Abrysvo (respiratory syncytial virus vaccine, preF A and B/PF)

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Vaccines/Pariglasgene Brecaparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)

DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Vaccines/Hepatitis B Vaccine (Fendrix)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)

CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)

DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)

*History of severe allergic reaction (e.g., anaphylaxis) to any component of respiratory syncytial virus (RSV) vaccine.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Immunosuppression

The most common local and systemic adverse reactions in pregnant individuals (>=10%) were pain at the injection site, headache, muscle pain, and nausea.

The most common local and systemic adverse reactions in individuals >=60 years of age (>=10%) were fatigue, headache, pain at the injection site, and muscle pain.

The most common local and systemic adverse reactions in individuals 18-59 years of age (>=10%) were pain at the injection site, muscle pain, joint pain, and nausea.

Rare or Very Rare

• Guillain-barre syndrome

More Frequent

• Fatigue
• Headache disorder
• Injection site pain
• Myalgia

Less Frequent

• Arthralgia
• Chills
• Diarrhea
• Extensive limb swelling after injection
• Injection site erythema
• Nausea

Rare or Very Rare

• Anaphylaxis
• Skin rash
• Syncope
• Urticaria
• Vomiting

No enhanced messaging available.

The safety and effectiveness of RSV preF vaccine for prevention of RSV LRTD and severe RSV LRTD in infants born to individuals vaccinated at <10 years of age have not been established.

The safety and effectiveness of RSV vaccine to prevent RSV LRTD in non-pregnant individuals <18 years of age via active immunization have not been established.

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to RSV preF vaccine during pregnancy. Individuals who receive the vaccine during pregnancy are encouraged to contact, or have their healthcare provider contact 1-800-616-3791 to enroll in or obtain information about the registry.

In a randomized controlled trial that enrolled pregnant individuals, preterm births were higher in those who received RSV preF vaccine at 24 through 36 weeks' gestation compared to those who received placebo; however, available data are insufficient to establish or exclude a causal relationship to the drug. There was no evidence of a vaccine-associated increase in the risk of congenital anomalies or fetal deaths. To avoid the potential risk of preterm birth with use of RSV preF vaccine before 32 weeks of gestation, administer the vaccine as indicated in pregnant individuals at 32 through 36 weeks gestational age. RSV preF vaccine has not been studied in pregnant individuals <24 weeks gestational age, and those at increased risk for preterm birth.

Results of a developmental toxicity study in animals showed no evidence of fetal harm or adverse effects on postnatal survival, growth, or development.

It is not known whether RSV preF vaccine is excreted in human milk. Data are not available to assess the effects of the vaccine 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 the RSV preF vaccine and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition. For preventative vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

In the principal efficacy study of RSV preF vaccine in individuals 60 years of age and older and an additional study in immunocompromised adults >=18 years of age, 63% of the participants were 60-69 years of age, 32% were 70-79 years of age, and 5% were >=80 years of age.