(zanamivir) Inhalation Powder, for Oral Inhalation
This leaflet contains important patient information about RELENZA (zanamivir) Inhalation Powder, and
should be read completely before beginning treatment. It does not, however, take the place of
discussions with your healthcare provider about your medical condition or your treatment. This
summary does not list all benefits and risks of RELENZA. The medication described here can only be
prescribed and dispensed by a licensed healthcare provider, who has information about your medical
condition and more information about the drug, including how to take it, what to expect, and potential
side effects. If you have any questions about RELENZA, talk with your healthcare provider.
What is RELENZA?
RELENZA is a medicine for the treatment of influenza (flu, infection caused by influenza virus) and for
reducing the chance of getting the flu in community and household settings. It belongs to a group of
medicines called neuraminidase inhibitors. These medications attack the influenza virus and prevent it
from spreading inside your body. RELENZA treats the cause of influenza at its source, rather than
simply masking the symptoms.
Important Safety Information About RELENZA
Some patients have had bronchospasm (wheezing) or serious breathing problems when they used
RELENZA. Many but not all of these patients had previous asthma or chronic obstructive pulmonary
disease. RELENZA has not been shown to shorten the duration of influenza in people with these
diseases. Because of the risk of side effects and because it has not been shown to help them,
RELENZA is not recommended for people with chronic respiratory disease such as asthma or chronic
obstructive pulmonary disease.
If you develop worsening respiratory symptoms such as wheezing or shortness of breath, stop using
RELENZA and contact your healthcare provider right away.
If you have chronic respiratory disease such as asthma and chronic obstructive pulmonary disease and
your healthcare provider has prescribed RELENZA, you should have a fast-acting, inhaled
bronchodilator available for your use. If you are scheduled to use an inhaled bronchodilator at the same
time as RELENZA, use the inhaled bronchodilator before using RELENZA.
Read the rest of this leaflet for more information about side effects and risks.
Other kinds of infections can appear like influenza or occur along with influenza, and need different
kinds of treatment. Contact your healthcare provider if you feel worse or develop new symptoms during
or after treatment, or if your influenza symptoms do not start to get better.
Who should not take RELENZA?
RELENZA is not recommended for people who have chronic lung disease such as asthma or chronic
obstructive pulmonary disease. RELENZA has not been shown to shorten the duration of influenza in
people with these diseases, and some people have had serious side effects of bronchospasm and
worsening lung function. (See the section of this Patient Information entitled “Important Safety Information About RELENZA.”)
You should not take RELENZA if you are allergic to zanamivir or any other ingredient of RELENZA.
Also tell your healthcare provider if you have any type of chronic condition including lung or heart
disease, if you are allergic to any other medicines, milk proteins or other food products, or if you are
RELENZA was not effective in reducing the chance of getting the flu in 2 studies in nursing home
RELENZA does not treat flu-like illness that is not caused by influenza virus.
Who should consider taking RELENZA?
Adult and pediatric patients at least 7 years of age who have influenza symptoms that appeared within the
previous day or two. Typical symptoms of influenza include sudden onset of fever, cough, headache,
fatigue, muscular weakness, and sore throat.
RELENZA can also help reduce the chance of getting the flu in adults and children at least 5 years of
age who have a higher chance of getting the flu because they spend time with someone who has the flu.
RELENZA can also reduce the chance of getting the flu if there is a flu outbreak in the community.
The use of RELENZA for the treatment of flu has not been shown to reduce the risk of spreading the
virus to others.
Can I take other medications with RELENZA?
RELENZA has been shown to have an acceptable safety profile when used as labeled, with minimal risk
of drug interactions. Your healthcare provider may recommend taking other medications, including
over-the-counter medications, to reduce fever or other symptoms while you are taking RELENZA.
Before starting treatment, make sure that your healthcare provider knows if you are taking other
medicines. If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, you
should use the inhaled bronchodilator before using RELENZA.
Before taking RELENZA, please let your healthcare provider know if you received live attenuated
influenza vaccine (FLUMIST® ) intranasal in the past 2 weeks.
How and when should I take RELENZA?
RELENZA is packaged in medicine disks called ROTADISKS® and is inhaled by mouth using a
delivery device called a DISKHALER® . Each ROTADISK contains 4 blisters. Each blister contains
5 mg of active drug and 20 mg of lactose powder (which contains milk proteins).
You should receive a demonstration on how to use RELENZA in the DISKHALER from a healthcare
provider. Before taking RELENZA, read the “Patient Instructions for Use.” Make sure that you
understand these instructions and talk to your healthcare provider if you have any questions. Children
who use RELENZA should always be supervised by an adult who understands how to use RELENZA.
Proper use of the DISKHALER to inhale the drug is necessary for safe and effective use of
If you have the flu the usual dose for treatment is 2 inhalations of RELENZA (1 blister per inhalation)
twice daily (in the morning and evening) for 5 days. It is important that you begin your treatment with
RELENZA as soon as possible from the first appearance of your flu symptoms. Take 2 doses on the
first day of treatment whenever possible if there are at least 2 hours between doses.
To reduce the chance of getting the flu, the usual dose is 2 inhalations of RELENZA (1 blister per
inhalation) once daily for 10 or 28 days as prescribed by your healthcare provider.
Never share RELENZA with anyone, even if they have the same symptoms. If you feel worse or
develop new symptoms during treatment with RELENZA, or if your flu symptoms do not start to get
better, stop using the medicine and contact your healthcare provider.
What if I miss a dose?
If you forget to take your medicine at any time, take the missed dose as soon as you remember, except if
it is near the next dose (within 2 hours). Then continue to take RELENZA at the usual times. You do not
need to take a double dose. If you have missed several doses, inform your healthcare provider and
follow the advice given to you.
What are important or common possible side effects of taking RELENZA?
Some patients have had breathing problems while taking RELENZA. This can be very serious and need
treatment right away. Most of the patients who had this problem had asthma or chronic obstructive
pulmonary disease, but some did not. If you have trouble breathing or have wheezing after your dose of
RELENZA, stop taking RELENZA and get medical attention.
In studies, the most common side effects with RELENZA have been headaches; diarrhea; nausea;
vomiting; nasal irritation; bronchitis; cough; sinusitis; ear, nose, and throat infections; and dizziness.
Other side effects that have been reported, but were not as common, include rashes and allergic
reactions, some of which were severe.
People with influenza (the flu), particularly children and adolescents, may be at an increased risk of
seizures, confusion, or abnormal behavior early in their illness. These events may occur after beginning
RELENZA or may occur when flu is not treated. These events are uncommon but may result in
accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior
and a healthcare professional should be contacted immediately if the patient shows any signs of unusual
If you are not feeling well when you take RELENZA, you may faint or become lightheaded after
inhaling RELENZA. You should sit down in a relaxed position before inhaling the dose of RELENZA,
and you should only hold your breath for as long as is comfortable after inhaling the dose.
If you are not feeling well, you are advised to have someone with you while you are inhaling the dose
This list of side effects is not complete. Your healthcare provider or pharmacist can discuss with you a
more complete list of possible side effects with RELENZA. Talk to your healthcare provider promptly
about any side effects you have.
Call your healthcare provider for medical advice about side effects. You may report side effects to
FDA at 1-800-FDA-1088.
Please refer to the section entitled “Important Safety Information About RELENZA” for additional
Should I get a flu shot?
RELENZA is not a substitute for a flu shot. You should receive an annual flu shot according to
guidelines on immunization practices that your healthcare provider can share with you.
What if I am pregnant or nursing?
If you are pregnant or planning to become pregnant while taking RELENZA, talk to your healthcare
provider before taking this medication. RELENZA is normally not recommended for use during
pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
How and where should I store RELENZA?
RELENZA should be stored at room temperature below 77°F (25°C). RELENZA is not in a childproof
container. Keep RELENZA out of the reach of children. Discard the DISKHALER after finishing your
INSTRUCTIONS FOR USE
IMPORTANT: Read Step-by-Step Instructions before using the DISKHALER® .
Be sure to take the dose your healthcare provider has prescribed.
BEFORE YOU START:
Please read the entire Patient Information leaflet for important information about the effects of
RELENZA including the section “Important Safety Information About RELENZA” for
information about the risk of breathing difficulties .
If RELENZA is prescribed for a child, dosing should be supervised by an adult who understands
how to use RELENZA and has been instructed in its use by a healthcare provider.
Step-by-step instructions for using the DISKHALER®
Step A: Load the medicine into the DISKHALER
- Start by pulling off the blue cover.
- Always check inside the mouthpiece to make sure it is clear before each use. If foreign
objects are in the mouthpiece, they could be inhaled and cause serious harm.
- Pull the white mouthpiece by the edges to extend the white tray all the way.
- Once the white tray is extended all the way, find the raised ridges on each side of it. Press in these
ridges, both sides at the same time, and pull the whole white tray out of the DISKHALER body.
- Place one silver medicine disk onto the dark brown wheel, flat side up. The four silver blisters on
the underside of the medicine disk will drop neatly into the four holes in the wheel.
- Push in the white tray as far as it will go. Now the DISKHALER is loaded with medicine.
Step B: Puncture the blister
Be sure to keep the DISKHALER level.
The DISKHALER punctures one blister of medicine at a time so you can inhale the right amount.
It does not matter which blister you start with. Check to make sure that the silver foil is
- Be sure to keep the DISKHALER level so the medicine does not spill out.
- Locate the half-circle flap with the name “RELENZA” on top of the DISKHALER.
- Lift this flap from the outer edge until it cannot go any farther. Flap must be straight up for the
plastic needle to puncture both the top and bottom of the silver medicine disk inside.
- Keeping the DISKHALER level, click the flap down into place.
Step C: Inhale
- Before putting the white mouthpiece into your mouth, breathe all the way out (exhale).
Then put the white mouthpiece into your mouth. Be sure to keep the DISKHALER level so
the medicine does not spill out.
- Close your lips firmly around the mouthpiece. Be sure not to cover the small holes on either side
- Breathe in through your mouth steadily and as deeply as you can. Your breath pulls the medicine
into your airways and lungs.
- Hold your breath for a few seconds to help RELENZA stay in your lungs where it can work.
To take another inhalation, move to the next blister by following Step D below.
Once you’ve inhaled the number of blisters prescribed by your healthcare provider, replace the
cover until your next dose.
Step D: Move the medicine disk to the next blister
- Pull the mouthpiece to extend the white tray, without removing it.
- Then push it back until it clicks. This pull-push motion rotates the medicine disk to the next
- To take your next inhalation, repeat Steps B and C.
If all 4 blisters in the medicine disk have been used, you are ready to start a new medicine disk
(see Step A). Check to make sure that the silver foil is unbroken each time you are ready to
puncture the next blister.
Read this entire leaflet before using RELENZA. Even if you have had a previous prescription for
RELENZA, read this leaflet to see if any information has changed.
If you have the flu, the usual dose is 2 inhalations twice daily. To reduce the chance of getting the
flu, the usual dose is 2 inhalations once daily. However, you must take the number of inhalations your
healthcare provider has prescribed.
If you feel worse or develop new symptoms during or after treatment, or if your flu symptoms do not
start to improve, stop using the medicine and contact your healthcare provider.
Keep out of reach of children.
Always check inside the mouthpiece to make sure it is clear before each use. If foreign objects are in
the mouthpiece, they could be inhaled and cause serious harm.
Always replace the cover after each use.
Throw away the DISKHALER after treatment is completed.
This DISKHALER is for use only with RELENZA. Do not use the RELENZA DISKHALER device
with FLOVENT® (fluticasone propionate) and do not use RELENZA with the FLOVENT
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room
REMEMBER: This medicine has been prescribed for you by your healthcare provider. DO NOT
give this medicine to anyone else.