Hiberix Inj, Vial
It is used to prevent Haemophilus influenzae type b disease.
Drug Class
Vaccine
Pharmacologic Class
Bacterial vaccine; Conjugate vaccine; Haemophilus influenzae type b vaccine
Pregnancy Category
Not applicable (Vaccine, generally not indicated for routine use in pregnancy)
FDA Approved
Aug 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hiberix is a vaccine given by injection to help protect children against serious infections caused by Haemophilus influenzae type b (Hib) bacteria. Hib can cause severe illnesses like meningitis (infection of the brain and spinal cord lining), pneumonia, and epiglottitis (a life-threatening throat swelling). This vaccine helps your child's body make its own protection (antibodies) against Hib.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication is administered via intramuscular injection.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Ensure your child completes the full vaccine series as recommended by their doctor to achieve the best protection.
- Keep a record of your child's vaccinations.
- Discuss any concerns or questions about the vaccine with your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mL single dose (for specific indications)
Dose Range:
0.5 - 0.5 mg
Condition-Specific Dosing:
asplenia:
0.5 mL single dose (if not previously vaccinated)
hematopoietic stem cell transplant (HSCT) recipients:
0.5 mL as a 3-dose series starting 6-12 months post-transplant, with doses 1 month apart
Pediatric Dosing
Neonatal:
Not established (typically starts at 2 months of age)
Infant:
Primary series: 0.5 mL intramuscularly at 2, 4, and 6 months of age. Booster dose: 0.5 mL intramuscularly at 12-15 months of age (after the primary series).
Child:
Catch-up schedule varies by age and previous vaccination status. For unvaccinated children 7-11 months: 2 doses, 1 month apart, then a booster at 12-15 months (or 2 months after last dose). For unvaccinated children 12-14 months: 1 dose, then a booster 2 months later. For unvaccinated children 15 months-5 years: 1 dose.
Adolescent:
Generally not indicated for routine vaccination in healthy adolescents. May be given to unvaccinated adolescents with specific risk factors (e.g., asplenia, HSCT).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment; efficacy may be reduced in immunocompromised individuals, including those on dialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Hiberix is a Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate). It contains purified capsular polysaccharide (PRP) of Haemophilus influenzae type b (Hib) covalently bound to tetanus toxoid (TT) protein. The conjugation to a protein carrier converts the T-independent polysaccharide antigen into a T-dependent antigen, leading to enhanced immunogenicity in infants, induction of T-cell memory, and booster responses. Vaccination stimulates the production of bactericidal antibodies against the Hib capsular polysaccharide, providing active immunity against invasive disease caused by H. influenzae type b.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine)
Tmax:
Not applicable (vaccine)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (vaccine)
ProteinBinding:
Not applicable (vaccine)
CnssPenetration:
Not applicable
Elimination:
HalfLife:
Not applicable (vaccine)
Clearance:
Not applicable (vaccine)
ExcretionRoute:
Not applicable (vaccine)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Antibody response typically begins within 1-2 weeks after the primary series. Protective levels are generally achieved after completion of the primary series and booster dose.
PeakEffect:
Peak antibody levels are usually observed 1-2 months after the booster dose.
DurationOfAction:
Long-term protection, generally considered lifelong after completion of the recommended series.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal sensations, such as burning, numbness, or tingling
Reduced facial muscle movement
Difficulty controlling body movements
Muscle weakness
Changes in eyesight
High fever
Severe dizziness or fainting, which can occur before or after receiving a vaccine; if you feel dizzy, inform your doctor immediately
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Pain, redness, or swelling at the injection site
Irritability
Fussiness
Drowsiness
Decreased appetite
Mild fever
Restlessness
Diarrhea
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal sensations, such as burning, numbness, or tingling
Reduced facial muscle movement
Difficulty controlling body movements
Muscle weakness
Changes in eyesight
High fever
Severe dizziness or fainting, which can occur before or after receiving a vaccine; if you feel dizzy, inform your doctor immediately
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
Pain, redness, or swelling at the injection site
Irritability
Fussiness
Drowsiness
Decreased appetite
Mild fever
Restlessness
Diarrhea
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
Seek Immediate Medical Attention If You Experience:
- Signs of a severe allergic reaction (anaphylaxis) such as hives, swelling of the face or throat, difficulty breathing, wheezing, dizziness, or a fast heartbeat. These usually occur within minutes to hours after the shot.
- High fever (over 102°F or 39°C).
- Unusual crying for several hours.
- Limpness or unresponsiveness.
- Seizures.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently ill with a fever.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently ill with a fever.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
Important Information for Patients Taking This Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this drug. This will ensure that you receive the best possible care.
Effectiveness of the Vaccine
As with all vaccines, this medication may not provide complete protection for everyone who receives it. If you have any questions or concerns, be sure to discuss them with your doctor.
Special Considerations
If you have a weakened immune system or are taking medications that suppress the immune system, you should consult with your doctor. The vaccine may not be as effective in these situations.
Additionally, if you have a latex allergy, you should inform your doctor, as some products may contain latex.
Impact on Laboratory Tests
This medication may affect the results of certain laboratory tests. It is essential that you notify all of your healthcare providers and laboratory personnel that you are taking this drug.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or are breastfeeding, you should discuss the potential benefits and risks of this medication with your doctor.
Special Precautions for Children
If your child is a premature infant, this medication should be used with caution. There is a rare possibility that your child may experience more side effects. Your doctor will help you weigh the potential benefits and risks of using this medication in this situation.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this drug. This will ensure that you receive the best possible care.
Effectiveness of the Vaccine
As with all vaccines, this medication may not provide complete protection for everyone who receives it. If you have any questions or concerns, be sure to discuss them with your doctor.
Special Considerations
If you have a weakened immune system or are taking medications that suppress the immune system, you should consult with your doctor. The vaccine may not be as effective in these situations.
Additionally, if you have a latex allergy, you should inform your doctor, as some products may contain latex.
Impact on Laboratory Tests
This medication may affect the results of certain laboratory tests. It is essential that you notify all of your healthcare providers and laboratory personnel that you are taking this drug.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or are breastfeeding, you should discuss the potential benefits and risks of this medication with your doctor.
Special Precautions for Children
If your child is a premature infant, this medication should be used with caution. There is a rare possibility that your child may experience more side effects. Your doctor will help you weigh the potential benefits and risks of using this medication in this situation.
Overdose Information
Overdose Symptoms:
- Overdose with Hiberix is unlikely to cause specific symptoms beyond those seen with standard vaccination, though local reactions might be more pronounced.
What to Do:
Contact a healthcare professional or poison control center (1-800-222-1222) for advice. Management would be supportive care for any adverse reactions.
Drug Interactions
Contraindicated Interactions
- Known hypersensitivity to any component of the vaccine, including tetanus toxoid, or to a previous dose of any Hib vaccine.
Major Interactions
- Immunosuppressive therapies (e.g., high-dose corticosteroids, chemotherapy, radiation therapy): May reduce the immune response to the vaccine, leading to decreased efficacy. Vaccination should be deferred until immune function recovers, if possible.
Moderate Interactions
- Other vaccines: Hiberix can be administered concomitantly with other routine pediatric vaccines (e.g., DTaP, IPV, HepB, MMR, Varicella, Pneumococcal conjugate vaccine) at separate injection sites. No evidence of interference with immune response.
Monitoring
Baseline Monitoring
Medical history and allergies
Rationale: To identify contraindications (e.g., severe allergic reaction to previous dose or vaccine component) and precautions (e.g., moderate or severe acute illness).
Timing: Prior to vaccination
Current health status
Rationale: To ensure the patient is not experiencing a moderate or severe acute illness with or without fever, which may warrant deferral of vaccination.
Timing: Immediately prior to vaccination
Routine Monitoring
Observation for immediate adverse reactions
Frequency: For 15-20 minutes post-vaccination
Target: Absence of anaphylaxis or severe allergic reactions
Action Threshold: Any signs of allergic reaction (e.g., rash, urticaria, angioedema, respiratory distress, hypotension) require immediate medical intervention.
Local injection site reactions (pain, redness, swelling)
Frequency: Within 24-48 hours post-vaccination
Target: Mild to moderate, self-limiting
Action Threshold: Severe or persistent reactions, or signs of infection, warrant medical evaluation.
Systemic reactions (fever, irritability, loss of appetite)
Frequency: Within 24-72 hours post-vaccination
Target: Mild to moderate, self-limiting
Action Threshold: High fever, persistent crying, or other concerning symptoms warrant medical evaluation.
Symptom Monitoring
- Pain, redness, swelling at injection site
- Fever
- Irritability
- Loss of appetite
- Unusual crying
- Vomiting
- Diarrhea
- Signs of allergic reaction (hives, rash, swelling of face/throat, difficulty breathing, dizziness, weakness)
Special Patient Groups
Pregnancy
Hiberix is not routinely recommended for use during pregnancy. Hib disease is uncommon in pregnant women. If vaccination is considered necessary due to high risk of exposure or specific medical conditions, the potential benefits should outweigh the potential risks. Data on vaccine safety in pregnant women are limited.
Trimester-Specific Risks:
First Trimester:
Limited data; generally avoided unless clearly indicated.
Second Trimester:
Limited data; generally avoided unless clearly indicated.
Third Trimester:
Limited data; generally avoided unless clearly indicated.
Lactation
It is not known whether Hiberix is excreted in human milk. However, vaccines containing inactivated bacteria or bacterial components are generally not considered to be a risk to the breastfeeding infant. The benefits of breastfeeding outweigh any theoretical risks.
Infant Risk:
Low risk
Pediatric Use
Hiberix is indicated for active immunization against invasive disease caused by H. influenzae type b in children 2 months through 5 years of age. It is the primary target population for this vaccine. Dosing and schedule vary by age and previous vaccination status.
Geriatric Use
Hiberix is not indicated for routine use in individuals 6 years of age and older. Hib disease is rare in healthy older adults. Vaccination may be considered for specific high-risk geriatric patients (e.g., functional or anatomic asplenia, hematopoietic stem cell transplant recipients) if they have not been previously vaccinated.
Clinical Information
Clinical Pearls
- Hiberix is a Hib vaccine conjugated to tetanus toxoid. It is NOT a tetanus vaccine and does not provide protection against tetanus.
- Ensure proper reconstitution of the lyophilized vaccine with the supplied diluent before administration.
- Administer intramuscularly, typically in the anterolateral thigh for infants and young children, or the deltoid muscle for older children/adults.
- Do not administer intravenously or intradermally.
- A severe allergic reaction to a previous dose of any Hib vaccine or to any component of Hiberix (including tetanus toxoid) is a contraindication.
- Immunocompromised individuals may have a diminished immune response to the vaccine.
- Always observe patients for 15-20 minutes after vaccination for immediate adverse reactions.
Alternative Therapies
- ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate])
- PedvaxHIB (Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate])
Cost & Coverage
Average Cost:
Varies significantly by provider and purchasing contract per 0.5 mL dose
Insurance Coverage:
Generally covered by most public and private health insurance plans as a routine childhood immunization. May be covered under Vaccines for Children (VFC) program for eligible children.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.