
Prior to administration, clean skin over the injection site with a suitable cleansing agent. The preferred injection site is the deltoid region of the upper arm. Do not inject into an area that has been or will be used for another injections.
Using a sterile syringe and 23- or 25-gauge needle (5/8th inch in length), removed 0.5 ml of the reconstituted solution from the vial.
Administer 0.5 ml of the vaccine by injecting the needle subcutaneously at a 45-degree angle. A separate syringe and needle MUST be used for each patient.

Guillain-Barre syndrome / Delayed / Incidence not known
angioedema / Rapid / Incidence not known

erythema / Early / 5.7-16.0
dyspnea / Early / Incidence not known

injection site reaction / Rapid / 2.8-48.1
headache / Early / 20.3-41.8
fatigue / Early / 25.1-32.3
malaise / Early / 16.8-22.3
arthralgia / Delayed / 5.3-16.0
diarrhea / Early / 10.2-14.0
irritability / Delayed / 0-12.2
drowsiness / Early / 0-11.2
anorexia / Delayed / 7.7-9.9
chills / Rapid / 3.5-5.6
fever / Early / 0.5-5.2
vomiting / Early / 1.4-2.7
rash / Early / 0.8-1.4
paresthesias / Delayed / Incidence not known
asthenia / Delayed / Incidence not known
urticaria / Rapid / Incidence not known
nausea / Early / Incidence not known
dizziness / Early / Incidence not known
pruritus / Rapid / Incidence not known

Menomune A/C/Y/W-135

Rx

Polysaccharide vaccine containing antigens from N. meningitidis serogroups A, C, Y, and W-135
For prophylaxis against meningococcal disease in patients 2 years of age and older
Preferred meningococcal vaccine for vaccine-naive adults 56 years of age and older if only a single dose is anticipated

Primary immunization is a single 0.5 mL subcutaneous injection; deltoid region preferred. Revaccination with a second dose may be given to patients at continued high risk for meningococcal disease.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.

Menomune A/C/Y/W-135 Subcutaneous Inj Pwd F/Sol

0.5 ml/dose SC.

0.5 ml/dose SC.

0.5 ml/dose SC.

>= 2 years: 0.5 ml/dose SC.
< 2 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

The meningococcal polysaccharide (MPSV4) vaccine is made from the outer polysaccharide capsule of the meningococcal bacteria. The meningococcal vaccine induces production of bactericidal antibodies specific to the capsular polysaccharides of Neisseria meningitidis serogroups A, C, Y, and W-135. Bacterial anti-capsular antibodies have been associated with protection against invasive meningococcal disease.

The meningococcal polysaccharide vaccine (MPSV4) is administered subcutaneously. Vaccination does not ensure immunity.
 
During a clinical study, vaccine efficacy was determined by measuring the percentage of patients to achieve a >= 4-fold increase in antibody concentration over baseline. Twenty eight days after a single vaccine dose in 1098 adults 18—55 years of age, 84.6%, 89.7%, 79.4%, and 94.4% developed at least a 4-fold increase in antibody titers against N. meningitidis serogroups A, C, Y, and W-135, respectively. The seroconversion rate (>= 4-fold increase) was found to be higher in those vaccine recipients with undetectable titers at baseline (i.e., < 8 at Day 0); 99% serogroup A (n = 143/144), 98% serogroup C (n = 297/304), 97% serogroup Y (n = 221/228), and 99% serogroup W-135 (n = 325/328). Distrubution, metabolism, and excretion of the vaccine has not been defined.

The meningococcal polysaccharide vaccine is classified as FDA pregnancy risk category C. No adequate and well controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect the reproductive system is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women have not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration of the vaccine only if the potential benefit to the mother justifies the potential risk to the fetus.

Data are limited regarding use of the meningococcal polysaccharide vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), inactivated, polysaccharide vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.