Hiberix 10mcg Inj, 1 Vial
It is used to prevent Haemophilus influenzae type b disease.
Drug Class
Vaccines
Pharmacologic Class
Bacterial Vaccines; Haemophilus b Conjugate Vaccine
Pregnancy Category
Not assigned (Vaccine - generally considered safe if indicated)
FDA Approved
Aug 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hiberix is a vaccine that helps protect children from serious infections caused by *Haemophilus influenzae* type b (Hib) bacteria. These infections can be very dangerous and include meningitis (a brain infection), epiglottitis (a severe throat swelling), and blood infections. The vaccine works by teaching your child's body to make antibodies that fight off the Hib bacteria, helping them stay healthy.
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.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Ensure your child completes the full vaccination series as recommended by their healthcare provider to achieve maximum protection.
- Keep a record of your child's vaccinations.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mL intramuscularly (IM) as a single dose for specific indications (e.g., asplenia, hematopoietic stem cell transplant recipients). Not routinely recommended for healthy adults.
Dose Range:
0.5 - 0.5 mg
Condition-Specific Dosing:
asplenia:
0.5 mL IM, single dose
hematopoietic stem cell transplant:
0.5 mL IM, 3 doses 4 weeks apart, starting 6-12 months post-transplant
Pediatric Dosing
Neonatal:
Not established (typically starts at 2 months of age)
Infant:
Primary series: 0.5 mL IM at 2, 4, and 6 months of age. Booster dose: 0.5 mL IM at 12-15 months of age.
Child:
Catch-up schedule applies for unvaccinated or partially vaccinated children up to 5 years of age. Generally, a single dose for children 15 months to 5 years who have not received a primary series.
Adolescent:
Not routinely recommended unless specific risk factors (e.g., asplenia, certain immunocompromising conditions).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations; vaccine efficacy may be reduced in immunocompromised individuals.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Hiberix contains purified capsular polysaccharide (polyribosylribitol phosphate, PRP) of *Haemophilus influenzae* type b (Hib) covalently bound to tetanus toxoid. This conjugation converts the T-independent polysaccharide antigen into a T-dependent antigen, allowing for a robust T-cell dependent immune response in infants, including the generation of memory B-cells. This leads to the production of anti-PRP antibodies, which are protective against invasive Hib disease.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine)
Tmax:
Not applicable (vaccine)
FoodEffect:
Not applicable (vaccine)
Distribution:
Vd:
Not applicable (vaccine)
ProteinBinding:
Not applicable (vaccine)
CnssPenetration:
Not applicable (vaccine)
Elimination:
HalfLife:
Not applicable (vaccine)
Clearance:
Not applicable (vaccine)
ExcretionRoute:
Not applicable (vaccine)
Unchanged:
Not applicable (vaccine)
Pharmacodynamics
OnsetOfAction:
Seroconversion (protective antibody levels) typically achieved within 1-2 weeks after completion of the primary series.
PeakEffect:
Peak anti-PRP antibody titers are generally observed 1-2 months after completion of the primary series or booster dose.
DurationOfAction:
Long-lasting immunity, generally considered protective through childhood and beyond after the full recommended series.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Facial muscle weakness or difficulty moving facial muscles
Trouble 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 right away
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 notice any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Pain, redness, or swelling at the injection site
Irritability
Fussiness
Drowsiness
Decreased appetite
Mild fever
Restlessness
Diarrhea
This is not an exhaustive list of possible 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 when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Facial muscle weakness or difficulty moving facial muscles
Trouble 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 right away
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 notice any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Pain, redness, or swelling at the injection site
Irritability
Fussiness
Drowsiness
Decreased appetite
Mild fever
Restlessness
Diarrhea
This is not an exhaustive list of possible 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 (e.g., hives, swelling of the face or throat, difficulty breathing, dizziness, weakness) occurring within minutes to hours after vaccination.
- High fever (over 102°F or 39°C).
- Unusual behavior, persistent crying, or extreme drowsiness.
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 allergic reaction and its symptoms.
If you currently have an illness accompanied by a fever.
This medication may interact with other health conditions or medications. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 allergic reaction and its symptoms.
If you currently have an illness accompanied by a fever.
This medication may interact with other health conditions or medications. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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 medication. This will ensure that you receive the best possible care.
Vaccine Effectiveness and Immune System Considerations
Like all vaccines, this vaccine may not provide complete protection for everyone who receives it. If you have questions or concerns, be sure to discuss them with your doctor. Additionally, if you have a weakened immune system or are taking medications that suppress the immune system, you should talk to your doctor, as this vaccine may not be as effective in these situations.
Latex Allergy Precautions
If you have a latex allergy, it is essential to inform your doctor, as some products may contain latex.
Impact on Laboratory Tests
This medication may affect the results of certain laboratory tests. Therefore, it is vital that you inform all of your healthcare providers and laboratory personnel that you are taking this medication.
Pregnancy and Breastfeeding Considerations
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 Considerations for Children
If your child is a premature infant, this medication should be used with caution, as there is a potential for increased side effects in this population.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will ensure that you receive the best possible care.
Vaccine Effectiveness and Immune System Considerations
Like all vaccines, this vaccine may not provide complete protection for everyone who receives it. If you have questions or concerns, be sure to discuss them with your doctor. Additionally, if you have a weakened immune system or are taking medications that suppress the immune system, you should talk to your doctor, as this vaccine may not be as effective in these situations.
Latex Allergy Precautions
If you have a latex allergy, it is essential to inform your doctor, as some products may contain latex.
Impact on Laboratory Tests
This medication may affect the results of certain laboratory tests. Therefore, it is vital that you inform all of your healthcare providers and laboratory personnel that you are taking this medication.
Pregnancy and Breastfeeding Considerations
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 Considerations for Children
If your child is a premature infant, this medication should be used with caution, as there is a potential for increased side effects in this population.
Overdose Information
Overdose Symptoms:
- Not applicable for vaccines; overdose is unlikely to cause specific toxic symptoms beyond potential local reactions.
What to Do:
Contact a healthcare professional or poison control center (1-800-222-1222) for any concerns.
Drug Interactions
Contraindicated Interactions
- Known hypersensitivity to any component of the vaccine, including tetanus toxoid.
Major Interactions
- Immunosuppressive therapies (e.g., high-dose corticosteroids, chemotherapy, radiation therapy, disease-modifying antirheumatic drugs [DMARDs], biologics): May diminish the immune response to the vaccine, leading to reduced efficacy.
Monitoring
Baseline Monitoring
Allergy history (especially to vaccine components or tetanus toxoid)
Rationale: To identify individuals at risk for hypersensitivity reactions.
Timing: Prior to vaccine administration
Current health status (acute moderate or severe illness with or without fever)
Rationale: Vaccination should be deferred in such cases.
Timing: Prior to vaccine administration
Routine Monitoring
Observation for immediate adverse reactions (e.g., anaphylaxis)
Frequency: For at least 15 minutes post-vaccination
Target: Absence of allergic symptoms
Action Threshold: Any signs of allergic reaction (e.g., hives, swelling, difficulty breathing, dizziness, weakness)
Local injection site reactions (pain, redness, swelling)
Frequency: Patient/caregiver self-monitoring for 24-48 hours post-vaccination
Target: Minimal or no reaction
Action Threshold: Severe pain, extensive swelling, or signs of infection
Systemic reactions (fever, irritability, drowsiness, loss of appetite)
Frequency: Patient/caregiver self-monitoring for 24-48 hours post-vaccination
Target: Absence or mild symptoms
Action Threshold: High fever (>102°F or 39°C), persistent crying, unusual behavior
Symptom Monitoring
- Injection site pain
- Redness
- Swelling
- Fever
- Irritability
- Drowsiness
- Loss of appetite
- Unusual crying
- Signs of allergic reaction (hives, facial swelling, difficulty breathing, dizziness, weakness)
Special Patient Groups
Pregnancy
Hiberix is not routinely recommended for use during pregnancy. However, if a pregnant woman is at high risk for Hib disease (e.g., due to asplenia) and the potential benefits of vaccination outweigh the potential risks, it may be considered. Inactivated vaccines are generally considered safe during pregnancy.
Trimester-Specific Risks:
First Trimester:
No specific risks identified, but generally avoided unless clearly indicated.
Second Trimester:
No specific risks identified, but generally avoided unless clearly indicated.
Third Trimester:
No specific risks identified, but generally avoided unless clearly indicated.
Lactation
Hiberix is compatible with breastfeeding. The vaccine is not excreted in breast milk and poses no known risk to the breastfed infant.
Infant Risk:
L1 (Safest)
Pediatric Use
Hiberix is primarily indicated for active immunization of infants and children from 2 months through 5 years of age against invasive disease caused by *Haemophilus influenzae* type b. Adherence to the recommended immunization schedule is crucial for optimal protection.
Geriatric Use
Not routinely recommended for geriatric populations unless specific risk factors for invasive Hib disease are present (e.g., asplenia, certain immunocompromising conditions).
Clinical Information
Clinical Pearls
- Hiberix is a 3-dose primary series vaccine (2, 4, 6 months) with a booster (12-15 months). It is important to note that other Hib vaccines (e.g., PedvaxHIB) have a 2-dose primary series. While interchangeability of Hib vaccines is generally acceptable, it's preferable to complete the series with the same vaccine if possible.
- Administer intramuscularly (IM) only, typically in the anterolateral aspect of the thigh in infants or the deltoid muscle in older children/adults. Do not administer intravenously or intradermally.
- Ensure proper storage at refrigerated temperatures (2°C to 8°C / 36°F to 46°F); do not freeze, as freezing destroys the potency of the vaccine.
- Hiberix protects only against *Haemophilus influenzae* type b and not against other types of *Haemophilus influenzae* or other organisms causing invasive disease.
- Always have epinephrine and other appropriate medical treatment readily available in case of an anaphylactic reaction following vaccine administration.
Alternative Therapies
- PedvaxHIB (Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate])
- ActHIB (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate])
Cost & Coverage
Average Cost:
Typically $30-$50 per dose
Insurance Coverage:
Most private insurance plans, Medicaid, and CHIP cover recommended childhood vaccines. Eligible children may receive the vaccine through the Vaccines for Children (VFC) program.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Many communities offer drug take-back programs, which can be an effective way to dispose of unused medications.
Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is essential to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. They can provide personalized guidance and support to ensure you use your medication safely and effectively.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to help healthcare professionals provide timely and effective treatment.
To ensure safe use, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Many communities offer drug take-back programs, which can be an effective way to dispose of unused medications.
Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is essential to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. They can provide personalized guidance and support to ensure you use your medication safely and effectively.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to help healthcare professionals provide timely and effective treatment.