DTaP-IPV-Hep B-Hib

DTaP-IPV-Hep B-Hib is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b for use as a three-dose series in children aged 6 weeks to 4 years (before fifth birthday).

• DTaP-IPV-Hep B-Hib is available under the following different brand names: Vaxelis, DTaP/IPV/Hep B/Hib

Common side effects of DTaP-IPV-Hep B-Hib include:

• irritability
• crying
• injection site reactions (pain, redness, swelling)
• drowsiness
• decreased appetite
• fever
• vomiting

Serious side effects of DTaP-IPV-Hep B-Hib include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• Rare side effects of Diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis B vaccine/Haemophilus influenzae type b vaccine include:

Rare side effects of Diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis B vaccine/Haemophilus influenzae type b vaccine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Injectable suspension

• 0.5 mL (single-dose vial)

Primary immunization

Pediatric dosage

• Children aged 6 weeks to younger than 5 years
  • 0.5 mL IM × 3 at 2, 4, 6 months
  • First dose may be given as early as age 6 weeks
• Children aged 5 years and older
  • Not approved for use

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• DTaP-IPV-Hep B-Hib has severe interactions with the following drug:
  • belimumab
• DTaP-IPV-Hep B-Hib has serious interactions with at least 43 other drugs
• DTaP-IPV-Hep B-Hib has moderate interactions with at least 96 other drugs
• DTaP-IPV-Hep B-Hib has minor interactions with the following drugs:
  • chloroquine
  • ozanimod

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to any ingredient of Vaxelis or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Haemophilus influenzae type b vaccine
• History of encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine
• History of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, until a treatment regimen is established, and the condition has stabilized

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis b vaccine/Haemophilus influenzae type b vaccine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis b vaccine/Haemophilus influenzae type b vaccine?”

Cautions

• Epinephrine HCl solution (1:1000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs
• Patients who develop Guillain-Barre syndrome (GBS) within 6 weeks of receipt of a vaccine containing tetanus-toxoid should not receive any further doses; patients who develop GBS more than 6 weeks after immunization may receive subsequent doses of the vaccine
• If administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained
• Apnea following IM vaccination observed in some infants born prematurely; the decision about when to administer an IM vaccine to an infant born prematurely should be based on consideration of the infant's medical status and potential benefits and possible risks for vaccination
• Vaccination may not protect all individuals
• Sensitive tests (eg, latex agglutination kits) detected vaccine-derived polyribosylribitol phosphate in the urine of vaccinees for 30 days and more after vaccination with Haemophilus b conjugate vaccine; urine antigen detection may not have definite diagnostic value in suspected Haemophilus influenzae type b disease after vaccination
• Adverse reactions after prior pertussis vaccination
• If any of the following events occur after the administration of a pertussis vaccine, carefully consider the use of Vaxelis
• Temperature of 40.5 °C and more (105 °F and more) within 48 hours, not attributable to another identifiable cause
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
• Persistent, inconsolable crying lasting 3 hours and more within 48 hours
• Seizures with or without fever within 3 days

Pregnancy and Lactation

• Not approved for use in individuals older than 5 years
• No human or animal data are available to assess vaccine-associated risks in pregnancy
• Lactation
  • Not approved for use in individuals older than 5 years
  • No human or animal data are available to assess the effect on milk production, its presence in breast milk, or its effects on the breastfed infant