Diphtheria Toxoid, Adsorbed (dif-THEER-ee-a TOX-oyd, ad-SORBD), Haemophilus B Conjugate Vaccine (hee-MOF-i-lus B KON-joo-gate VAX-een), Hepatitis B Vaccine Recombinant (hep-a-TYE-tis B VAX-een re-KOM-bin-ant), Pertussis Vaccine, Acellular (per-TUS-iss VAX-een, a-SELL-yoo-lar), Poliovirus Vaccine, Inactivated (POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated), Tetanus Toxoid (TET-a-nus TOX-oyd)

Prevents diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliomyelitis, hepatitis B, and infection with Haemophilus influenzae type b (Hib) bacteria in babies and young children.

Brand Name(s):

Vaxelis

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles. Most children will receive a series of 3 shots at 2, 4, and 6 months of age.
• A nurse or other health provider will give you this medicine.
• Missed dose: If this vaccine is part of a series of vaccines, it is important that your child receive all of the shots. Try to keep all scheduled appointments. Make another appointment as soon as possible if your child misses a dose of this vaccine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how DTaP/poliovirus/haemophilus B conjugate/hepatitis B vaccine works. Tell the doctor if your child has received another vaccine (including PedvaxHIB® at least 30 days before starting this medicine.

Warnings While Using This Medicine:

• Tell your doctor if your child has a weak immune system.
• This vaccine may cause the following problems:
  • Severe nerve and muscle problems (including Guillain-Barré syndrome, brachial neuritis)
  • Breathing problems (including apnea), in premature babies
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bluish lips or skin
• Crying constantly for 3 hours or more
• Fever over 105 degrees F
• Lightheadedness or fainting
• Seizures
• Sudden numbness and weakness in the arms and legs, problem moving the arms and legs, numbness or tingling of the hands, feet, or face

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite, vomiting
• Drowsiness, restlessness, lack of energy
• Fussiness or irritability
• Redness, pain, or swelling where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088