Vaxelis Pf Syringe Inj, 0.5ml
It is used to prevent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae infection.
Drug Class
Vaccine, Immunizing Agent
Pharmacologic Class
Vaccine, Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B (Recombinant), Inactivated Poliovirus, Haemophilus influenzae type b Conjugate
Pregnancy Category
Not applicable (indicated for infants)
FDA Approved
Dec 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vaxelis is a vaccine given to infants to protect them against six serious diseases: Diphtheria, Tetanus, Pertussis (whooping cough), Hepatitis B, Polio, and Haemophilus influenzae type b (Hib). It helps your baby's body build protection against these diseases without getting sick.
How to Use This Medicine
To ensure your child takes this medication correctly, follow the doctor's instructions precisely. Carefully review all the information provided to you and adhere to the guidelines. This medication is administered via an intramuscular injection.
For proper storage and disposal, consult with your child's doctor, nurse, or pharmacist to determine the best approach if you need to keep the medication at home.
If a dose is missed, contact your child's doctor immediately to receive guidance on the next steps to take.
For proper storage and disposal, consult with your child's doctor, nurse, or pharmacist to determine the best approach if you need to keep the medication at home.
If a dose is missed, contact your child's doctor immediately to receive guidance on the next steps to take.
Lifestyle & Tips
- Ensure your child completes the full vaccination series as recommended by their doctor to get the best protection.
- Keep a record of your child's vaccinations.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use.
Pediatric Dosing
Neonatal:
Not established (first dose at 2 months of age).
Infant:
0.5 mL administered intramuscularly as a 3-dose series at 2, 4, and 6 months of age.
Child:
Not indicated for routine immunization beyond infancy.
Adolescent:
Not indicated.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended. Immunogenicity may be reduced in immunocompromised individuals.
Moderate:
No specific adjustment recommended. Immunogenicity may be reduced in immunocompromised individuals.
Severe:
No specific adjustment recommended. Immunogenicity may be reduced in immunocompromised individuals.
Dialysis:
No specific adjustment recommended. Immunogenicity may be reduced in immunocompromised individuals.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Vaxelis induces active immunity by stimulating the production of specific antibodies against Diphtheria toxoid, Tetanus toxoid, Pertussis antigens (pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae 2 and 3), Hepatitis B surface antigen (HBsAg), Poliovirus types 1, 2, and 3, and Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine, administered IM)
Tmax:
Not applicable
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
Not applicable
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Development of protective antibody titers typically occurs weeks to months after completion of the primary vaccination series.
PeakEffect:
Achieved after the primary 3-dose series.
DurationOfAction:
Varies by component, generally providing protection for several years, requiring boosters for some components as per ACIP recommendations.
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 your child exhibits any of the following symptoms, contact their 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
High fever
Seizures
Confusion
Abnormal burning, numbness, or tingling sensations
Limited ability to move facial muscles
Difficulty controlling body movements
Prolonged crying
Additionally, severe dizziness or fainting can occur after or sometimes before receiving a vaccine. If your child feels dizzy, inform their doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to monitor your child's condition. If your child experiences any of the following side effects or if they persist or bother your child, consult their doctor:
Mild fever
Vomiting
Pain, redness, or swelling at the injection site
Irritability
Drowsiness
Decreased appetite
* Unusual crying
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your child's 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 your child exhibits any of the following symptoms, contact their 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
High fever
Seizures
Confusion
Abnormal burning, numbness, or tingling sensations
Limited ability to move facial muscles
Difficulty controlling body movements
Prolonged crying
Additionally, severe dizziness or fainting can occur after or sometimes before receiving a vaccine. If your child feels dizzy, inform their doctor right away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to monitor your child's condition. If your child experiences any of the following side effects or if they persist or bother your child, consult their doctor:
Mild fever
Vomiting
Pain, redness, or swelling at the injection site
Irritability
Drowsiness
Decreased appetite
* Unusual crying
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your child's 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 weakness. These usually occur within minutes to hours after the shot.
- High fever (over 105°F or 40.5°C).
- Unusual crying that lasts for several hours.
- Limpness or unresponsiveness.
- Seizures (convulsions).
Before Using This Medicine
Before Your Child Takes This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
If your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Please describe the allergy and the symptoms your child experienced.
If your child currently has an infection or an illness accompanied by a fever.
If your child has a history of seizures or any other brain or nervous system disorders.
If your child has experienced a brain problem, such as a coma, reduced level of consciousness, or seizures from an unknown cause within 7 days of receiving a previous pertussis-containing vaccine.
This list is not exhaustive, and it is crucial to discuss all of your child's medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with the doctor and pharmacist. To ensure safe treatment, verify that it is safe to administer this medication in conjunction with all of your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without first consulting with the doctor.
It is essential to inform your doctor about the following:
If your child is allergic to this medication, any of its components, or any other medications, foods, or substances. Please describe the allergy and the symptoms your child experienced.
If your child currently has an infection or an illness accompanied by a fever.
If your child has a history of seizures or any other brain or nervous system disorders.
If your child has experienced a brain problem, such as a coma, reduced level of consciousness, or seizures from an unknown cause within 7 days of receiving a previous pertussis-containing vaccine.
This list is not exhaustive, and it is crucial to discuss all of your child's medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with the doctor and pharmacist. To ensure safe treatment, verify that it is safe to administer this medication in conjunction with all of your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without first consulting with the doctor.
Precautions & Cautions
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. As with all vaccines, this vaccine may not provide complete protection for every individual who receives it. If you have any questions or concerns, be sure to discuss them with your child's doctor.
This medication may interfere with certain laboratory tests, so it is crucial to notify all of your child's healthcare providers and laboratory personnel that your child is taking this drug.
If your child has a weakened immune system or is taking medications that suppress the immune system, consult with your child's doctor, as this vaccine may be less effective.
Note that different brands of this medication may be approved for use in children of varying ages. Before administering this drug to a child, consult with your child's doctor to ensure you are using the correct brand and dosage.
If your child is a premature infant, exercise caution when using this medication, as there is a potential increased risk of side effects in this population.
This medication may interfere with certain laboratory tests, so it is crucial to notify all of your child's healthcare providers and laboratory personnel that your child is taking this drug.
If your child has a weakened immune system or is taking medications that suppress the immune system, consult with your child's doctor, as this vaccine may be less effective.
Note that different brands of this medication may be approved for use in children of varying ages. Before administering this drug to a child, consult with your child's doctor to ensure you are using the correct brand and dosage.
If your child is a premature infant, exercise caution when using this medication, as there is a potential increased risk of side effects in this population.
Overdose Information
Overdose Symptoms:
- Administering more than the recommended dose of Vaxelis is not an 'overdose' in the typical sense but an administration error. Symptoms would likely be an exaggeration of common vaccine side effects (e.g., increased local reactions, fever, irritability).
- No specific antidote exists.
What to Do:
If more than the recommended dose is administered, contact a healthcare professional or Poison Control Center (1-800-222-1222) immediately for guidance. Monitor the patient for increased local or systemic adverse reactions.
Drug Interactions
Contraindicated Interactions
- Severe allergic reaction (e.g., anaphylaxis) to any component of Vaxelis or to a previous dose of Vaxelis or any other diphtheria toxoid, tetanus toxoid, pertussis-containing, hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b vaccine.
- Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a previous dose of any pertussis-containing vaccine not attributable to another identifiable cause.
Major Interactions
- Immunosuppressive therapies (e.g., corticosteroids, chemotherapy, radiation therapy): May reduce the immune response to Vaxelis, leading to suboptimal protection. Vaccination should be deferred in patients receiving immunosuppressive therapy, if possible, or administered with the understanding that the immune response may be diminished.
Moderate Interactions
- Other vaccines: If co-administered, Vaxelis should be given at a separate injection site.
- Blood products/immunoglobulins: Administration of immunoglobulins or other blood products may interfere with the immune response to live attenuated vaccines, but this is generally not a concern for inactivated vaccines like Vaxelis. However, it's prudent to consider the timing relative to Hep B component.
Monitoring
Baseline Monitoring
Medical history and immunization record review
Rationale: To identify contraindications, precautions, and ensure appropriate dosing schedule.
Timing: Prior to administration of each dose.
Allergy assessment
Rationale: To identify known severe allergies to vaccine components or previous doses.
Timing: Prior to administration of each dose.
Routine Monitoring
Observation for immediate adverse reactions
Frequency: For at least 15 minutes post-vaccination.
Target: Absence of anaphylaxis or severe allergic reactions.
Action Threshold: Any signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing) require immediate medical intervention.
Parent/caregiver counseling on potential local and systemic reactions
Frequency: After each dose.
Target: N/A
Action Threshold: Advise to seek medical attention for severe or persistent reactions (e.g., high fever, severe pain/swelling, unusual crying, signs of allergic reaction).
Symptom Monitoring
- Injection site reactions (pain, redness, swelling, tenderness)
- Fever
- Irritability/fussiness
- Drowsiness
- Loss of appetite
- Vomiting
- Diarrhea
- Unusual crying
- Serious allergic reactions (hives, swelling of face/throat, difficulty breathing, dizziness, weakness)
Special Patient Groups
Pregnancy
Vaxelis is indicated for infants and is not intended for use in pregnant individuals. There are no human data on the use of Vaxelis in pregnant women.
Trimester-Specific Risks:
First Trimester:
Not applicable (indicated for infants).
Second Trimester:
Not applicable (indicated for infants).
Third Trimester:
Not applicable (indicated for infants).
Lactation
Vaxelis is indicated for infants and is not intended for use in lactating individuals. It is not known whether Vaxelis is excreted in human milk.
Infant Risk:
Not applicable (indicated for infants).
Pediatric Use
Vaxelis is specifically indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease caused by Haemophilus influenzae type b in infants 2, 4, and 6 months of age.
Geriatric Use
Not indicated for use in geriatric individuals.
Clinical Information
Clinical Pearls
- Vaxelis is a hexavalent (6-in-1) vaccine, simplifying the immunization schedule for infants by reducing the number of injections.
- Administer intramuscularly (IM) only, preferably in the anterolateral aspect of the thigh for infants.
- Ensure the full 3-dose series is completed for optimal protection against all six diseases.
- Vaxelis is not interchangeable with other DTaP-IPV-HepB-Hib vaccines for the entire series unless specifically indicated by clinical guidelines.
- Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze.
- Always have epinephrine and other appropriate medical treatment available for immediate use in case of an anaphylactic reaction.
Alternative Therapies
- Individual vaccines for each component: DTaP (Daptacel, Infanrix), IPV (Ipol), HepB (Engerix-B, Recombivax HB), Hib (ActHIB, Hiberix, PedvaxHIB).
Cost & Coverage
Average Cost:
$100 - $150 per dose (estimated) per 0.5 mL syringe
Insurance Coverage:
Generally covered by most private and public health insurance plans (e.g., Medicaid, CHIP) as a preventive vaccine, often without cost-sharing, under the Affordable Care Act (ACA) and Vaccines for Children (VFC) program.
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safety, never share your child's medication with others, and do not administer someone else's medication to your child. 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance and inform you about potential drug take-back programs in your area. Some medications may include an additional patient information leaflet, which can be obtained from your pharmacist. If you have any questions or concerns about this medication, it is crucial 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 medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to ensure prompt and effective treatment.