Clinical Information
Gen. Code and Des.
80841 dipht,pert(a),tet-polio/Hib/PF INTRAMUSC KIT 15-48-5-62
GCN and Des.
47823 dipht,pert(a),tet-polio/Hib/PF INTRAMUSC KIT 15-48-5-62
Strength
Dose Form
KIT
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
4389 Haemophilus B polysaccharide conj w/tetanus toxoid
7715 diphtheria,pertussis (acell),tetanus,polio vaccine
9870 preservative free
Inactive Ingredients
These highlights do not include all the information needed to use Pentacel safely and effectively. See full prescribing information for Pentacel.
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Suspension for Intramuscular Injection
Initial U.S. Approval: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 7/2022
Warnings and Precautions (5.8) 7/2022
INDICATIONS AND USAGE
Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5th birthday). (1)
DOSAGE AND ADMINISTRATION
The four dose immunization series consists of a 0.5 mL intramuscular injection, after reconstitution, administered at 2, 4, 6 and 15-18 months of age. (2.1)
Pentacel consists of a liquid vaccine component (DTaP-IPV component) and a lyophilized vaccine component (ActHIB vaccine). Reconstitute the ActHIB vaccine component with the DTaP-IPV component immediately before administration. (2.2)
DOSAGE FORMS AND STRENGTHS
Suspension for injection (0.5 mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single-dose vials. (3)
CONTRAINDICATIONS
Severe allergic reaction (eg, anaphylaxis) after a previous dose of Pentacel, any ingredient of Pentacel, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or H. influenzae type b vaccine. (4.1)
Encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause. (4.2)
Progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized. (4.3)
WARNINGS AND PRECAUTIONS
Carefully consider benefits and risks before administering Pentacel to persons with a history of:
-
fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine. (5.2)
-
seizures within 3 days after a previous pertussis-containing vaccine. (5.2)
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Pentacel. (5.3)
For infants and children with a history of previous seizures, an antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with Pentacel and for the next 24 hours. (5.4)
Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including Pentacel, to an infant born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. (5.7)
ADVERSE REACTIONS
Rates of adverse reactions varied by dose number. Systemic reactions that occurred in >50% of participants following any dose included fussiness/irritability and inconsolable crying. Fever ≥38.0°C occurred in 6-16% of participants, depending on dose number. Injection site reactions that occurred in >30% of participants following any dose included tenderness and increase in arm circumference. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 and https://vaers.hhs.gov.
DRUG INTERACTIONS
Do not mix Pentacel or any of its components with any other vaccine or diluent. (7.1)
Immunosuppressive therapies may reduce the immune response to Pentacel. (7.2)
Urine antigen detection may not have definitive diagnostic value in suspected H. influenzae type b disease within one week following Pentacel. (7.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2023
