Dosing & Uses
Dosage Forms & Strengths
IM suspension
- 0.5mL single-dose prefilled syringe
- 5mL multidose vial
Influenza Prophylaxis
Inactivated vaccine indicated for active immunization to prevent influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
0.5 mL IM x1 dose/season
Dosing Considerations
Contains the following 4 viral strains for 2023-2024 Northern Hemisphere season
- A/Wisconsin/67/2022 (H1N1)pdm09-like virus (new for 2023-2024)
- A/Darwin/6/2021 (H3N2)-like virus (no change from last season)
- B/Austria/1359417/2021 (B/Victoria lineage)-like virus (no change from last season)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
Dosage Forms & Strengths
IM suspension
- 0.5mL single-dose prefilled syringe
- 5mL multidose vial
Influenza Prophylaxis
Inactivated vaccine indicated for active immunization to prevent influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
<6 months: Safety and efficacy not established
≥9 years: 0.5 mL IM x1 dose/season
6 months to 8 years
- 0.5 mL IM x1-2 dose(s)/season
-
Children requiring 2 doses
- Have never received seasonal influenza vaccine or for whom vaccination history is unknown
- Have not received at least 2 doses of seasonal influenza vaccine (trivalent or quadrivalent) before previous July 1
- Doses do not need to have been received during the same or consecutive influenza seasons
Dosing Considerations
Contains the following 4 viral strains for 2023-2024 Northern Hemisphere season
- A/Wisconsin/67/2022 (H1N1)pdm09-like virus (new for 2023-2024)
- A/Darwin/6/2021 (H3N2)-like virus (no change from last season)
- B/Austria/1359417/2021 (B/Victoria lineage)-like virus (no change from last season)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
Influenza Prophylaxis
Inactivated vaccine indicated for active immunization to prevent influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
0.5 mL IM x1 dose/season
In clinical trials, antibody responses were lower in the geriatric population than in younger subjects
Dosing Considerations
Contains the following 4 viral strains for 2022-2023 Northern Hemisphere season
- A/Wisconsin/67/2022 (H1N1)pdm09-like virus (new for 2023-2024)
- A/Darwin/6/2021 (H3N2)-like virus (no change from last season)
- B/Austria/1359417/2021 (B/Victoria lineage)-like virus (no change from last season)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
Adverse Effects
>10%
Aged ≥65 yr
- Injection site pain (21.6%)
- Injection site erythema (11.9%)
Aged 18-64 yr
- Injection site pain (45.4%)
- Headache (18.7%)
- Fatigue (17.8%)
- Myalgia (15.4%)
- Injection site erythema (13.4%)
- Induration (11.9%)
Aged 9-17 yr
- Injection site pain (58%)
- Headache (22%)
- Injection site erythema (19%)
- Fatigue (18%)
- Myalgia (16%)
- Induration (15%)
- Aged 6-8 yr H4
- Injection site pain (54%)
- Injection site erythema (22%)
- Induration (16%)
- Headache (14%)
- Fatigue (13%)
- Myalgia (12%)
Aged 4-5 yr
- Tenderness at injection site (46%)
- Injection site erythema (18%)
- Sleepiness (19%)
- Irritability (16%)
- Induration (13%)
1-10%
Aged ≥65 yr
- Headache (9.3%)
- Fatigue (9.1%)
- Induration (8.7%)
- Myalgia (8.2%)
- Arthralgia (5.5%)
- Injection site ecchymosis (4.7%)
- Chills (4.4%)
- Diarrhea (4.3%)
- Loss of appetite (4%)
- Nausea (3.8%)
Aged 18-64 yr
- Nausea (9.7%)
- Loss of appetite (8.3%)
- Arthralgia (8.1%)
- Diarrhea (7.4%)
- Chills (6.2%)
- Injection site ecchymosis (3.8%)
- Vomiting (2.6%)
Aged 9-17 yr
- Nausea (9%)
- Loss of appetite (9%)
- Chills (7%)
- Arthralgia (6%)
- Injection site ecchymosis (4%)
- Diarrhea (4%)
- Vomiting (2%)
- Fever (1%)
Aged 6-8 yr
- Injection site ecchymosis (9%)
- Loss of appetite (9%)
- Nausea (8%)
- Chills (4%)
- Arthralgia (4%)
- Fever (4%)
- Vomiting (3%)
- Diarrhea (3%)
Aged 4-5 yr
- Change in eating habits (10%)
- Injection site ecchymosis (9%)
- Chills (5%)
- Vomiting (4%)
- Diarrhea (4%)
- Fever (4%)
<1%
Aged ≥65 yr
- Vomiting (0.9%)
- Fever (0.3%)
Aged 18-64 yr
- Fever (0.8%)
Postmarketing Reports
Immune system disorders: Allergic or immediate hypersensitivity reactions, including anaphylactic shock
Nervous systems disorders: Syncope, presyncope, paresthesia
Skin and subcutaneous tissue disorders: Generalized skin reactions including pruritus, urticaria, or nonspecific rash
General disorders and administration site conditions: Extensive swelling of injected limb
Warnings
Contraindications
History of allergic reaction to any component of the vaccine
Cautions
The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barré syndrome (GBS); evidence for a causal relationship of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is estimated to be slightly more than 1 additional case per 1 million persons vaccinated
Assure availability of appropriate medical treatment and supervision to manage possible anaphylactic shock
Syncope can occur in association with administration of injections; procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position
Immunocompromised individuals, including those receiving immunosuppressive therapy, may have reduced immune response to vaccine
Vaccination may not protect all vaccine recipients against influenza disease
Pregnancy & Lactation
Pregnancy
There are insufficient data on influenza vaccine in pregnant females to inform vaccine-associated risk
Pregnancy exposure registry
- Monitors pregnancy outcomes in women exposed to influenza vaccine during pregnancy
- Register by calling 1-855-358-8966 or sending an email to Seqirus at us.medicalinformation@seqirus.com
Animal data
- No adverse effects observed on preweaning or vaccine-related fetal malformations when administered to female rabbits before pregnancy or during pregnancy
Clinical considerations
- Pregnant females are at increased risk of complications associated with influenza infection compared with nonpregnant females
- The CDC recommends pregnant females be immunized with influenza vaccine by injection and not the live-attenuated influenza vaccine (LAIV; intranasal influenza vaccine)
- Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to 50%; immunization also confers some immunity to infants for the first several months after their birth, when they are too young to be vaccinated
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy 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.Pharmacology
Mechanism of Action
Cell-derived (ie, egg-free) vaccine that contains inactivated influenza virus types A and B subunits
Conveys active immunity via stimulation of production of endogenously produced antibodies
Pharmacokinetics
Onset: ~2 weeks
Duration: Several months
Effectiveness: Varies seasonally, depending on viral strain and mutations; lower antibody response in patients aged >65 yr or immunosuppressed individuals
Administration
IM Preparation
Visually inspect for particulate matter and discoloration before administration; if either condition exists, discard vaccine
Shake syringe vigorously before administering
Multidose vial
- Shake multidose vial preparation each time before withdrawing a dose
- Use a separate sterile syringe and needle for each injection to prevent transmission of infectious agents from one person to another
- Use small syringes (0.5-1 mL) to minimize any product loss
IM Administration
Do not administer IV, intradermally (ID), or SC
Administer IM in deltoid muscle
Storage
Refrigerate at 2-8ºC (36-46ºF)
Between uses, return multidose vial to refrigerator
Do not freeze; discard vaccine that has been frozen
Images
Formulary
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