Euvax-B20 mcg/ml

Euvax-B is indicated for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV). It is used as follows:

• Established/routine use: Universal immunization of infants, children, and adolescents as part of the routine national immunization schedule, regardless of the mother's hepatitis B surface antigen (HBsAg) status.
• Established/guideline-supported use in adults: Immunization of adults at increased risk of HBV exposure, including healthcare and laboratory workers, patients on hemodialysis or with chronic kidney disease, household and sexual contacts of HBsAg-positive persons, injection drug users, persons with multiple sexual partners, men who have sex with men, persons with chronic liver disease or HIV infection, inmates of correctional facilities, and international travelers to regions with high or intermediate HBV endemicity.
• Adjunct/combination use: In infants born to HBsAg-positive mothers, Euvax-B is given in combination with hepatitis B immune globulin (HBIG) within 12 hours of birth for post-exposure prophylaxis; the vaccine alone is not sufficient in this setting.
• Off-label/expanded use: Accelerated or post-exposure schedules (e.g., after needle-stick injury or sexual exposure) are used per clinical guidance and are considered an established but specialized application rather than routine dosing.

Each dose of Hepatitis B Vaccine [rDNA] contains purified hepatitis B surface antigen (HBsAg) produced by recombinant DNA technology in yeast cells (e.g., Saccharomyces cerevisiae), adsorbed onto an aluminum-containing adjuvant (aluminum hydroxide or aluminum phosphate). It does not contain live virus and cannot cause hepatitis B infection.

Euvax-B is a non-infectious, recombinant subunit vaccine used to induce active immunity against hepatitis B virus. The surface antigen protein is manufactured in genetically engineered yeast cells rather than being purified from human blood, eliminating the risk of transmitting blood-borne pathogens. It is supplied as a sterile suspension for intramuscular injection and is a cornerstone of global hepatitis B prevention programs endorsed by the WHO and national immunization schedules, including Bangladesh's Expanded Programme on Immunization (EPI).

Euvax-B belongs to the therapeutic class of viral vaccines, specifically recombinant subunit (inactivated, non-live) vaccines used for active immunization against hepatitis B virus infection.

Mechanism of Action

Hepatitis B Vaccine [rDNA] works by presenting purified hepatitis B surface antigen (HBsAg) to the immune system. This stimulates the body's humoral and cell-mediated immune response, leading to production of protective anti-HBs antibodies without exposing the recipient to actual hepatitis B virus or infectious material.

Immune Response

Following a complete vaccination series, protective antibody titers (anti-HBs ≥10 mIU/mL) develop in the great majority of healthy infants, children, and younger adults. Immune memory generally persists for many years, and booster doses are not routinely recommended for immunocompetent individuals who have completed the primary series, though certain high-risk or immunocompromised groups (e.g., dialysis patients) may require periodic antibody testing and booster doses.

Euvax-B is administered by intramuscular (IM) injection only. In infants and young children, the preferred site is the anterolateral thigh; in older children and adults, the deltoid muscle is preferred. The vaccine must not be injected intravenously, intradermally, or subcutaneously in most patients (subcutaneous administration may be considered only in patients with bleeding disorders such as hemophilia, at the discretion of the treating physician, with adequate pressure applied afterward). The vial or syringe should be shaken well before use to ensure a uniform, slightly turbid white suspension; do not use if it cannot be resuspended or contains particulate matter/discoloration.

Euvax-B can generally be administered concurrently with other routinely recommended vaccines (e.g., DTaP, Hib, polio, pneumococcal, rotavirus), using separate syringes and separate injection sites.

• Immunosuppressive therapy (e.g., corticosteroids, chemotherapy, biologics): May reduce the immune response to the vaccine; antibody response should be verified by serologic testing in immunocompromised patients when clinically indicated.
• Immune globulin products (e.g., HBIG): Concurrent administration with HBIG (at a different injection site) does not impair the vaccine's effectiveness and is standard practice for post-exposure prophylaxis.
• Other injectable vaccines: No clinically significant interference has been established when co-administered at separate sites; do not mix in the same syringe with other vaccines unless specifically licensed as a combination product.

Most adverse effects of Euvax-B are mild and self-limited.

Common

• Injection site pain, soreness, redness, or swelling
• Low-grade fever
• Fatigue or irritability (especially in infants)
• Headache
• Mild nausea

Uncommon/Rare

• Generalized rash or urticaria
• Transient joint or muscle pain
• Lymphadenopathy

Rare but Serious

• Anaphylaxis or other severe hypersensitivity reactions (see Contraindications)
• Syncope (fainting), particularly in adolescents, sometimes causing secondary injury — observation for 15 minutes post-injection is recommended

Pregnancy: Euvax-B contains non-infectious, non-live antigen and is not expected to pose a risk to the fetus based on available data. It should be used during pregnancy only if clearly needed, and the potential benefit is generally considered to justify the potential risk when a pregnant woman is at risk of hepatitis B exposure (e.g., unvaccinated with a risk factor). Consult a physician before vaccination during pregnancy.

Lactation: Euvax-B is considered compatible with breastfeeding; it is not known to adversely affect the breastfed infant or milk production. A physician should still be consulted before administration during breastfeeding.

Vaccination with Euvax-B should generally be postponed (not necessarily cancelled) in individuals with moderate-to-severe acute illness, with or without fever, until the condition has resolved; minor illnesses (e.g., mild cold) are not a reason to defer vaccination.

• Bleeding disorders: Administer with caution in patients with thrombocytopenia or any coagulation disorder, using a fine needle and firm pressure at the injection site (see Administration for the subcutaneous-route exception).
• Immunocompromised individuals: May have a reduced antibody response; post-vaccination serologic testing may be advisable in high-risk groups (e.g., dialysis patients, HIV-positive individuals).
• Syncope: Observe recipients, especially adolescents, for 15 minutes after injection due to the possibility of vasovagal syncope.
• Latex sensitivity: Some prefilled syringes/vial stoppers may contain latex or dry natural rubber; check product-specific packaging in latex-sensitive individuals.
• This vaccine does not protect against hepatitis caused by other agents (e.g., hepatitis A, C, or E) or against infections caused by other pathogens.

There is no established clinical data specifically describing vaccine overdose, as it is administered in fixed, single doses by a healthcare professional. If more than the recommended dose or volume of Euvax-B is inadvertently administered, or if a severe or unusual reaction occurs, seek immediate medical attention or contact emergency services/a poison control center. Do not attempt any home treatment for a suspected overdose or severe reaction.

Store Euvax-B refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze; freezing destroys the vaccine's potency and it must be discarded if it has been frozen. Protect from light. Keep out of reach of children. Do not use after the expiry date printed on the packaging.

Pediatric Use

Euvax-B is a routine part of the infant immunization schedule from birth, using an age-appropriate pediatric formulation and dose (see Dosage and Administration).

Elderly

Safety and immunogenicity have been demonstrated in older adults, although antibody response may be somewhat lower than in younger adults; the standard adult schedule is used unless otherwise directed.

Renal Impairment

Patients on hemodialysis or with chronic kidney disease often have a reduced immune response and may require a higher-dose formulation and/or additional doses, with post-vaccination antibody testing per physician guidance.

Hepatic Impairment

No specific dose adjustment is established for hepatic impairment; patients with chronic liver disease are, in fact, a priority group for vaccination given their increased risk of severe outcomes from HBV infection.

Immunocompromised Patients

May show a reduced or delayed antibody response; modified schedules and serologic monitoring may be recommended by the treating physician.

Euvax-B is given as a complete primary series (typically 3 doses over 6 months, or more per specific schedules) rather than a continuous treatment course. All doses in the series should be completed on schedule for optimal protection; if a dose is delayed, the series does not need to be restarted, but the next dose should be given as soon as possible. Routine booster doses are not required for immunocompetent individuals after a completed series, though selected high-risk groups may need periodic monitoring or booster doses as advised by a physician.

Recombinant viral subunit vaccine; hepatitis B surface antigen (HBsAg) vaccine.

Hepatitis B Vaccine [rDNA] introduces purified, non-infectious hepatitis B surface antigen (HBsAg) into the body. Antigen-presenting cells process this protein and present it to the immune system, stimulating B lymphocytes to produce specific anti-HBs antibodies and generating memory T and B cells. This confers active, long-lasting immunity, so that if the vaccinated person is later exposed to actual hepatitis B virus, the immune system can mount a rapid protective response and prevent infection.

Euvax-B is approved and recommended for use starting at birth as part of the routine infant immunization schedule, using an age-appropriate pediatric dose/formulation. Safety and efficacy in the pediatric population are well established through decades of global use and surveillance. For infants born to HBsAg-positive mothers, the vaccine must be combined with hepatitis B immune globulin (HBIG) within 12 hours of birth (see Dosage and Administration). Preterm and low-birth-weight infants may follow a slightly modified schedule per pediatric guidance.