Afluria Quadrivalent

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Afluria Quadrivalent Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Quadrivalent, inactivated, "split virion" influenza vaccine (Types A and B); 0.25mL dose contains a total of 30mcg hemagglutinin; 0.5mL dose contains a total of 60mcg hemagglutinin; formulation changes annually; susp for IM inj; may contain trace amounts of neomycin sulfate, polymyxin B.

    Pharmacological Class

    Influenza vaccine.

    How Supplied

    Single-dose prefilled syringe 0.5mL (preservative-free)—10 (without needles); Multi-dose vial 5mL (contains thimerosal)—1

    Storage

    • Store refrigerated at 2−8°C (36−46°F). Do not freeze. Discard if product has been frozen. 

    • Do not use beyond the expiration date printed on the label.

    • Once the stopper of the multi-dose vial has been pierced, the vial must be discarded within 28 days. The number of needed punctures should not exceed 20 per multi-dose vial.

    Manufacturer

    Seqirus

    Generic Availability

    NO

    Mechanism of Action

    Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change to one or more new strains in each year's influenza vaccine. Therefore, inactivated influenza vaccines are standardized to contain the HA of four strains (ie, typically two type A and two type B) representing the influenza viruses likely to be circulating in the U.S. during the upcoming winter.

    Afluria Quadrivalent Indications

    Indications

    Influenza immunization.

    Afluria Quadrivalent Dosage and Administration

    Adults and Children

    <6mos: not established. Give by IM inj once in the anterolateral thigh (6–11mos) or in the deltoid (≥12mos). May be administered by needle and syringe (≥6mos) or PharmaJet Stratis Needle-Free Injection System (18–64yrs only); see full labeling. If 2 doses, give at least 1 month apart. 6–35mos: 1 or 2 doses (0.25mL) depending on vaccination history as per annual ACIP recommendation. 36mos–8yrs: 1 or 2 doses (0.5mL) depending on vaccination history as per annual ACIP recommendation. ≥9yrs: 1 dose (0.5mL).

    Adults and Children

    Afluria Quadrivalent is not established for patients less than 6 months of age.

    For intramuscular (IM) use only.

    • By needle and syringe (6 months of age and older)

    • By PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years of age)

    The dose and schedule for Afluria Quadrivalent are as follows:

    • If 2 doses, give at least 1 month apart.

    • 6–35 months of age: 1 or 2 doses (0.25mL each) depending on vaccination history as per annual ACIP recommendation.

    • 36 months –8  years: 1 or 2 doses (0.5mL each) depending on vaccination history as per annual ACIP recommendation. 

    • 9 years and older: 1 dose (0.5mL).

    The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the upper arm if muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle of the upper arm in persons ≥ 36 months of age.

    Administration

    Immediately before use, shake thoroughly and inspect visually.

    • Needle and Syringe: Draw up the exact dose using a separate sterile needle and syringe for each individual patient. It is recommended that small syringes (0.5 mL or 1 mL) be used to minimize any product loss.

    • PharmaJet Stratis Needle-Free Injection System: For instructions on withdrawal of a 0.5 mL dose and use of the PharmaJet Stratis Needle-Free Injection System, refer to the Instructions For Use for the PharmaJet Stratis Needle-Free Injection System.

    The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the upper arm if muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle of the upper arm in persons ≥ 36 months of age.

    Afluria Quadrivalent Contraindications

    Contraindications

    Severe allergy to egg protein, or after a previous dose of any flu vaccine.

    Afluria Quadrivalent Boxed Warnings

    Not Applicable

    Afluria Quadrivalent Warnings/Precautions

    Warnings/Precautions

    Use current formulation only. Have appropriate medical treatment and supervision readily available. Guillain-Barre syndrome within 6 weeks of previous flu vaccine. Immunocompromised. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Guillain-Barré Syndrome

    • Carefully consider the potential benefits and risks to give Afluria Quadrivalent if Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination.

    • Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.

    Preventing and Managing Allergic Reactions

    • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

    Altered Immunocompetence

    • Immune response may be diminished if Afluria Quadrivalent is given to immunocompromised individuals, including those receiving immunosuppressive therapy.

    Limitations of Vaccine Effectiveness

    • Afluria Quadrivalent may not protect all individuals.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Afluria Quadrivalent during pregnancy. Women who are vaccinated with Afluria Quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to Seqirus at [email protected]. 

    Risk summary

    • Data for Afluria (trivalent formulation) administered to pregnant women are relevant to Afluria Quadrivalent. 

    • There are limited data for Afluria Quadrivalent administered to pregnant women, and available data for Afluria (trivalent formulation) administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

    Clinical Considerations

    • Disease-associated Maternal and/or Embryo-Fetal Risk: Pregnant women are at increased risk for severe illness due to influenza compared to nonpregnant women. Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.

    Nursing Mother Considerations

    Risk Summary

    • It is not known whether Afluria Quadrivalent is excreted in human milk.

    • Consider the developmental and health benefits of breastfeeding with the mother’s clinical need for Afluria Quadrivalent and any potential adverse effects on the breastfed child from Afluria Quadrivalent or from the underlying maternal condition.

    Pediatric Considerations

    • Safety and efficacy of Afluria Quadrivalent in persons less than 6 months of age have not been established. 

    • The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering Afluria Quadrivalent to children and adolescents less than 18 years of age due to lack of adequate data supporting safety and effectiveness in this population.

    Geriatric Considerations

    • The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering Afluria Quadrivalent to adults 65 years of age and older due to lack of adequate data supporting safety and effectiveness in this population. 

    Afluria Quadrivalent Pharmacokinetics

    See Literature

    Afluria Quadrivalent Interactions

    Interactions

    Concomitant vaccines: insufficient data (see full labeling). Immunosuppressants: may get suboptimal response.

    Afluria Quadrivalent Adverse Reactions

    Adverse Reactions

    Local reactions (eg, tenderness, redness, swelling, pain, itching, bruising), headache, myalgia, malaise, fatigue, irritability, diarrhea, loss of appetite.

    Adverse Reactions

    The most common reported injection-site adverse reaction and systemic adverse event(s) with Afluria Quadrivalent administered by needle and syringe:

    • Children 6 months through 35 months of age: pain and redness (≥ 20%); irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).

    • Children 36 months through 59 months of age: pain (≥ 30%) and redness (≥ 20%); malaise and fatigue, and diarrhea (≥ 10%).

    • Children 5 through 8 years of age: pain (≥ 50%) and redness and swelling (≥ 10%); headache (≥ 10%).

    • Children 9 through 17 years of age: pain (≥ 50%) and redness and swelling (≥ 10%); headache, myalgia, and malaise and fatigue (≥ 10%).

    • Adults 18–64 years of age: pain (≥ 40%); myalgia and headache (≥ 20%).

    • Adults ≥ 65 years of age and older: pain (≥ 20%); myalgia (≥ 10%).

    The safety experience with Afluria (trivalent formulation) is relevant to Afluria Quadrivalent. The most common reported injection-site adverse reaction and systemic adverse event(s) with Afluria (trivalent formulation) using the PharmaJet Stratis Needle-Free Injection System:

    • Adults 18 through 64 years of age: tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%), and bruising (≥ 10%); myalgia, malaise (≥ 30%), and headache ( ≥ 20%).

    Afluria Quadrivalent Clinical Trials

    Clinical Trials

    Efficacy Against Laboratory-Confirmed Influenza

    • The efficacy of Afluria (trivalent formulation) is relevant to Afluria Quadrivalent. 

    • The efficacy of Afluria (trivalent formulation) was based on the randomized, observer-blind, placebo-controlled Study 5 which included 15,044 participants 18 to 64 years of age. Participants were randomly assigned 2:1 to receive a single dose of Afluria (trivalent formulation) or placebo.

    • Laboratory-confirmed influenza was assessed by active and passive surveillance of influenza-like illness (ILI) beginning 2 weeks post-vaccination until the end of the influenza season, approximately 6 months post-vaccination. ILI was defined as at least one respiratory symptom (e.g., cough, sore throat, nasal congestion) and at least one systemic symptom (e.g., oral temperature of 100.0ºF or higher, feverishness, chills, body aches). 

    • Vaccine efficacy of Afluria against laboratory-confirmed influenza infection due to influenza A or B virus strains contained in the vaccine was 60% with a lower limit of the 95% CI of 41%.

    • Vaccine efficacy of Afluria against laboratory-confirmed influenza infection due to any influenza virus strains was 42% with a lower limit of the 95% CI of 28%.

    Immunogenicity of Afluria Quadrivalent in Adults and Older Adults Administered by Needle and Syringe

    • Study 1 was a randomized, double-blind, active-controlled trial conducted in the US in adults aged 18 years of age and older. Participants received 1 dose of either Afluria Quadrivalent (N=1691) or 1 of 2 formulations of comparator trivalent influenza vaccine (Afluria, trivalent) each containing an influenza type B virus.

    • The co-primary endpoints were HI Geometric Mean Titer (GMT) ratios (adjusted for baseline HI titers) and the difference in seroconversion rates for each vaccine strain, 21 days after vaccination.

    • Serum H1 antibody responses to Afluria Quadrivalent were noninferior to both trivalent (TIV) formulations  for all influenza strains for individuals 18 years of age and older. Noninferiority was also shown to both endpoints in both age subgroups, adults 18–64 years and 65 years and older, for all strains.

    • Afluria Quadrivalent showed superior immune responses to each of the influenza B strains relative to the antibody response after TIV formulations not containing that B lineage strain for individuals 18 years of age and older. Afluria Quadrivalent was superior against the alternate B strain for each of the influenza B strains in both age subgroups.

    Immunogenicity of Afluria (trivalent formulation) Administered by PharmaJet Stratis Needle-Free Injection System

    • Study 2 was a randomized, comparator-controlled, non-inferiority study enrolled 1250 adults 18 through 64 years of age. The study evaluated the immune response following administration of Afluria (trivalent formulation) when delivered intramuscularly using either the PharmaJet Stratis Needle-Free Injection System or needle and syringe.

    • The co-primary endpoints were HI GMT ratios for each vaccine strain and the absolute difference in seroconversion rates for each vaccine strain 28 days after vaccination.

    • The PharmaJet Stratis Needle-Free Injection System demonstrated noninferiority to administration via needle and syringe. The PharmaJet Stratis Needle-Free Injection System also elicited higher immunological responses in younger patients (18 to 49 years) vs older patients (50 to 64 years).

    Immunogenicity of Afluria Quadrivalent in Children 5 through 17 Years Administered by Needle and Syringe

    • Study 3 was a randomized, observer-blinded, comparator-controlled trial conducted in the US in 2278 children 5 through 17 years of age. Patients were randomly assigned 3:1 to receive 1 or 2 doses of Afluria Quadrivalent or a US licensed comparator quadrivalent influenza vaccine. Patients 5 to 8 years of age were eligible to receive a second dose at least 28 days after the first dose depending on their influenza vaccination history.

    • The co-primary endpoints were HI Geometric Mean Titer (GMT) ratios (adjusted for baseline HI titers and other covariates) and seroconversion rates for each vaccine strain, 28 days after the last vaccination.

    • Serum HI antibody responses to Afluria Quadrivalent were noninferior for both GMT ratio and seroconversion rates relative to the comparator vaccine for all influenza strains.

    Immunogenicity of Afluria Quadrivalent  in Children 6 Months through 59 Months Administered by Needle and Syringe

    • Study 4 was a randomized, observer-blind, comparator-controlled trial conducted in the US in 2247 children 6 months through 59 months of age. Patients were randomly assigned 3:1 to receive Afluria Quadrivalent or a US-licensed comparator quadrivalent influenza vaccine.

    • Children 6 months to 35 months received 1 or 2 doses (0.25mL each) and children 36 months to 59 months received 1 or 2 doses (0.5mL each). Patients were eligible to receive a second dose at least 28 days after the first dose based on their influenza vaccination history.

    • The co-primary endpoints were HI GMT ratios for each vaccine strain and the absolute difference in seroconversion rates for each vaccine strain 28 days after vaccination.

    • Serum HI antibody responses to Afluria Quadrivalent were noninferior for both GMT ratio and seroconversion rates relative to the comparator vaccine for all influenza strains.

    Afluria Quadrivalent Note

    Not Applicable

    Afluria Quadrivalent Patient Counseling

    Patient Counseling

    • Inform the vaccine recipient or guardian of the potential benefits and risks of immunization with Afluria Quadrivalent. 

    • Ιnform the vaccine recipient or guardian that Afluria Quadrivalent is an inactivated vaccine that cannot cause influenza but stimulates the immune system to produce antibodies that protect against influenza, and that the full effect of the vaccine is generally achieved approximately 3 weeks after vaccination. 

    • Instruct the vaccine recipient or guardian to report any severe or unusual adverse reactions to their healthcare provider. 

    • Encourage women who receive Afluria Quadrivalent while pregnant to enroll in the pregnancy registry. Pregnant women can enroll in the pregnancy registry by calling 1-855-358-8966 or sending an email to Seqirus at [email protected]. 

    • Provide the vaccine recipient Vaccine Information Statements prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). 

    • Instruct the vaccine recipient that annual revaccination is recommended.

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