Tripedia

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a five-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). Because of the substantial risks of complications from pertussis disease in infants, completion of a primary series of vaccine early in life is strongly recommended (see DOSAGE AND ADMINISTRATION section).3

When ActHIB vaccine is reconstituted with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine (TriHIBit vaccine), the combined vaccines are indicated for the active immunization of children 15 to 18 months of age who have been immunized previously against diphtheria, tetanus and pertussis with three doses consisting of either whole-cell pertussis DTP vaccine or Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine and three or fewer doses of ActHIB vaccine within the first year of life for the prevention of diphtheria, tetanus, pertussis and invasive diseases caused by H influenzae type b.2 (Refer to ActHIB vaccine package insert.)

Children who have had well-documented pertussis (ie, positive culture for B pertussis or epidemiologic linkage to a culture positive case) should complete the vaccination series with at least DT vaccine. Some experts recommend including the pertussis component as well (ie, administration of DTaP vaccine). Although well-documented pertussis disease is likely to confer immunity against pertussis, the duration of such immunity is unknown.15, 22

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is not to be used for treatment of B pertussis, C diphtheriae, or C tetani infections.

If passive immunization is needed for tetanus prophylaxis or for treatment of diphtheria, either Tetanus Immune Globulin (Human) (TIG) or Diphtheria Antitoxin, respectively, should be administered as required.3,11 (See DOSAGE AND ADMINISTRATION section.)

As with any vaccine, vaccination with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine may not protect 100% of individuals.

Before administration of this vaccine, health-care personnel should inform the parent, guardian or other responsible adult of the benefits and risks of the vaccine and the importance of completing the immunization series unless a contraindication to further immunization exists.(See ADVERSE REACTIONS and WARNINGS sections.)

The physician should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine and other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. Parents or guardians should be instructed to report any adverse reactions to their health-care provider.

IT IS EXTREMELY IMPORTANT WHEN A CHILD RETURNS FOR THE NEXT DOSE IN THE SERIES THAT THE PARENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE OF THE SAME VACCINE (SEE CONTRAINDICATIONS AND ADVERSE REACTIONS SECTIONS).

Adverse events following immunization should be reported by health-care providers to the Vaccine Adverse Events Reporting System (VAERS). (See ADVERSE REACTIONS section, Reporting of Adverse Events subsection.)

In the U.S.

• Daptacel
• Infanrix
• Tripedia

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

This section provides information on the proper use of a number of products that contain diphtheria, tetanus, and acellular pertussis vaccine. It may not be specific to Tripedia. Please read with care.

A nurse or other trained health professional will give your child this vaccine. The vaccine is given as a shot into one of your child's muscles.

This vaccine is usually given as a series of 4 or 5 shots. It is important that your child receive all of the shots in this series. Try to keep all scheduled appointments. If your child must miss a shot, make another appointment with the child's doctor as soon as possible.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Your child may also receive a medicine to help prevent or treat some of the minor side effects of the vaccine, like fever and soreness.

Applies to diphtheria and tetanus toxoids / pertussis, acellular: intramuscular suspension

Along with its needed effects, diphtheria and tetanus toxoids / pertussis, acellular may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking diphtheria and tetanus toxoids / pertussis, acellular:

• Collapse or shock-like state
• crying for 3 hours or more
• fever over 102.2 °F
• redness or swelling of 4 inches or more at the injection site
• seizures (convulsions)
• severe pain at the injection site

• Agitation
• back pain
• black, tarry stools
• bleeding gums
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blood in the urine or stools
• bloody nose
• bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• confusion
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• drowsiness
• fast heartbeat
• hallucinations
• headache
• hoarseness
• irritability
• irritation
• joint pain, stiffness, or swelling
• loss of bladder control
• loss of consciousness
• loss of strength or energy
• muscle pain or weakness
• nausea and vomiting
• pain or cramping in the abdomen or stomach
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash with flat lesions or small raised lesions on the skin
• screaming
• shortness of breath
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• stiff neck
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• total body jerking
• unusual bleeding or bruising
• unusual tiredness or weakness (sudden and severe)

Some side effects of diphtheria and tetanus toxoids / pertussis, acellular 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:

• Fever of 99.5 °F or more
• fussiness
• loss of appetite
• mild pain, redness, swelling, or tenderness at the injection site
• restlessness
• weight loss

• Crying
• ear pain

Applies to diphtheria and tetanus toxoids / pertussis, acellular: intramuscular suspension

Local

Local side effects have included erythema, swelling, tenderness, and pain.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rare reports of anaphylactic reactions (ie, hives, swelling of the mouth, difficulty breathing, hypotension, or shock). Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid.[Ref]

General

General side effects have included fever greater than 101 degrees F (rectal), high-pitched cry, persistent cry, and irritability.[Ref]

Gastrointestinal

Gastrointestinal side effects have included anorexia and vomiting.[Ref]

Nervous system

Nervous system side effects have included drowsiness. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.[Ref]

Some side effects of Tripedia (DTaP) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.