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Recombinant hemagglutinin influenza vaccine (RIV4): Drug information

Recombinant hemagglutinin influenza vaccine (RIV4): Drug information
(For additional information see "Recombinant hemagglutinin influenza vaccine (RIV4): Pediatric drug information" and see "Recombinant hemagglutinin influenza vaccine (RIV4): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Flublok Quadrivalent
Brand Names: Canada
  • Supemtek
Pharmacologic Category
  • Vaccine;
  • Vaccine, Recombinant
Dosing: Adult

Note: Influenza seasons vary in the timing and duration from year to year. In general, vaccination should preferably occur during September or October (in the United States) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community. Early vaccination (in July or August) for an upcoming influenza season has been associated with suboptimal immunity before the end of an influenza season, particularly in older adults. Vaccination should continue throughout the influenza season as long as vaccine is available. The Centers for Disease Control and Prevention does not recommend revaccination later in the season for those persons who have already been fully vaccinated (CDC/ACIP [Grohskopf 2023]).

Immunization

Immunization: IM: 0.5 mL/dose (1 dose per season).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing. For persons ≥65 years of age, the ACIP recommends a higher dose or adjuvanted influenza vaccine (ie, HD-IIV4, RIV4, or aIIV4). If one of these vaccines is not available, then any other age-appropriate vaccine may be used (CDC/ACIP [Grohskopf 2023]).

Dosing: Pediatric

(For additional information see "Recombinant hemagglutinin influenza vaccine (RIV4): Pediatric drug information")

Immunization, annual

Immunization, annual: Note: Influenza seasons vary in their timing and duration from year to year. In general, vaccination should preferably occur by the end of October (in the United States) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community. Vaccination should continue throughout the influenza season as long as vaccine is available (CDC/ACIP [Grohskopf 2023]).

Adolescents ≥18 years: IM: 0.5 mL per dose as a single dose per season.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Local: Pain at injection site (19% to 37%), tenderness at injection site (34% to 48%)

Nervous system: Fatigue (12% to 17%), headache (13% to 20%)

Neuromuscular & skeletal: Myalgia (9% to 13%)

1% to 10%:

Gastrointestinal: Nausea (5% to 9%)

Local: Erythema at injection site (3% to 4%), swelling at injection site (≤5%, including firmness)

Nervous system: Chills (≤7%), shivering (≤7%)

Neuromuscular & skeletal: Arthralgia (8% to 10%)

Miscellaneous: Fever (≤2%)

Postmarketing:

Dermatologic: Urticaria

Hypersensitivity: Anaphylaxis, hypersensitivity reaction

Contraindications

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine

Warnings/Precautions

Concerns related to adverse effects:

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).

• Guillain-Barré syndrome: Use with caution in patients with history of Guillain-Barré syndrome (GBS); patients with history of GBS have a greater likelihood of developing GBS than those without. As a precaution, the Advisory Committee on Immunization Practices (ACIP) recommends that patients with a history of GBS and who are not at higher risk for severe influenza complications and patients known to have experienced GBS within 6 weeks following previous influenza vaccination should generally not be vaccinated (consider influenza antiviral chemoprophylaxis in these patients). The benefits of vaccination may outweigh the potential risks in persons with a history of GBS who are also at higher risk for severe complications of influenza. Influenza infection itself may cause GBS (CDC/ACIP [Grohskopf 2023]). Recent studies of patients who received the trivalent inactivated influenza vaccine or the monovalent H1N1 influenza vaccine have shown the risk of GBS is lower with vaccination than with influenza infection (Baxter 2013; Greene 2013; Kwong 2013).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).

• Vaccines: In order to maximize vaccination rates, the ACIP, as well as the Canadian National Advisory Committee on Immunization (NACI), recommend simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]; NACI 2023).

Special populations:

• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroid]) if appropriate; may have a reduced response to vaccination. Inactivated vaccine (inactivated influenza vaccine [IIV] or recombinant influenza vaccine [RIV]) is preferred over live virus vaccine (LAIV) for immunocompromised persons, household members, health care workers, and others coming in close contact with severely immunosuppressed persons requiring care in a protected environment (ACIP [Kroger 2023]; CDC/ACIP [Grohskopf 2023]). Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).

• Pediatric: In a clinical trial of infants and children 6 months through 3 years of age, a decreased response to Flublok was reported compared to currently licensed US influenza vaccine for this population, suggesting that it would not be effective in children ≤3 years of age; safety and efficacy in older pediatric patients have not been established; use has not been studied.

• Older adults: Antibody responses may be lower and decline faster in older adults ≥65 years of age compared to younger adults; however, deferral to later in the season may result in missed vaccination opportunities or early season infection. For persons ≥65 years of age, the ACIP recommends a higher dose or adjuvanted influenza vaccine (ie, HD-IIV4, RIV4, or aIIV4). If one of these vaccines is not available, then any other age-appropriate vaccine may be used (CDC/ACIP [Grohskopf 2023]).

Dosage form specific issues:

• Chicken egg protein: Flublok Quadrivalent and Supemtek [Canadian product] are influenza vaccines produced using continuous insect cell lines. They are recombinant hemagglutinin (rHA) vaccines and do not use the influenza virus or eggs during the production process. ACIP states they may be used in persons with an egg allergy of any severity if otherwise appropriate (CDC/ACIP [Grohskopf 2023]; NACI 2023).

Other warnings/precautions:

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to Centers for Disease Control and Prevention [CDC] schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions, as well as contacts of immunocompromised patients, are available from the Infectious Diseases Society of America (Rubin 2014).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).

• Other influenza vaccines: Influenza vaccines from previous seasons must not be used. Vaccines formulated for the northern hemisphere may differ in composition from the southern hemisphere vaccine; consult CDC Yellow Book for more information regarding travel vaccines (ACIP [Kroger 2023]; CDC/ACIP [Grohskopf 2023]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Prefilled Syringe, Intramuscular [preservative free]:

Flublok Quadrivalent: 0.5 mL (0.5 mL [DSC]) [egg free, latex free]

Flublok Quadrivalent: 0.5 mL (0.5 mL [DSC]) [egg free]

Flublok Quadrivalent: 0.5 mL (0.5 mL [DSC]) [latex free]

Flublok Quadrivalent: 0.5 mL (0.5 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Flublok Quadrivalent Intramuscular)

0.5 mL (per 0.5 mL): $77.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Intramuscular:

Supemtek: 0.5 mL (1 ea)

Administration: Adult

IM: For IM administration only. Gently invert the syringe prior to affixing the needle. Inspect for particulate matter and discoloration prior to administration. Avoid use if visible particles or discoloration are present in the solution after shaking. Use proper injection technique to inject into the deltoid muscle (eg, injecting into the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013). Do not inject into the gluteal region or areas where there may be a major nerve trunk. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. May administer simultaneously with other vaccines (eg, COVID-19 vaccine) (CDC/ACIP [Grohskopf 2023]). To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2023]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Unless otherwise indicated in product labeling, jet injectors should not be used to administer recombinant influenza vaccines. Currently, Afluria Quadrivalent inactivated influenza vaccine is the only influenza vaccine licensed in the United States with data about use with a jet-injector device.

Note: For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting-factor disorders (ACIP [Kroger 2023]).

Administration: Pediatric

To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2023]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

For IM administration only. Gently invert the syringe prior to affixing the needle. Inspect for particulate matter and discoloration prior to administration; avoid use if visible particles are present in the solution after shaking. Use proper injection technique to inject into the deltoid muscle (eg, injecting into the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013). Do not inject into the gluteal region or areas where there may be a major nerve trunk. Jet injectors should not be used to administer recombinant influenza vaccines unless otherwise indicated in product labeling.

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2023]).

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at https://www.cdc.gov/vaccines/hcp/vis/vis-statements/flu.pdf.

Use: Labeled Indications

Influenza disease prevention: Active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine in persons ≥18 years of age

Recommendations for annual seasonal influenza prevention:

The Advisory Committee on Immunization Practices (ACIP) recommends routine annual vaccination with seasonal influenza vaccine for all persons ≥6 months who do not otherwise have contraindications to the vaccine. ACIP recommends use of any age and risk factor appropriate product and does not express any preference for an influenza vaccine product for persons 6 months to <65 years of age. For persons ≥65 years of age, the ACIP recommends a higher dose or adjuvanted influenza vaccine (ie, HD-IIV4, RIV4, or aIIV4). If one of these vaccines is not available, then any other age-appropriate vaccine may be used. In addition to RIV, other products are available for certain patient populations: Persons ≥6 months of age may receive the inactivated influenza vaccine. Live attenuated influenza vaccine is also an option for persons 2 to 49 years of age (CDC/ACIP [Grohskopf 2023]).

The Canadian National Advisory Committee on Immunization (NACI) recommends annual vaccination with seasonal influenza vaccine for all persons ≥6 months of age who do not have contraindications to the vaccine (NACI 2023). The following influenza vaccine preferences should be considered (Note: Trivalent inactivated influenza vaccines [IIV3] will not be available in Canada during the 2023-2024 influenza season.)

• Persons 6 to 23 months of age: Quadrivalent inactivated influenza vaccine (IIV4) is preferred; use trivalent inactivated influenza vaccine (IIV3) if IIV4 is not available.

• Persons 2 to 17 years of age: Either IIV4-SD, LAIV4 (if appropriate), or IIV4-cc (RIV) is preferred; use IIV3-SD if the other options are not available.

• Persons 18 to 64 years of age: Any age- and risk factor–appropriate product may be used.

• Persons ≥65 years of age: IIV-HD (high dose) is preferred over IIV-SD (standard dose); however, any available influenza vaccine may be used for public health program-level decision making.

• Health care workers: Either IIV4 or IIV3 are recommended; LAIV should not be used.

Prioritization when vaccine supply is limited:

When vaccine supply is limited, target groups for vaccination (those at higher risk of complications from influenza infection and their close contacts) include the following (CDC/ACIP [Grohskopf 2023]; NACI 2023): Note: Only use RIV if appropriate.

• All infants and children 6 to 59 months of age

• Persons ≥50 years of age

• Infants, children, and adolescents (6 months to 18 years of age) who are receiving aspirin or salicylate therapy, and therefore, may be at risk for developing Reye syndrome after influenza

• Residents of nursing homes and other long-term care facilities

• Persons with chronic pulmonary disorders (including asthma) or cardiovascular systems disorders (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)

• Persons who have immunosuppression due to any cause (including immunosuppression caused by medications or HIV)

• Persons who are or will be pregnant during the influenza season

• Health care personnel, including students in these professions and other persons not directly involved in patient care, who may be exposed to patients or to infectious agents (eg, clerical, housekeeping, volunteers)

• Household contacts (≥6 months of age) and caregivers of neonates, infants, and children <5 years of age (particularly neonates and infants <6 months of age) and adults ≥50 years of age

• Household contacts (≥6 months of age) and caregivers of persons with medical conditions that put them at higher risk of severe complications from influenza infection

• Indigenous people (including American Indians/Alaska Natives)

• Persons with extreme obesity (BMI ≥40 for adults)

• In addition, the NACI includes the following: persons who provide services within closed or relatively closed settings to persons at high risk; persons who provide essential community services; and persons in direct contact with poultry infected with avian influenza during culling operations

Medication Safety Issues
Sound-alike/look-alike issues:

COVID-19 vaccine may be confused with influenza virus vaccine. Medication errors have occurred when COVID-19 vaccine was inadvertently administered instead of influenza virus vaccine (and vice versa). These products may be stored in close proximity to each other. Confirm the correct vaccine has been selected prior to administration (ISMP/NAN 2021).

Influenza virus vaccine may be confused with flumazenil, perflutren lipid microspheres

Influenza virus vaccine may be confused with tetanus toxoid and tuberculin products. Medication errors have occurred when tuberculin skin tests (PPD) have been inadvertently administered instead of tetanus toxoid products and influenza virus vaccine. These products are refrigerated and often stored in close proximity to each other.

Influenza virus vaccine may be confused with insulin. Medication errors have occurred when insulin was inadvertently administered instead of influenza virus vaccine. These products are refrigerated and may be stored in close proximity to each other.

Influenza virus vaccine may be confused with COVID-19 vaccines. Medication errors have occurred when COVID-19 vaccine was inadvertently administered instead of influenza virus vaccine.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating methotrexate if possible. If vaccination occurs less than 2 weeks prior to or during methotrexate therapy, revaccinate 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Influenza virus vaccines are not recommended in the 2 weeks prior to teplizumab treatment, during treatment, or for 6 weeks after treatment. Reduced efficacy of the vaccine may occur if administer to patients taking teplizumab. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification

Reproductive Considerations

Using data prospectively collected from the Pregnancy Study Online (PRESTO), an internet-based preconception cohort study of patients planning to become pregnant, use of the seasonal influenza vaccine by either partner did not adversely affect the probability of conceiving (time and date of influenza vaccination in proximity to pregnancy was self-reported) (Orta 2020).

Influenza vaccination with any licensed, recommended, age-appropriate vaccine is recommended for all patients who may become pregnant during the influenza season and who do not otherwise have contraindications to the vaccine (CDC/ACIP [Grohskopf 2023]).

Pregnancy Considerations

Outcome data specific to the use of recombinant influenza vaccine in pregnancy are limited (CDC/ACIP [Grohskopf 2023]; Hansen 2020; Hsiao 2022).

Maternal vaccination provides passive immunization to the newborn and decreases the risk of hospitalization due to influenza in infants <6 months of age who are not eligible to be vaccinated (ACOG 2018).

The risk for severe illness and complications from influenza infection is increased during pregnancy, particularly during the second and third trimesters (CDC/ACIP [Grohskopf 2023]). Pregnant patients infected with influenza have a higher risk than nonpregnant patients of progression to pneumonia, hospitalization, and ICU admission (ACOG 2018). Influenza vaccination decreases the risk of laboratory-confirmed influenza and hospitalization in pregnant patients (Thompson 2014; Thompson 2019).

Influenza vaccination is recommended annually and should be given to pregnant patients even if they were vaccinated in a prior pregnancy. The efficacy of influenza vaccination in pregnant patients is similar to nonpregnant adults (ACOG 2018). Influenza vaccination with any licensed, recommended, age-appropriate inactivated influenza vaccine or recombinant influenza vaccine is recommended for all patients who are pregnant during the influenza season and who do not otherwise have contraindications to the vaccine (CDC/ACIP [Grohskopf 2023]). Vaccination may be done during any trimester (ACOG 2018). Vaccination of nonpregnant patients is typically offered by the end of October; however, to decrease the risk of infection to the neonate, consider vaccination of pregnant patients who are in their third trimester in July or August, or as soon as the vaccine is available (CDC/ACIP [Grohskopf 2023]).

Pregnant patients should observe the same precautions as nonpregnant patients to reduce the risk of exposure to influenza and other respiratory infections (CDC/HHS 2023). When vaccine supply is limited, focus should be given to on delivering the vaccine to patients who are pregnant or will be pregnant during the flu season, as well as contacts or caregivers of children <5 years of age (particularly contacts of neonates and infants <6 months of age) (CDC/ACIP [Grohskopf 2023]).

Data collection to monitor pregnancy and infant outcomes following exposure to influenza vaccine is ongoing. Persons exposed to this vaccine during pregnancy may contact the Flublok pregnancy registry at 1-800-822-2463.

Breastfeeding Considerations

It is not known if the components of this vaccine are present in breast milk.

According to the manufacturer, the decision to breastfeed following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of vaccination to the mother. Recombinant vaccines do not affect the safety of breastfeeding for the mother or the infant. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).

The risk for severe illness and complications from influenza infection is increased postpartum, and influenza vaccination decreases the risk for respiratory illness and influenza in postpartum patients (CDC/ACIP [Grohskopf 2023]). When vaccine supply is limited, focus on delivering the vaccine should be given to patients who are pregnant or will be pregnant during the flu season, as well as contacts or caregivers of children <5 years of age (particularly contacts of neonates and infants <6 months of age) (CDC/ACIP [Grohskopf 2023]). Postpartum patients who are breastfeeding and who did not receive the influenza vaccine during pregnancy may be vaccinated (ACOG 2018).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Mechanism of Action

Promotes immunity to seasonal influenza virus by inducing specific antibody production. Preparations from previous seasons must not be used.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Most adults have antibody protection within 2 weeks of vaccination (CDC/ACIP [Grohskopf 2023]).

Duration: Vaccine effectiveness declines at a variable rate, depending on virus subtypes, patient age, and other confounding factors (CDC/ACIP [Grohskopf 2023]).

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Topic 88426 Version 242.0

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