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Fluarix

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Fluarix

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. There is the possibility that broad use of FLUARIX could reveal adverse reactions not observed in clinical trials.

Adults

In adults, the most common ( ≥ 10%) local adverse reactions and general adverse events observed with FLUARIX were pain and redness at the injection site, muscle aches, fatigue, and headache.

FLUARIX has been administered to 10,317 adults 18 through 64 years of age and 606 subjects 65 years of age and older in 4 clinical trials.

One of the 4 clinical trials was a randomized, double-blind, placebo-controlled study that evaluated a total of 952 subjects: FLUARIX (N = 760) and placebo (N = 192). The population was 18 through 64 years of age (mean 39.1), 54% were female and 80% were white. Solicited events were collected for 4 days (day of vaccination and the next 3 days) (Table 2). Unsolicited events that occurred within 21 days of vaccination (day 0-20) were recorded using diary cards supplemented by spontaneous reports and a medical history as reported by subjects.

Table 2: Incidence of Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of Vaccination in Adults 18 Through 64 Years of Ageb (Total Vaccinated Cohort)

  FLUARIX
N = 760
%
Placebo
N = 192
%
Local Adverse Reactions
Pain 55 12
Redness 18 10
Swelling 9 6
General Adverse Events
Muscle aches 23 12
Fatigue 20 18
Headache  19 21
Arthralgia 6 6
Shivering 3 3
Fever ≥ 100.4°F (38.0°C) 2 2
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.
a 4 days included day of vaccination and the subsequent 3 days.
b NCT00100399.

Unsolicited adverse events that occurred in ≥ 1% of recipients of FLUARIX and at a rate greater than placebo included upper respiratory tract infection (3.9% versus 2.6%), nasopharyngitis (2.5% versus 1.6%), nasal congestion (2.2% versus 2.1%), diarrhea (1.6% versus 0%), influenza-like illness (1.6% versus 0.5%), vomiting (1.4% versus 0%), and dysmenorrheal (1.3% versus 1.0%).

A randomized, single-blind, active-controlled US study evaluated subjects randomized to receive FLUARIX (N = 917) or FLUZONE (N = 910), a US-licensed trivalent, inactivated influenza virus vaccine (Sanofi Pasteur SA) stratified by age: 18 through 64 years and 65 years of age and older. In the overall population, 59% of subjects were female and 91% were white. Solicited events were collected using diary cards for 4 days (day of vaccination and the next 3 days) (Table 3). Unsolicited events that occurred within 21 days of vaccination (day 0-20) were recorded using diary cards.

Table 3: Incidence of Solicited Local Adverse Reactions or General Adverse Events in Adults Within 4 Daysa of Vaccination With FLUARIX or Comparator Influenza Vaccine by Age Groupb (Total Vaccinated Cohort)

  18 Through 64 Years of Age 65 Years of Age and Older
FLUARIX
N = 315
%
Comparator Influenza Vaccine
N = 314
%
FLUARIX
N = 601-602
%
Comparator Influenza Vaccine
N = 596
%
Local Adverse Reactions
Pain 48 53 19 18
Redness 13 16 11 13
Swelling 9 11 6 9
General Adverse Events
Fatigue 21 18 9 10
Headache 20 21 8 8
Muscle aches 16 13 7 7
Arthralgia 9 9 6 5
Shivering 3 5 2 2
Fever ≥ 99.5 °F (37.5°C) 3 1 2 1
Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.
a 4 days included day of vaccination and the subsequent 3 days.
b NCT00197288.

Unsolicited adverse events that occurred in ≥ 1% of all recipients of FLUARIX or the comparator influenza vaccine in the 21-day post-vaccination period included headache (2.8% versus 2.3%), back pain (1.5% versus 0.4%), pain in extremity (1.2% versus 0.7%), pharyngolaryngeal pain (1.2% versus 0.9%), cough (1.1% versus 0.9%), fatigue (1.1% versus 0.7%), nasopharyngitis (1.0% versus 1.3%), nausea (0.4% versus 1.0%), arthralgia (0.3% versus 1.0%), and injection site pruritus (0.2% versus 1.0%).

A double-blind, placebo-controlled study in subjects 18 through 64 years of age randomized (2:1) to receive FLUARIX (N = 5,103) or placebo (N = 2,549) was conducted to evaluate the efficacy of FLUARIX. In the total population, 60% were female and 99.9% were white. In a subset (FLUARIX [N = 305] and placebo [N = 155]), unsolicited events that occurred within 21 days of vaccination (day 0-20) were recorded on diary cards. The percentage of subjects reporting at least one unsolicited event was similar among the groups (24.3% for FLUARIX and 22.6% for placebo). Unsolicited adverse events that occurred in ≥ 1% of recipients of FLUARIX and at a rate greater than placebo included injection site pain (5.2% versus 1.3%), dysmenorrhea (1.3% versus 0.6%), and migraine (1.0% versus 0.0%).

Incidence of Adverse Events Reported in ≥ 1% of Subjects in Non-US Clinical Trials: The following additional adverse events have been observed in adults in non-US clinical trials with FLUARIX. No adverse events were observed at an incidence of > 10%.

General Disorders and Administration Site Conditions: Injection site ecchymosis, injection site induration, malaise.

Infections and Infestations: Rhinitis.

Musculoskeletal and Connective Tissue Disorders: Musculoskeletal pain, neck pain.

Skin and Subcutaneous Tissue Disorders: Sweating.

Serious Adverse Events: In the 4 clinical trials in adults (N = 10,923), there was a single case of anaphylaxis reported with FLUARIX ( < 0.01%).

Children

In children 5 years through 17 years of age, the most common ( ≥ 10%) local and general adverse events were similar to those in adults but also included swelling at the injection site. In children 3 years through 4 years of age, the most common ( ≥ 10%) local and general adverse events included pain, redness, and swelling at the injection site, irritability, loss of appetite, and drowsiness.

A single-blind, active-controlled US study evaluated subjects 6 months through 17 years of age who received FLUARIX (N = 2,081) or FLUZONE (N = 1,173), a US-licensed trivalent, inactivated influenza virus vaccine (Sanofi Pasteur SA) (Study 005). Children 6 months through 8 years of age with no history of influenza vaccination received 2 doses approximately 28 days apart. Children 6 months through 8 years of age with a history of influenza vaccination and children 9 years of age and older received 1 dose. Children 6 months through 35 months of age received 0.25 mL of FLUARIX or comparator influenza vaccine, and children 3 years of age and older received 0.5 mL of FLUARIX or comparator influenza vaccine.

Study subjects were 6 months through 17 years of age and 49% were female; 68% were white, 18% were black, 3% were Asian, and 11% were of other racial/ethnic groups.

Solicited local and general adverse events were collected using diary cards for 4 days (day of vaccination and the next 3 days). Unsolicited adverse events that occurred within 28 days of vaccination (day 0-27) after the first vaccination in all subjects and 21 days (day 0-20) after the second vaccination in unprimed subjects were recorded using diary cards.

The frequencies of solicited adverse events for children 3 years through 4 years of age and for children 5 years through 17 years of age were similar for FLUARIX and the comparator vaccine (Table 4).

Table 4: Incidence of Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of First Vaccination With FLUARIX or Comparator Influenza Vaccine by Age Group in Children 3 Through 17 Years of Ageb

  3 Through 4 Years of Age 5 Through 17 Years of Age
FLUARIX
N = 350
%
Comparator Influenza Vaccine
N = 341
%
FLUARIX
N = 1,348
%
Comparator Influenza Vaccine
N = 451
%
Local Adverse Reactions
Pain 35 38 56 56
Redness 23 20 18 16
Swelling 14 13 14 13
General Adverse Events
Irritability 21 22
Loss of appetite 13 15
Drowsiness 13 20
Fever ≥ 99.5 °F (37.5°C) 7 8 4 3
Muscle aches 29 29
Fatigue 20 19
Headache 15 16
Arthralgia 6 6
Shivering 3 4
a 4 days included day of vaccination and the subsequent 3 days.
b NCT00383123.

In children who received a second dose of FLUARIX or the comparator vaccine, the incidences of adverse events following the second dose were similar to those observed after the first dose.

Unsolicited adverse events that occurred in ≥ 1% of recipients of FLUARIX 6 months through 17 years of age included upper respiratory tract infection (5.5%), pyrexia (4.8%), cough (4.7%), vomiting (3.2%), headache (2.8%), rhinorrhea (2.7%), diarrhea (2.5%), pharyngolaryngeal pain (2.4%), nasopharyngitis (2.3%), otitis media (2.0%), nasal congestion (1.8%), upper abdominal pain (1.4%), and upper respiratory tract congestion (1.0%). The incidences of these events were similar in recipients of the comparator vaccine.

Postmarketing Experience

Worldwide voluntary reports of adverse events received for FLUARIX since market introduction of this vaccine are listed below. This list includes serious events or events which have causal connection to FLUARIX. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Blood and Lymphatic System Disorders: Lymphadenopathy.

Cardiac Disorders: Tachycardia.

Ear and Labyrinth Disorders: Vertigo.

Eye Disorders: Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal Disorders: Abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue.

General Disorders and Administration Site Conditions: Asthenia, chest pain, chills, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches.

Immune System Disorders: Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness.

Infections and Infestations: Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis.

Musculoskeletal and Connective Tissue Disorders: Pain in extremity.

Nervous System Disorders: Convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, syncope.

Respiratory, Thoracic, and Mediastinal Disorders: Asthma, bronchospasm, cough, dyspnea, respiratory distress, stridor.

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, urticaria.

Vascular Disorders: Henoch-Schönlein purpura, vasculitis.

Adverse Events Associated With Influenza Vaccines

Immediate and presumably allergic reactions (e.g., hives, angioedema, allergic asthma, and systemic anaphylaxis) rarely occur after influenza vaccination. These reactions probably result from hypersensitivity to certain vaccine components, such as residual egg protein. Although FLUARIX contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy [see CONTRAINDICATIONS].

Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.

Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.

Read the Fluarix (influenza virus vaccine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Vaccine Administration

FLUARIX should not be mixed with any other vaccine in the same syringe or vial.

There are insufficient data to assess the concurrent administration of FLUARIX with other vaccines. When concomitant administration of other vaccines is required, the vaccines should be administered at different injection sites.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to FLUARIX.

Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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