Version July 2025
The FDA has issued a drug safety communication to inform health care providers of safety labeling changes to the Warnings and Precautions section of Pfizer’s Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline Biologicals’ Arexvy (respiratory syncytial virus vaccine, adjuvanted) to include that the results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.
Further information may be found at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and.
Respiratory syncytial virus (RSV)– associated lower respiratory tract disease prevention:
Adults 18 to 59 years of age who are at increased risk of severe RSV disease: IM: ~0.5 mL as a single dose. Note: There is currently no ACIP recommendation for RSV vaccination in this population.
Adults 60 to 74 years of age who are at increased risk of severe RSV disease: IM: ~0.5 mL as a single dose. Note: Persons who have previously received RSV vaccination are NOT recommended to receive another dose at this time (Ref).
Pregnant patients 32 through 36 weeks' gestation: IM: ~0.5 mL as a single dose. Note: There is currently no ACIP recommendation for RSV vaccination in subsequent pregnancies (data not yet available) (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Respiratory syncytial virus (RSV)–associated lower respiratory tract disease prevention:
Adults 60 to 74 years of age who are at increased risk of severe RSV disease: IM: 0.5 mL as a single dose. Note: Persons who have previously received RSV vaccination are NOT recommended to receive another dose at this time (Ref).
Adults ≥75 years of age: IM: 0.5 mL as a single dose. Note: Persons who have previously received RSV vaccination are NOT recommended to receive another dose at this time (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Gastrointestinal: Nausea (12%)
Local: Pain at injection site (11% to 35%)
Nervous system: Fatigue (16%), headache (13%)
Neuromuscular & skeletal: Arthralgia (8% to 12%), myalgia (10% to 24%)
1% to 10%:
Gastrointestinal: Diarrhea (6%), vomiting (2%)
Local: Erythema at injection site (3% to 6%), swelling at injection site (3% to 7%)
Miscellaneous: Fever (2%)
<1%:
Dermatologic: Urticaria
Hypersensitivity: Hypersensitivity reaction
Nervous system: Guillain-Barré syndrome (including Miller Fisher syndrome)
Severe hypersensitivity (eg, anaphylaxis) to respiratory syncytial virus vaccine (recombinant) or to any component of the formulation.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including injectable epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Guillain-Barré syndrome/inflammatory neurologic events: A postmarketing study suggests an increased risk of Guillain-Barré syndrome during the first 6 weeks after vaccination. There have been rare reports of Guillain-Barré syndrome (1 report), Miller Fisher syndrome (1 report), and undifferentiated motor-sensory axonal polyneuropathy with worsening of preexisting symptoms (1 report) (CDC/ACIP [Melgar 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, 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 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]).
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 Advisory Committee on Immunization Practices recommends 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]).
Special populations:
• Altered immunocompetence: The manufacturer's efficacy study excluded persons with immunocompromising conditions. Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. 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]).
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). See manufacturer's labeling.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• 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 is improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular [preservative free]:
Abrysvo: 120 mcg/0.5 mL (1 ea) [latex free; contains polysorbate 80]
Abrysvo: 120 mcg/0.5 mL (1 ea) [contains polysorbate 80]
No
Solution (reconstituted) (Abrysvo Intramuscular)
120 mcg/0.5 mL (per each): $368.16
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Abrysvo: 120 mcg/0.5 mL (1 ea, 5 ea, 10 ea) [contains polysorbate 80]
IM: Prior to using, the powder (antigen vial) must be reconstituted with the provided diluent. Administer by IM injection into the deltoid muscle (Ref). Use proper injection technique 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 (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adults should be vaccinated while seated or lying down (Ref). If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, vaccine information statement edition date and date it was provided, and the administering person’s name, title, and address be recorded.
For patients at risk of hemorrhage following IM injection, the Advisory Committee on Immunization Practices recommends that 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 (Ref).
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at https://www.cdc.gov/vaccines/hcp/vis/vis-statements/rsv.html
Respiratory syncytial virus associated lower respiratory tract disease prevention: Active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in persons ≥60 years of age and in persons 18 to 59 years of age who are at increased risk of LRTD caused by RSV; active immunization of pregnant individuals at 32 through 36 weeks' GA for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.
Advisory Committee on Immunization Practices recommendations:
The Advisory Committee on Immunization Practices (ACIP) recommends vaccination in pregnant patients 32 through 36 weeks’ gestation using seasonal administration (September through January in most of the continental United States) to prevent RSV-associated LRTD in infants <6 months of age (CDC/ACIP [Fleming-Dutra 2023]).
The ACIP also recommends vaccination in persons ≥75 years of age and in persons 60 to 74 years of age who are at increased risk of severe RSV disease. Risk factors for severe RSV disease include the following (CDC/ACIP [Britton 2024]):
Chronic medical conditions (eg, cardiovascular disease, lung or respiratory disease, liver disease, hematologic conditions, diabetes mellitus with end-stage organ damage or requiring insulin or sodium-glucose cotransporter-2 inhibitor, end-stage kidney disease, dependence on renal replacement therapy)
Neurologic or neuromuscular conditions that may impair airway clearance or respiratory muscle weakness
Moderately or severely immunocompromising conditions
Severe obesity (BMI ≥40 kg/m2)
Persons residing in a nursing home
Other chronic conditions or risk factors that may increase the risk for severe disease due to viral respiratory infection (eg, frailty)
Respiratory syncytial virus vaccine (recombinant) may be confused with respiratory syncytial virus vaccine (recombinant [adjuvanted]) and respiratory syncytial virus vaccine (mRNA).
Abrysvo (respiratory syncytial virus vaccine [recombinant]; RSVpreF vaccine) may be confused with Arexvy (respiratory syncytial virus vaccine [recombinant (adjuvanted)]; RSVPreF3 vaccine).
RSVpreF vaccine (respiratory syncytial virus vaccine [recombinant]; Abrysvo) may be confused with RSVPreF3 vaccine (respiratory syncytial virus vaccine [recombinant (adjuvanted)]; Arexvy) and RSV (mRNA) vaccine (respiratory syncytial virus vaccine [mRNA]; mRESVIA).
RSV vaccine may be confused with RZV vaccine (zoster vaccine [recombinant]).
Abrysvo is supplied with a prefilled diluent syringe. After reconstitution of the vial contents, the vaccine is to be withdrawn back into the syringe; relabel the syringe with the vaccine name to prevent mix-ups with other prefilled syringes (ISMP [Gaunt 2023]).
Respiratory syncytial virus (RSV) vaccines (eg, Abrysvo, Arexvy, and Mrsevia), which are only approved for use in adult patients, have the potential to be confused with anti-RSV monoclonal antibodies (eg, nirsevimab [Beyfortus] or palivizumab [Synagis]) and in some cases have been inadvertently administered to pediatric patients (ISMP 2024; Moro 2024).
None known.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May decrease therapeutic effects 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 decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider Therapy Modification
Atidarsagene Autotemcel: May increase adverse/toxic effects of Vaccines. Atidarsagene Autotemcel may decrease therapeutic effects of Vaccines. Risk X: Avoid
Cladribine: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification
Dinutuximab Beta: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Risk X: Avoid
Elivaldogene Autotemcel: May increase adverse/toxic effects of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may decrease therapeutic effects 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
Fingolimod: May decrease therapeutic effects of Vaccines (Non-Live/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 decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Immunosuppressants (Miscellaneous Oncologic Agents): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
Methotrexate: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification
Propacetamol: May decrease therapeutic effects 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 decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Avoid administration of non-live/inactivated/non-replicating vaccines during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider Therapy Modification
Teplizumab: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Vaccination with non-live/inactivated/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
Antibodies generated following respiratory syncytial virus (RSV) vaccination of pregnant patients between 24 and 36 weeks' gestation can be detected in cord blood at delivery (Simões 2022).
Outcome data following maternal use of the RSV vaccine during pregnancy are available (Son 2024).
The Advisory Committee on Immunization Practices recommends vaccination in pregnant patients 32 through 36 weeks’ gestation using seasonal administration (September through January in most of the continental United States) to prevent RSV-associated lower respiratory infection in infants <6 months of age. Follow local guidance on timing of vaccination in areas with RSV season outside of this time period. The RSV vaccine may be administered simultaneously with other vaccines routinely administered during pregnancy. It is not known if additional RSV vaccination is required in subsequent pregnancies. Additional recommendations are available; refer to current CDC guidelines (CDC 2024b; CDC/ACIP [Fleming-Dutra 2023]).
Patients at risk for preterm delivery were generally excluded from clinical trials; to avoid the potential risk of preterm birth, this vaccine should not be administered prior to 32 weeks' gestation.
Abrysvo (respiratory syncytial virus vaccine [recombinant]) is the only RSV vaccine approved for use during pregnancy. Pregnant patients administered Arexvy (respiratory syncytial virus [recombinant, adjuvanted]) vaccine in error should not be given a dose of Abrysvo. Refer to current CDC guidance if Arexvy is inadvertently administered during pregnancy (CDC 2024b).
Data collection to monitor pregnancy and infant outcomes following exposure to this vaccine is ongoing:
Health care providers are encouraged to enroll patients exposed to Abrysvo during pregnancy in the pregnancy registry (800-616-3791); patients may also enroll themselves.
The CDC is also monitoring adverse events following vaccination in pregnant persons through VAERS and the Vaccine Safety Datalink (https://www.cdc.gov/vaccine-safety-systems/vsd/?CDC_AAref_Val=https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html) (CDC/ACIP [Fleming-Dutra 2023]).
It is not known if the components of this vaccine are present in breast milk.
According to the manufacturer, the decision to breastfeed following vaccination should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment. Nonlive vaccines have not been shown to affect the safety of the breastfed infant or mother (ACIP [Kroger 2023]).
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.
Promotes active immunization against respiratory syncytial virus prefusion F (RSVPre) glycoprotein to protect against RSV-A and/or B-associated lower respiratory tract disease. The vaccine contains recombinant RSV preF A and RSV preF B (Walsh 2023a). When administered to pregnant patients, antibodies to RSV antigens are transferred to the fetus to protect infants up to 6 months of age from RSV-associated lower respiratory tract disease.
Duration: A single dose of respiratory syncytial virus (RSV) vaccine provides protection for at least 2 RSV seasons (CDC/ACIP [Britton 2024]).
