Dosing and uses of Fluad (influenza virus vaccine trivalent, adjuvanted)
Adult dosage forms and strengths
Not indicated (see Geriatric Dosing)
Pediatric dosage forms and strengths
Not indicated
Geriatric dosage forms and strengths
Adult dosage forms and strengths
suspension for IM injection
0.5mL/prefilled syringe
Influenza
Indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine for adults aged ≥65 yr
0.5 mL IM x1 dose
Dosing Considerations
Contains the following 3 viral strains for 2016-2017 northern hemisphere season:
A/California/7/2009 (H1N1)pdm09-like virus (same strain as was used for 2009 H1N1 monovalent vaccines)
A/Hong Kong/4801/2014 (H3N2)-like virus (new for 2016-2017)
B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus) (new for the trivalent vaccine for 2016-2017)
Fluad (influenza virus vaccine trivalent, adjuvanted) adverse (side) effects
>10%
Injection site pain (25%)
Injection site tenderness (21%)
Myalgia (15%)
Headache (13%)
Fatigue (13%)
1-10%
Arthralgia (8.5%)
Diarrhea (5%)
Fever (3.6%)
Nausea (3%)
Vomiting (1.4%)
Injection site erythema, induration, swelling (~1%)
Postmarketing Reports
Blood and lymphatic system disorders: Thrombocytopenia, some cases were severe with platelet counts <5,000 per mm³, lymphadenopathy
General disorders and administration site conditions: Extensive swelling of injected limb lasting more than 1 week, injection site cellulitislike reactions (some cases of swelling, pain, and redness extending >10 cm and lasting >1 week)
Immune system disorders: Allergic reactions including anaphylactic shock, anaphylaxis, and angioedema
Musculoskeletal and connective-tissue disorders: Muscular weakness
Nervous system disorders: Encephalomyelitis, Guillain-Barré syndrome, convulsions, neuritis, neuralgia, paraesthesia, syncope, presyncope
Skin and subcutaneous tissue disorders: Generalized skin reactions including erythema multiforme, urticaria, pruritus, or nonspecific rash
Vascular disorders: Vasculitis with transient renal involvement
Warnings
Contraindications
Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine
Cautions
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give the vaccine should be based on careful consideration of the potential benefits and risks; the 1976 swine influenza vaccine was associated with an elevated risk of GBS, although evidence for a causal relationship of GBS with other influenza vaccines is inconclusive
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine
The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
The immune response in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals
Syncope may occur in association with administration of injectable vaccines
May not protect all vaccine recipients against influenza disease
Drug interaction overview
- Data are not available to assess concomitant administration with other vaccines; if coadministered with other injectable vaccines, administer at different injection sites
- Immunosuppressive or corticosteroid therapies may reduce the immune response to the vaccine
Pregnancy and lactation
Not applicable
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 of Fluad (influenza virus vaccine trivalent, adjuvanted)
Mechanism of action
Vaccine contains inactivated influenza viruses (2 subtypes for A and 1 subtype for B) that are determined annually
Conveys active immunity via stimulation of production of endogenously produced antibodies
Manufactured using an egg-based process
It is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oiL
Squalene, a naturally occurring substance found in humans, animals, and plants, is highly purified for the vaccine manufacturing process
Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individuaL
Administration
IM Administration
Gently shake each syringe (vaccine is a milky-white suspension)
Inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit; if either condition exists, do not administer
Administer by IM injection, preferably in the region of the deltoid muscle of the upper arm
Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk
Storage
Refrigerate at 2-8°C (36-46°F)
Protect from light
Do not freeze; discard if the vaccine has been frozen
Do not use after expiration date
The tip caps of prefilled syringes contain natural rubber latex
The syringe and syringe plunger stopper are not made with natural rubber latex
