FluMist Quadrivalent
Aug 1, 2020 16:36:31 GMT
Post by Admin on Aug 1, 2020 16:36:31 GMT
FLUMIST QUADRIVALENT is a vaccine that is sprayed into the nose to help protect against influenza.
It can be used in people 2 through 49 years old.
FLUMIST QUADRIVALENT may not prevent influenza in everyone who gets vaccinated.
It can be used in people 2 through 49 years old.
FLUMIST QUADRIVALENT may not prevent influenza in everyone who gets vaccinated.
Package Insert - FluMist Quadrivalent
www.fda.gov/media/83072/download
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FLUMIST® QUADRIVALENT safely and effectively. See full prescribing
information for FLUMIST® QUADRIVALENT.
FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)
Intranasal Spray
2019-2020 Formula
Initial U.S. Approval: 2003
----------------------------INDICATIONS AND USAGE---------------------------
FluMist Quadrivalent is a vaccine indicated for active immunization for the
prevention of influenza disease caused by influenza A subtype viruses and
type B viruses contained in the vaccine. (1, 11)
FluMist Quadrivalent is approved for use in persons 2 through 49 years of
age. (1)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Each 0.2 mL dose is a suspension supplied in a single-dose pre-filled
intranasal sprayer. (3)
-------------------------------CONTRAINDICATIONS------------------------------
• Severe allergic reaction (e.g., anaphylaxis) to any component of FluMist
Quadrivalent, including egg protein, or after a previous dose of any
influenza vaccine. (4.1, 11)
• Concomitant aspirin therapy in children and adolescents. (4.2)
-----------------------WARNINGS AND PRECAUTIONS------------------------
• In clinical trials, risks of hospitalization and wheezing were increased in
children younger than 2 years of age who received FluMist (trivalent
Influenza Vaccine Live, Intranasal). (5.1)
• Children younger than 5 years of age with recurrent wheezing and persons
of any age with asthma may be at increased risk of wheezing following the
administration of FluMist Quadrivalent. (5.2)
• If Guillain-Barré syndrome has occurred within 6 weeks of any prior
influenza vaccination, the decision to give FluMist Quadrivalent should be
based on careful consideration of the potential benefits and risks. (5.3)
• FluMist Quadrivalent has not been studied in immunocompromised
persons. (5.4)
------------------------------ADVERSE REACTIONS-------------------------------
The most common solicited adverse reactions (≥ 10% in vaccine recipients
and at least 5% greater than in placebo recipients) reported after FluMist were
runny nose or nasal congestion (ages 2 years through 49 years), fever over
100°F (children ages 2 years through 6 years), and sore throat (adults ages 18
years through 49 years).
Among children and adolescents 2 through 17 years of age who received FluMist
Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever
over 100°F.
Among adults 18 through 49 years of age who received FluMist Quadrivalent, 44%
reported runny nose or nasal congestion and 19% reported sore throat. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or
VAERS at 1-800-822-7967 or vaers.hhs.gov.
------------------------------DRUG INTERACTIONS-------------------------------
• Antiviral drugs that are active against influenza A and/or B may reduce the
effectiveness of FluMist Quadrivalent if administered within 48 hours
before, or within 2 weeks after, receipt of the vaccine. (7.2)
-----------------------USE IN SPECIFIC POPULATIONS------------------------
• In clinical trials, in children 6 through 23 months of age, FluMist was
associated with an increased risk of hospitalization and wheezing. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
Revised: 8/2019
12.2 Pharmacodynamics
Shedding Studies
Shedding of vaccine viruses within 28 days of vaccination with FluMist was evaluated in (1) multi-center
Study MI-CP129 which enrolled healthy individuals 6 through 59 months of age (N = 200); and (2) multicenter Study FM026 which enrolled healthy individuals 5 through 49 years of age (N = 344).
In each study, nasal secretions were obtained daily for the first 7 days and every other day through either Day 25 and on Day 28 or through Day 28.
In Study MI-CP129, individuals with a positive shedding sample at Day 25 or Day 28 were to have additional shedding samples collected every 7 days until culture negative on 2 consecutive samples.
Results of these studies are presented in Table 5.
What are the possible side effects of FluMist Quadrivalent?
The most common side effects are:
• runny or stuffy nose
• sore throat
• fever over 100°F
Other possible side effects include:
• decreased appetite
• irritability
• tiredness
• cough
• headache
muscle ache
• chills
Call your healthcare provider or go to the emergency department right away if you or your child experience:
• hives or a bad rash
• trouble breathing
• swelling of the face, tongue, or throat
These are not all the possible side effects of FluMist Quadrivalent.
You can ask your healthcare provider for a complete list of side effects that is available to healthcare professionals.
Call your healthcare provider for medical advice about side effects.
You may report side effects to VAERS at 1-800-822-7967
or vaers.hhs.gov.
www.fda.gov/media/83072/download
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
FLUMIST® QUADRIVALENT safely and effectively. See full prescribing
information for FLUMIST® QUADRIVALENT.
FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)
Intranasal Spray
2019-2020 Formula
Initial U.S. Approval: 2003
----------------------------INDICATIONS AND USAGE---------------------------
FluMist Quadrivalent is a vaccine indicated for active immunization for the
prevention of influenza disease caused by influenza A subtype viruses and
type B viruses contained in the vaccine. (1, 11)
FluMist Quadrivalent is approved for use in persons 2 through 49 years of
age. (1)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Each 0.2 mL dose is a suspension supplied in a single-dose pre-filled
intranasal sprayer. (3)
-------------------------------CONTRAINDICATIONS------------------------------
• Severe allergic reaction (e.g., anaphylaxis) to any component of FluMist
Quadrivalent, including egg protein, or after a previous dose of any
influenza vaccine. (4.1, 11)
• Concomitant aspirin therapy in children and adolescents. (4.2)
-----------------------WARNINGS AND PRECAUTIONS------------------------
• In clinical trials, risks of hospitalization and wheezing were increased in
children younger than 2 years of age who received FluMist (trivalent
Influenza Vaccine Live, Intranasal). (5.1)
• Children younger than 5 years of age with recurrent wheezing and persons
of any age with asthma may be at increased risk of wheezing following the
administration of FluMist Quadrivalent. (5.2)
• If Guillain-Barré syndrome has occurred within 6 weeks of any prior
influenza vaccination, the decision to give FluMist Quadrivalent should be
based on careful consideration of the potential benefits and risks. (5.3)
• FluMist Quadrivalent has not been studied in immunocompromised
persons. (5.4)
------------------------------ADVERSE REACTIONS-------------------------------
The most common solicited adverse reactions (≥ 10% in vaccine recipients
and at least 5% greater than in placebo recipients) reported after FluMist were
runny nose or nasal congestion (ages 2 years through 49 years), fever over
100°F (children ages 2 years through 6 years), and sore throat (adults ages 18
years through 49 years).
Among children and adolescents 2 through 17 years of age who received FluMist
Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever
over 100°F.
Among adults 18 through 49 years of age who received FluMist Quadrivalent, 44%
reported runny nose or nasal congestion and 19% reported sore throat. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or
VAERS at 1-800-822-7967 or vaers.hhs.gov.
------------------------------DRUG INTERACTIONS-------------------------------
• Antiviral drugs that are active against influenza A and/or B may reduce the
effectiveness of FluMist Quadrivalent if administered within 48 hours
before, or within 2 weeks after, receipt of the vaccine. (7.2)
-----------------------USE IN SPECIFIC POPULATIONS------------------------
• In clinical trials, in children 6 through 23 months of age, FluMist was
associated with an increased risk of hospitalization and wheezing. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
Revised: 8/2019
12.2 Pharmacodynamics
Shedding Studies
Shedding of vaccine viruses within 28 days of vaccination with FluMist was evaluated in (1) multi-center
Study MI-CP129 which enrolled healthy individuals 6 through 59 months of age (N = 200); and (2) multicenter Study FM026 which enrolled healthy individuals 5 through 49 years of age (N = 344).
In each study, nasal secretions were obtained daily for the first 7 days and every other day through either Day 25 and on Day 28 or through Day 28.
In Study MI-CP129, individuals with a positive shedding sample at Day 25 or Day 28 were to have additional shedding samples collected every 7 days until culture negative on 2 consecutive samples.
Results of these studies are presented in Table 5.
What are the possible side effects of FluMist Quadrivalent?
The most common side effects are:
• runny or stuffy nose
• sore throat
• fever over 100°F
Other possible side effects include:
• decreased appetite
• irritability
• tiredness
• cough
• headache
muscle ache
• chills
Call your healthcare provider or go to the emergency department right away if you or your child experience:
• hives or a bad rash
• trouble breathing
• swelling of the face, tongue, or throat
These are not all the possible side effects of FluMist Quadrivalent.
You can ask your healthcare provider for a complete list of side effects that is available to healthcare professionals.
Call your healthcare provider for medical advice about side effects.
You may report side effects to VAERS at 1-800-822-7967
or vaers.hhs.gov.
Full information on Package Insert below
www.fda.gov/media/83072/download
-
FluMist Quadrivalent Side Effects
www.drugs.com/sfx/flumist-quadrivalent-side-effects.html
Side effects requiring immediate medical attention
Along with its needed effects, influenza virus vaccine, live, trivalent (the active ingredient contained in FluMist Quadrivalent) may cause some unwanted effects.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking influenza virus vaccine, live, trivalent:
More common
Chills
cough
decreased appetite
fever
headache
muscle aches
sore throat
stuffy or runny nose
tiredness or weakness
Less common
Earache
pain or tenderness around the eyes and cheekbones
redness or swelling in the ear
shortness of breath or troubled breathing
sneezing
tightness of the chest or wheezing
Rare
Difficulty with breathing or swallowing
hives
itching, especially of the feet or hands
reddening of the skin, especially around the ears
swelling of the eyes, face, or inside of the nose
unusual tiredness or weakness (sudden and severe)
Incidence not known
[Meaning: few people have reported it or no one kept a count - Admin]
Anxiety
bloody nose
blue or pale skin
chest pain, possibly moving to the left arm, neck, or shoulder
confusion
diarrhea
dizziness
drowsiness
fast heartbeat
general feeling of illness
hoarseness
inability to move the arms and legs
irritation
itching
joint pain, stiffness, or swelling
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
severe headache
skin rash
stiff neck and/or back
sudden numbness and weakness in the arms and legs
swelling or puffiness of the face
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusual tiredness or weakness
vomiting
weakness of the muscles in your face
Along with its needed effects, influenza virus vaccine, live, trivalent (the active ingredient contained in FluMist Quadrivalent) may cause some unwanted effects.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking influenza virus vaccine, live, trivalent:
More common
Chills
cough
decreased appetite
fever
headache
muscle aches
sore throat
stuffy or runny nose
tiredness or weakness
Less common
Earache
pain or tenderness around the eyes and cheekbones
redness or swelling in the ear
shortness of breath or troubled breathing
sneezing
tightness of the chest or wheezing
Rare
Difficulty with breathing or swallowing
hives
itching, especially of the feet or hands
reddening of the skin, especially around the ears
swelling of the eyes, face, or inside of the nose
unusual tiredness or weakness (sudden and severe)
Incidence not known
[Meaning: few people have reported it or no one kept a count - Admin]
Anxiety
bloody nose
blue or pale skin
chest pain, possibly moving to the left arm, neck, or shoulder
confusion
diarrhea
dizziness
drowsiness
fast heartbeat
general feeling of illness
hoarseness
inability to move the arms and legs
irritation
itching
joint pain, stiffness, or swelling
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
severe headache
skin rash
stiff neck and/or back
sudden numbness and weakness in the arms and legs
swelling or puffiness of the face
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusual tiredness or weakness
vomiting
weakness of the muscles in your face
www.drugs.com/sfx/flumist-quadrivalent-side-effects.html