Hiberix (Haemophilus b conjugate vaccine(tetanus toxoid conjugate)/PF)

The dosage schedule (i.e., number of doses) recommended for primary immunization against Hib infection varies according to the specific Hib vaccine administered and the age at which vaccination is started. The age-appropriate recommendations for the specific preparation used should be followed.

Monovalent PRP-OMP and monovalent PRP-T are considered interchangeable for both primary and booster immunization. If the primary immunization series included both PRP-OMP and PRP-T or if there is uncertainty about which vaccine type was administered previously, 3 primary doses and a booster dose are needed to complete the series.

The Centers for Disease Control and Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) state that use of PRP-OMP (available as a monovalent vaccine (PedvaxHIB(R)) or as part of a fixed-combination vaccine (Vaxelis(R))) is preferred for primary immunization in American Indian and Alaskan native children.

If interruptions or delays result in an interval between Hib vaccine doses longer than recommended, it is not necessary to administer additional doses or start the vaccination series over.

The usual dose of PRP-OMP (PedvaxHIB(R)) or PRP-T (ActHIB(R), Hiberix(R)) is 0.5 mL.

Haemophilus b (Hib) conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB(R)) and Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB(R), Hiberix(R)) are administered by IM injection.

The fixed-combination vaccine containing diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), poliovirus vaccine inactivated (IPV), and Hib conjugate vaccine (DTaP-IPV/Hib; Pentacel(R)) and the fixed-combination vaccine containing DTaP, hepatitis B (HepB), poliovirus, and Hib antigens (DTaP-IPV/Hib/HepB; Vaxelis(R)) are also administered by IM injection. Consult the prescribing information for these fixed-combination vaccines for additional information.

Monovalent Hib vaccine and combination vaccines containing Hib and other antigens should not be given IV, subcutaneously, or intradermally.

Depending on patient age, IM injections should be made into the anterolateral muscles of the thigh or deltoid muscle of the arm.

In infants younger than 12 months of age, IM injections should preferably be made into the anterolateral thigh; in certain circumstances (e.g., physical obstruction at other sites and no reasonable indication to defer the vaccine dose), IM injections can be made into the gluteal muscle using care to identify anatomical landmarks prior to injection.

In infants and children 1 through 2 years of age, the anterolateral thigh is preferred; alternatively, IM injections can be made into the deltoid muscle if muscle mass is adequate.

In adults, adolescents, and children 3 years of age or older, IM injections should preferably be made into the deltoid muscle; IM injections also can be made into the anterolateral thigh.

To ensure delivery into muscle, IM injections should be made at a 90degrees angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, the volume to be injected, and the injection technique.

Some manufacturers state that Hib vaccine should not be injected into the gluteal area or any area where there may be a major nerve trunk.

Hib vaccine may be given concurrently with other age-appropriate vaccines. Use of fixed-combination vaccines can reduce the number of injections a patient receives and alleviate concerns about the number of injections. When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and different injection sites. The 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. For infants and younger children receiving >2 vaccines in a single limb, the thigh is the preferred site due to greater mass. For older children and adults, more than one IM injection can be administered into the deltoid muscle.

PRP-OMP (PedvaxHIB(R))

PRP-OMP (PedvaxHIB(R)) is administered undiluted.

Single-dose vials of PRP-OMP should be shaken well prior to withdrawing the dose. Thorough agitation is necessary to maintain a suspension; the vaccine should appear as a slightly opaque white suspension.

PRP-OMP (PedvaxHIB(R)) should be refrigerated at 2-8degreesC and should not be frozen.

PRP-T (ActHIB(R))

Single-dose vials of lyophilized PRP-T (ActHIB(R)) should be reconstituted by adding 0.6 mL of the 0.4% sodium chloride diluent supplied by the manufacturer. The vial should be agitated thoroughly to ensure complete reconstitution; the reconstituted vaccine should appear clear and colorless. The manufacturer's labeling should be consulted for additional information regarding reconstitution of ActHIB(R).

PRP-T should be administered promptly after reconstitution or may be stored at 2-8degreesC and administered within 24 hours after reconstitution. The reconstituted vaccine should be shaken well prior to use.

PRP-T should not be mixed with any other vaccine or solution.

Lyophilized PRP-T (ActHIB(R)) and the 0.4% sodium chloride diluent provided by the manufacturer should be refrigerated at 2-8degreesC and should not be frozen. The vaccine contains no preservatives.

PRP-T (Hiberix(R))

PRP-T (Hiberix(R)) is supplied in 2 presentations: a vial and vial presentation and a vial and prefilled syringe presentation. For both presentations, the lyophilized antigen component should be reconstituted only with the accompanying saline diluent. The reconstituted vaccine should be a clear and colorless solution. The manufacturer's labeling should be consulted for additional information regarding reconstitution of Hiberix(R).

PRP-T should be administered promptly after reconstitution.

Lyophilized PRP-T (Hiberix(R)) should be stored at 2-8degreesC and protected from light. The 0.9% sodium chloride diluent supplied by the manufacturer should be stored at 2-8degreesC or at room temperature between 2 and 25degreesC. The diluent should not be frozen and should be discarded if freezing occurs.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Non-Live Or Non-Replicating Vaccines/Efalizumab

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Efalizumab-induced immunosuppression may prevent proper immune response to the vaccine.(1)

CLINICAL EFFECTS: The use of vaccines in patients who have recently received efalizumab may be ineffective.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients should receive all appropriate immunizations prior to beginning efalizumab therapy. The use of vaccines in patients who have recently received efalizumab may be ineffective.(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: In a small study with intravenous efalizumab, a single dose of 0.3 mg/kg of efalizumab given before primary immunization with a neoantigen decreased the secondary immune response, and a dose of 1 mg/kg almost completely ablated it. (This dose has comparable pharmacodynamic effects to the recommended subcutaneous dose of 1 mg/kg.) In chimpanzees treated with greater than 10 times the normal clinical exposure level of efalizumab, antibody responses were decreased following immunization with tetanus toxoid compared with untreated control animals.(1)

Non-Live, Non-Replicating Vaccine/Rebisufligene Etisparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)

DISCUSSION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines.(1)

Vaccines/Pariglasgene Brecaparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)

DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

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)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Non-Live Or Non-Rep Vaccines/Systemic Corticosteroids; Acth

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)

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.

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)

Non-Live Or Non-Replicating Vaccines/Ocrelizumab

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ocrelizumab 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 ocrelizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ocrelizumab therapy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ocrelizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving ocrelizumab. Vaccinations given during ocrelizumab 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 ocrelizumab treatment.(1)

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.

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.

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)

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)

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)

Non-Live Or Nonreplicating Vaccine/Vusolimogene Oderparepvec

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The interaction potential of non-live or non-replicating vaccines with vusolimogene oderparepvec is unknown.

CLINICAL EFFECTS: Concurrent administration of non-live or non-replicating vaccines with vusolimogene oderparepvec may alter the effectiveness or toxicities of either agent.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of vusolimogene oderparepvec states that non-live and non-replicating vaccines should ideally be delayed until the current course of vusolimogene oderparepvec therapy is completed. If vaccination is required during treatment, separate administration of the vaccine and vusolimogene oderparepvec by at least 14 days.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)

DISCUSSION: The concomitant use of non-live or non-replicating vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is intended to minimize potential interactions and confounding factors in the safety assessments of vaccines and vusolimogene oderparepvec therapy.(2)

Vaccines/Hepatitis B Vaccine (Fendrix)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)

CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)

DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)

*Haemophilus b (Hib) conjugate vaccine (meningococcal protein conjugate) (PRP-OMP; PedvaxHIB(R)): hypersensitivity to any vaccine component.

*Hib conjugate vaccine (tetanus toxoid conjugate) (PRP-T; ActHIB(R), Hiberix(R)): severe allergic reaction (e.g., anaphylaxis) after dose of any Hib vaccine, dose of any vaccine containing tetanus toxoid, or any component in PRP-T.

There are no contraindication contraindications for this drug.

• Guillain-barre syndrome

• High fever >101 degrees fahrenheit

Adverse effects reported in more than 1% of pediatric patients receiving PRP-OMP (PedvaxHIB(R)) vaccine in clinical studies were irritability, sleepiness, injection site pain/soreness, injection site erythema, injection site swelling/induration, unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.

The most common adverse effects following a single dose of PRP-T (ActHIB(R)) vaccine in pediatric patients 2-16 months of age were fussiness/irritability (75%), inconsolable crying (58%), and decreased activity/lethargy (51%). In pediatric patients 15-20 months of age, tenderness (20%) was the most common local reaction following administration of ActHIB(R).

Adverse effects reported in at least 20% of pediatric patients receiving PRP-T (Hiberix(R)) vaccine include pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Extensive limb swelling after injection
• Seizure disorder
• Syncope

More Frequent

• Anorexia
• Drowsy
• Fever
• Injection site sequelae
• Irritability
• Lethargy

Less Frequent

• Diarrhea
• Induration of skin
• Skin swelling

Rare or Very Rare

• Erythema
• Peripheral edema
• Pruritus of skin
• Skin rash
• Urticaria
• Vomiting

No enhanced messaging available.

PRP-OMP (PedvaxHIB(R)): Safety and efficacy have not been established in infants younger than 6 weeks of age or in children 6 years of age or older. The manufacturer states that administration of PRP-OMP before 6 weeks of age may result in immunologic tolerance to the vaccine (i.e., impaired ability to respond to subsequent exposure to PRP antigen).

PRP-T (ActHIB(R)): Safety and efficacy have not been established in infants younger than 6 weeks of age or in children and adolescents 6 years of age or older.

PRP-T (Hiberix(R)): Safety and efficacy have not been established in infants younger than 6 weeks of age or in children and adolescents 5-16 years of age.

ACIP and AAP state that immunization against Hib infection using an age-appropriate vaccine can be initiated as early as 6 weeks of age. Hib vaccines should not be administered to infants younger than 6 weeks of age.

Apnea has been reported following IM administration of vaccines in some infants born prematurely. Decisions regarding when to administer an IM vaccine in infants born prematurely should be based on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.

Hib vaccines are not labeled by FDA for use in adolescents or adults, as Hib disease is uncommon in this age group.

Animal reproduction studies have not been performed with Hib vaccines. It is not known whether the vaccines can cause fetal harm when administered to pregnant women or whether they can affect fertility.

According to ACIP, there is no evidence of risk to the fetus when inactivated vaccines are administered during pregnancy.

Hib vaccines are not labeled by FDA for use in adolescents or adults, as Hib disease is uncommon in this age group.

It is not known whether antigens contained in Hib vaccines are distributed into human milk, affect milk production, or affect the breast-fed infant.

ACIP states that administration of an inactivated vaccine to a woman who is breast-feeding does not pose any safety concerns for the woman or the breast-fed infant.

Manufacturers make no specific dosage recommendations for geriatric patients.

Safety and efficacy of Hib vaccines have not been established in adults, including geriatric adults, and these vaccines are not usually used in this age group.