- April 6, 2023
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Brand Name :
Abrysvo
Synonyms :
respiratory syncytial virus (RSV) vaccine
Class :
Vaccines, Inactivated
Brand Name :
Abrysvo
Synonyms :
respiratory syncytial virus (RSV) vaccine
Class :
Vaccines, Inactivated
Dosage Forms & Strengths
Injection kit, lyophilized antigen component and sterile water diluent
Once reconstitution done, each dose of 0.5 ml contains 120 mcg of respiratory syncytial virus stabilized prefusion F proteins
respiratory Syncytial Virus (RSV)
Administer dose of 0.5 ml intramuscularly as a single dose
Dosing Considerations
Limitation of effectiveness: all vaccine individuals may not be protected
Safety and efficacy not determined
Refer to adult dosing
may increase the immunosuppressive effect of Immunosuppressants
may increase the immunosuppressive effect of Immunosuppressants
may increase the immunosuppressive effect of Immunosuppressants
may increase the immunosuppressive effect of Immunosuppressants
may increase the immunosuppressive effect of Immunosuppressants
May decrease the diagnostic effect when combined with tuberculin Tests
May decrease the diagnostic effect when combined with tuberculin Tests
may decrease the therapeutic effect of Immunosuppressants
may decrease the therapeutic effect of Immunosuppressants
may decrease the therapeutic effect when combined
acetaminophen/doxylamine/dextromethorphan
may decrease the therapeutic effect of acetaminophen
may diminish the therapeutic effect of immunosuppressants
may increase the immunosuppressive effect of Immunosuppressants
tixagevimab and cilgavimab (Investigational)
may decrease the therapeutic effect of COVID-19 Vaccines
may decrease the therapeutic effect of immunosuppressants
may decrease the therapeutic effect when combined with Vaccines
may decrease the therapeutic effect when combined with Vaccines
may decrease the therapeutic effect when combined with Vaccines
may decrease the therapeutic effect when combined with Vaccines
may decrease the therapeutic effect when combined with Vaccines
lansoprazole, amoxicillin, and clarithromycin
may decrease the therapeutic effect when combined with vaccine
may decrease the therapeutic effect when combined with vaccine
may decrease the therapeutic effect when combined with vaccine
may decrease the therapeutic effect when combined with vaccine
may decrease the therapeutic effect when combined with vaccine
may have a decreased therapeutic effect of influenza virus vaccines
may have a decreased therapeutic effect of influenza virus vaccines
may have a decreased therapeutic effect of influenza virus vaccines
The potential efficacy of vaccines may be reduced. (Inactivated/Non-Replicating)
fingolimod may diminish the therapeutic effect of vaccines (Inactivated/Non-Replicating)
may increase the toxic effect of Immunosuppressants
immunosuppressants decrease the efficacy of vaccines
immunosuppressants decrease the efficacy of vaccines
immunosuppressants decrease the efficacy of vaccines
immunosuppressants decrease the efficacy of vaccines
immunosuppressants decrease the efficacy of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may reduce the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may diminish the therapeutic effect of vaccines
may decrease the therapeutic effect of Immunosuppressants
Actions and Spectrum:
In order to create antibodies against the virus, the respiratory syncytial virus vaccine stimulates the immune system. This aids in either preventing RSV infection or lessening the severity of symptoms if it does. The vaccine may also reduce the possibility of the virus spreading from an infected person to another person.
The RSV vaccine’s range is specialised to the RSV virus, which is a frequent cause of respiratory tract infections in kids, especially those under two years old. The RSV strains, particularly the A and B subtypes of the virus, that are most frequently linked to severe illness, hospitalisation, and mortality, are among those against which the vaccine is intended to provide defence.
Frequency defined
1-10%
Injection site pain, mild (9.4%)
Joint pain, any (7.5%)
Diarrhea, any (5.9%)
Fatigue, mild (9.3%)
Diarrhea, mild (4.4%)
Headache, moderate (3.7%)
Joint pain, mild (4.5%)
Muscle pain, moderate (3.5%)
Injection site pain, moderate (1.1%)
Redness, mild (1.5%)
Diarrhea, moderate (1.3%)
Redness, moderate (1.1%)
Joint pain, moderate (2.9%)
Fever, ≥38ºC (1.4%)
Redness, any (2.7%)
Nausea, any (3.4%)
Muscle pain, mild (6.5%)
Headache, mild (9%)
Nausea, mild (2.5%)
Swelling, mild (1.5%)
Fatigue, moderate (5.9%)
>10%
Injection site pain, any (10.5%)
Muscle pain, any (10.1%)
Fatigue, any (15.5%)
Headache, any (12.8%)
<1%
Nausea, mild (0.7%)
Swelling, moderate (0.9%)
Diarrhea, severe (0.1%)
Headache, severe (0.1%)
Swelling, severe (0.1%)
Joint pain, severe (<0.1%)
Fever >38.9-40ºC (<0.1%)
Redness, severe (0.1%)
Fever 38-38.4ºC (0.6%)
Injection site pain, severe (<0.1%)
Muscle pain, severe (0.2%)
Nausea, moderate (0.2%)
Fever >38.4-38.9ºC (0.8%)
Nausea, moderate (0.9%)
Fatigue, severe (0.3%)
Black Box Warning:
None
Contraindication
Caution
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
Immune systems are induced by RSV vaccine to develop antibodies against the virus. This immune response works to stave against RSV infection or, if it does, lessen the severity of symptoms.
A little portion of the virus possibly a protein or a bit of genetic material that stimulates an immune response may be included in the RSV vaccine. The immune system is trained to detect and respond to RSV in the future because to this antigen presentation.
Pharmacodynamics:
Immune systems are induced by RSV vaccine to develop antibodies against the virus. The immune system produces antibodies, which are proteins, in response to a particular antigen (such as a viral protein). Induction of RSV-specific antibodies by RSV vaccine is anticipated to help prevent RSV infection or lessen the severity of symptoms if infection does occur.
Pharmacokinetics:
Absorption
RSV vaccines are often given intravenously, bypassing the digestive system and going straight to the circulation. The formulation of the vaccine, the place of injection, and the recipient’s immunological response are only a few examples of the variables that may affect the speed and degree of absorption.
Distribution
The RSV vaccine is delivered to numerous tissues and organs all over the body after it has entered the circulation. Factors including the vaccine’s composition and the recipient’s immunological response may have an impact on how the vaccine is administered.
Metabolism
Immune systems are induced by RSV vaccine to develop antibodies against the virus. Although the body does not metabolize the vaccine itself, the immunological response it induces may include intricate metabolic processes.
Elimination and Excretion
It is not anticipated that RSV vaccine would stay in the body for a very long time. Instead, the immunological response brought on by the vaccination may offer months or even years of protection against RSV infection.
Administration:
Injections are often used to give RSV vaccine. Depending on the vaccine composition, the injection may be administered intramuscularly or subcutaneously.
Patient information leaflet
Generic Name: respiratory syncytial virus (RSV) vaccine
Why do we use respiratory syncytial virus (RSV) vaccine?
RSV is a frequent cause of respiratory disease in young children, and a potent vaccine might help in reducing the number of hospitalizations and illnesses attributable to RSV.
An additional layer of protection from a severe RSV infection may be offered by an RSV vaccine for infants who were born prematurely or who have certain underlying medical issues.