Recombivax Hb Pediatric/adolescent

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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Recombivax Hb Pediatric/adolescent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hepatitis B surface antigen vaccine (recombinant) 5mcg/0.5mL; susp for IM inj; aluminum hydroxide adsorbed; preservative-free.

    Pharmacological Class

    HB.

    See Also

    How Supplied

    Ped/Adolescent 5mcg/0.5mL: single-dose vials (yellow cap), single-dose prefilled syringes (yellow plunger rod)—10; Adult 10mcg/1mL: single-dose vials (green cap)—1, 10, and single-dose prefilled syringes (green plunger rod)—10; Dialysis 40mcg/1mL: single-dose vials (blue cap)—1

    How Supplied

    Pediatric/Adolescent Formulation (Preservative free) 

    • 0.5 mL (5 mcg) in single-dose vials and prefilled Luer-Lok® syringes

    • Box of ten 0.5 mL single-dose vials: color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons.

    • Carton of 10 prefilled single-dose Luer-Lok® syringes with tip caps: color coded with a yellow plunger rod.

    Storage

    • Protect from light. 

    • Store vials and syringes at 2-8°C (36-46°F). 

    • Do not freeze since freezing destroys potency. 

    • Recombivax HB is stable at temperatures from 0° to 25° C (32° to 77°F) for 72 hours. These data are not recommendations for shipping or storage but may guide decisions for use in case of temporary temperature excursions.

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Mechanism of Action

    Recombivax HB has been shown to elicit antibodies to hepatitis B virus as measured by ELISA. Antibody concentrations ≥10mIU/mL against HBsAg are recognized as conferring protection against hepatitis B infection.

    Recombivax Hb Pediatric/adolescent Indications

    Indications

    Hepatitis B immunization.

    Recombivax Hb Pediatric/adolescent Dosage and Administration

    Adults and Children

    Use correct formulation; see full labeling. Give IM into anterolateral thigh for children; deltoid for adults. May give SC if risk of hemorrhage. Patients 0–19yrs of age (three-dose regimen): give 1st dose of 5mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Or, for patients 11–15yrs of age, may use alternate two-dose regimen: give 1st dose of 10mcg at elected date and repeat after 4–6 months (2nd dose). Patients ≥20yrs of age: give 1st dose of 10mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Dialysis and pre-dialysis patients: give 1st dose of 40mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose); consider booster dose if antibody levels fall to <10mIU/mL. High-risk infants (mother is HBsAg positive or unknown) or if exposed to HBsAg: give hepatitis B immune globulin also (see full labeling).

    Adults and Children

    Dosage and Schedule

    • Give IM into anterolateral thigh for children; deltoid for adults. 

    • Recombivax HB:

      • Patients 0–19 years of age (three-dose regimen): give 1st dose of 5 mcg (0.5 mL each) at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose).

      • Adolescents 11–15 years of age (three-dose regimen): give 1st dose of 5 mcg (0.5 mL each) at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose), or (two-dose regimen): give 1st dose of 10mcg (1.0 mL each) at elected date and repeat after 4–6 months (2nd dose). 

      • Persons 20 years of age and older (three-dose regimen): give 1st dose of 10mcg (1.0 mL) at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose).

      • The duration of the protective effect of Recombivax HB in healthy vaccinees is unknown and the need for booster doses is not yet defined.

    • Recombivax HB Dialysis Formulation:

      • Approved for use in adult predialysis and dialysis patients 18 years of age and older.

      • Adults on dialysis and predialysis patients (three-dose regimen): give 1st dose of 40mcg (1.0 mL each) at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose).

      • Consider booster dose or revaccination if antibody levels fall to <10 mIU/mL at 1 to 2 months after the third dose.

      • Assess the need for a booster dose annually by antibody testing, and give a booster dose when the anti-HBs level declines to <10 mIU/mL.

    Known or Presumed Exposure to Hepatitis B Virus

    • Known or Presumed Exposure to HBsAg:

      • Refer to ACIP recommendations and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus).

      • When recommended, administer Recombivax HB and HBIG intramuscularly at separate sites (e.g., opposite anterolateral thighs for exposed neonates) as soon as possible after exposure. Administer additional doses of Recombivax HB (to complete a vaccination series) in accordance with ACIP recommendations.

    Administration

    • Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. 

    • Discard if the suspension does not appear homogeneous or if extraneous particulate matter remains or if discoloration is observed.

    • For single-dose vials, withdraw and administer the entire dose of Recombivax HB intramuscularly using a sterile needle and syringe. Discard vial after use.

    • For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of Recombivax HB intramuscularly. Discard syringe after use.

    • The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection. 

    • The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. Recombivax HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected.

    • Recombivax HB may be administered subcutaneously to persons at risk for hemorrhage following intramuscular injections (e.g., hemophiliacs). However, hepatitis B vaccines are known to result in lower antibody response when administered subcutaneously. Consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.

    • Do not administer intravenously or intradermally.

    Recombivax Hb Pediatric/adolescent Contraindications

    Contraindications

    Yeast hypersensitivity.

    Recombivax Hb Pediatric/adolescent Boxed Warnings

    Not Applicable

    Recombivax Hb Pediatric/adolescent Warnings/Precautions

    Warnings/Precautions

    Have epinephrine inj (1:1000) available. Latex allergy. Delay vaccination in infants weighing <2000g. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Hypersensitivity to Latex

    • The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

    Apnea in Premature Infants

    • In some infants born prematurely, apnea has been observed following administration.

    • Consider the infant’s medical status and the potential benefits and risks of vaccination when deciding to administer Recombivax HB to infants born prematurely.

    • For Recombivax HB, assess mother’s hepatitis B antigen status and the high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

    Infants Weighing Less Than 2000 g 

    • Delay hepatitis B vaccination until 1 month of age or hospital discharge in infants weighing <2000g if the mother is documented to be HBsAg negative at the time of the infant’s birth. 

    • Infants weighing <2000g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin (HBIG) in accordance with ACIP recommendations if HBsAg status cannot be determined.

    Prevention and Management of Allergic Vaccine Reactions

    • Have appropriate medical treatment and supervision available to manage potential anaphylactic reactions after vaccination.

    Limitations of Vaccine Effectiveness

    • Hepatitis B virus has a long incubation period.

    • Recombivax HB may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination. Additionally, vaccination with Recombivax HB may not protect all individuals.

    Pregnancy Considerations

    Risk Summary

    • No adequate and well-controlled studies have been conducted to evaluate Recombivax HB in pregnant women.

    • Available post-approval data do not suggest an increased risk of miscarriage or major birth defects in women who received Recombivax HB during pregnancy.

    Nursing Mother Considerations

    Risk Summary

    • It is not known whether Recombivax HB is excreted in human milk.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Recombivax HB and any potential adverse effects on the breastfed child from Recombivax HB or from the underlying maternal condition.

    Pediatric Considerations

    • Safety and effectiveness of Recombivax HB have been established in all pediatric age groups.

    • Safety and effectiveness of Recombivax HB Dialysis Formulation in children have not been established.

    Geriatric Considerations

    • Later clinical studies have shown that Recombivax HB resulted in a diminished antibody response in persons older than 60 years of age.

    Recombivax Hb Pediatric/adolescent Pharmacokinetics

    See Literature

    Recombivax Hb Pediatric/adolescent Interactions

    Interactions

    Concomitant vaccines: see full labeling. May administer concomitantly at different sites with HBIG. May interfere with lab tests (eg, serum HBsAg detection).

    Interactions

    Concomitant Administration with Other Vaccines

    • Do not mix Recombivax HB with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.

    • In a clinical trial, the safety and immunogenicity of Recombivax HB was similar for separate administration compared with concomitant administration of 1 or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis; oral Poliomyelitis vaccine; Measles, Mumps, and Rubella Virus Vaccine, Live; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) or a booster dose of Diphtheria, Tetanus, acellular Pertussis. 

    • In another clinical trial, there were no serious vaccine-related adverse events reported and no impairment of immune responses when a related HBsAg-containing product, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combination product (no longer licensed), was given concomitantly with eIPV (enhanced inactivated Poliovirus vaccine) or Varivax® [Varicella Virus Vaccine Live (Oka/Merck)].

    • The Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combination product (no longer licensed) has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.

    Concomitant Administration with Immune Globulin

    • Recombivax HB may be administered concomitantly with HBIG. The first dose of Recombivax HB may be given at the same time as HBIG, but the injections should be administered at different sites.

    Interference with Laboratory Tests

    • Hepatitis B surface antigen (HBsAg) derived from hepatitis B vaccines has been transiently detected in blood samples following vaccination. Serum HBsAg detection may not have diagnostic value within 28 days after receipt of a hepatitis B vaccine, including Recombivax HB.

    Recombivax Hb Pediatric/adolescent Adverse Reactions

    Adverse Reactions

    Local reactions, irritability, fatigue, headache, fever, malaise, nausea, diarrhea, anorexia, pharyngitis, upper respiratory infection, anaphylaxis; apnea in premature infants.

    Recombivax Hb Pediatric/adolescent Clinical Trials

    Clinical Trials

    Efficacy in Neonates with Peripartum Exposure to Hepatitis B

    • Three 5 mcg doses of Recombivax HB was evaluated in neonates born to mothers positive for both HBsAg and HBeAg. The clinical study included 130 infants who received 1 dose of HBIG at birth followed by the three-dose regimen of Recombivax. 

    • Results showed that 96% of infants did not have chronic infection after 9 months of follow-up. The estimated efficacy for the prevention of chronic hepatitis B infection was 95% when compared with the infection rate in untreated historical controls.

    • Moreover, the incidence of chronic infection was significantly less when infants received 1 dose of HBIG followed by the three-dose regimen compared with historical controls who received only a single dose of HBIG.

    Immunogenicity of a Three-Dose Regimen in Healthy Infants, Children, and Adolescents

    • Three 5 mcg doses of Recombivax HB induced a protective level of antibody in 100% of 92 infants, 99% of 129 children, and in 99% of 112 adolescents.

    Immunogenicity of a Two-Dose Regimen in Healthy Adolescents 11 through 15 Years of Age

    • An open, randomized, multicenter study evaluated the immunogenicity of a two-dose regimen (10 mcg at 0 and 4–6 months) in adolescents 11 through 15 years of age compared with the standard three-dose regimen (5 mcg at 0, 1, and 6 months).

    • 99% of 255 patients who received the two-dose regimen achieved a protective level of antibody 1 month after the last dose compared with 98% of 121 patients who received the three-dose regimen.

    • After the first 10 mcg dose of the two-dose regimen, 72% of patients achieved a protective level of antibody.

    Immunogenicity in Healthy Adults

    • In adults who received the three-dose regimen, the protective level of antibody was induced in 98% of 787 patients 20–29 years of age, 94% of 249 patients 30–39 years of age, and in 89% of 177 patients 40 years of age and older.

    Efficacy and Immunogenicity in Specific Populations

    • Chronic Hepatitis C Infection:

      • In a clinical study, the seroprotection rate was approximately 70% in patients with chronic hepatitis C virus infection who received the standard regimen of Recombivax HB. In a second study, HCV infection did not affect the response to Recombivax HB.

    • Predialysis and Dialysis Adult Patients:

      • Predialysis and dialysis adults have a lower response to hepatitis B vaccine compared with healthy individuals. Higher seroconversion rates are achieved in adults who are vaccinated early in the course of their renal disease vs vaccination after dialysis has been initiated. 

      • Lower responses to these vaccines are observed when the vaccine is administered as a buttock injection. 89% of 28 patients developed anti-HBs with 86% achieved levels of greater than or equal to 10 mIU/mL when administered IM in the deltoid muscle. When administered in the buttock or a combination of buttock and deltoid, 62% of 47 patients developed anti-HBs with 55% achieving levels of greater than or equal to 10 mIU/mL.

    Recombivax Hb Pediatric/adolescent Note

    Not Applicable

    Recombivax Hb Pediatric/adolescent Patient Counseling

    Patient Counseling

    Information for Vaccine Recipients and Parents/Guardians 

    • Inform of the potential benefits and risks associated with vaccination, as well as the importance of completing the immunization series. 

    • Question the vaccine recipient, parent or guardian about the occurrence of any symptoms and/or signs of adverse reaction after a previous dose of hepatitis B vaccine. 

    • Report adverse events to the physician or clinic where the vaccine was administered. 

    • Prior to vaccination, give the patient, parent or guardian the Vaccine Information Statements which are required by the National Vaccine Injury Act of 1986. The materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). 

    • Tell the patient, parent or guardian that the United States Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events by the National Childhood Vaccine Injury Act of 1986. The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov .

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