Vaxelis Inj, 0.5ml
It is used to prevent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae infection.
Drug Class
Vaccine
Pharmacologic Class
Combination vaccine; Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B (recombinant), Inactivated Poliovirus, and Haemophilus influenzae type b Conjugate Vaccine
Pregnancy Category
Not applicable (Pediatric vaccine)
FDA Approved
Dec 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vaxelis is a vaccine given to babies to protect them from six serious diseases: Diphtheria, Tetanus, Whooping Cough (Pertussis), Hepatitis B, Polio, and Haemophilus influenzae type b (Hib). It helps your baby's body build protection against these diseases without getting sick from them.
How to Use This Medicine
Taking This Medication
To ensure your child takes this medication correctly, follow the instructions provided by their doctor. Carefully read all the information given to you and adhere to the guidelines. This medication is administered via an intramuscular injection.
Storing and Disposing of This Medication
If you need to store this medication at home, consult with your child's doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If a dose is missed, contact your child's doctor to receive guidance on the next steps to take.
To ensure your child takes this medication correctly, follow the instructions provided by their doctor. Carefully read all the information given to you and adhere to the guidelines. This medication is administered via an intramuscular injection.
Storing and Disposing of This Medication
If you need to store this medication at home, consult with your child's doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If a dose is missed, contact your child's doctor 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 achieve the best protection.
- Keep a record of your child's vaccinations.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable
Pediatric Dosing
Neonatal:
Not established
Infant:
0.5 mL administered intramuscularly as a 3-dose series at 2, 4, and 6 months of age. The first dose can be given as early as 6 weeks of age.
Child:
Not indicated
Adolescent:
Not indicated
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended; use with caution in individuals with severe renal impairment due to potential for reduced immune response.
Moderate:
No specific adjustment recommended; use with caution in individuals with severe renal impairment due to potential for reduced immune response.
Severe:
No specific adjustment recommended; use with caution in individuals with severe renal impairment due to potential for reduced immune response.
Dialysis:
No specific adjustment recommended; use with caution due to potential for reduced immune response.
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. These antibodies provide protection against the respective diseases.
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:
Antibody response typically begins within weeks after vaccination, with protective levels achieved after the primary series.
PeakEffect:
Peak antibody titers are generally observed 1-2 months after completion of the primary vaccination series.
DurationOfAction:
Duration of protection varies by antigen, generally lasting several years, requiring booster doses for sustained immunity for some components (e.g., Tetanus, Diphtheria, Pertussis).
Confidence:
Medium
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 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
Inability to move facial muscles normally
Difficulty controlling body movements
Prolonged crying
Severe dizziness or fainting, which can occur before or after receiving the 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, contact their doctor:
Mild fever
Vomiting
Pain, redness, or swelling at the injection site
Irritability
Drowsiness
Decreased appetite
Abnormal crying
This list is not exhaustive, and your child may experience other 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 your child exhibits any of the following symptoms, contact their doctor immediately or seek 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
Inability to move facial muscles normally
Difficulty controlling body movements
Prolonged crying
Severe dizziness or fainting, which can occur before or after receiving the 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, contact their doctor:
Mild fever
Vomiting
Pain, redness, or swelling at the injection site
Irritability
Drowsiness
Decreased appetite
Abnormal crying
This list is not exhaustive, and your child may experience other 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) that does not respond to fever reducers.
- Unusual crying that lasts for several hours.
- Limpness or unresponsiveness.
- Seizures.
- Any other severe or unexpected symptoms.
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 of unknown cause within 7 days of receiving a previous pertussis-containing vaccine.
This list is not exhaustive, and it is crucial to discuss all 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 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 of unknown cause within 7 days of receiving a previous pertussis-containing vaccine.
This list is not exhaustive, and it is crucial to discuss all 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 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.
It is also important to note that different brands of this medication may be approved for use in children of varying ages. Before administering this medication to a child, consult with your child's doctor to ensure you are using the correct brand and dosage.
Additionally, if your child is a premature infant, use this medication with caution, as there is a rare risk of increased side effects.
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.
It is also important to note that different brands of this medication may be approved for use in children of varying ages. Before administering this medication to a child, consult with your child's doctor to ensure you are using the correct brand and dosage.
Additionally, if your child is a premature infant, use this medication with caution, as there is a rare risk of increased side effects.
Overdose Information
Overdose Symptoms:
- Overdose is unlikely with proper administration by a healthcare professional. If more than the recommended dose is given, symptoms would likely be an exaggeration of typical vaccine side effects (e.g., increased local reactions, fever).
What to Do:
Contact a healthcare professional immediately. Symptomatic and supportive care should be provided. For general poison control, call 1-800-222-1222.
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, acellular pertussis, hepatitis B, inactivated poliovirus, or Haemophilus influenzae type b conjugate vaccine.
- Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine, not attributable to another identifiable cause.
- Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Vaccination should be deferred until a treatment regimen has been established and the condition has stabilized.
Major Interactions
- Immunosuppressive therapies (e.g., corticosteroids, chemotherapy, radiation therapy): May reduce the immune response to Vaxelis. Defer vaccination if possible, or consider serologic testing after vaccination if appropriate.
- Blood products (e.g., immune globulin, whole blood, plasma): May interfere with the immune response to live attenuated vaccines (not Vaxelis, but relevant for general vaccine considerations). For inactivated vaccines like Vaxelis, generally not a contraindication, but consult ACIP guidelines for specific timing.
Moderate Interactions
- Other vaccines: Administer Vaxelis at a separate injection site if given concomitantly with other injectable vaccines. No specific interval is required between Vaxelis and other routinely recommended childhood vaccines.
- Antipyretics: Prophylactic use of antipyretics before or at the time of vaccination is not routinely recommended as it may blunt the immune response, though evidence is conflicting. If used for fever/discomfort post-vaccination, it's acceptable.
Minor Interactions
- Not typically listed for vaccines.
Monitoring
Baseline Monitoring
Medical history and immunization status
Rationale: To identify contraindications, precautions, and ensure appropriate vaccine scheduling.
Timing: Prior to vaccination
Allergy history (especially to vaccine components or previous vaccine doses)
Rationale: To identify individuals at risk for severe allergic reactions.
Timing: Prior to vaccination
Routine Monitoring
Observation for immediate adverse reactions (e.g., anaphylaxis)
Frequency: For at least 15 minutes post-vaccination
Target: Absence of severe allergic reactions
Action Threshold: Any signs of anaphylaxis (e.g., rash, swelling, difficulty breathing, hypotension) requires immediate medical intervention.
Local injection site reactions (pain, redness, swelling)
Frequency: Patient/caregiver monitoring for several days post-vaccination
Target: Mild to moderate, self-limiting reactions
Action Threshold: Severe or persistent reactions, or signs of infection, warrant medical evaluation.
Systemic reactions (fever, irritability, decreased appetite, vomiting, diarrhea)
Frequency: Patient/caregiver monitoring for several days post-vaccination
Target: Mild to moderate, self-limiting reactions
Action Threshold: High fever, persistent crying, or other severe symptoms warrant medical evaluation.
Symptom Monitoring
- Fever
- Irritability
- Crying
- Decreased appetite
- Vomiting
- Diarrhea
- Injection site pain
- Injection site redness
- Injection site swelling
- Unusual drowsiness
- Limpness
- Pale skin
- Signs of allergic reaction (hives, rash, swelling of face/throat, difficulty breathing, wheezing, dizziness, weakness, fast heartbeat)
Special Patient Groups
Pregnancy
Vaxelis is not indicated for use in pregnant individuals. It is a pediatric vaccine.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Vaxelis is not indicated for use in lactating individuals. It is a pediatric vaccine.
Infant Risk:
Not applicable
Pediatric Use
Vaxelis is specifically indicated for active immunization against Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliovirus, and Haemophilus influenzae type b in infants 6 weeks through 4 months of age (as a 3-dose series at 2, 4, and 6 months). It is not indicated for children 5 years of age or older.
Geriatric Use
Vaxelis is not indicated for use in geriatric individuals. It is a pediatric vaccine.
Clinical Information
Clinical Pearls
- Vaxelis is a 6-in-1 vaccine, simplifying the immunization schedule for infants by reducing the number of injections.
- Ensure proper storage at 2°C to 8°C (36°F to 46°F) and protect from light. Do not freeze.
- Administer intramuscularly, preferably in the anterolateral aspect of the thigh for infants.
- Always have epinephrine and other appropriate medical treatment available for immediate use in case of an anaphylactic reaction.
- Caregivers should be advised about common local and systemic reactions and when to seek medical attention.
- Do not administer Vaxelis to infants younger than 6 weeks of age.
- If a dose of Vaxelis is missed, follow ACIP catch-up schedules for combination vaccines.
Alternative Therapies
- Individual vaccines for each component: DTaP, Hepatitis B vaccine, Inactivated Poliovirus Vaccine (IPV), Haemophilus influenzae type b (Hib) vaccine.
Cost & Coverage
Average Cost:
Varies, typically $100-$150 per dose per 0.5 mL single-dose vial/syringe
Insurance Coverage:
Generally covered by most private health insurance plans and public health programs (e.g., Vaccines for Children (VFC) program in the US) as a routine childhood immunization.
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 and efficacy, never share your child's medication with others, and do not administer someone else's medication to your child.
All medications should be stored 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 or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, as they can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to ensure prompt and effective treatment.
All medications should be stored 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 or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, as they can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to ensure prompt and effective treatment.