Arexvy Adjuvant Component (Pf) (vaccine adjuvant system, AS01E/PF, component vial 1 of 2)
Intramuscular Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Respiratory syncytial virus (RSV) vaccine, adjuvanted is a protein subunit vaccine that stimulates active immunity to RSV infection; the vaccine is a recombinant RSV glycoprotein stabilized in pre-fusion F conformation (RSVpreF3) antigen with an ASO1E adjuvant (RSVpreF3-AS01).
Respiratory syncytial virus vaccine, adjuvanted (RSVpreF3-AS01) is a recombinant RSV glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) with AS01E adjuvant. The AS01E-based adjuvant is composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation.
RSVpreF3-AS01 stimulates an immune response against RSVPreF3 to protect against lower respiratory tract disease (LRTD) caused by RSV. RSV F glycoprotein (pre-fusion and post-fusion) mediates viral fusion and host-cell entry, elicits neutralizing antibodies, and is highly conserved across the 2 RSV subtypes (A and B). In animal studies, significantly higher neutralizing activity occurred following immunization with pre-fusion forms of the F protein antigen compared to post-fusion forms.
Following vaccination with AS01E-adjuvanted formulations, RSV-specific CD4+ T-cell frequencies increased in older adults to similar levels to those observed in young adults.
Generic name: vaccine adjuvant system, AS01E/PF, component vial 1 of 2
Therapeutic class: Chemicals-Pharmaceutical Adjuvants
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Arexvy Adjuvant Component (Pf)
Indications
No indications are available for this drug.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse reactions occurring in >=10% of individuals 60 years of age and older receiving RSVpreF3-AS01d were injection site pain, fatigue, myalgia, headache, and arthralgia.
The most common adverse reactions occurring in >=10% of individuals 50 through 59 years of age receiving RSVpreF3-AS01 were injection site pain, fatigue, myalgia, headache, arthralgia, erythema, and swelling.
The most common adverse reactions occurring in >=10% of individuals 18-49 years of age receiving RSVpreF3-AS01 were injection site pain, myalgia, fatigue, headache, and arthralgia.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Evidence from animal models strongly suggests that RSVpreF3-AS01 is unsafe in children <2 years of age because of an increased risk of enhanced respiratory disease. Safety and effectiveness of the vaccine in individuals 2 to 17 years of age have not been established.
There are no data from clinical trials on the use of RSVpreF3-AS01 in pregnant individuals.
In a randomized, controlled trial that enrolled pregnant individuals, preterm births were higher in those who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as RSVpreF3-AS01 compared with those who received placebo. The available data are insufficient to determine a causal relationship between preterm birth and RSVpreF3-AS01.
In an animal reproduction study, no adverse effects on female fertility or pre-weaning development up to postnatal day 35 were observed following IM administration of RSVpreF3-AS01 to female rabbits prior to mating and during gestation.
It is not known whether the vaccine is distributed into human milk; no human or animal data are available to assess vaccine effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition (the susceptibility to disease prevented by the vaccine).
In the principal efficacy study, 55.8% of patients were 60-69 years of age, 36% were 70-79 years of age, and 8.2% were >=80 years of age. Efficacy against RSV-related lower respiratory tract disease was 81% among participants 60 to 69 years of age and 93.8% among participants 70 to 79 years of age; insufficient cases were available to determine efficacy in patients >=80 years of age.
ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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