PEDIARIX (hep b virus,rcmb/dipth,pertus(acell),tet,polio vaccine/pf)

There are 0 contraindications.

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Febrile convulsions
Guillain-barre syndrome
High fever >101 degrees fahrenheit
Infantile spasms
Uncontrolled epilepsy

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Fever
Multiple sclerosis

There are 14 severe adverse reactions.

More Frequent	Less Frequent
None.	Irregular sleep-wake rhythm

Rare/Very Rare
Angioedema Cellulitis Cyanosis Encephalopathy Erythema Hypersensitivity drug reaction Hypotonia Idiopathic thrombocytopenic purpura Intussusception of intestine Jaundice Syncope Thrombocytopenic disorder Tonic clonic seizure

There are 26 less severe adverse reactions.

More Frequent	Less Frequent
Fever Injection site sequelae Irritability	Anorexia Nervousness

Rare/Very Rare
Abdominal pain with cramps Alopecia Arthralgia Diarrhea Drowsy Earache Edema Erythema multiforme General weakness Headache disorder Lethargy Lymphadenopathy Malaise Nausea Pallor Petechiae Pruritus of skin Skin rash Upper respiratory infection Urticaria Vomiting

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)). Engerix-B(R) or Recombivax HB(R): Animal reproduction studies have not been performed with the vaccine. There are no adequate and well-controlled studies of the vaccine in pregnant women in the U.S.

Available data do not suggest an increased risk of major birth defects or miscarriage in women who received the vaccine during pregnancy. Twinrix(R): An animal development study in female rats found no adverse effects on fetal or pre-weaning development when the vaccine was administered prior to mating and during gestation. There are no adequate and well-controlled studies of the vaccine in pregnant women in the U.S.

Available data do not suggest an increased risk of major birth defects or miscarriage in women who received the vaccine within 28 days prior to conception or during pregnancy. Heplisav-B(R): An animal development toxicity study in female rats found no evidence of fetal harm due to a vaccine formulation containing 2.5 mcg HBsAg and 3000 mcg cytidine phospho-guanosine (CpG) 1018 adjuvant administered prior to mating and during gestation; a full human dose of Heplisav-B(R) contains 20 mcg HBsAg and 3000 mcg CpG 1018 adjuvant.

There are no adequate and well-controlled studies of the vaccine in pregnant women. Available data, primarily in individuals who received one dose of the vaccine in the 28 days prior to or during pregnancy, do not suggest an increased risk of major birth defects and miscarriage. Vaxelis(R) and Pediarix(R) are not indicated for use in women of childbearing age. ACIP states that pregnant women who require hepatitis B vaccination may receive any of the available single-antigen hepatitis B vaccines or Twinrix(R) (if vaccination against both hepatitis A and hepatitis B is desired).

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. Engerix-B(R), Recombivax HB(R), Twinrix(R), and Heplisav-B(R): It is not known whether the vaccine is distributed into human milk, or affects the breast-fed child or milk production.

The manufacturers state that the benefits of breast-feeding and the importance of the vaccine to the mother should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to meningococcal infection). Although specific data are not available, ACIP states that breast-feeding is not a contraindication to administration of hepatitis B vaccine and lactating women should receive the vaccine as recommended for other adults.

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.

Clinical studies of Engerix-B(R) and Recombivax HB(R) did not include sufficient numbers of individuals 65 years of age or older to determine whether these individuals respond differently than younger individuals. However, later studies have found that a diminished antibody response may occur in geriatric individuals >60 years of age. In clinical studies of Heplisav-B(R), 90% of adults 65-70 years of age achieved seroprotective antibody levels to HBsAg, compared with 96% of adults 18-64 years of age.

The safety and efficacy of Heplisav-B(R) in adults over 70 years of age were extrapolated from data obtained in participants younger than 70 years of age. Clinical studies of Twinrix(R) did not include sufficient numbers of individuals 65 years of age or older to determine whether geriatric individuals respond differently than younger adults. Vaxelis(R) and Pediarix(R) are not indicated for use in adults, including geriatric adults.