Twinrix

Hepatitis Vaccines

 
NOTE: Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients.
 
NOTE: According to U.S. federal laws, the health care provider must record the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine in the patient's permanent record.

Administer intramuscularly; do not inject intravenously or intradermally.
Visually inspect parenteral products for particulate matter and discoloration prior to administration. After thorough agitation, the injection should appear as a slightly turbid, white suspension. Discard if it appears otherwise.

Upon storage, a fine white deposit with a clear colorless layer above may be present. The vaccine should be re-suspended before withdrawal and use.
To re-suspend the vaccine, hold the vaccine in a closed hand and shake the syringe by tipping it upside down and back upright again vigorously for at least for at least 15 seconds. If the vaccine appears as a uniform hazy white suspension, it is ready to use. If not, tip upside down and back upright again for at least another 15 seconds and inspect again.
Attach a sterile needle to the prefilled syringe and administer intramuscularly.[30899]
Follow the ACIP guidelines for intramuscular injection in individuals with clotting disorders.
 
Intramuscular (IM) injection:
Inject into a muscle in the deltoid region; do not inject into the gluteal region as this may result in a suboptimal response.
Use the vaccine as supplied; no dilution or reconstitution is necessary. After removal of the appropriate volume from a single-dose vial, any vaccine remaining in the vial should be discarded.
When concomitant administration of other vaccines or immunoglobulin is required they should be given with different syringes and at different injection sites.[30899]

erythema nodosum / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
serum sickness / Delayed / Incidence not known
vasculitis / Delayed / Incidence not known
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
optic neuritis / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
seizures / Delayed / Incidence not known
myelitis / Delayed / Incidence not known

erythema / Early / 8.0-11.0
migraine / Early / 0-1.0
lymphadenopathy / Delayed / Incidence not known
dyspnea / Early / Incidence not known
encephalopathy / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
hypertonia / Delayed / Incidence not known
neuritis / Delayed / Incidence not known
photophobia / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known
constipation / Delayed / Incidence not known

injection site reaction / Rapid / 0-41.0
headache / Early / 13.0-22.0
fatigue / Early / 11.0-14.0
diarrhea / Early / 4.0-6.0
fever / Early / 2.0-4.0
nausea / Early / 2.0-4.0
flushing / Rapid / 0-1.0
back pain / Delayed / 0-1.0
myalgia / Early / 0-1.0
irritability / Delayed / 0-1.0
arthralgia / Delayed / 0-1.0
rash / Early / 0-1.0
urticaria / Rapid / 0-1.0
alopecia / Delayed / 0-1.0
weakness / Early / 0-1.0
paresthesias / Delayed / 0-1.0
dizziness / Early / 0-1.0
vertigo / Early / 0-1.0
insomnia / Early / 0-1.0
syncope / Early / 0-1.0
anorexia / Delayed / 0-1.0
abdominal pain / Early / 0-1.0
vomiting / Early / 0-1.0
malaise / Early / Incidence not known
chills / Rapid / Incidence not known
ecchymosis / Delayed / Incidence not known
hypoesthesia / Delayed / Incidence not known
tinnitus / Delayed / Incidence not known
purpura / Delayed / Incidence not known
dysgeusia / Early / Incidence not known

Twinrix

Rx

Intramuscular, bivalent vaccine
Used to confer immunity in adults at risk of hepatitis A virus and hepatitis B virus
Antibody responses to this bivalent vaccine equivalent to the use of the individual vaccines

1 mL IM for 3 or 4 doses. For the 3 dose standard regimen, give the second dose 1 month after the initial dose and the third dose 6 months after the initial dose. For the 4 dose accelerated regimen, give the second dose 7 days after the initial dose and the third dose 21 to 30 days after the initial dose, followed by a booster dose at month 12. [53026]

Dosage regimen is not yet established. An initial dose of 0.5 mL IM, repeated at 1 and 6 months after initial dose, has been used. An alternative, 2-injection schedule has been used. Initial dose is 1 mL IM; repeat at 6 months after initial dose.

No dosage adjustments are needed.

No dosage adjustments are needed.

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hepatitis B Immune Globulin, HBIG: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

Twinrix Intramuscular Inj Susp: 1mL, 720-20mcg

1 mL/dose IM.

1 mL/dose IM.

Safety and efficacy have not been established; 1 mL/dose IM has been used.

Safety and efficacy have not been established; 1 mL/dose IM has been used.

Safety and efficacy have not been established.

Active immunization with hepatitis A and B vaccine stimulates the immune system to produce antibodies without exposing the patient to the risks of active infection. Infection with hepatitis D can occur only with concurrent hepatitis B infection, so vaccination with hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant provides protection against hepatitis D as well.
 
Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant contains inactivated hepatitis A virus (HAV, strain HM175) that is propagated in MRC5 cells and combined with purified hepatitis B surface antigen (HBsAg). The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Natural infection with either HAV or HBV that results in adequate antibody titers provides lifelong immunity. Routine booster doses of hepatitis A and hepatitis B vaccine are not currently recommended by the ACIP, except for the use of hepatitis B vaccine boosters in hemodialysis patients.

Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant is administered by intramuscular injection only.
 
The distribution, metabolism, and elimination of these vaccines are not well characterized. Anti-HAV antibody titers >= 33 milliunits/mL are considered consistent with seroconversion; anti-HBs antibodies >= 1 milliunits/mL indicate seroconversion and titers >= 10 milliunits/mL are considered protective. Antibodies to both HAV and HBV persisted in adults for at least 4 years after the 3-dose series of hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant. In this study, immunogenicity was positive in > 95% of subjects at month two. Follow-up determined that after 4 years, 100% of evaluated subjects were positive for anti-HAV and 95.3% were protected against hepatitis B. A decline in antibody titers did occur, but titers were similar to those seen with the corresponding monovalent vaccines. The seroprotection rate for hepatitis B at month 13 after 4 doses of Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant given on days 0, 7, 21—30, and month 12 was 96.4% (92.7—98.5). In contrast, the seroprotection rate for hepatitis B after separate vaccinations with monovalent hepatitis A vaccine at 0 and 12 months and hepatitis B vaccine at 0, 1, 2, and 12 months was 93.4% (89—96.4). The seroconversion rate for hepatitis A at month 13 was 100% (98.1—100) for both groups.

No adequate and well controlled studies have been conducted with hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant during pregnancy. A pregnancy exposure registry of 245 women who received hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant during pregnancy or within 28 days prior to conception found that the rates of miscarriage and major birth defects were consistent with estimated background rates. Additionally, 45 pregnant women who were inadvertently administrated hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant in pre- and post-licensure clinical studies had no increased rates of miscarriage or major birth defects. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated or recombinant virus vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration to pregnant women only if clearly indicated.[30899] [43236]

Data are limited regarding use of the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant during breast feeding and its' excretion in human milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however, according to the Advisory Committee on Immunization Practices (ACIP), inactivated and recombinant vaccines pose no risk to breast-feeding mothers or their infant. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.