Engerix-B Adult

Drug overview for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf):

Generic name: HEPATITIS B VIRUS VACCINE RECOMBINANT/PF (hep-uh-TIE-tuss B)
Drug class: Hepatitis B Vaccine
Therapeutic class: Biologicals

Hepatitis B vaccine (recombinant; Engerix-B(R), Recombivax HB(R)) and hepatitis B vaccine (recombinant) adjuvanted (Heplisav-B(R)) are inactivated recombinant vaccines containing hepatitis B surface antigen (HBsAg); they are used to stimulate active immunity to hepatitis B virus (HBV) infection.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf) have been approved by the FDA:

Indications:
Hepatitis B vaccination

Professional Synonyms:
Vaccination to prevent hepatitis B infection

The following dosing information is available for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf):

Dosing
Administration
Dosing Information
Generic

Dosage recommendations for hepatitis B vaccine vary depending on the specific preparation used, the recipient's age, the HBsAg status of the mother (for neonates), and the presence of underlying disease.

Because the recommended doses for each vaccine are different, dosage recommendations for the specific preparation used should be followed.

In general, the various brands of age-appropriate hepatitis B vaccines are interchangeable within an immunization series; however, adolescents who start their vaccination series with the adult formulation of Recombivax HB(R) cannot complete the series with the adult formulation of Engerix-B(R), and patients who start their vaccination series with Heplisav-B(R) should complete it with the same product or receive a 3-dose series rather than the 2-dose series that is used with Heplisav-B(R).

The complete hepatitis B vaccine series must be administered to ensure optimal protection. Refer to guidance for specific recommendations if there are interruptions or delays in dosing.

Booster doses of hepatitis B vaccine are not recommended for immunocompetent individuals. Consult expert guidelines for booster dose recommendations (when anti-HBsAg antibody levels decline to <10 mIU/mL) for patients receiving hemodialysis in outpatient centers, pediatric patients with HIV, and other immunocompromised patients with an ongoing risk for HBV exposure.

Hepatitis B vaccines are administered by IM injection. Hepatitis B vaccine is commercially available as three monovalent vaccines: hepatitis B vaccine (recombinant; Engerix-B(R) and Recombivax HB(R)) and hepatitis B vaccine (recombinant), adjuvanted (Heplisav-B(R)). Hepatitis B vaccine also is commercially available in a fixed-combination vaccine with hepatitis A virus vaccine (HepA-HepB; Twinrix(R)), in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix(R)), and in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and Haemophilus influenza type b (Hib) antigens (DTaP-IPV-Hib-HepB; Vaxelis(R)).

The manufacturers of the nonadjuvanted recombinant vaccines (Engerix-B(R), Recombivax HB(R)) state that the vaccines may be administered by subcutaneous injection, but only when necessary in individuals at risk of hemorrhage following IM injections (e.g., patients with thrombocytopenia or a bleeding disorder such as hemophilia). Subcutaneous administration is known to result in a lower antibody response. Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions (e.g., subcutaneous nodules) has been observed.

The vaccines should not be administered IV or intradermally. To ensure delivery of hepatitis B vaccine into the muscle, IM injections should be made at a 90degrees angle to the skin using a needle size that is appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique. Depending on the age of the patient, the IM injection should be made preferably into the deltoid or anterolateral thigh.

Since syncope may occur following vaccination, vaccinees should be observed for approximately 15 minutes after the vaccine dose is administered. If syncope occurs, the patient should be observed until symptoms resolve. Syncope after vaccination occurs most frequently in adolescents and young adults.

Hepatitis B vaccine may be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different injection sites). Monovalent hepatitis B vaccine (Engerix-B(R), Recombivax HB(R)) may be given simultaneously with hepatitis B immune globulin (HBIG) (using different syringes and different injection sites) when passive immunization is considered necessary in addition to active immunization with the vaccine (e.g., in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) women, in persons who experienced percutaneous or permucosal exposure to the virus).

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)	TZIELD

Drug Interaction

Drug Names

Non-Live or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames.

The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.

Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

TZIELD

There are 8 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Fingolimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)	FINGOLIMOD, GILENYA, TASCENSO ODT
Non-Live or Non-Replicating Vaccines/Siponimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2) CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)	MAYZENT
Non-Live or Non-Replicating Vaccines/Satralizumab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)	ENSPRYNG
Non-Live or Non-Replicating Vaccines/Ublituximab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)	BRIUMVI
Systemic Corticosteroids; Corticotropin/Non-Live or Non-Replicating Vaccines SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1) DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, JAYTHARI, KENALOG-10, KENALOG-40, KENALOG-80, KHINDIVI, KYMBEE, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, P-PACK PREDNISONE, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PROCTOCORT, PYQUVI, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Non-Live or Non-Replicating Vaccines/Etrasimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.	VELSIPITY
Non-Live or Non-Replicating Vaccines/Ozanimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.	ZEPOSIA
Non-Live or Non-Replicating Vaccines/Ponesimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.	PONVORY

The following contraindication information is available for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

*Hypersensitivity to any ingredient in the vaccine, including yeast (Engerix-B(R), Recombivax HB(R), Heplisav-B(R)). *History of previous hypersensitivity to any hepatitis B vaccine (Engerix-B(R), Recombivax HB(R), Heplisav-B(R)). *History of hypersensitivity to any ingredient in the vaccine (e.g., yeast, neomycin, polymyxin B) (Pediarix(R)).

*History of hypersensitivity to a previous dose of the vaccine or any vaccine component (Vaxelis(R)). *History of serious allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis B-, or poliovirus-containing vaccine (Pediarix(R)). *History of serious allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis antigen, hepatitis B, inactivated poliovirus, or H.

influenzae type b-containing vaccine (Vaxelis(R)). *Encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a previous dose of vaccine containing pertussis antigens that could not be attributed to another identifiable cause (Pediarix(R), Vaxelis(R)). *Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy; vaccine should not be administered to patients with these conditions until the neurological status has stabilized (Pediarix(R), Vaxelis(R)).

*Hypersensitivity to any ingredient in the vaccine, including yeast and neomycin (Twinrix(R)). *Previous hypersensitivity reactions to any hepatitis A- or hepatitis B- containing vaccines (Twinrix(R)).

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

The following adverse reaction information is available for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

In healthy infants and children (<=10 years of age), the most frequently reported systemic adverse reactions (>1% of the injections) with Recombivax HB(R) were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions were reported following 17% of the injections and systemic adverse reactions were reported following 15% of the injections. The most common solicited adverse reactions with Engerix-B(R) were injection-site soreness (22%) and fatigue (14%).

The most common solicited adverse reactions following any dose (>=25%) of Pediarix(R) included local injection site reactions (pain, redness, and swelling), fever (>=38.0degreesC), drowsiness, irritability/fussiness, and loss of appetite. The most common (>=10%) solicited injection site reactions following any dose of Twinrix(R) included soreness (35-41%) and erythema (8-11%), and the most common solicited systemic adverse reactions were headache (13-22%) and fatigue (11-14%). The most common local reaction with Heplisav-B(R) was injection site pain (9-39%), and the most common systemic reactions were fatigue (10-17%) and headache (5-17%).

The most common solicited adverse reactions following any dose of Vaxelis(R) were irritability (>=55%), crying (>=45%), injection site pain (>=44%), somnolence (>=40%), injection site erythema (>=25%), decreased appetite (>=23%), fever >=38.0degreesC (>=19%), injection site swelling (>=18%), and vomiting (>=9%).

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

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

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

The following precautions are available for ENGERIX-B ADULT (hepatitis b virus vaccine recombinant/pf):

Pediatric
Pregnant
Lactation
Geriatric

Recombivax HB(R) is approved for use in pediatric patients of any age. In neonates, passively acquired maternal anti-HBs antibodies do not appear to interfere with the active immune response to hepatitis B vaccine. Safety and efficacy of Recombivax(R) HB Dialysis Formulation have not been established in children.

Engerix-B(R) is approved for use in pediatric patients of any age. In neonates, passively acquired maternal anti-HBs antibodies do not appear to interfere with the active immune response to hepatitis B vaccine. The timing of the first dose in infants weighing <2000 g at birth depends on the HBsAg status of the mother.

Safety and efficacy of Heplisav-B(R) have not been established in pediatric patients younger than 18 years of age. Safety and efficacy of Pediarix(R) have not been established in infants younger than 6 weeks of age or in children 7 years of age or older. Safety and efficacy of Twinrix(R) have not been established in pediatric patients younger than 18 years of age. Safety and efficacy of Vaxelis(R) have not been established in infants younger than 6 weeks of age or in children 5 years of age or older.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.