Learn About HIBERIX | HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for Healthcare Professionals

Indication and Usage of HIBERIX

HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children aged 6 weeks through 4 years (prior to fifth birthday).

HIBERIX is supplied in 2 presentations¹:

Vial and Prefilled Syringe Presentation includes a vial of Lyophilized Antigen Component and a prefilled syringe of Sterile Saline Diluent. A single dose after reconstitution is approximately 0.5 mL.
Vial and Vial Presentation includes a vial of Lyophilized Antigen Component and a vial of Sterile Saline Diluent. A single dose after reconstitution is 0.5 mL.

VIAL AND PREFILLED SYRINGE PRESENTATION
VIAL AND VIAL PRESENTATION

Instructions for Reconstitution via the HIBERIX Vial and Prefilled Syringe Presentation¹

Step 1

Hold the ungraduated prefilled syringe of Sterile Saline Diluent by the barrel and unscrew the syringe cap by twisting it counterclockwise. Align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock.

Step 2

Cleanse the Lyophilized Antigen Component vial stopper. Transfer the entire contents of the prefilled syringe into the vial.

Step 3

Shake the vial well until the powder is completely dissolved.

Step 4

After reconstitution, withdraw the entire contents of reconstituted vaccine into the same syringe and after changing the needle administer the vaccine intramuscularly.

Video transcript
TEXT ONSCREEN:

HIBERIX

Haemophilus b Conjugate Vaccine

(Tetanus Toxoid Conjugate)

HIBERIX Vial and Prefilled Syringe Presentation

Reconstitution video

Trademarks are property of their respective owners.

©2024 GSK or licensor.

HIBSTBD230001 February 2024

Produced in USA.

ANNOUNCER:

This is the reconstitution video for the HIBERIX Vial and Prefilled Syringe Presentation.

TEXT ONSCREEN:

Do not freeze. Discard if the diluent has been frozen.

ANNOUNCER:

Store the Lyophilized Antigen Component vials refrigerated between 2° and 8°C or 36° and 46°F. Protect vials from light.

Store the Sterile Saline Diluent prefilled syringes refrigerated or at controlled room temperature between 2° and 25°C or 36° and 77°F.

Do not freeze.

Discard if the diluent has been frozen.

ANNOUNCER:

The entire carton should be placed in the refrigerator upon receiving the shipment.

ANNOUNCER:

HIBERIX is supplied in a carton containing:

10 single-dose vials of Lyophilized Antigen Component and

10 single-dose, prefilled, ungraduated TIP-LOK syringes also known as Luer Lock syringes of Sterile Saline Diluent packaged without needles.

ANNOUNCER:

For each vaccine dose, make sure to pull one syringe and one vial from the carton.

ANNOUNCER:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

TEXT ONSCREEN:

As shown

ANNOUNCER:

Reconstitute the Lyophilized Antigen Component only with the accompanying Sterile Saline Diluent to form HIBERIX. Hold the ungraduated prefilled syringe of Sterile Saline Diluent by the barrel and unscrew the syringe cap by twisting it counterclockwise.

TEXT ONSCREEN:

As shown

ANNOUNCER:

Align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.

ANNOUNCER:

Remove the vial cap.

ANNOUNCER:

Cleanse the Lyophilized Antigen Component vial stopper.

TEXT ONSCREEN:

Sterile Saline diluent

Lyophilized Antigen Component

ANNOUNCER:

Transfer the entire contents of the prefilled syringe into the Lyophilized Antigen Component vial.

ANNOUNCER:

Shake the vial well until the powder is completely dissolved.

ANNOUNCER:

After reconstitution, withdraw the entire contents of the reconstituted vaccine into the same syringe.

ANNOUNCER:

The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

ANNOUNCER:

After changing the needle used for reconstitution, administer the vaccine intramuscularly immediately after reconstitution.

ANNOUNCER:

The Lyophilized Antigen Component vial, prefilled syringe of Sterile Saline Diluent, and carton are each labeled with a different 5-digit alphanumeric lot number and may have different expiration dates.

ANNOUNCER:

For documentation of HIBERIX vaccination, the recommendation is to record the lot number and expiration date from the HIBERIX carton.

TEXT ONSCREEN:

Please refer to the Prescribing Information for additional information about HIBERIX.

Trademarks are property of their respective owners.

©2024 GSK or licensor.

HIBSTBD230001 February 2024

Produced in USA.

ANNOUNCER:

Please refer to the Prescribing Information for additional information about HIBERIX.

Reconstitute the Lyophilized Antigen Component only with the accompanying Sterile Saline Diluent to form HIBERIX. The reconstituted vaccine should be a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. Administer HIBERIX intramuscularly immediately after reconstitution.¹

Instructions for Reconstitution via the HIBERIX Vial and Vial Presentation

Step 1

Cleanse both vial stoppers.

Using a graduated syringe, withdraw 0.6 mL of Sterile Saline Diluent from accompanying vial.

Step 2

Transfer 0.6 mL Sterile Saline Diluent into Lyophilized Antigen Component vial.

Step 3

Shake the vial well until the powder is completely dissolved.

Step 4

After reconstitution, withdraw 0.5 mL of reconstituted vaccine into the same syringe and administer intramuscularly.

INDICATIONS & IMPORTANT SAFETY INFO FOR PEDIARIX, INFANRIX, AND KINRIX

INDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus,

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7^th birthday).

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to 7^th birthday).

A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to 7^th birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

Indication for HIBERIX

HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).

Indication for ENGERIX-B

ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

IMPORTANT SAFETY INFORMATION FOR PEDIARIX, INFANRIX, AND KINRIX

tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus,

Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for

Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders
In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥105°F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine
The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions
Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX or INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite
Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients

IMPORTANT SAFETY INFORMATION FOR HIBERIX

Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX
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 HIBERIX, should be based on careful consideration of the potential benefits and possible risks
Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, 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
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
Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained
Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX
Immunization with HIBERIX does not substitute for routine tetanus immunization
Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, sleepiness, fussiness, and restlessness
Vaccination with HIBERIX may not result in protection in all vaccine recipients

IMPORTANT SAFETY INFORMATION FOR ENGERIX-B

Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast, is a contraindication to administration of ENGERIX-B
The tip caps of the prefilled syringes for ENGERIX-B contain natural rubber latex, which may cause allergic reactions
Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Temporarily defer ENGERIX-B vaccination of infants with a birth weight less than 2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers
Apnea following intramuscular vaccination has been observed in some infants born prematurely
lmmunocompromised persons, including individual receiving immunosuppressive therapy, may have a diminished immune response to ENGERIX-B
In clinical trials with ENGERIX-B, the most frequently reported adverse reactions were injection-site soreness and fatigue
Vaccination with ENGERIX-B may not result in protection in all vaccine recipients

Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Prescribing Information for INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

Prescribing Information for KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Prescribing Information for HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]

Prescribing Information for ENGERIX-B [Hepatitis B Vaccine (Recombinant)]

Indication and Usage of HIBERIX

Instructions for Reconstitution via the HIBERIX Vial and Prefilled Syringe Presentation1

Step 1

Step 2

Step 3

Step 4

Instructions for Reconstitution via the HIBERIX Vial and Vial Presentation

Step 1

Step 2

Step 3

Step 4

Indication for HIBERIX

Indication for ENGERIX-B

IMPORTANT SAFETY INFORMATION FOR HIBERIX

IMPORTANT SAFETY INFORMATION FOR ENGERIX-B

Instructions for Reconstitution via the HIBERIX Vial and Prefilled Syringe Presentation¹