Engerix-B Pediatric (Pf)

Drug overview for ENGERIX-B PEDIATRIC (PF) (hepatitis b virus vaccine recombinant/pf):

Generic name: hepatitis B virus vaccine recombinant/PF (hep-uh-TIE-tuss B)
Drug class: Hepatitis B Vaccine
Therapeutic class: Biologicals

Hepatitis B vaccine is an inactivated (recombinant) vaccine containing hepatitis B surface antigen (HBsAg) and is used to stimulate active immunity to hepatitis B virus (HBV) infection. Hepatitis B vaccine is commercially available in the US as monovalent vaccines (Engerix-B(R), Recombivax HB(R)). Hepatitis B vaccine also is commercially available in a fixed-combination vaccine with Haemophilus influenzae type b (Hib) vaccine (Hib-HepB; Comvax(R)), in a fixed-combination vaccine with hepatitis A virus vaccine (HepA-HepB; Twinrix(R)), and in a fixed-combination vaccine that contains diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix(R)).

Hepatitis B vaccine (recombinant) is used to stimulate active immunity to hepatitis B virus (HBV) for prevention of HBV infection in susceptible individuals, including those considered at risk of potential exposure to HBV or hepatitis B surface antigen-positive (HBsAg-positive) materials (e.g., blood, plasma, serum). The US Public Health Service Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), and American Academy of Family Physicians (AAFP) recommend that all neonates and infants and all previously unvaccinated children and adolescents through 18 years of age receive routine primary immunization against HBV infection with hepatitis B vaccine, unless contraindicated. In addition, the ACIP, AAFP, American College of Obstetricians and Gynecologists (ACOG), and American College of Physicians (ACP) recommend preexposure vaccination with hepatitis B vaccine for all susceptible adults with medical, occupational, behavioral, or other factors that put them at risk for HBV infection and for any other susceptible adult requesting protection from HBV.

Postexposure prophylaxis using combined active immunization with hepatitis B vaccine and passive immunization with hepatitis B immune globulin (HBIG) is used to prevent perinatal HBV infection in neonates born to HBsAg-positive women and also is used to prevent HBV infection in certain susceptible individuals exposed to HBV or HBsAg-positive material (e.g., blood, plasma, serum). (See Uses: Postexposure Prophylaxis.) Successful prevention of HBV infection, either by primary or preexposure vaccination with hepatitis B vaccine or postexposure prophylaxis with hepatitis B vaccine and HBIG, generally will also prevent hepatitis D virus (HDV) infection (delta virus infection). HDV infection occurs only as a coinfection or superinfection in patients with HBV infection.

HDV is dependent on HBV for replication; therefore, individuals immune to HBV also should be immune to HDV infection. Routes of transmission of HDV are similar to those for HBV, and HDV infection in the US most commonly affects individuals at high risk for HBV, particularly parenteral drug abusers and individuals receiving plasma-derived clotting factor concentrates. Individuals who are carriers of HBsAg are at risk of HDV infection, especially if they are at high risk of repeated exposure to HBV (e.g., parenteral drug abusers, homosexuals); however, there currently is no effective means for preexposure or postexposure prophylaxis of HDV infection in HBsAg carriers.

With the exception of HDV, monovalent hepatitis B vaccine will not prevent hepatitis caused by other viruses known to infect the liver, including hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis E virus (HEV). Primary immunization against HBV can be integrated with age-appropriate primary immunization against diphtheria, tetanus, pertussis, hepatitis A, Haemophilus influenzae type b (Hib), human papillomavirus (HPV), influenza, measles, mumps, rubella, pneumococcal disease, meningococcal disease, poliomyelitis, rotavirus, and varicella. (See Drug Interactions: Vaccines.)

DRUG IMAGES

ENGERIX-B PEDI 10 MCG/0.5 SYRN

The following indications for ENGERIX-B PEDIATRIC (PF) (hepatitis b virus vaccine recombinant/pf) have been approved by the FDA:

Indications:
Hepatitis B vaccination

Professional Synonyms:
Vaccination to prevent hepatitis B infection

The following dosing information is available for ENGERIX-B PEDIATRIC (PF) (hepatitis b virus vaccine recombinant/pf):

Dosing
Administration
Dosing Information
Generic

Dosage recommendations for hepatitis B vaccine vary depending on the specific preparation used, the recipient's age, the HBsAg status of the mother (for neonates), and the presence of underlying disease.

Because the recommended doses for Recombivax HB(R) and Engerix-B(R) are different, dosage recommendations for the specific preparation used should be followed.

Monovalent hepatitis B vaccines (Engerix-B(R), Recombivax HB(R)) generally are considered interchangeable; therefore, if the hepatitis B vaccine series is started with one monovalent vaccine, it may be completed using a different vaccine given in the dosage recommended for that specific preparation.

Only monovalent hepatitis B vaccine (Engerix-B(R), Recombivax HB(R)) should be used for the initial (birth) dose in neonates or infants younger than 6 weeks of age. However, the vaccine series can be completed using either a monovalent hepatitis B vaccine or an age-appropriate fixed-combination vaccine containing hepatitis B vaccine.

The complete hepatitis B vaccine series must be administered to ensure optimal protection. Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved. In addition, it is not necessary to give additional doses or start the vaccination series over.

If the hepatitis B vaccination series is interrupted after the initial dose, the second dose should be given as soon as possible (minimum interval between first and second dose is 4 weeks) and the third dose should be given at least 8 weeks after the second dose (minimum interval between first and third dose is 16 weeks). If only the third dose is delayed, it should be administered as soon as possible. Infants should receive the final dose at 24 weeks of age or older.

The duration of protection and the need for booster doses after primary immunization with hepatitis B vaccine has not been fully determined.

Antibodies induced by hepatitis B vaccine decline steadily with time and between 30-50% of vaccinees who develop an adequate antibody response to a 3-dose primary series will lose detectable antibody within 7 years, but protection against viremic infection and clinical disease appears to persist in adults and children despite declining antibodies. (See Pharmacology: Duration of Immunity.) Therefore, ACIP states that booster doses are not routinely recommended in immunocompetent individuals who were vaccinated as infants, children, adolescents, or adults and routine serologic testing to assess antibody levels in these individuals are only necessary in certain circumstances.

The ACIP and AAP state that routine annual serologic testing to monitor anti-HBs levels and determine the need for booster doses is indicated in hemodialysis patients since the immunologic response in these individuals is usually less and of shorter duration than that in healthy individuals, and protection may persist only as long as the anti-HBs level is at least 10 mIU/mL. The ACIP and AAP state that hemodialysis patients should receive a booster dose of vaccine when anti-HBs levels decline to less than 10 mIU/mL.

For other immunocompromised individuals (e.g., HIV-infected individuals, hematopoietic stem-cell transplant recipients, individuals receiving chemotherapy or immunosuppressive therapy), the need for booster doses has not been determined. The ACIP and other experts recommend that annual anti-HBs testing be done in such individuals and that booster doses of the vaccine be considered when anti-HBs levels decline to less than 10 mIU/mL.

Monovalent hepatitis B vaccine (recombinant) (Engerix-B(R), Recombivax HB(R)) usually is administered by IM injection. Hepatitis B vaccine may be administered by subcutaneous injection, but only when necessary in individuals at risk of hemorrhage following IM injections (e.g., patients with thrombocytopenia or a bleeding disorder such as hemophilia). (See Individuals with Bleeding Disorders under Cautions: Precautions and Contraindications.) The vaccine should not be administered IV or intradermally; there is evidence that intradermal administration may be associated with reduced immunogenicity.

The fixed-combination vaccine containing Haemophilus influenzae type b (Hib) and hepatitis B antigens (Hib-HepB; Comvax(R)), the fixed-combination vaccine containing hepatitis A and hepatitis B antigens (HepA-HepB; Twinrix(R)), and the fixed-combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HepB-IPV; Pediarix(R)) are administered by IM injection. These fixed-combination vaccines should not be given IV, intradermally, or subcutaneously. Prior to administration, the vaccine should be inspected visually for particulate matter and discoloration.

The vaccine should be shaken well immediately prior to administration and should not be used if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation. Monovalent hepatitis B vaccine or fixed-combination vaccines containing hepatitis B vaccine should not be diluted and should not be mixed with any other vaccine or solution. Depending on the age of the patient, the IM injection should be made into the deltoid or anterolateral thigh.

To ensure delivery of vaccine into the muscle, IM injections should be made at a 90degrees angle to the skin using a needle size that is appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique. In neonates and young children (up to 12 months of age), IM injections should be made into the anterolateral thigh. For children 1-2 years of age, IM injections should preferably be administered into the anterolateral thigh; the deltoid muscle is an alternative if the muscle mass is adequate.

For adults, adolescents, and children 3 years of age or older, the deltoid is preferred, although the anterolateral thigh is an alternative. Generally, muscles of the buttock should not be used for administration of vaccines in children because of the well-documented potential for injection-associated injury to the sciatic nerve. In addition, studies in adults indicate that the seroconversion rate may be lower when the vaccine is given into the buttocks rather than the deltoid.

The vaccine should not be injected into or near blood vessels. Although some experts state that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) can be performed to ensure that a blood vessel has not been entered, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) state that this procedure is not required because large blood vessels are not present at the recommended IM injection sites. Since syncope may occur following vaccination, vaccinees should be observed for approximately 15 minutes after the vaccine dose is administered.

If syncope occurs, the patient should be observed until symptoms resolve. Syncope after vaccination occurs most frequently in adolescents and young adults. Monovalent hepatitis B vaccine (Engerix-B(R), Recombivax HB(R)) may be given simultaneously with hepatitis B immune globulin (HBIG) (using different syringes and different injection sites) when passive immunization is considered necessary in addition to active immunization with the vaccine (e.g., in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) women, postexposure prophylaxis in certain individuals exposed to hepatitis B virus (HBV) or HBsAg-positive materials).

Hepatitis B vaccine and HBIG should not be given in the same syringe and should not be injected at the same site. Hepatitis B vaccine may be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites). (See Drug Interactions: Vaccines.) When multiple vaccines are administered during a single visit, administration of each preparation at a different anatomic site is preferred.

In younger children, the thigh is the preferred injection site when more than 2 vaccines must be administered into a single limb. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur. The deltoid may be used in older children and adults when more than one vaccine must be administered.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for ENGERIX-B PEDIATRIC (PF) (hepatitis b virus vaccine recombinant/pf):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Teplizumab SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)	TZIELD

Drug Interaction

Drug Names

Non-Live or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames.

The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.

Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

TZIELD

There are 8 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Non-Live or Non-Replicating Vaccines/Fingolimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)	FINGOLIMOD, GILENYA, TASCENSO ODT
Non-Live or Non-Replicating Vaccines/Siponimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2) CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3) DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)	MAYZENT
Non-Live or Non-Replicating Vaccines/Satralizumab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)	ENSPRYNG
Non-Live or Non-Replicating Vaccines/Ublituximab SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)	BRIUMVI
Systemic Corticosteroids; Corticotropin/Non-Live or Non-Replicating Vaccines SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1) PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1) PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1) DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)	ACTHAR, ACTHAR SELFJECT, ADRENOCORTICOTROPHIC HORMONE, ALDOSTERONE, ALKINDI SPRINKLE, ANUCORT-HC, ANUSOL-HC, BECLOMETHASONE DIPROPIONATE, BETA 1, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, BSP 0820, BUDESONIDE, BUDESONIDE DR, BUDESONIDE EC, BUDESONIDE ER, BUDESONIDE MICRONIZED, BUPIVACAINE-DEXAMETH-EPINEPHRN, CELESTONE, CLOBETASOL PROPIONATE MICRO, CORTEF, CORTENEMA, CORTICOTROPHIN, CORTIFOAM, CORTISONE ACETATE, CORTROPHIN, DEFLAZACORT, DEPO-MEDROL, DESONIDE MICRONIZED, DESOXIMETASONE, DESOXYCORTICOSTERONE ACETATE, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DMT SUIK, DOUBLEDEX, EMFLAZA, EOHILIA, FLUDROCORTISONE ACETATE, FLUNISOLIDE, FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE MICRO, FLUOCINONIDE MICRONIZED, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE MICRO, HEMADY, HEMMOREX-HC, HEXATRIONE, HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE SOD SUCCINATE, KENALOG-10, KENALOG-40, KENALOG-80, LIDOCIDEX-I, MAS CARE-PAK, MEDROL, MEDROLOAN II SUIK, MEDROLOAN SUIK, METHYLPREDNISOLONE, METHYLPREDNISOLONE AC MICRO, METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCC, MILLIPRED, MILLIPRED DP, MOMETASONE FUROATE, ORAPRED ODT, ORTIKOS, PEDIAPRED, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PRO-C-DURE 5, PRO-C-DURE 6, PROCTOCORT, RAYOS, SOLU-CORTEF, SOLU-MEDROL, TAPERDEX, TARPEYO, TRIAMCINOLONE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATE MICRO, TRILOAN II SUIK, TRILOAN SUIK, UCERIS, VERIPRED 20, ZCORT
Non-Live or Non-Replicating Vaccines/Etrasimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.	VELSIPITY
Non-Live or Non-Replicating Vaccines/Ozanimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.	ZEPOSIA
Non-Live or Non-Replicating Vaccines/Ponesimod SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1) CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.	PONVORY

Moderate List
Fever
Multiple sclerosis

The following adverse reaction information is available for ENGERIX-B PEDIATRIC (PF) (hepatitis b virus vaccine recombinant/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 25 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Angioedema Apnea Bell's palsy Bronchospastic pulmonary disease Encephalitis Encephalopathy Erythema multiforme Erythema nodosum Guillain-barre syndrome Herpes zoster Lichen planus Meningitis Muscle weakness Myelitis Optic neuritis Purpura Seizure disorder Serum sickness Stevens-johnson syndrome Syncope Thrombocytopenic disorder Tonic clonic seizure Vasculitis

Rare/Very Rare

Abnormal hepatic function tests
Anaphylaxis
Angioedema
Apnea
Bell's palsy
Bronchospastic pulmonary disease
Encephalitis
Encephalopathy
Erythema multiforme
Erythema nodosum
Guillain-barre syndrome
Herpes zoster
Lichen planus
Meningitis
Muscle weakness
Myelitis
Optic neuritis
Purpura
Seizure disorder
Serum sickness
Stevens-johnson syndrome
Syncope
Thrombocytopenic disorder
Tonic clonic seizure
Vasculitis

There are 54 less severe adverse reactions.

More Frequent	Less Frequent
Fatigue Injection site sequelae	Dizziness Erythema Fever Headache disorder Induration of skin Pain Vertigo

Rare/Very Rare
Abdominal pain with cramps Agitation Alopecia Anorexia Arthralgia Arthritis Back pain Chills Conjunctivitis Constipation Diarrhea Drowsy Dyspepsia Earache Ecchymosis Eczema Flu-like symptoms Flushing General weakness Hyperhidrosis Hypoesthesia Hypotension Insomnia Irritability Keratitis Lymphadenopathy Malaise Migraine Myalgia Nausea Neck pain Neck stiffness Palpitations Paresthesia Peripheral sensory neuropathy Petechiae Pruritus of skin Shoulder pain Skin rash Tachycardia Tinnitus Upper respiratory infection Urticaria Visual changes Vomiting

Rare/Very Rare

Abdominal pain with cramps
Agitation
Alopecia
Anorexia
Arthralgia
Arthritis
Back pain
Chills
Conjunctivitis
Constipation
Diarrhea
Drowsy
Dyspepsia
Earache
Ecchymosis
Eczema
Flu-like symptoms
Flushing
General weakness
Hyperhidrosis
Hypoesthesia
Hypotension
Insomnia
Irritability
Keratitis
Lymphadenopathy
Malaise
Migraine
Myalgia
Nausea
Neck pain
Neck stiffness
Palpitations
Paresthesia
Peripheral sensory neuropathy
Petechiae
Pruritus of skin
Shoulder pain
Skin rash
Tachycardia
Tinnitus
Upper respiratory infection
Urticaria
Visual changes
Vomiting

The following precautions are available for ENGERIX-B PEDIATRIC (PF) (hepatitis b virus vaccine recombinant/pf):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Animal reproduction studies have not been performed with hepatitis B vaccine. It is not known whether the vaccine can cause fetal harm when administered to a pregnant woman. Hepatitis B vaccine should be used during pregnancy only when clearly needed.

Because of the potential risks from exposure to HBV infection in a pregnant woman and the potential for development of chronic infection in the neonate, pregnancy is not considered a contraindication to use of hepatitis B vaccine when clearly needed. Since hepatitis B vaccine contains only noninfectious hepatitis B surface antigen (HBsAg) particles, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that the theoretical risk to the fetus from the vaccine should be negligible. HepA-HepB (Twinrix(R)) should be used during pregnancy only when clearly needed.

Clinicians are encouraged to register pregnant women who receive Twinrix(R) with the manufacturer's vaccination pregnancy registry at 888-452-9622. Hib-HepB (Comvax(R)) and DTaP-HepB-IPV (Pediarix(R)) are not indicated for use in women of childbearing age.

It is not known whether the antigens contained in hepatitis B vaccine are distributed into milk. The manufacturers state that hepatitis B vaccine (Engerix-B(R), Recombivax HB(R)) and HepA-HepB (Twinrix(R)) should be used with caution in nursing women. Although specific data are not available, the ACIP, CDC, and AAP state that breast-feeding is not a contraindication to administration of hepatitis B vaccine and lactating women should receive the vaccine as recommended for other adults.

No enhanced Geriatric Use information available for this drug.