influenza virus vaccine quadrivalent, cell-cultured (Rx)

>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

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

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.

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

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