Version May 2024
Primary immunization:
Note: Consult CDC/Advisory Committee on Immunization Practices (ACIP) annual immunization schedules or National Advisory Committee on Immunization guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions.
US labeling: IM: 1 mL given on a 0-, 1-, and 6-month schedule for a total of 3 doses.
Accelerated regimen: IM: 1 mL on day 0, day 7, and days 21 to 30, followed by a booster at 12 months for a total of 4 doses.
Canadian labeling:
Adults 18 to <19 years of age: Twinrix Junior: IM: 0.5 mL given on a 0-, 1-, and 6-month schedule for a total of 3 doses.
Adults ≥19 years of age: Twinrix: IM: 1 mL given on a 0-, 1-, and 6-month schedule for a total of 3 doses.
Accelerated regimen: IM: 1 mL on day 0, day 7, and day 21, followed by a booster at 12 months for a total of 4 doses.
Interchangeability (Ref):
Hepatitis A vaccine: Completing the vaccine series with a product from the same manufacturer is preferred when possible. Twinrix provides a hepatitis A virus (HAV) vaccine dose equivalent to the pediatric dose of hepatitis A vaccine (720 ELISA units inactivated HAV antigen per 1 mL dose). Twinrix Junior [Canadian product] provides 360 ELISA units inactivated HAV antigen per 0.5 mL dose.
For persons 18 to <19 years of age, if 1 dose (1 mL) of Twinrix has been given, then administer 2 doses of pediatric hepatitis A vaccine (separated by 5 months) to complete the hepatitis A vaccine series. If 2 doses (1 mL/dose) of Twinrix have been given, then administer 1 dose of pediatric hepatitis A vaccine (5 months after the second dose) to complete the hepatitis A vaccine series.
For persons ≥19 years of age, if 1 dose (1 mL) of Twinrix has been given, then administer 2 doses of adult hepatitis A vaccine (separated by 5 months) to complete the hepatitis A vaccine series. If 2 doses (1 mL/dose) of Twinrix have been given, then administer 1 dose of adult hepatitis A vaccine (5 months after the second dose) to complete the hepatitis A vaccine series.
Hepatitis B vaccine: Twinrix is equivalent to a standard adult dose of hepatitis B vaccine and may be substituted for any dose of the hepatitis B series.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Hepatitis A virus and recombinant hepatitis B virus vaccine (HepA-HepB): Pediatric drug information")
Primary immunization:
Note: Consult CDC/Advisory Committee on Immunization Practices annual immunization schedules or National Advisory Committee on Immunization guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions.
Adolescents ≥18 years: Twinrix:
Standard regimen: IM: 1 mL/dose administered on a 0-, 1-, and 6-month schedule for a total of 3 doses.
Accelerated regimen: IM: 1 mL/dose administered on day 0, day 7, and days 21 to 30, followed by a booster dose at 12 months for a total of 4 doses.
Canadian labeling: Note: Product selection (Twinrix Junior or Twinrix) determined by schedule; use caution.
Standard regimen: Twinrix Junior: Children and Adolescents: IM: 0.5 mL/dose administered on a 0-, 1-, and 6-month schedule for a total of 3 doses.
Alternate regimen: Twinrix: Children and Adolescents ≤15 years: IM: 1 mL/dose for 2 doses; administer second dose 6 to 12 months after the first.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults. Also see individual agents.
>10%:
Local: Injection-site reaction (including bruising at injection site [<1%], burning sensation at injection site, erythema at injection site [8% to 11%], induration at injection site [1% to 10%], injection-site pruritus [<1%], local soreness/soreness at injection site [35% to 41%], pain at injection site, and swelling at injection site [4% to 6%])
Nervous system: Fatigue (11% to 14%), headache (13% to 22%)
1% to 10%:
Gastrointestinal: Diarrhea (4% to 6%), nausea (2% to 4%), vomiting (≤1%)
Respiratory: Upper respiratory tract infection
Miscellaneous: Fever (2% to 4%)
<1%:
Cardiovascular: Flushing, syncope
Dermatologic: Diaphoresis, erythema of skin, skin rash, urticaria
Gastrointestinal: Abdominal pain, anorexia
Hematologic & oncologic: Petechia
Nervous system: Agitation, asthenia, dizziness, drowsiness, insomnia, irritability, migraine, paresthesia, vertigo
Neuromuscular & skeletal: Arthralgia, back pain, myalgia
Respiratory: Flu-like symptoms
Postmarketing:
Cardiovascular: Palpitations, tachycardia, vasculitis
Dermatologic: Alopecia, eczema, erythema multiforme, erythema nodosum, hyperhidrosis, lichen planus
Gastrointestinal: Dyspepsia
Hematologic & oncologic: Immune thrombocytopenia, thrombocytopenia
Hepatic: Abnormal hepatic function tests, hepatitis, jaundice
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, nonimmune anaphylaxis, serum sickness-like reaction (days to weeks after vaccination)
Infection: Herpes zoster infection
Nervous system: Bell palsy, chills, encephalitis, encephalopathy, Guillain-Barré syndrome, hypoesthesia, malaise, meningitis, multiple sclerosis, myasthenia, neuritis, neuropathy, paralysis, paresis, seizure, transverse myelitis
Neuromuscular & skeletal: Arthritis, myelitis
Ophthalmic: Conjunctivitis, optic neuritis, visual disturbance
Otic: Otalgia, tinnitus
Respiratory: Bronchospasm, dyspnea
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis A–containing or hepatitis B–containing vaccine, or any component of the formulation, including yeast and neomycin.
Canadian labeling: Additional contraindications (not in US labeling): Acute severe febrile illness.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever) unless they are at immediate risk of hepatitis A or hepatitis B infection; vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]). Canadian product labeling recommends subcutaneous administration for patients with thrombocytopenia or at risk for hemorrhage; however, antibody response may be suboptimal.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and potential adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Older adults: Patients >40 years may have slightly lower response rates to the hepatitis B portion of the vaccine.
• Hemodialysis: Use with caution in patients undergoing hemodialysis; may not obtain adequate antibody titers following primary immunization.
Dosage form specific issues:
• Yeast, neomycin, aluminum: May contain aluminum, yeast, and trace amounts of neomycin.
Other warnings/precautions:
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and is improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]). Due to the long incubation periods for hepatitis, unrecognized hepatitis A or B infection may be present; immunization may not prevent infection in these patients.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [preservative free]:
Twinrix: Hepatitis A virus antigen 720 ELISA units and hepatitis B surface antigen 20 mcg per mL (1 mL) [contains aluminum, formaldehyde, yeast protein, and trace amounts of neomycin; may contain natural rubber/natural latex in prefilled syringe]
No
Suspension Prefilled Syringe (Twinrix Intramuscular)
720-20ELU-MCG/ML (per mL): $151.14
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [preservative free]:
Twinrix Junior: Hepatitis A virus antigen 360 ELISA units and hepatitis B surface antigen 10 mcg per 0.5 mL (0.5 mL) [contains aluminum and trace amounts of neomycin]
IM: Resuspend vaccine prior to use by shaking vigorously for at least 15 to 30 seconds until a uniform hazy white appearance occurs. Discard if the suspension is discolored, clear, or does not appear homogenous after shaking. Administer IM in the deltoid region; do not administer in the gluteal region (may give suboptimal response). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not administer IV, intradermally, or SUBQ (US labeling). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref). Although subcutaneous administration is not recommended (antibody response may be suboptimal), the Canadian product labeling suggests that subcutaneous administration may be used in patients at risk for hemorrhage, including those with thrombocytopenia, despite potentially suboptimal response.
Parenteral: Before use, shake vigorously for at least 15 to 30 seconds until a uniform hazy white appearance occurs. Discard if the suspension is discolored, clear, or does not appear homogenous after shaking.
IM: Adolescents ≥18 years: Administer IM in the deltoid region; do not administer in the gluteal region (may give suboptimal response). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not administer IV, intradermally, or SUBQ. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Canadian labeling (Twinrix, Twinrix Junior): Children and Adolescents:
IM: Administer IM, preferably in the deltoid region or in the anterolateral thigh in infants; do not administer in the gluteal region (may give suboptimal response). If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref).
SubQ: Although subcutaneous administration is not recommended (antibody response may be suboptimal), the manufacturer suggests that subcutaneous administration may be used in patients at risk for hemorrhage (including those with thrombocytopenia).
In the US, the appropriate Centers for Disease Control and Prevention (CDC)-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html and http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html .
Hepatitis A and B diseases prevention:
Twinrix: Active immunization of persons 18 years and older (US labeling) or 19 years and older (Canadian labeling) against disease caused by hepatitis A virus and hepatitis B virus (all known subtypes)
Canadian labeling: Additional uses (not in US labeling): Approved for active immunization of children and adolescents ages 1 to 15 years.
Twinrix Junior [Canadian product]: Active immunization of children and adolescents ages 1 to 18 years against disease caused by hepatitis A virus and hepatitis B virus (all known subtypes).
Limitations of use: Hepatitis A/hepatitis B vaccine cannot be used for postexposure prophylaxis (CDC/ACIP [Nelson 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Based on data collected from a pregnancy registry between 2001 and 2015, an increased risk of major birth defects or miscarriage was not observed following maternal use of hepatitis A and hepatitis B vaccine.
Nonlive vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]). Refer to current immunization schedule for vaccinating pregnant females.
It is not known if the components of this vaccine are present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding following immunization should take into account the risk of infant exposure, benefits of breastfeeding to the infant, and benefits of vaccination to the mother. Administration does not affect the safety of breastfeeding for the mother or the infant (ACIP [Kroger 2023]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Hepatitis A vaccine, an inactivated virus vaccine, offers active immunization against hepatitis A virus infection at an effective immune response rate in up to 99% of subjects.
Recombinant hepatitis B vaccine is a noninfectious subunit viral vaccine. The vaccine is derived from hepatitis B surface antigen (HBsAg) produced through recombinant DNA techniques from yeast cells. The portion of the hepatitis B gene which codes for HBsAg is cloned into yeast which is then cultured to produce hepatitis B vaccine.
In immunocompetent people, Twinrix provides active immunization against hepatitis A virus infection (at an effective immune response rate >99% of subjects) and against hepatitis B virus infection (at an effective immune response rate of 93% to 97%) 30 days after completion of the 3-dose series. This is comparable to using hepatitis A vaccine and hepatitis B vaccine concomitantly.
Onset of action: Seroconversion for antibodies against HAV and HBV were detected 1 month after completion of the 3-dose series.
Duration: HAV and HBV seropositivity have been observed for 15 years in adults and for 10 years in children (Diaz-Mitoma 2008, Van Herck 2007).
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