Weight & Length
Less than 5 kg gets a _____ dose and 5kg or greater gets a ____ dose.
50 mg & 100 mg
BEYFORTUS must be administered by a:
Healthcare Provider
Most common adverse reactions are _______ (0.9%), and __________ (0.3%)
Rash & Injection Site Reactions
Incidence of MA RSV LRTI in Infants Born at ≥35 Weeks Through 150 Days Post Dose (Trial 04).
74.9%
BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) _____ respiratory tract disease in:
• ______________________ born during or entering their ______ RSV season.
• Children up to ____________ who remain vulnerable to severe RSV disease through their second RSV season.
lower & neonates and infants & first & 24 months.
For neonates and infants born during or entering the RSV season, administer BEYFORTUS starting from ______. For infants born outside the RSV season, administer BEYFORTUS _____ prior to the start of the RSV season considering duration of protection provided by BEYFORTUS.
birth & once
BEYFORTUS is available in a 50 mg and a 100 mg _____________. Check the labels on the BEYFORTUS carton and pre-filled syringe to ensure the correct 50 mg or 100 mg product is being used.
pre-filled syringes
BEYFORTUS is contraindicated in individuals with a history of serious - _______________________, including anaphylaxis, to nirsevimab-alip or to any of the excipients.
hypersensitivity reactions
In the second RSV season of Trial 05, there were ______ cases of MA RSV LRTI through Day 150 post-dose in subjects who received either BEYFORTUS or palivizumab.
NO
BEYFORTUS is a __________________________________________________.
Monoclonal antibody with anti-RSV activity
For children less than 24 months of age who remain at increased risk for severe RSV in their second RSV season, the recommended dosage of BEYFORTUS is a single _____ mg dose administered as ______ IM injections (2 x 100 mg).
200 mg dose & 2 IM injections.
_____________________ should not be administered to infants who have already received BEYFORTUS in the same season.
palivizumab
__________________________- Serious hypersensitivity reactions, including anaphylaxis, have been observed rarely with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.
Hypersensitivity including anaphylaxis
Incidence of MA RSV LRTI in Infants Born at ≥29 Weeks to <35 Weeks Through 150 Days Post Dose (Trial 03).
70.1%
BEYFORTUS (nirsevimab-alip) injection is a sterile, _______________, clear to opalescent, colorless to yellow solution for intramuscular injection
preservative-free
The typical length of an RSV season in days and months
5 months & 150 days
50mg PFS has a _____ color plunger rod.
100mg PFS has a ______ color plunger rod.
purple & light blue
_______________________________________- As with any other IM injections, BEYFORTUS should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
Use in Individuals with clinically significant bleeding disorders.
The safety and PK of BEYFORTUS were evaluated in a Phase 2/3 randomized, double-blind, palivizumab-controlled multicenter trial (Trial 05) in pediatric subjects born less than ___ weeks GA and infants with _____ of prematurity or hemodynamically significant _____.
35 & CLD & CHD
BEYFORTUS _______ be given concomitantly with childhood vaccines. When administered concomitantly with injectable vaccines, they should be given with ______________ and at _____________________. Do not _____ BEYFORTUS with any vaccines or medications in the same syringe or vial.
can & separate syringes & different injection sites & mix.
Store ______________ between 36°F to 46°F (2°C to 8°C). BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of _________. After removal from the refrigerator, BEYFORTUS must be used within _________ or discarded.
Refrigerated & 8 hours & 8 hours.
Administer the entire contents of the BEYFORTUS pre-filled syringe as an IM injection, preferably in the ___________________________.
anterolateral aspect of the thigh
For immunological assay results which are ___________ when clinical observations are consistent with RSV infection, it is recommended to confirm using an RT-PCR-based assay.
negative
In the first RSV season of Trial 05, the incidence of MA RSV LRTI through _____ days post dose was ______ (4/616) in the BEYFORTUS group and _______ (3/309) in the palivizumab group.
150 & 0.6% & 1.0%
Nirsevimab-alip is a recombinant human IgG1κ monoclonal antibody that provides ________ immunity by targeting the _____________ conformation of the RSV ____________. Nirsevimab-alip is long-acting due to a triple amino acid substitution (YTE) in the Fc region to extend serum half-life.
…it neutralizes RSV by inhibiting conformation changes in the F protein necessary for ________ of the viral and cellular membranes and viral entry.
passive & pre-fusion & protein & fusion