Included as part of the PRECAUTIONS section.

Guillain-Barré Syndrome

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including MENHIBRIX, should be based on consideration of the potential benefits and possible risks.

Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including MENHIBRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including MENHIBRIX, to infants born prematurely should be based on consideration of the individual infant's medical status, and the potential benefits and possible risks of vaccination.

Preventing and Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the patient's immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

Altered Immunocompetence

Safety and effectiveness of MENHIBRIX in immunosuppressed children have not been evaluated. If MENHIBRIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained.

Tetanus Immunization

Immunization with MENHIBRIX does not substitute for routine tetanus immunization.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

MENHIBRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with MENHIBRIX. It is also not known whether MENHIBRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of MENHIBRIX in children younger than 6 weeks of age and in children 19 months to 16 years of age have not been established.

REFERENCES

All NCT numbers are as noted in the National Library of Medicine clinical trial database (see www.clinicaltrials.gov).

7. Rothstein EP, Madore DV, Girone JAC, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J 1991;10:311-314.

Last reviewed on RxList: 7/23/2012
This monograph has been modified to include the generic and brand name in many instances.