AdultPediatricDosage Forms & Strengths injection kit, lyophilized antigen component and sterile water diluent After reconstitution, each 0.5-mL dose contains 120 mcg of RSV stabilized prefusion F proteins (60mcg RSV PreF A and 60mcg RSV PreF B) Prevention of Respiratory Syncytial Infection Indicated for active immunization for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection in adults aged ≥60 years 0.5 mL IM as a single dose Dosing Considerations Limitation of effectiveness: May not protect all vaccine recipients Ongoing clinical trial Clinical trial participants will remain in the study through several RSV seasons to assess duration of effectiveness, as well as safety and effectiveness of repeat vaccination Data for a single dose from the first RSV season of the study were available for the FDA’s analysis for approval Safety and efficacy not established VAERS Reporting Instruct vaccine recipients to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) or call 1-800-822-7967 >10% Fatigue, any (15.5%) Headache, any (12.8%) Injection site pain, any (10.5%) Muscle pain, any (10.1%) 1-10% Injection site pain, mild (9.4%) Fatigue, mild (9.3%) Headache, mild (9%) Joint pain, any (7.5%) Muscle pain, mild (6.5%) Fatigue, moderate (5.9%) Diarrhea, any (5.9%) Joint pain, mild (4.5%) Diarrhea, mild (4.4%) Headache, moderate (3.7%) Muscle pain, moderate (3.5%) Nausea, any (3.4%) Joint pain, moderate (2.9%) Redness, any (2.7%) Nausea, mild (2.5%) Swelling, any (2.4%) Swelling, mild (1.5%) Redness, mild (1.5%) Fever, ≥38ºC (1.4%) Diarrhea, moderate (1.3%) Redness, moderate (1.1%) Injection site pain, moderate (1.1%) <1% Swelling, moderate (0.9%) Nausea, moderate (0.9%) Nausea, any (0.9%) Fever >38.4-38.9ºC (0.8%) Nausea, mild (0.7%) Fever 38-38.4ºC (0.6%) Fatigue, severe (0.3%) Muscle pain, severe (0.2%) Nausea, moderate (0.2%) Swelling, severe (0.1%) Redness, severe (0.1%) Headache, severe (0.1%) Diarrhea, severe (0.1%) Injection site pain, severe (<0.1%) Joint pain, severe (<0.1%) Fever >38.9-40ºC (<0.1%) Contraindications History of severe allergic reaction (eg, anaphylaxis) to any of the vaccine components Cautions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration Syncope (fainting) may occur in association with administration; ensure procedures are established to avoid injury from fainting Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response Pregnancy Not approved for use in persons aged <60 yr Human data Data from a clinical trial (NCT04424316) that enrolled pregnant individuals who were randomly assigned 1:1 to receive RSV vaccine or placebo (0.5 mL dose, containing the same buffer ingredients in the same quantities as in a single dose of Abrysvo at 24-36 weeks’ gestation revealed no evidence for vaccine-associated increase in the risk of congenital anomalies or fetal deaths In this study, there was a numerical imbalance in preterm births, with more preterm infants born to individuals in the RSV vaccine group compared than to individuals in the placebo group Animal data A developmental and reproductive toxicity study was performed in female rabbits administered a vaccine formulation containing 2 times the antigen content of a single human dose before and during gestation Results showed no evidence of fetal harm or of adverse effects on postnatal survival, growth, or development Lactation Not approved for use in persons aged <60 yr Unknown if excreted in human milk; no human or animal data are available to assess effects on breastfed infants or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Vaccine composed of equal amounts of recombinant RSV prefusion F from subgroups A and B Induces an immune response against RSV pre F that protects against lower respiratory tract disease caused by RSV IM Preparation Prepare by reconstituting lyophilized antigen component (sterile white powder) with the accompanying prefilled syringe containing sterile water diluent component and a vial adapter See prescribing information for diagrams Step 1 - Removal of cap Remove plastic flip off cap from vial and cleanse rubber stopper Without removing vial adapter from its packaging, peel off top cover Step 2 - Attachment of vial adapter Hold base of vial on flat surface Keep vial adapter in packaging and orient it vertically over center of vial so that adapter spike aligns with center of vial’s rubber stopper Connect vial adapter to vial with a straight downward push; vial adapter will lock into place Do not push vial adapter in at an angle as this may result in leaking during use Remove vial adapter packaging Step 3 - Removal of syringe cap For all syringe assembly steps, hold syringe only by Luer lock adapter located at tip of the syringe; this will prevent Luer lock adapter from detaching during use Remove syringe cap by slowly turning cap counter-clockwise while holding Luer lock adapter Step 4 - Connection of syringe to vial adapter Hold the syringe’s Luer lock adapter and connect it to vial adapter by turning clockwise Stop turning when you feel resistance, overtightening syringe may result in leaking during use When syringe is securely attached to vial adapter, there will be a small space between top of vial adapter and the Luer lock adapter of syringe Step 5 - Reconstitution of lyoophilized antigen component Inject entire contents of syringe containing sterile water diluent into vial Do not remove empty syringe While holding plunger rod down, gently swirl vial in circular motion until powder is completely dissolved (<1 min) Do not shake Step 6 - Withdrawal of reconstituted vaccine Invert vial completely with vial adapter and syringe still attached Slowly withdraw entire contents into syringe to ensure ~0.5 mL dose of vaccine for administration Do not pull plunger rod out Step 7 - Disconnection of syringe Hold Luer lock adapter of syringe and disconnect syringe from vial adapter by turning counter-clockwise Step 8 - Attachement of new needle Attach sterile needle suitable for IM injection to syringe containing vaccine Step 9 - Visual inspection Solution should appear clear and colorless Inspect visually for particulate matter and discoloration Discard if either condition is present Store at room temperature and use within 4 hr after reconstitution IM Administration For IM injection only Storage Lyophilized antigen and diluent Refrigerated at 2-8ºC (36-46ºF) in original carton Do not freeze; discard if frozen Reconstituted solution If not administered immediately, store at room temperature up to 15-30ºC (59-86ºF) and use within 4 hr Do not store reconstituted vaccine in refrigerator Do not freeze reconstituted vaccine No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. Plans Select State: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Done Non-Medicare Plans Medicare Plans Done CLOSE Additional Offers CLOSE Email to Patient From: To: The recipient will receive more details and instructions to access this offer. By clicking send, you acknowledge that you have permission to email the recipient with this information. Send CLOSE Email Forms to Patient From: To: The recipient will receive more details and instructions to access this offer. By clicking send, you acknowledge that you have permission to email the recipient with this information. Send