Hepatitis A and Hepatitis B Recombinant Vaccine

Use hepatitis A and hepatitis B recombinant vaccine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• Your doctor will give this medicine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• A burning, numbness, or tingling feeling that is not normal.
• Trouble controlling body movements.
• Change in eyesight.

• If you need to store hepatitis A and hepatitis B recombinant vaccine at home, talk with your doctor, nurse, or pharmacist about how to store it.

• Engerix-B and Havrix
• Havrix and Engerix-B
• HepA
• HepA-HepB
• Hepatitis A
• Hepatitis B
• Hepatitis B and Hepatitis A Vaccine
• HepB

Primary immunization: IM:

US labeling: 1 mL given on a 0-, 1-, and 6-month schedule for a total of 3 doses

Accelerated regimen: 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 ≥19 years (Twinrix): 1 mL given on a 0-, 1-, and 6-month schedule for a total of 3 doses

Accelerated regimen: 1 mL on day 0, day 7, and day 21, followed by a booster at 12 months for a total of 4 doses

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 (NCIRD/ACIP 2011).

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011). 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:

• 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 inactivated) for which a person is eligible at a single clinic 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 (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Elderly: Patients >60 years may have lower response rates to hepatitis B vaccine.

• Hemodialysis: Use with caution in patients undergoing hemodialysis; may not obtain adequate antibody titers following primary immunization.

Dosage form specific issues:

• Latex: Packaging may contain natural latex rubber.

• Yeast, neomycin, aluminum: May contain aluminum, yeast, and trace amounts of neomycin.

Other warnings/precautions:

• 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. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011). 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.

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Applies to hepatitis a adult vaccine / hepatitis b adult vaccine: intramuscular suspension

No adjustment recommended.

The vaccine should be refrigerated to maintain potency. Avoid freezing and discard any vaccine that has been frozen.

The vaccine should be shaken well before withdrawing a dose and administering it.

Injection into the deltoid muscle is preferred in adults. Injection into the buttocks may result in a lower seroconversion rate.

Health care providers should report any allergic or unusual adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (USA) and the manufacturer.