Vaxelis dip,pert(a)tet/hepB/pol/Hib/PF Vaccine 10X0.5ML SDV by

Rx Item:Vaxelis dip,pert(a)tet/hepB/pol/Hib/PF Vaccine 10X0.5ML SDV by Sanofi

Part Number: RX730726

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Description

Item No. RX730726, 730726, NDC# 63361-0243-10 63361-243-10 6336102431 63361024310 UPC Code: 0-63361-02431-0 063361-024310 063361024310 Supplier Part No.: 24310 Generic Group Description:Dip Pert(A)Tet/Hepb/Pol/H Generic Group Number:40619 Therapeutic Code:800800 Generic Form Code:SDV Generic Strength Code:15-5-10 Unit Dose Indicator: Item Form Code:SDV Vendor Name:Sanofi Pasteur/Vaxelis Item External Description: Item Category:RX Only Physician,Pharmacy,Dentist, Drug Mfg.,Distributor,Gov,Hospit

Clinical Information

Gen. Code and Des.

79568 dip,pert(a)tet/hepB/pol/Hib/PF INTRAMUSC VIAL 15-5-10

GCN and Des.

40619 dip,pert(a)tet/hepB/pol/Hib/PF INTRAMUSC VIAL 15-5-10

Strength

Dose Form

VIAL (ML)

Product Category

RX Pharmaceuticals

Fine Line Class

850085008510 All Rx Products

DEA Class

OMP Family

AHFS Class

80080000 TOXOIDS

80120000 VACCINES

Active Ingredients

3036 poliomyelitis vaccine,killed

4076 diphtheria,pertussis(acell),tetanus pedi vaccine

9870 preservative free

6319 Haemophilus B polysach conjugat with meningococcal

8320 hepatitis B virus vaccine, recombinant

Inactive Ingredients

2551 polysorbates 9005645

9283 beef derived (bovine)

These highlights do not include all the information needed to use VAXELIS safely and effectively. See full prescribing information for VAXELIS.

VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)

Suspension for Intramuscular Injection

Initial U.S. Approval: 2018

INDICATIONS AND USAGE

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). (1)

DOSAGE AND ADMINISTRATION

The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for injection (0.5 mL dose) available in single-dose vials and prefilled syringes. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Haemophilus 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 VAXELIS 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 VAXELIS. (5.3)

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, 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. (5.5)

Urine antigen detection may not have definitive diagnostic value in suspected H. influenzae type b disease following vaccination with VAXELIS. (5.7) (7.1)

ADVERSE REACTIONS

The solicited adverse reactions following any dose were irritability (=55%), crying (=45%), injection site pain (=44%), somnolence (=40%), injection site erythema (=25%), decreased appetite (=23%), fever =38.0°C (=19%), injection site swelling (=18%), and vomiting (=9%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 and http://vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2022

Rx Item:Vaxelis dip,pert(a)tet/hepB/pol/Hib/PF Vaccine 10X0.5ML SDV by Sanofi

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