Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intramuscular [preservative free]:
Heplisav-B: Hepatitis B surface antigen 20 mcg/0.5 mL (0.5 mL [DSC]) [contains polysorbate 80]
Solution Prefilled Syringe, Intramuscular [preservative free]:
Heplisav-B: 20 mcg/0.5 mL (0.5 mL) [contains polysorbate 80]
Pharmacology
Mechanism of Action
Recombinant (adjuvanted) hepatitis B vaccine is a noninfectious viral vaccine, which confers active immunity via formation of antihepatitis B antibodies.
Use: Labeled Indications
Hepatitis B virus disease prevention: Prevention of infection caused by all known subtypes of hepatitis B virus in adults
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following (CDC/ACIP [Schillie 2018b]):
- All unvaccinated adults requesting protection from HBV infection
- All unvaccinated adults at risk for HBV infection such as those with:
Behavioral risks: Sexually active persons not in a long-term, mutually monogamous relationship; persons seeking evaluation or treatment for a sexually transmitted disease; men who have sex with men; injection drug users
Occupational risks: Health care personnel (HCP) and public safety workers with reasonably anticipated risk for exposure to blood or blood contaminated body fluids
Medical risks: Persons with ESRD (including predialysis, hemodialysis, peritoneal dialysis, and home dialysis); persons with HIV infection; persons with chronic liver disease (eg, hepatitis C virus infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST level >2 times the upper limit of normal); adults (<60 years of age) with diabetes mellitus; adults ≥60 years of age with diabetes mellitus may also be vaccinated at the discretion of their treating clinician
Other risks: Household contacts or sex partners of persons who are HBsAg-positive; residents and staff of facilities for developmentally disabled persons; international travelers to regions with high or intermediate levels of endemic HBV infection; incarcerated persons
Contraindications
Severe hypersensitivity (eg, anaphylaxis) to any hepatitis B vaccine or any component of the formulation (including yeast)
Dosage and Administration
Dosing: Adult
Hepatitis B virus disease prevention: IM: 0.5 mL/dose given as a 2-dose series at least 1 month apart
CDC/ACIP recommendations (CDC [Schillie 2018b]): The ACIP recommends completing the vaccine series with the same product whenever possible. If continuing with same product will cause vaccination to be deferred, or if product used previously is unknown or unavailable, vaccination should be completed with the product available. The 2-dose HepB vaccine series only applies when both doses in the series consist of HepB-CpG. If 1 dose of HepB-CpG (Heplisav-B) and another dose from a different manufacturer was previously given, then a third vaccine dose should be given. Minimum intervals: 4 weeks between dose 1 and 2; 8 weeks between dose 2 and 3; 16 weeks between dose 1 and 3. If a dose was administered prior to the minimum interval, then the dose should be repeated unless the series contained 2 doses of HepB-CpG given at least 4 weeks apart.
Revaccination: Anti-HBs testing is recommended 1 to 2 months after the final dose for certain persons (eg, hemodialysis patients, HIV patients, other immunocompromised persons, health care personnel, sex partners of HBsAg-positive persons). If anti-HBs <10 milliunits/mL, revaccinate with either a second complete series (eg, 2-dose series of HepB-CpG) or a single HepB vaccine dose. Repeat anti-HBs testing 1 to 2 months later; if repeat anti-HBs <10 milliunits/mL and patient has not received a second full series, then complete the series and check anti-HBs levels in 1 to 2 months following the final dose.
Dosing: Geriatric
Refer to adult dosing.
Administration
Administer by IM injection in the deltoid muscle. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
For patients at risk of hemorrhage following intramuscular injection, the ACIP recommends that the vaccine should be administered intramuscularly 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) can 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 (ACIP [Kroger 2017]).
Storage
Store refrigerated at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if the vaccine has been frozen.
Drug Interactions
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Test Interactions
Following vaccination, hepatitis B surface antigen (HBsAg), a component of the vaccine, has been transiently detected in blood samples. Therefore, serum HBsAg detection may not have diagnostic value within 28 days after receipt of hepatitis B vaccine.
Adverse Reactions
>10%
Central nervous system: Fatigue (11% to 17%), headache (8% to 17%)
Local: Pain at injection site (23% to 39%)
1% to 10%:
Central nervous system: Malaise (7% to 9%)
Local: Erythema at injection site (≤4%), swelling at injection site (≤2%)
Neuromuscular & skeletal: Myalgia (6% to 9%)
Miscellaneous: Fever (≤2%)
<1%, postmarketing, and/or case reports: Graves disease, Guillain-Barre syndrome, herpes zoster, lichen planus, myocardial infarction, Wegener granulomatosis
Warnings/Precautions
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 2017]).
- 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 2017]).
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. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2017]).
- 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 2017]).
Special populations:
- Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (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. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; IDSA [Rubin 2014]).
- Elderly: Patients ≥65 years of age may have lower response rates.
Concurrent drug therapy issues:
- Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
- 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 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 2017]).
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 (ACIP [Kroger 2017]). Due to the long incubation period for hepatitis, unrecognized hepatitis B infection may be present prior to vaccination; immunization may not prevent infection in these patients.
Monitoring Parameters
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Pregnancy
Pregnancy Considerations
The ACIP recommends HBsAg testing for all pregnant women (CDC/ACIP [Schillie 2018a]). When vaccination is clinically indicated, the ACIP recommends use of a different hepatitis B vaccine until additional information related to this formulation in pregnancy is available (CDC/ACIP [Schillie 2018b]).
Females exposed to this vaccine during pregnancy are encouraged to enroll in the HEPLISAV-B Pregnancy Registry 1-844-443-7734.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience injection site pain, loss of strength and energy, headache, or muscle pain (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
