Recombivax HB

Hepatitis Vaccines

 
Inform the patient or parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. This action is required by the National Childhood Vaccine Injury Act of 1986.
Record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine in the patient's permanent record. These actions are required by the National Childhood Vaccine Injury Act of 1986.[52653]
Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients.

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Administer as soon as possible after removal from refrigeration.
Use as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.
Hepatitis B vaccine is administered intramuscularly (preferred; administer Heplisav-B and Prehevbrio intramuscularly only) or subcutaneously (only for those who are at risk). Do not administer intravenously or intradermally.
Prior to withdrawing a dose from the vial, shake vial or pre-filled syringe thoroughly to obtain a uniform suspension.
Hepatitis B vaccine should not be given in the same syringe nor injected at the same site as hepatitis B immune globulin; inactivation of the vaccine can occur.
Do not mix with any other vaccine.
A separate syringe and needle should be used for each person receiving the hepatitis B vaccine.
Preservative-free formulations: Once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Storage: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze. Storage at room temperature for up to 72 hours may be acceptable; however, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.[43106] [43406] [62619]

For vials, use a sterile syringe and needle to withdraw suspension from the vial. For prefilled syringes, attach a sterile needle.
Adults, adolescents, and older children: Inject into the deltoid muscle of the upper arm. Do NOT administer in the gluteal muscle; gluteal administration has resulted in lower hepatitis B seroconversion rates.
Neonates, infants, and young children: Inject into the anterolateral aspect of the mid-thigh.[43106] [43406]
Injection must be accomplished with a needle long enough to ensure IM deposition of the vaccine.
For adults, the needle size required for deltoid injection ranges from 5/8- to 1 1/2-inches, depending on patient size.
For pediatric patients 3 years and older, the needle size required for deltoid injection ranges from 5/8- to 1-inch.
For children 1 to 2 years, a needle at least 1 inch long is preferred for administration into the thigh; a 5/8 inch needle is sufficient for administration into the deltoid if the skin is stretched flat and the needle is inserted at a 90-degree angle.
For the majority of infants younger than 1 year, a 1-inch, 22- to 25-gauge needle is sufficient to penetrate thigh muscle.[43236]

Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after intramuscular injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including irritation, inflammation, nodules, or skin discoloration.
For vials, use a sterile syringe and needle to withdraw suspension from the vial. For prefilled syringes, attach a sterile needle. A 5/8-inch, 23- to 25-gauge needle is appropriate.
Administer at a 45-degree angle into the subcutaneous tissue.
Adults, adolescents, and older children: Inject into the deltoid area.
Infants and young children: Inject into the anterolateral thigh.[43106] [43236] [43406]

angioedema / Rapid / 0-1.0
erythema multiforme / Delayed / Incidence not known
serum sickness / Delayed / Incidence not known
erythema nodosum / Delayed / Incidence not known
vasculitis / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
optic neuritis / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
seizures / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
myocardial infarction / Delayed / Incidence not known

erythema / Early / 0.2-10.0
lymphadenopathy / Delayed / 0-1.0
hypotension / Rapid / 0-1.0
constipation / Delayed / 0-1.0
peripheral neuropathy / Delayed / Incidence not known
migraine / Early / Incidence not known
encephalopathy / Delayed / Incidence not known
neuritis / Delayed / Incidence not known
dyspnea / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known

injection site reaction / Rapid / 0.2-38.5
headache / Early / 1.0-33.8
myalgia / Early / 0-30.3
fatigue / Early / 10.0-29.7
fever / Early / 0.6-10.0
dizziness / Early / 0-10.0
malaise / Early / 1.0-9.2
agitation / Early / 0-1.0
flushing / Rapid / 0-1.0
back pain / Delayed / 0-1.0
petechiae / Delayed / 0-1.0
arthralgia / Delayed / 0-1.0
chills / Rapid / 0-1.0
paresthesias / Delayed / 0-1.0
insomnia / Early / 0-1.0
vertigo / Early / 0-1.0
urticaria / Rapid / 0-1.0
pruritus / Rapid / 0-1.0
rash / Early / 0-1.0
alopecia / Delayed / 0-1.0
dyspepsia / Early / 0-1.0
abdominal pain / Early / 0-1.0
vomiting / Early / 0-1.0
anorexia / Delayed / 0-1.0
irritability / Delayed / 1.0
weakness / Early / 1.0
nausea / Early / 1.0
diarrhea / Early / 1.0
ecchymosis / Delayed / Incidence not known
hypoesthesia / Delayed / Incidence not known
tinnitus / Delayed / Incidence not known
lichen planus-like eruption / Delayed / Incidence not known
purpura / Delayed / Incidence not known
syncope / Early / Incidence not known

Engerix-B, Engerix-B Pediatric, HEPLISAV-B, PreHevbrio, Recombivax HB, Recombivax HB Pediatric/Adolescent

Rx

Recombinant vaccine
Used for vaccination against hepatitis B virus infection
Vaccinate all neonates within 24 hours of birth using Engerix-B and Recombivax HB; may use for hepatitis B prophylaxis in all ages and can be used in conjunction with hepatitis B immune globulin (HBIG) for postexposure prophylaxis; Heplisav-B and Prehevbrio only approved in adults

10 mcg IM or subcutaneously at initial visit; repeat at 1 and 6 months after initial dose.[43106] Administer the second dose 1 month after the first dose, and administer the third dose at least 2 months after the second dose and at least 4 months after the first dose.[53026] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

5 mcg IM or subcutaneously at initial visit. Repeat at 1 and 6 months after the initial dose.[43106] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

Use dialysis formulation containing 40 mcg/mL of vaccine. Administer 40 mcg (1 mL) IM or subcutaneously at initial visit; repeat at 1 and 6 months after initial dose. For predialysis or dialysis patients, a booster dose or revaccination with 40 mcg IM or subcutaneously may be considered if the anti-HBs concentration is less than 10 milli-International Units/mL 1 to 2 months after the third dose. The ACIP recommends that the need for booster doses of vaccine be assessed by annual antibody testing. Give booster dose when antibody concentrations decline to less than 10 milli-International Units/mL.[43106] [53026] [53225] [65067] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

Revaccination with at least 1 dose of vaccine for nonresponse after the primary series increases the proportion of those achieving seroprotection. In a study (n = 178), 47% of nonresponders developed seroprotection after 1 additional dose. Of the 86 patients without seroprotection after the first revaccination, 42% developed seroprotection after 2 additional doses. A 3-dose revaccination (n = 17) with a higher dose of 40 mcg IM or subcutaneously improved the proportion of nonresponders achieving anti-HB levels of at least 10 milli-International Units/mL in a clinical trial; single dose revaccination with a higher dose has not been demonstrated in clinical trials.

5 mcg (0.5 mL) given IM or subcutaneously at initial visit. Repeat dose ideally at 1 and 6 months after initial dose; a minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. For pediatric patients between 11 and 15 years of age, an alternative regimen using the Recombivax HB Adult Formulation is 10 mcg (1 mL) given IM or subcutaneously for 2 doses, given 4 to 6 months apart. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43106] [53026]

5 mcg (0.5 mL) given IM or subcutaneously at initial visit. Repeat dose ideally at 1 and 6 months after initial dose; the final dose (3rd or 4th dose) should be administered no earlier than age 24 weeks. A minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. In infants and children born to HBsAg-positive mothers, test for HBsAg and antibody to HBsAg at age 9 through 12 months or 1 to 2 months after completion of the hepatitis B series if the series was delayed.[43106] [53026] Revaccinate HBsAg-negative infants with anti-HBs less than 10 milli-International Units/mL with a single dose of hepatitis B vaccine; serologic testing should follow 1 to 2 months later. Infants whose anti-HBs remains less than 10 milli-International Units/mL should receive 2 additional doses of hepatitis B vaccine to complete the second series, followed by serologic testing 1 to 2 months after the final dose.[62840] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43106]

5 mcg (0.5 mL) given IM or subcutaneously within 24 hours of birth. ACIP recommends repeat doses ideally at 1 and 6 months after initial dose; the final dose (3rd or 4th dose) should be administered no earlier than age 24 weeks. A minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. If the neonate weighs less than 2 kg at birth, delay the initial vaccination until 1 month of age or hospital discharge (whichever is earlier and even if weight is still less than 2 kg). Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.

5 mcg (0.5 mL) given IM or subcutaneously.[43106] Administer the vaccine within 12 hours of birth with hepatitis B immune globulin (HBIG). In neonates weighing less than 2 kg at birth, give the birth dose plus the standard 3-dose regimen. Test for HBsAg and antibody to HBsAg at age 9 through 12 months, preferably at the next well-child visit, or 1 to 2 months after completion of the hepatitis B series if the series was delayed.[53026] [53230] Revaccinate HBsAg-negative infants with anti-HBs less than 10 milli-International Units/mL with a single dose of hepatitis B vaccine; serologic testing should follow 1 to 2 months later. Infants whose anti-HBs remains less than 10 milli-International Units/mL should receive 2 additional doses of hepatitis B vaccine to complete the second series, followed by serologic testing 1 to 2 months after the final dose.[62840] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43106]

5 mcg (0.5 mL) given IM or subcutaneously.[43106] Administer the vaccine within 12 hours of birth. Give hepatitis B immune globulin (HBIG) concomitantly for neonates weighing less than 2 kg; give HBIG to infants weighing at least 2 kg only with positive maternal HBsAg test result (within age 1 week) or if evidence is suggestive of maternal HBV infection (e.g., presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV). In neonates whom it is not possible to determine the mother's HBsAg status (e.g., when a neonate is surrendered confidentially), complete the vaccine series according to a recommended schedule for infants born to HBsAg-positive mothers with the final dose in the series administered after 24 weeks. Test for HBsAg and antibody to HBsAg at age 9 through 12 months; revaccinate if necessary.[62840] In neonates weighing less than 2 kg, give the birth dose plus the standard 3-dose regimen.[53026] [53230] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43106]

20 mcg IM or subcutaneously at initial visit; repeat at 1 and 6 months after initial dose.[43406] Administer the second dose 1 month after the first dose, and administer the third dose at least 2 months after the second dose and at least 4 months after the first dose.[53026] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

20 mcg IM or subcutaneously at initial visit; repeat at 1 and 2 months after initial dose. Give additional 20 mcg IM or subcutaneously at 12 months for prolonged maintenance of titers. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

20 mcg IM or subcutaneously at initial visit; repeat at 1 and 2 months after initial dose. Give additional 20 mcg IM or subcutaneously at 12 months for prolonged maintenance of titers. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

40 mcg IM or subcutaneously at initial visit; repeat at 1, 2, and 6 months after initial dose. The ACIP recommends that the need for booster doses be assessed by antibody testing. Give booster dose (40 mcg IM or subcutaneously) if antibody concentrations decline to less than 10 milli-International Units/mL.[43406] [53026] [53225] [65067] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs).

Revaccination with at least 1 dose of vaccine for nonresponse after the primary series increases the proportion of those achieving seroprotection. In a study (n = 178), 47% of nonresponders developed seroprotection after 1 additional dose. Of the 86 patients without seroprotection after the first revaccination, 42% developed seroprotection after 2 additional doses. A 3-dose revaccination (n = 17) with a higher dose of 40 mcg IM or subcutaneously improved the proportion of nonresponders achieving anti-HB concentrations of at least 10 milli-International Units/mL in a clinical trial; single dose revaccination with a higher dose has not been demonstrated in clinical trials.

Give 3 doses of 10 mcg (0.5 mL) IM or subcutaneously. ACIP recommends the second and third doses ideally at 1 and 6 months after initial dose. A minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. Alternatively, a higher dose of 20 mcg (1 mL) may also be given at 0, 1, and 6 months. If prolonged duration of protective titers is desired, the higher dose of 20 mcg (1 mL) may be given at 0, 1, 2, and 12 months.[43406] [53026] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43406]

Give a 3 dose-series of 10 mcg (0.5 mL) IM or subcutaneously with the second and third dose given 12 and 24 months after the first, respectively. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.

10 mcg (0.5 mL) given IM or subcutaneously. Give 3 doses. ACIP recommends the second and third doses ideally at 1 and 6 months after initial dose. A minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. If prolonged duration of protective titers is desired, doses may be given at 0, 1, 2, and 12 months. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.

10 mcg (0.5 mL) given IM or subcutaneously. Give 3 doses with the second and third dose given 12 and 24 months after the first, respectively. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.

10 mcg (0.5 mL) given IM or subcutaneously at initial visit. ACIP recommends repeat doses ideally at 1 and 6 months after initial dose; the final dose (3rd or 4th dose) should be administered no earlier than age 24 weeks. A minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. In infants and children born to HBsAg-positive mothers, an alternative schedule of doses at 0, 1, 2, and 12 months may be used; the fourth dose is given at 12 months to prolong maintenance titers. In these infants and children, test for HBsAg and antibody to HBsAg at age 9 through 12 months, preferably at the next well-child visit, or 1 to 2 months after completion of the hepatitis B series if the series was delayed.[43406] [53026] Revaccinate HBsAg-negative infants with anti-HBs less than 10 milli-International Units/mL with a single dose of hepatitis B vaccine; serologic testing should follow 1 to 2 months later. Infants whose anti-HBs remains less than 10 milli-International Units/mL should receive 2 additional doses of hepatitis B vaccine to complete the second series, followed by serologic testing 1 to 2 months after the final dose.[62840] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43406]

10 mcg (0.5 mL) given IM or subcutaneously within 24 hours of birth. ACIP recommends repeat doses ideally at 1 and 6 months after initial dose; the final dose (3rd or 4th dose) should be administered no earlier than age 24 weeks. A minimum interval of 4 weeks is needed between doses 1 and 2, and a minimum interval of 8 weeks is needed between doses 2 and 3. If the neonate weighs less than 2 kg at birth, delay the initial vaccination until 1 month of age or hospital discharge (whichever is earlier and even if weight is still less than 2 kg). Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.

10 mcg (0.5 mL) given IM or subcutaneously.[43406] Administer the vaccine within 12 hours of birth with hepatitis B immune globulin (HBIG). In neonates weighing less than 2 kg at birth, give the birth dose plus the standard 3-dose regimen. Test for HBsAg and antibody to HBsAg at age 9 through 12 months, preferably at the next well-child visit, or 1 to 2 months after completion of the hepatitis B series if the series was delayed.[53026] [53230] Revaccinate HBsAg-negative infants with anti-HBs less than 10 milli-International Units/mL with a single dose of hepatitis B vaccine; serologic testing should follow 1 to 2 months later. Infants whose anti-HBs remains less than 10 milli-International Units/mL should receive 2 additional doses of hepatitis B vaccine to complete the second series, followed by serologic testing 1 to 2 months after the final dose.[62840] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43406]

10 mcg (0.5 mL) given IM or subcutaneously. Administer the vaccine within 12 hours of birth. Give HBIG concomitantly for neonates weighing less than 2 kg; give HBIG to infants weighing at least 2 kg only with positive maternal HBsAg test result (within age 1 week) or if evidence is suggestive of maternal HBV infection (e.g., presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV). In neonates whom it is not possible to determine the mother's HBsAg status (e.g., when a neonate is surrendered confidentially), complete the vaccine series according to a recommended schedule for infants born to HBsAg-positive mothers with the final dose in the series administered after 24 weeks. Test for HBsAg and antibody to HBsAg at age 9 through 12 months; revaccinate if necessary. In neonates weighing less than 2 kg born to mothers with unknown HBsAg status, give the birth dose plus the standard 3-dose regimen. Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.

20 mcg (1 mL) given IM or subcutaneously, whenever administration of a booster dose is appropriate. Studies have demonstrated a substantial increase in antibody titers after booster vaccination with Engerix-B.[43406] Routine booster doses are generally not recommended as the duration of protective effect is unknown. In hemodialysis patients, ACIP recommends annual antibody testing and revaccination when HBsAg antibody concentrations decline to less than 10 milli-International units/mL.[53225] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43406]

10 mcg (0.5 mL) given IM or subcutaneously, whenever administration of a booster dose is appropriate. Studies have demonstrated a substantial increase in antibody titers after booster vaccination with Engerix-B.[43406] Routine booster doses are generally not recommended as the duration of protective effect is unknown. In hemodialysis patients, ACIP recommends annual antibody testing and revaccination when HBsAg antibody concentrations decline to less than 10 milli-International units/mL.[53225] Use subcutaneous administration ONLY in patients who are at risk of hemorrhage after IM injection (e.g., hemophiliacs); patients may be at increased risk for local adverse reactions including subcutaneous nodules.[43406]

20 mcg (0.5 mL) IM given at initial visit; repeat at 1 month after initial dose.

10 mcg (1 mL) IM. Give 3 doses on a 0-, 1-, and 6-month schedule.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

In adult predialysis and dialysis patients, a special formulation containing 40 mcg/mL of vaccine should be administered. For all other patients with renal impairment, it appears that no dosage adjustments are needed.
 
Intermittent hemodialysis
A dialysis formulation containing 40 mcg/mL of vaccine should be used. See dosage for specific regimens.
 
Continuous hemodialysis
A dialysis formulation containing 40 mcg/mL of vaccine should be used. See dosage for specific regimens.
 
Peritoneal dialysis
A dialysis formulation containing 40 mcg/mL of vaccine should be used. See dosage for specific regimens.

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.

Engerix-B/Recombivax HB Intramuscular Inj Susp: 0.5mL, 1mL, 5mcg, 10mcg, 20mcg, 40mcg
HEPLISAV-B/Recombinant Hepatitis B Surface Antigen (ISOFORM S/SCI-B-VAC), Recombinant Hepatitis B Surface Antigen (ISOFORM M/SCI-B-VAC), Recombinant Hepatitis B Surface Antigen (ISOFORM L/SCI-B-VAC) Intramuscular Inj Sol: 0.5mL, 1mL, 20mcg, 10-10-10mcg
Recombivax HB Subcutaneous Inj Susp: 0.5mL, 1mL, 5mcg, 10mcg, 40mcg

20 years and older: 10 mcg/dose IM/subcutaneous for Recombivax HB; 20 mcg/dose IM/subcutaneous for Engerix-B; 20 mcg/dose IM for Heplisav-B; 10 mcg/dose IM for Prehevbrio.
18 to 19 years: 5 mcg/dose IM/subcutaneous for Recombivax HB; 20 mcg/dose IM/subcutaneous for Engerix-B; 20 mcg/dose IM for Heplisav-B; 10 mcg/dose IM for Prehevbrio.

10 mcg/dose IM/subcutaneous for Recombivax HB; 20 mcg/dose IM/subcutaneous for Engerix-B; 20 mcg/dose IM for Heplisav-B; 10 mcg/dose IM for Prehevbrio.

16 to 17 years: 5 mcg/dose IM/subcutaneous for Recombivax HB; 20 mcg/dose IM/subcutaneous for Engerix-B.
13 to 15 years: 5 mcg/dose IM/subcutaneous for Recombivax HB standard, 3-dose regimen or 10 mcg/dose IM/subcutaneous for Recombivax HB 2-dose regimen; 20 mcg/dose IM/subcutaneous for Engerix-B.

11 to 12 years: 5 mcg/dose IM/subcutaneous for Recombivax HB standard, 3-dose regimen or 10 mcg/dose IM/subcutaneous for Recombivax HB 2-dose regimen; 20 mcg/dose IM/subcutaneous for Engerix-B.
1 to 10 years: 5 mcg/dose IM/subcutaneous for Recombivax HB; 10 mcg/dose IM/subcutaneous for Engerix-B.

5 mcg/dose IM/subcutaneous for Recombivax HB; 10 mcg/dose IM/subcutaneous for Engerix-B.

5 mcg/dose IM/subcutaneous for Recombivax HB; 10 mcg/dose IM/subcutaneous for Engerix-B.

Many epidemiological studies indicate that patients who develop anti-hepatitis B surface antigen antibodies (anti-HBs) following infection with hepatitis B are immune to the virus upon reexposure. Active immunization with hepatitis B vaccine stimulates the immune system to produce anti-HBs 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 recombinant hepatitis B vaccine provides protection against hepatitis D as well.
 
The recombinant hepatitis B vaccine is produced by injecting Saccharomyces cerevisiae (yeast) with a plasmid that codes for the adw subtype of HBsAg. The genetically altered yeast produce significant quantities of HBsAg, which are released by cell disruption, collected, and purified. The particulate matter present in the hepatitis B vaccine, recombinant contains large amounts of protein derived from HBsAg against which an immune response occurs, resulting in the formation of anti-HBs. Extensive study of the recombinant-stimulated antibodies reveals that they are remarkably similar to naturally occurring anti-HBs in variety, biochemistry, potency, and protective efficacy.

Engerix-B and Recombivax HB are intended for intramuscular administration, although both can be given subcutaneously in patients where IM injections are contraindicated. Heplisav-B is administered intramuscularly. The pharmacokinetics of hepatitis B vaccine recombinant are not well understood. The exact distribution of the recombinant hepatitis B vaccines is not clear, and it is not known if HBsAg crosses the placenta or is excreted in human milk. Similarly, the metabolism and elimination of these vaccines are not well characterized.

Studies evaluating plasma-derived hepatitis B vaccine reveal that anti-HBs appear in the serum 2 weeks after IM administration, peak within 6 months, and can remain detectable for 3 to 7 years. The minimum anti-HBs titer needed to provide protection against active viral infection is 10 milliunits/mL.

No adequate and well controlled studies have been conducted with hepatitis B vaccine, recombinant during pregnancy. In pre- and post-licensure clinical studies, 58 pregnant women who were inadvertently administrated hepatitis B vaccine, recombinant had rates of miscarriage and major birth defects that were consistent with estimated background rates. A pregnancy exposure registry of 245 women who received hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant (a bivalent vaccine containing the same hepatitis B surface antigen component and quantity as used in the 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. Reproductive and developmental toxicity studies performed in rats administered Heplisav-B or Prehevbrio revealed no vaccine-related fetal malformations or variations. Animal reproduction studies have not been conducted with Engerix-B or Recombivax HB. According to the Advisory Committee on Immunization Practices (ACIP), administration of 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.[43106] [43406] [43236] [62619] There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to Heplisav-B (1-844-443-7734) and Prehevbrio (1-888-421-8808).[62619]

Data are limited regarding use of the hepatitis B vaccine, recombinant during breast feeding and its' excretion in human milk is unknown. According to the Advisory Committee on Immunization Practices (ACIP), recombinant vaccines pose no risk to breast-feeding mothers or their infants. The manufacturer recommends caution when administering to nursing mothers. 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.