Pedvaxhib

Drug overview for PEDVAXHIB (haemophilus b conjugate vaccine (meningococcal prot.conj)/pf):

Generic name: HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROT.CONJ)/PF (HEE-moe-FIL-us IN-floo-EN-za vak-SEEN)
Drug class: Haemophilus B Vaccine
Therapeutic class: Biologicals

Haemophilus b (Hib) vaccine is an inactivated (polysaccharide) vaccine that is used to stimulate active immunity to invasive disease caused by Haemophilus influenzae type B (Hib).

No enhanced Uses information available for this drug.

DRUG IMAGES

PEDVAXHIB VACCINE VIAL

The following indications for PEDVAXHIB (haemophilus b conjugate vaccine (meningococcal prot.conj)/pf) have been approved by the FDA:

Indications:
Haemophilus influenzae type b vaccination

Professional Synonyms:
Active immunization against Haemophilus b
Vaccination to prevent Hib infection

The following dosing information is available for PEDVAXHIB (haemophilus b conjugate vaccine (meningococcal prot.conj)/pf):

Dosing
Administration
Dosing Information
Generic

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 available.

No generic dosing information available.

The following drug interaction information is available for PEDVAXHIB (haemophilus b conjugate vaccine (meningococcal prot.conj)/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, BETALOAN SUIK, BETAMETHASONE ACETATE MICRO, BETAMETHASONE ACETATE-SOD PHOS, BETAMETHASONE DIPROPIONATE, BETAMETHASONE SOD PHOS-ACETATE, BETAMETHASONE SOD PHOS-WATER, BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE VALERATE, 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, JAYTHARI, KENALOG-10, KENALOG-40, KENALOG-80, KHINDIVI, KYMBEE, 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, P-PACK PREDNISONE, PREDNISOLONE, PREDNISOLONE ACETATE MICRONIZE, PREDNISOLONE MICRONIZED, PREDNISOLONE SODIUM PHOS ODT, PREDNISOLONE SODIUM PHOSPHATE, PREDNISONE, PREDNISONE INTENSOL, PREDNISONE MICRONIZED, PROCTOCORT, PYQUVI, 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

Severe List
High fever >101 degrees fahrenheit

The following adverse reaction information is available for PEDVAXHIB (haemophilus b conjugate vaccine (meningococcal prot.conj)/pf):

Overview
Severe
Less Severe

Adverse reaction overview.

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.

There are 5 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema Extensive limb swelling after injection Seizure disorder Syncope

There are 15 less severe adverse reactions.

More Frequent	Less Frequent
Anorexia Drowsy Fever Injection site sequelae Irritability Lethargy	Diarrhea Induration of skin Skin swelling

Rare/Very Rare
Erythema Peripheral edema Pruritus of skin Skin rash Urticaria Vomiting

The following precautions are available for PEDVAXHIB (haemophilus b conjugate vaccine (meningococcal prot.conj)/pf):

Pediatric
Pregnant
Lactation
Geriatric

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

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.

Haemophilus influenzae type b vaccination
Z23	Encounter for immunization