influenza virus vaccine quadrivalent, cell-cultured (Rx)

Brand and Other Names:Flucelvax Quadrivalent
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Dosing & Uses

AdultPediatricGeriatric

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 2020-2021 Northern Hemisphere season

  • A/Hawaii/70/2019 (H1N1)pdm09-like virus (new for 2020-2021)
  • A/Hong Kong/45/2019 (H3N2)-like virus (new for 2020-2021)
  • B/Washington/02/2019 (B/Victoria lineage)-like virus (new for 2020-2021)
  • 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

<4 years: Safety and efficacy not established

≥9 years: 0.5 mL IM x1 dose/season

4 to <9 years

  • Not previously vaccinated, has not received ≥2 doses during the same or different seasons, or status unknown: 0.5 mL IM x 2 doses administered at least 4 weeks apart
  • Vaccinated with ≥2 doses during the same or different seasons: 0.5 mL IM x 1 dose

Dosing Considerations

Contains the following 4 viral strains for 2020-2021 Northern Hemisphere season

  • A/Hawaii/70/2019 (H1N1)pdm09-like virus (new for 2020-2021)
  • A/Hong Kong/45/2019 (H3N2)-like virus (new for 2020-2021)
  • B/Washington/02/2019 (B/Victoria lineage)-like virus (new for 2020-2021)
  • 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 2020-2021 Northern Hemisphere season

  • A/Hawaii/70/2019 (H1N1)pdm09-like virus (new for 2020-2021)
  • A/Hong Kong/45/2019 (H3N2)-like virus (new for 2020-2021)
  • B/Washington/02/2019 (B/Victoria lineage)-like virus (new for 2020-2021)
  • B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
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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

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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

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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.

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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

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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

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.