Afluria

Name: Afluria

Missed dose

Not applicable.

Afluria Drug Class

Afluria is part of the drug class:

  • Influenza vaccines

Afluria Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • corticosteroids
  • medicines that suppress your immune system

This is not a complete list of Afluria drug interactions. Ask your doctor or pharmacist for more information.

Inform MD

Before receiving Afluria, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Afluria or to any component of the vaccine including egg protein
  • have had Guillain-Barre Syndrome
  • have a weakened immune system 
  • have problems with your heart, kidneys, or lungs
  • have diabetes
  • are pregnant or nursing

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

What do I need to tell my doctor BEFORE I take Afluria?

  • If you have an allergy to any part of Afluria (influenza virus vaccine (inactivated)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Afluria?

  • Tell all of your health care providers that you take Afluria. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have a latex allergy, talk with your doctor.
  • This medicine may not protect all people who use it. Talk with the doctor.
  • This medicine is a vaccine with a virus that is not active. It cannot cause the disease.
  • This medicine is not a cure for the flu. It must be given before you are exposed to the flu in order to work. Most of the time, it takes a few weeks for this medicine to work.
  • This medicine only protects you for 1 flu season. You will need to get the flu vaccine each year.
  • Not all brands of vaccines are for all children. Talk with your child's doctor.
  • Some children may need to have more than 1 dose of this vaccine. Talk with your child's doctor.
  • Some children have had a fever and seizures caused by fevers with some flu vaccines. Most of the time, this happened in children younger than 5 years of age. Fever has also been seen in children 5 to younger than 9 years of age. Talk with your child's doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Afluria while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use in specific populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Afluria. It is also not known whether Afluria can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Afluria should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Afluria has not been evaluated in nursing mothers. It is not known whether Afluria is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Afluria is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Afluria in children below 6 months of age have not been established. The safety and immunogenicity of Afluria was evaluated in 298 children between the ages of 6 months and 9 years (Study 4). In this study the incidence of fever in children 6 months to < 3 years of age following the first and second doses of Afluria was 23%. Among children 3 years to < 9 years of age the incidence was 16% following the first dose and 8% following the second dose. Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years (see Adverse Reactions [6.2] and Warnings and Precautions [5.1]).

Geriatric Use

In four clinical studies, 343 subjects ages 65 years and older received Afluria. Hemagglutination-inhibiting antibody responses in geriatric subjects were lower after administration of Afluria in comparison to younger adult subjects (see Clinical Studies [14]). Adverse event rates were generally similar in frequency to those reported in subjects ages 18 to less than 65 years, although some differences were observed (see Adverse Reactions [6.2]).

Where can i get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.01. Revision date: 1/22/2013.

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Side effects

In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA administered by needle and syringe were pain (≥60%), redness (≥20%) and swelling (≥10%). The most common systemic adverse events were headache, myalgia (≥20%), irritability, malaise and fever (≥10%).

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), redness and itching (≥10%). The most common systemic adverse events observed were muscle aches (≥30%), headache and malaise (≥20%).

In adults 18 through 64 years of age, using the PharmaJet Stratis Needle-Free Injection System, the most common injection-site adverse reactions observed in a clinical study with AFLURIA up to 7 days post-vaccination were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events within this period were myalgia, malaise (≥30%) and headache (≥20%).

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥30%) and pain (≥10%). No systemic adverse reactions occurred in ≥10% of subjects in this age group.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reflect the rates observed in clinical practice.

Children

In clinical studies, AFLURIA has been administered to, and safety information collected for, 3,009 children ages 6 months through 17 years. The exposure in children includes 1,601 ages 6 months to less than 5 years, 756 children ages 5 years to less than 9 years and 652 children ages 9 years through 17 years. Clinical safety data for AFLURIA in children are presented from three clinical studies (Studies 1, 2 and 3). Data from a comparator-controlled trial (Study 1) are presented, followed by pooled data from two open label studies (Studies 2 and 3). Subjects 6 months through 8 years of age received one or two vaccinations, administered by needle and syringe, as determined by previous vaccination history (for further details on clinical study design, dosing and demographics see Clinical Studies).

Study 1 included 1,468 subjects for safety analysis, ages 6 months through 17 years, randomized to receive AFLURIA (735 subjects) or another US-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur, Inc.) (733 subjects).

Study 2 included 1,976 subjects for safety analysis, ages 6 months through 17 years. All subjects received AFLURIA.

Study 3 included 298 subjects for safety analysis, ages 6 months through 8 years. All subjects received AFLURIA.

The safety assessment was similar for the three pediatric studies. Local (injection site) adverse reactions and systemic adverse events were solicited for 7 days post-vaccination (Tables 2 and 3). Unsolicited adverse events were collected for 30 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Among the pediatric studies, there were no vaccine-related deaths or vaccinerelated serious adverse events reported in children 5 years of age and older.

In this section, safety data from the pediatric studies are limited to children 5 years of age and older. AFLURIA is not approved for use in children less than 5 years of age. See Warnings and Precautions [5.1] and Use in Specific Populations [8.4] for risks of AFLURIA in children less than 5 years of age. In the comparator-controlled trial (Study 1), the rate of fever after the first dose of AFLURIA in subjects aged 5 through 8 years was 16% as compared to 8% in subjects who received the comparator. The rate of fever in subjects aged 9 through 17 years following a single dose of AFLURIA was 6% as compared to 4% in subjects who received the comparator. In all three pediatric studies, the rates of fever in subjects aged 5 through 8 years who received AFLURIA were lower after dose 2 than dose 1.

Data in Tables 2 and 3 are presented for children 5 years and older.

Table 2: Proportion of Subjects 5 through 17 Years of Age with Solicited Local Adverse Reactions or Systemic Adverse Events within 7 Days after Administration of First or Second Dose of AFLURIA, Irrespective of Causality (Study 1)

  Percentagea of Subjects in each Age Group Reporting Event
Subjects 5 through 8 years Subjects 9 through 17 years
AFLURIA
N=161b
Comparator
N=165b
AFLURIA
N=254b
Comparator
N=250b
After the First Dose
Local Adverse Reactions
Pain 63 60 66 60
Redness 23 27 17 17
Induration 17 17 15 16
Systemic Adverse Events
Myalgia 34 30 40 37
Malaise 24 13 22 20
Headache 21 19 27 26
Any Fever 16 8 6 4
Fever ≥102.2°F 5 1 3 1
Nausea/ Vomiting 12 8 9 10
Diarrhea 7 7 8 10
  AFLURIA
N=39b
Comparator
N=53b
   
After the Second Dose
Local Adverse Reactions
Pain 36 38 - -
Redness 10 19 - -
Induration 8 17 - -
Systemic Adverse Events
Diarrhea 13 6 - -
Headache 13 13 - -
Myalgia 13 17 - -
Malaise 5 8 - -
Nausea/ Vomiting 3 8 - -
Any Fever 0 2 - -
Fever ≥102.2°F 0 0 - -
a Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
b N = number of subjects in the Safety Population for each treatment group.

Table 3: Proportion of Subjects 5 through 17 Years of Age with Solicited Local Adverse Reactions or Systemic Adverse Events Within 7 Days after Administration of AFLURIA, Irrespective of Causality (Studies 2 and 3)

  Percentagea of Subjects in each Age Group Reporting Event
Studies 2 and 3
Subjects 5 through 8 years
Study 2
Subjects 9 through 17 years
Dose 1
N=82-595b
Dose 2
N=82-426b
Dose 1
N=397b
Local Adverse Reactions
Pain 61 56 68
Erythema 24 23 17
Swelling 17 17 13
Systemic Adverse Events
Irritabilityd 18 16 -
Headache 16 10 27
Malaise or feeling generally unwellc 16 8 17
Any Fever 13 6 5
Fever ≥ 102.2°F 3 2 1
General Muscle Ache (Myalgia) 12 8 20
Nausea/Vomitingc 7 3 5
Vomiting/Diarrhead 5 6 -
Loss of appetited 5 4 -
Diarrheac 4 2 5
a Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
b N = number of subjects in the Safety Population for each treatment group. Denominators for Dose 1 were: N=82 for Vomiting/Diarrhea, Irritability, Loss of appetite, N=513 for Malaise, Diarrhea, Nausea/ Vomiting and N=593-595 for all other parameters. Denominators for Dose 2 were: N=82 for Vomiting/ Diarrhea, Irritability, Loss of appetite, N=344 for Malaise, Diarrhea and Nausea/Vomiting and N=421-426 for all other parameters.
c These preferred terms were used to describe Solicited Adverse Events in Study 2.
d These preferred terms were used to describe Solicited Adverse Events in Study 3.

In Study 1, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 5 years through 8 years following the first or second dose included cough (15%) and pyrexia (9%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years through 17 years following the first dose included cough (7%), oropharyngeal pain (7%), headache (7%) and nasal congestion (6%).

In Studies 2 and 3, unsolicited adverse events that occurred in ≥ 5% of subjects ages 5 years through 8 years after the first or second dose included the following: upper respiratory tract infection (13%), cough (10%), rhinorrhea (7%), headache (5%), nasopharyngitis (5%) and pyrexia (5%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years through 17 years following the first dose included upper respiratory tract infection (9%) and headache (8%).

Adults

In clinical studies comparing AFLURIA to placebo or a comparator trivalent inactivated influenza vaccine, a single dose of AFLURIA was administered to, and safety information collected for, 11,104 subjects ages 18 through 64 years and 836 subjects ages 65 years and older. Clinical safety data for AFLURIA in adults are presented from three clinical studies (Studies 4 through 6) conducted in the US and one clinical study (Study 7) conducted in the UK. Study 4 included 1,357 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA (1,089 subjects) or placebo (268 subjects) (see Clinical Studies).

Study 5 included 15,020 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA (10,015 subjects) or placebo (5,005 subjects) (see Clinical Studies).

Study 6 included 1,266 subjects for safety analysis, ages 65 years and older, randomized to receive AFLURIA (630 subjects) or another US-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.) as an active comparator (636 subjects) (see Clinical Studies). Study 7 included 275 subjects for safety analysis, ages 65 year and older, randomized to receive AFLURIA (206 subjects) or a UK-licensed trivalent inactivated influenza vaccine (manufactured by GSK) as an active comparator (69 subjects).

The safety assessment was identical for the four adult studies. Local (injectionsite) adverse reactions and systemic adverse events were solicited for 5 days post-vaccination (Table 4, studies 4 through 6). Unsolicited adverse events were collected for 21 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Among adult studies, there were no vaccine-related deaths or vaccine-related serious adverse events reported.

Table 4: Proportion of Subjects 18 Years of Age and Older with Solicited Local Adverse Reactions or Systemic Adverse Events within 5 Days after Administration of AFLURIA or Placebo, Irrespective of Causality (Studies 4, 5 and 6)

  Percentage a of Subjects in each Age Group Reporting Event
Study 4
Subjects 18 through 64 years
Study 5
Subjects 18 through 64 years
Study 6
Subjects ≥ 65 years
AFLURIA
N=1087- 1088 b
Placebo
N=266 b
AFLURIA
N=10,015 b
Placebo
N=5005 b
AFLURIA
N=630 b
Comparator
N=636 b
Local Adverse Reactions
Tenderness
(Pain on touching)
60 18 69 17 36 31
Pain
(without touching)
40 9 48 11 15 14
Redness 16 8 4 <1 3 1
Swelling 9 1 4 <1 7 8
Bruising 5 1 1 1 <1 1
Systemic Adverse Events
Headache 26 26 25 23 9 11
Malaise 19 19 29 26 7 6
Muscle aches 13 9 21 12 9 8
Nausea 6 9 7 6 2 1
Chills/ Shivering 3 2 5 4 2 2
Fever 1 1 3 2 <1 1
a Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
b N = number of subjects in the Safety Population for each treatment group.

In Study 4, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (8% versus 6%, respectively). In Study 5, unsolicited adverse events that occurred in ≥5% of subjects who received AFLURIA or placebo included headache (AFLURIA 12%, placebo 11%) and oropharyngeal pain (AFLURIA 5%, placebo 5%).

In Study 6, headache was the only unsolicited adverse event that occurred in ≥5% of subjects who received AFLURIA (5%).

Studies 1 to 7 were all conducted when AFLURIA was administered by needle and syringe.

Additionally, safety information has been collected in a clinical study of AFLURIA administered using the PharmaJet Stratis Needle-Free Injection System (Study 8). Study 8 included 1,247 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA by either the PharmaJet Stratis Needle-Free Injection System (624 subjects) or needle and syringe (623 subjects). No deaths or vaccine-related serious adverse events were reported in Study 8. Local (injection-site) adverse reactions and systemic adverse events were solicited for 7 days post-vaccination (Table 5).

Table 5: Proportion of Subjects 18 through 64 Years of Age with Solicited Local Adverse Reactions or Systemic Adverse Events within 7 Days after Administration of AFLURIA by PharmaJet Stratis Needle-Free Injection System or Needle and Syringe Irrespective of Causality (Study 8).

  Percentage a of Subjects Reporting Event
Study 8
Subjects 18 through 64 years
AFLURIA
PharmaJet Stratis Needle- Free Injection System
N=540-616 b
Needle and Syringe
N=599-606 b
Local Adverse Reactions
Tenderness 89 78
Swelling 65 20
Pain 64 49
Redness 60 19
Itching c 28 10
Bruising 18 5
Systemic Adverse Events
Myalgia 36 36
Malaise 31 28
Headache 25 22
Chills 7 7
Nausea 7 7
Vomiting 1 2
Fever 0 0
a Proportion of subjects reporting each local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/ symptom (individual event denominators).
b N = number of subjects in the Safety Population for each treatment group. Denominators for the PharmaJet Stratis Needle-Free Injection System group were: N=540 for itching and N=605-616 for all other parameters. Denominators for the needle and syringe group were: N=527 for itching and N=599- 606 for all other parameters.
c A total of 155 subjects (approximately randomly distributed between PharmaJet Stratis Needle-Free Injection System and needle and syringe groups) received Diary Cards without itching listed as a solicited symptom.

In Study 8, no unsolicited adverse events occurred in ≥5% of subjects who received AFLURIA administered via PharmaJet Stratis Needle-Free Injection System up to 28 days post-vaccination.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. These adverse reactions reflect experience in both children and adults and include those identified during post-approval use of AFLURIA outside the US since 1985.

Blood And Lymphatic System Disorders

Thrombocytopenia

Immune System Disorders

Allergic or immediate hypersensitivity reactions including anaphylactic shock and serum sickness

Nervous System Disorders

Neuralgia, paresthesia, convulsions (including febrile seizures), encephalomyelitis, encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS

Vascular Disorders

Vasculitis which may be associated with transient renal involvement

Skin And Subcutaneous Tissue Disorders

Pruritus, urticaria, and rash

General Disorders And Administration Site Conditions

Cellulitis and large injection site swelling Influenza-like illness

Adverse Reactions Associated With Influenza Vaccination

Anaphylaxis has been reported after administration of AFLURIA. Egg protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis (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 polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.

Read the entire FDA prescribing information for Afluria (Influenza Virus Vaccine)

Read More »

What happens if I miss a dose?

Since flu shots are usually given only one time per year, you will most likely not be on a dosing schedule. Call your doctor if you forget to receive your yearly flu shot in October or November.

If your child misses a booster dose of Afluria, call your doctor for instructions.

Influenza virus vaccine, inactivated Pregnancy Warnings

Animal studies did not show effects on pregnancy, embryo-fetal development, postnatal development, or fertility. There are no controlled data in human pregnancy. Limited post-marketing data do not indicate adverse fetal or maternal outcomes. A pregnancy registry has been established in the US for women receiving FLULAVAL(R), FLUARIX(R), or FLUARIX QUADRIVALENT(R) flu vaccine at 1-888-452-9633, for Flublock(R) at 1-888-855-7871, or for Fluzone(R) (all formulations) at 1-800-822-2463 AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C Comments: -Pregnant women, particularly during the second and third trimester, are at increased risk of influenza related complications. -Vaccination before pregnancy and/or flu season is recommended.

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