PREHEVBRIO (PF) (hepatitis b virus vaccine recombinant,isoform s,m,l/pf)

There are 0 contraindications.

There are 0 severe contraindications.

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 25 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare

Abnormal hepatic function tests Anaphylaxis Angioedema Apnea Bell's palsy Bronchospastic pulmonary disease Encephalitis Encephalopathy Erythema multiforme Erythema nodosum Guillain-barre syndrome Herpes zoster Lichen planus Meningitis Muscle weakness Myelitis Optic neuritis Purpura Seizure disorder Serum sickness Stevens-johnson syndrome Syncope Thrombocytopenic disorder Tonic clonic seizure Vasculitis

There are 54 less severe adverse reactions.

More Frequent	Less Frequent
Fatigue Injection site sequelae	Dizziness Erythema Fever Headache disorder Induration of skin Pain Vertigo

Rare/Very Rare

Abdominal pain with cramps Agitation Alopecia Anorexia Arthralgia Arthritis Back pain Chills Conjunctivitis Constipation Diarrhea Drowsy Dyspepsia Earache Ecchymosis Eczema Flu-like symptoms Flushing General weakness Hyperhidrosis Hypoesthesia Hypotension Insomnia Irritability Keratitis Lymphadenopathy Malaise Migraine Myalgia Nausea Neck pain Neck stiffness Palpitations Paresthesia Peripheral sensory neuropathy Petechiae Pruritus of skin Shoulder pain Skin rash Tachycardia Tinnitus Upper respiratory infection Urticaria Visual changes Vomiting

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).

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 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.