MENHIBRIX

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MENHIBRIX

Classes

All Other Vaccine Combinations

Administration

 
Inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements (VIS) from the Centers for Disease Control and Prevention (CDC) to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
Per U.S. federal law, record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record.
If a prior meningococcal, Haemophilus influenzae type b, or tetanus toxoid-containing vaccine dose has been given, question the parent or guardian about any symptoms or signs of an adverse reaction after the previous dose. 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 (see Contraindications).
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.

Injectable Administration

Administer meningococcal Haemophilus influenzae type b conjugate vaccine intramuscularly; do not give intravenously, intradermally, or subcutaneously.
Do not give fractional doses (doses < 0.5 ml).
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. After reconstitution, the vaccine is clear and colorless.

Intramuscular Administration

Reconstitution:
Reconstitute only with the accompanying saline diluent.
Using aseptic, technique, withdraw 0.6 ml of the saline diluent and inject into the vaccine vial.
Shake vigorously. The final solution should be clear and colorless.
Storage of reconstituted vaccine: Administer the vaccine immediately after reconstituting; do not store for future use.[50705]
 
Intramuscular injection:
Use a separate syringe and needle for each patient.
If the meningococcal Haemophilus influenzae type b conjugate vaccine is given concomitantly with other vaccines, use separate syringes and administer at different injection sites. Do not mix with any other vaccine in the same syringe or vial.
The preferred injection sites are the anterolateral aspect of the thigh for most infants younger than 1 year. The deltoid muscle of the upper arm is usually large enough for intramuscular injection in older children.
Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.[50705]

Adverse Reactions
Severe

apnea / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

Moderate

erythema / Early / 20.6-35.5
edema / Delayed / 14.7-25.4
hypotonia / Delayed / Incidence not known

Mild

irritability / Delayed / 62.1-70.8
drowsiness / Early / 48.7-62.8
injection site reaction / Rapid / 0-46.2
fever / Early / 11.0-25.9
urticaria / Rapid / Incidence not known
syncope / Early / Incidence not known
rash / Early / Incidence not known

Common Brand Names

MENHIBRIX

Dea Class

Rx

Description

Used for prevention of disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b
4-dose series for infants 6 weeks through 18 months
First meningococcal vaccine approved for infants

Dosage And Indications
For simultaneous meningococcal infection prophylaxis due to Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b prophylaxis. Intramuscular dosage Infants and Children 6 weeks—18 months

0.5 mL IM per dose, given as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. The first dose may be given as early as 6 weeks and the fourth dose as late as 18 months of age. If administration of the first dose is delayed until 12 months of age or later, the Advisory Committee on Immunization Practices (ACIP) recommends 2 doses administered at least 8 weeks apart.

Dosing Considerations
Hepatic Impairment

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

Renal Impairment

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

Drug Interactions

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.
Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

How Supplied

MENHIBRIX Intramuscular Inj Pwd F/Sol

Maximum Dosage
Adults

Safety and efficacy have not been established.

Geriatric

Safety and efficacy have not been established.

Adolescents

Safety and efficacy have not been established.

Children

over 18 months: Safety and efficacy have not been established.
12 to 18 months: 0.5 mL IM.

Infants

6 weeks of age and older: 0.5 mL IM.
under 6 weeks of age: Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

The presence of bacterial anti-capsular antibodies has been associated with protection from invasive meningococcal disease. Meningococcal Haemophilus influenzae type b conjugate vaccine induces the production of bactericidal antibodies against the capsular polysaccharide of Neisseria meningitidis serogroups C and Y.
 
The high virulence of Haemophilus influenzae type b (Hib) is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. The Haemophilus influenzae type b conjugate vaccine contains the capsule polysaccharides from Hib conjugated to inactivated tetanus toxoid. Haemophilus influenzae type b conjugate vaccine exposure stimulates the immune system to produce Hib capsule-specific antibodies (anti-PRP) that presumably destroy the capsule, making the organism vulnerable to antibody and cell-mediated immunity. Based on studies with an unconjugated Haemophilus influenzae type b vaccine, anti-PRP concentrations of 0.15 mcg/ml have been accepted as the minimal protective level.

Pharmacokinetics

The meningococcal Haemophilus influenzae type b conjugate vaccine is administered intramuscularly. Protective antibody concentrations may not occur for several weeks after administration of the vaccine. The distrubution, metabolism, and excretion of the vaccine has not been defined.

Pregnancy And Lactation
Pregnancy


Meningococcal Haemophilus influenzae type b conjugate 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 to affect reproduction capacity is unknown. This vaccine is not approved for use in women of childbearing age.


The meningococcal Haemophilus influenzae type b conjugate vaccine is not indicated for use in women of child-bearing age; it is only indicated for use during the childhood immunization series. However, according to the Advisory Committee on Immunization Practices, inactivated, polysaccharide, conjugate vaccines and toxoids, such as meningococcal Haemophilus influenzae type b conjugate vaccine, pose no risk for breast-feeding 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.