In the U.S.—

Another commonly used name is DTaP-HepB-IPV

• Immunizing agent, active

Diphtheria and tetanus toxoids and pertussis ( dif-THEER-ee-a and TET-niss and per-TUSS-is) vaccine (also known as DTP vaccine) combined with hepatitis B and poliovirus (hep-uh-TI-tis B and PO-lee-o-vi-rus) vaccine (also known as HepB and IPV) is a combination immunizing agent used to prevent illness caused by diphtheria, tetanus, pertussis, hepatitis B, and poliovirus. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

This vaccine combines five agents into one vaccine. In order to complete the series, you must get three injections of this vaccine at separate intervals. Because there are many different diseases you will need to be vaccinated against, be sure to follow your doctor's directions about your vaccination schedule.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications is greater in very young children and the elderly.

Tetanus (also known as lockjaw) is a very serious illness that causes seizures and severe muscle spasms that can be strong enough to cause bone fractures of the spine. The disease continues to occur almost exclusively among people who do not get vaccinated or do not have enough protection from previous vaccines.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis can also cause pneumonia, long lasting bronchitis, seizures, brain damage, and death.

Hepatitis B infection is a major cause of serious liver diseases including liver cancer. You get hepatitis B by being exposed to someone else's body fluids. Pregnant women can also give hepatitis B to their unborn child. People who have the virus can give it to others without them knowing it.

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you to walk and breathe. A polio infection may leave a person unable to breathe without the help of a breathing machine. It may also leave a person unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio.

This vaccine is available in the following dosage form:

Parenteral
• Injection (U.S. only)

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For DTaP-HepB-IPV vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to diphtheria toxoid, tetanus toxoid, pertussis vaccine, DTP vaccine, hepatitis B vaccine, or polio vaccine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as thimerosal, neomycin, polymyxin B, yeast, or other preservatives.

Pregnancy—Adequate and well controlled studies in pregnant humans have not been done. DTaP-HepB-IPV should not be given to women of child bearing age. It is not known whether DTaP-HepB-IPV can cause harm to the fetus if given to a pregnant woman or if it can cause problems with the ability to have children. Make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether DTaP-HepB-IPV vaccine passes into breast milk. Mothers who get this vaccine and who are breast feeding should discuss this with your doctor

Children—Safety and effectiveness have not been established in children younger than six weeks of age. This vaccine is also not recommended for children over seven years of age.

Older adults—DTaP-HepB-IPV is not approved for use in older adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription [OTC] medicine, especially:

• Anticoagulants (blood thinning medicines)—These medicines should not be given with the vaccine unless the potential benefit outweighs the risk

• Immunosuppressive medicines—These are medicines that decrease your immune response. Taking these with the vaccine may prevent your body from having a good response to the vaccine.

• Bleeding disorders (hemophilia or thrombocytopenia)—You may develop a formation of blood at the injection site. Your doctor should take steps to avoid this.

• Central nervous system disorders—If your child has certain disorders, you will need to look at the potential risks and benefits of getting DTaP-HepB-IPV. You should talk to your child's doctor to find out if your child should receive this vaccine.

• Disease of the brain—This includes coma, decreased level of consciousness, or seizures. People who have these symptoms within seven days of receiving a vaccine with pertussis in it should not get DTaP-HepB-IPV vaccine.

• Guillain-Barre syndrome—If you have ever had this condition after getting a vaccine with tetanus in it, you should weigh the potential benefits and possible risks of getting DTaP-HepB-IPV.

• Immunodeficiency disorder—If you have an immune system disorder, this vaccine may not work well for you

• Life threatening allergic reaction—You should not take this vaccine if you have had a severe allergic reaction to a previous dose of this vaccine or any ingredients in the vaccine. This includes polymyxin B, neomycin, and yeast.

• Moderate or severe illness, with or without fever—You should not get DTaP-HepB-IPV until the illness is gone and you feel better.

• Previous adverse reaction to this vaccine or any of its ingredients—If you have ever had an adverse reaction after getting a DTaP-HepB-IPV vaccine or another vaccine with pertussis in it, you should weigh the potential benefits and possible risks of getting DTaP-HepB-IPV. Adverse reactions include being unresponsive, crying continually without being able to stop for 3 hours or more, seizures with or without a fever, or a fever that is 105°F or higher.

• Progressive neurologic disorder—This includes infantile spasms, progressive brain disease, or uncontrolled epilepsy (seizures). DTaP-HepB-IPV should not be given until these conditions are treated and stabilized.

• Seizures, higher risk—Children at higher risk for seizures may be given a fever reducing medicine at the time the vaccine is given and for 24 hours after. By giving a fever reducing medicine, this may decrease the chance a fever may occur and cause a seizure.

Dosing—

The following information includes only the average doses of DTaP-HepB-IPV.

• For injection dosage form:
  • For prevention of diphtheria, tetanus, pertussis, hepatitis B, and poliovirus:
    • Adults and children greater than 7 years of age—Use is not approved.
    • Children up to 6 weeks—Use is not approved.
    • Children 6 weeks to 7 years of age—Three doses, 6 to 8 weeks apart. These doses are given into a muscle.
    • Children already vaccinated with one or more doses of hepatitis B vaccine—Infants vaccinated with hepatitis B at or shortly after birth should be given 3 doses according to the recommended schedule. The doses are given into a muscle.
    • Children previously vaccinated with Infanrix®—DTaP-HepB-IPV may be used to complete the first three doses of the DTaP and IPV series in infants who have received 1 or 2 doses of Infanrix® and are also due to get other components of DTaP-HepB-IPV.
    • Geriatric—Use is not approved for this group.

It is very important that your doctor check you at regular visits. Be sure to notify your doctor or clinic of any side effects that occur after you have received the vaccination. It is very important that you return to your doctor for the next dose in the series.

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that your child should not receive any more doses of DTaP-HepB-IPV vaccine.

Check with your doctor immediately if any of the following side effects occur:

• Incidence not determined
  • Abdominal or stomach pain;  agitation ;  back pain;  black, tarry stools;  bleeding gums;  blood in urine or stools;  bluish color of fingernails, lips, skin, palms, or nail beds;  blurred vision;  chills;  clay colored stools;  collapse or shock-like state;  coma;  confusion;  cough;  dark urine;  diarrhea;  difficulty swallowing;  dizziness;  drowsiness;  fast heartbeat;  fever;  hallucinations;  headache;  heavier menstrual periods;  hives or hive like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs;  hoarseness;  irritability;  irritation;  itchiness, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, hands, or feet;  itching ;  joint pain;  loosening of skin;  mood or mental changes;  nausea;  pain or cramping in abdomen;  pinpoint red spots on skin;  red irritated eyes;  redness of skin;  seizures;  skin rash;  shortness of breath;  sore throat;  sores, ulcers, or white spots in mouth or on lips;  stiff neck;  stiffness or swelling;  Sudden Infant Death Syndrome (SIDS);  swelling;  tightness in chest;  troubled breathing ;  unpleasant breath odor;  unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting or vomiting of blood;  weight loss;  wheezing;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Bleeding;  blistering;  burning;  coldness;  discoloration of skin;  fussiness;  feeling of pressure;  infection;  inflammation;  lumps;  numbness ;  pain;  restlessness;  scarring;  sleeping more than usual;  soreness;  stinging;  tenderness;  tingling;  ulceration ;  unusual cry;  warmth on skin 
  
  

• Incidence not determined
  • Arm or leg swelling;  difficulty in moving ;  dullness, tiredness, weakness or feeling of sluggishness ;  flushing;  itching skin ;  lack or loss of strength;  loss of appetite;  loss of strength or energy;  malaise;  muscle pain, weakness, or stiffness ;  pain in joints;  sneezing ;  sores, ulcers, or white spots in mouth or on lips ;  swollen, painful, or tender lymph glands in neck, armpit, or groin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Incidence not determined
  • Hair loss;  paleness of skin;  thinning of hair 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.