DAPTACEL (DTAP PEDIATRIC) (PF) (diphtheria, pertussis (acell), tetanus pediatric vaccine/pf)

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Coma
Guillain-barre syndrome
Uncontrolled epilepsy

There are 0 moderate contraindications.

There are 22 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema Apnea Brachial plexus disorder Cyanosis Encephalitis Encephalopathy Extensive limb swelling after injection Guillain-barre syndrome High fever >101 degrees fahrenheit Hypersensitivity drug reaction Hypotension IgA vasculitis Myelitis Myocarditis Myositis Seizure disorder Syncope Thrombocytopenic disorder Tonic clonic seizure Unconsciousness Urticaria

There are 31 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Fatigue Headache disorder Injection site sequelae Myalgia	Acute abdominal pain Arthralgia Chills Diarrhea Lymphadenopathy Nausea Skin rash Vomiting

Rare/Very Rare
Back pain Bronchitis Bruising Cellulitis Cough Drowsy Earache Edema Erythema Facial palsy Fever Hypoesthesia Induration of skin Injection site abscess Muscle spasm Paresthesia Pruritus of skin Upper respiratory infection

Tdap (Adacel(R), Boostrix(R)) is indicated for immunization during the third trimester of each pregnancy to prevent pertussis in infants <2 months of age. Available data indicate that rates of major birth defects and miscarriage are similar in women who received Adacel(R) or Boostrix(R) 28-30 days prior to pregnancy and during pregnancy compared to background estimated rates. A retrospective passive surveillance study compared outcomes between 225 women who received Adacel(R) during pregnancy and 675 controls matched by age and date of their first positive pregnancy test.

Of the Adacel(R) recipients, 110 were vaccinated in the first trimester, 33 during the second trimester, and 14 in the third trimester. Twenty-nine had an unknown time of vaccination, and 39 had received Adacel(R) within 2 weeks prior to their last menstrual period. Spontaneous abortions were reported in 15% of patients in the control group and 9.3%

of Adacel(R) recipients. The incidence of congenital anomalies was 8.4% in the control group and 6.7%

in the group exposed to Adacel(R). An assessment of 1236 prospective reports from an ongoing registry of exposure to Adacel(R) indicate that rates of assessed outcomes (e.g., congenital anomalies, spontaneous abortions) in the prospective population were consistent with estimated background rates. Among 256 reports with known pregnancy outcomes in women exposed to Boostrix(R) within 28 days prior to conception or during pregnancy, 19 women with first trimester exposure to Boostrix(R) had no reported major birth defects and 3 spontaneous abortions.

Twenty-eight women exposed in the second trimester and 199 in the third trimester also reported no major birth defects; an additional 10 women that were exposed to Boostrix(R) at an unknown timing during pregnancy reported no major birth defects. Other spontaneous reports and postmarketing data have shown that out of 138 reports with known pregnancy outcomes, there were no major birth defects and 2 spontaneous abortions among 17 women exposed to Boostrix(R) in the first trimester. Out of 26 exposures in the second trimester and 92 in the third trimester there were no major birth defects reported; 3 women exposed to Boostrix(R) at an unknown timing during pregnancy also had no major birth defects reported.

Irrespective of vaccine history, ACIP and ACOG recommend administering a single dose of Tdap (Adacel(R) or Boostrix(R)) in all pregnant women during each pregnancy as early as possible between 27 and 36 weeks gestation. Immunization with Tdap during the third trimester of pregnancy provides passive protection against pertussis via transplacental antibody transfer in infants <2 months of age. Clinicians are encouraged to register pregnant women who receive Tdap with the manufacturer's pregnancy registry at 800-822-2463 or https://www.sanofipasteurpregnancyregistry.com

(Adacel(R)) or 888-452-9622 or http://pregnancyregistry.gsk.com/boostrix.html (Boostrix(R)).

It is not known whether Tdap (Adacel(R), Boostrix(R)) is distributed into human milk and data on the effect on breast-fed infants or on milk production are not available. The manufacturers state that Tdap should be used with caution in breast-feeding women.

Clinical studies evaluating the safety and efficacy of Tdap (Boostrix(R)) included adults >=65 years of age, and this preparation is labeled by FDA for booster immunization in geriatric adults. Safety and efficacy of Tdap (Adacel(R)) have not been established in adults >=65 years of age. Although Tdap (Adacel(R)) is not labeled by FDA for use in adults >=65 years of age, ACIP states the vaccine can be used in this age group if it is the only Tdap vaccine available.