Dosing & Uses
Dosage Forms & Strengths
intranasal suspension
- 0.2mL (prefilled single use sprayer)
Influenza Prophylaxis
Indicated for prevention of influenza A and B infection in adults aged ≤49 years
Adults ≤49 years: 0.2 mL/dose (0.1 mL/nostril); 1 dose/season
Intranasal administration for age ≥50 years: Safety and efficacy not established
2019-2020 Northern Hemisphere viral strain vaccine contents
- A/Brisbane/02/2018 (H1N1)pdm09-like virus (New for 2019-2020)
- A/Kansas/14/2017 (H3N2)-like virus (New for 2019-2020)
- B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) (no change from last season)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
Live attenuated influenza vaccine (LAIV) not indicated for the following adults who
- have immunocompromising conditions, including HIV infection
- have anatomical or functional asplenia
- are pregnant
- have close contact with or are caregivers of severely immunocompromised persons in a protected environment
- have received influenza antiviral medications in the previous 48 hr
- have a cerebrospinal fluid leak or cochlear implant
Dosage Forms & Strengths
intranasal suspension
- 0.2mL (prefilled single use sprayer)
Influenza Prophylaxis
Indicated for prevention of influenza A and B infection children aged ≥2 years
<2 year: Safety and efficacy not established
2-8 years: 0.2 mL/dose (0.1 mL in each nostril) x1-2 doses/season (see Administration)
≥9 years: As in adults; 0.2 mL/dose (0.1 mL/nostril); 1 dose/season
2019-2020 Northern Hemisphere viral strain vaccine contents
- A/Brisbane/02/2018 (H1N1)pdm09-like virus (New for 2019-2020)
- A/Kansas/14/2017 (H3N2)-like virus (New for 2019-2020)
- B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage) (no change from last season)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
Live attenuated influenza vaccine (LAIV) not indicated for the following children who
- have immunocompromising conditions, including HIV infection
- have anatomical or functional asplenia
- are pregnant
- have close contact with or are caregivers of severely immunocompromised persons in a protected environment
- have received influenza antiviral medications in the previous 48 hr
- have a cerebrospinal fluid leak or a cochlear implant
- are aged 2-4 yr and who have received a diagnosis of asthma or wheezing within the preceding 12 months
- are receiving aspirin- or salicylate-containing medications
- have a history of severe allergic reaction of any component of the vaccine (except egg) or after a previous dose of any influenza vaccine
- Caution with the following conditions
- asthma in person aged ≥5 yr
- other underlying medical conditions (eg, chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus])
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Adults
- Runny nose (41-45%)
- Headache (41-45%)
- Sore throat (26-30%)
- Weakness (26-30%)
- Myalgia (16-20%)
- Cough (11-15%)
Children
- Runny nose/nasal congestion (46-50%)
- Cough (36-40%)
- Irritability (16-20%)
- Headache (16-20%)
1-10%
Adults
- Chills (6-10%)
- Nasal congestion (6-10%)
- Sinusitis (2-5%)
Warnings
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
Contraindications
Hypersensitivity to eggs, sulfites
IV/IM administration
Children/adolescents receiving aspirin
Asthma, reactive airway disease
Diabetes, renal dysfunction
Hemoglobinopathies
Immunodeficiency diseases
Patients on immunosuppressants
Any chronic pulmonary/cardivascular disorder
Cautions
Do not administer within 2 wk of inactivated vaccine or 4 week of live virus vaccine
Treatment for anaphylactoid and/or hypersensitivity reactions must be present during vaccine use
Use caution in patients with history of Guillain-Barre
Nasal congestion may impair delivery of vaccine (avoid use)
Not recommended in patients with neurologic or neuromuscular disorders
Avoid use in children aged 2 through 4 years who had wheezing in the past 12 months, or those who have any other underlying medical conditions that predispose them to influenza complications
Caution in patients aged ≥5 yr who have asthma
Pregnancy & Lactation
Pregnancy
Not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug
Clinical considerations
- Pregnant women infected with seasonal influenza are at increased risk of severe illness associated with influenza infection compared with nonpregnant women
- Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery
Lactation
Not absorbed systemically by the mother following intranasal administration and breastfeeding is not expected to result in exposure of the breastfed child
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
Mechanism of Action
Vaccine; vaccines convey active immunity via stimulation of production of endogenously produced antibodies
Pharmacokinetics
Onset: Three weeks after vaccination
Duration: 6 months or more
Distribution: Nasal cavity, stomach, brain, and lungs
Administration
Intranasal Administration
Administer at beginning of influenza season
Each sprayer contains a single dose (0.2 mL); administer one-half of the contents of the single-dose intranasal sprayer into each nostril
With the patient in upright position, place tip of syringe applicator just inside the nostril and depress plunger as rapidly as possible
Children aged 2 years through 8 years
- If child requires 2 doses, administer at least 4 weeks apart (see number of doses)
- Number of doses
- 2 doses administered a minimum of 4 weeks apart are required during child’s first season of vaccination for optimal protection
- Children who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine at least 4 weeks apart, require only 1 dose for the current flu season
- The 2 doses of influenza vaccine do not have to have been administered in the same season or consecutive seasons
- From ACIP recommendations: MMWR 2018 Aug 24 / 67(3);1-20
Images
Patient Handout
Formulary
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