Description
Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.
There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.
It is necessary to receive an influenza vaccine each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.
Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.
The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and over, all children, and all adults.
This product is available in the following dosage forms:
- Spray
Before Using
In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nasal influenza virus vaccine in children 2 years of age and older. However, this vaccine is not indicated for children younger than 2 years of age.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of nasal influenza virus vaccine in adults 50 years of age and older. Safety and efficacy have not been established.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.
- Aspirin
Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abarelix
- Abemaciclib
- Abiraterone
- Acalabrutinib
- Adagrasib
- Adalimumab
- Ado-Trastuzumab Emtansine
- Afamitresgene Autoleucel
- Afatinib
- Aldesleukin
- Alectinib
- Alemtuzumab
- Alpelisib
- Altretamine
- Aminoglutethimide
- Aminolevulinic Acid
- Amivantamab-vmjw
- Anastrozole
- Anifrolumab-fnia
- Ansuvimab-zykl
- Antithymocyte Globulin Rabbit
- Apalutamide
- Arsenic Trioxide
- Asciminib
- Asparaginase
- Atezolizumab
- Atidarsagene Autotemcel
- Atoltivimab
- Avapritinib
- Avelumab
- Axicabtagene Ciloleucel
- Axitinib
- Azacitidine
- Azathioprine
- Baloxavir Marboxil
- Baricitinib
- Belantamab Mafodotin
- Belatacept
- Belinostat
- Belumosudil
Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Carbamazepine
- Cytomegalovirus Immune Globulin, Human
- Hepatitis B Immune Globulin
- Rabies Immune Globulin
- Respiratory Syncytial Virus Immune Globulin, Human
- Tetanus Immune Globulin
- Vaccinia Immune Globulin, Human
- Varicella-Zoster Immune Globulin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to eggs, egg products, gentamicin, gelatin, or arginine (an amino acid), history of—Should not be used in patients with severe allergic reactions to these substances.
- Asthma, or
- Diabetes or
- Heart disease or
- Kidney disease or
- Lung disease or
- Trouble breathing or wheezing, history of—Use with caution. May make these conditions worse.
- Guillain-Barré syndrome (severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.
- Immune system problems (eg, cancer, HIV)—This vaccine may not work as well if you have weak immune system.
- Severe illness with fever—Should not be given when a fever is present. Your doctor will decide when you are well enough to get your influenza virus vaccine.
Proper Use
A nurse or other trained health professional may give you or your child this vaccine. This vaccine is given as a nasal spray. You may also be taught how to give yourself this vaccine at home.
Use the nasal spray only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
Before using the nasal spray, gently blow your nose to clear the nostrils.
Children 2 to 8 years of age who have not received the nasal vaccine before may need 2 doses at least 1 month apart.
This vaccine comes with a patient information leaflet and patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
To use the nasal spray:
- Use it within 12 hours of removing from the refrigerator.
- Check the liquid in the sprayer. It should be colorless to pale yellow and clear to slightly cloudy. Do not use if it is discolored. Do not use the spray if it has been dropped or damaged.
- Hold on to the sprayer body and pull off the gray cap. Do not remove the dose divider clip. Do not prime or remove bubbles from the sprayer. Do not insert it into the nostril before removing the cap.
- Keep head upright. Place the tip of the sprayer inside one nostril. The sprayer tip does not need to be inserted far into the nose. Do not insert the entire white tip inside the nostril.
- Spray into one nostril by pushing the plunger as quickly as possible until it stops at the dose divider clip. Do not remove the sprayer until the plunger has stopped. Breathe normally. There is no need to sniff or inhale.
- For spray 2, pinch and remove the dose divider clip from the plunger. Keeping head in upright position, place the sprayer tip inside the other nostril. Repeat the same steps.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal dosage form (spray):
- For prevention of infection:
- Adults—One-half of the contents of the sprayer in each nostril. Each sprayer contains a single-dose of 0.2 milliliters (mL) of this vaccine.
- Children 2 through 17 years of age—A nurse or other trained health professional will administer this vaccine.
- For prevention of infection:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Storage
Store in the refrigerator. Do not freeze.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
If your child needs a second dose, it is very important that he or she returns for the second dose at least one month after the first dose. . Be sure to notify your doctor of any side effects that occur after you receive this vaccine.
This vaccine should not be given to children and teenagers (2 to 17 years of age) who are also using aspirin or any medicine that contains aspirin (eg, Aggrenox®, Ecotrin®, Excedrin®, Soma® Compound, and many cold medicines). Also, children and teenagers should not be given aspirin for 4 weeks after getting FluMist® or FluMist® Quadrivalent unless your doctor tells you otherwise.
Children younger than 2 years of age are usually not given the flu vaccine nasal spray. Young children who need the flu vaccine are usually given the flu vaccine injection (a shot).
This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.
The nasal mist vaccine (FluMist® or FluMist® Quadrivalent) contains a live virus. Avoid contact with people who are sick or at increased risk of getting the infection after you or your child receive this vaccine. Talk to your doctor about this if you have concerns.
This vaccine will not treat flu symptoms if you already have the virus. It may not protect all persons who receive the vaccine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Chills
- cough
- decreased appetite
- fever
- headache
- muscle aches
- sore throat
- stuffy or runny nose
- tiredness or weakness
Less common
- Chest tightness
- earache
- pain or tenderness around the eyes and cheekbones
- redness or swelling in the ear
- sneezing
- trouble breathing
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
- 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 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
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Irritability
- loss of appetite
- stomach pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20066943
