Relenza: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RELENZA is an antiviral medicine for the treatment of influenza and for reducing the chance of getting the flu in community and household settings, in adults and children 7 years of age and older.

RELENZA is not a substitute for the flu shot. You should receive an annual flu shot according to guidelines on immunization practices that your doctor can share with you.

What influenza is:

The flu, or influenza, is an illness caused by a virus in your respiratory tract. Although the flu virus stays in your respiratory tract and is not carried by the blood, it can often make you feel sick all over.

True influenza is often confused with:

• the common cold (also caused by viruses)

• infections caused by bacteria, which may require

  antibiotics.

Antibiotics have no effect on viruses like the ones that cause influenza or colds. “Stomach flu” that causes vomiting and diarrhea is not related to influenza.

If you have the flu – You might need to be in bed for several days. You probably feel terrible. You will often have a fever, plus some or all of these symptoms:

• Chills
• Muscle aches
• Headache
• Sore throat
• Runny or stuffy nose
• Dry cough
• Tiredness

These symptoms are caused by your body’s defense system trying to fight the flu virus in your respiratory tract.

There are 2 main types of influenza viruses - A and B with several subtypes for each. These viruses change, or mutate, over time. Annual flu shot protects 80 to 85% of the time against one or more of the subtypes of flu that cause infections.

You might be surprised to find that you are still susceptible to flu even though you got your flu shot this year.

There are a few reasons why you may still have the flu:

• You were infected with the flu before the vaccine could protect you

• The flu vaccine did not completely protect you against the virus because:

  • the virus may have mutated or changed since the vaccine was developed
  • you may have a weakened immune system

What the medication does:

The influenza virus infects cells that line the inside of your respiratory tract. When RELENZA is inhaled, it helps stop the spread of the influenza virus to healthy cells in your respiratory tract.

With less flu virus in your respiratory tract, you should experience a less severe disease because your body’s defense system doesn’t have to work too hard to fight the virus. That means your flu symptoms should improve.

RELENZA should alleviate the symptoms you are feeling, shorten the duration of your flu (i.e. reduces duration of flu symptoms by about 1 or 2 days) and help you feel better sooner.

RELENZA can also help reduce the chance of getting the flu in persons 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.

When it should not be used:

You should not take RELENZA if you are allergic to zanamivir or any component of the zanamivir inhalation powder (see section entitled “What the important nonmedicinal ingredients are”).

What the medicinal ingredient is:

RELENZA contains the active ingredient zanamivir (zah-NA-mih-veer).

What the important nonmedicinal ingredients are:

RELENZA contains the nonmedicinal ingredient lactose (which contains milk protein).

What dosage forms it comes in:

RELENZA is a dry powder for inhalation. Each blister of RELENZA contains a dry loose powder mixture of zanamivir and lactose. The lactose acts as a carrier to deliver the medicine to the respiratory tract. The blister protects the powder from the air (until you inhale the powder). The DISKHALER inhalation device is used to inhale RELENZA directly into your respiratory tract.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Some patients have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these patients had asthma or chronic obstructive pulmonary disease. There is limited data on the use of RELENZA in patients with severe asthma or severe chronic obstructive pulmonary disease. Therefore, RELENZA is not generally recommended for such patients.

If you develop worsening respiratory symptoms such as wheezing or shortness of breath, stop using RELENZA and contact your doctor right away.

If you have chronic respiratory disease such as asthma or chronic obstructive pulmonary disease and your doctor 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.

Other kinds of infections can appear like influenza or occur along with influenza and need different kinds of treatment. Contact your doctor if you feel worse or develop new symptoms during or after treatment, or if your influenza symptoms do not start to get better.

BEFORE you use RELENZA talk to your doctor or pharmacist if:

• you suffer from asthma or chronic respiratory

  disease.

  Similar to other non-bronchodilator medications that are inhaled as a dry powder, a bronchospasm can occur when using RELENZA and a fast-acting inhaled bronchodilator (e.g. salbutamol) should be available if this occurs.

• you are pregnant, or likely to become pregnant soon,

  or if you are breast feeding.

  If you are pregnant or breast feeding, your doctor will help you decide whether you should take RELENZA.

  • you have any type of chronic condition including lung, kidney or heart disease.
  • you are allergic to lactose or milk protein.

INTERACTIONS WITH THIS MEDICATION

It is unlikely that RELENZA will interact with any medications you might be taking. Always be sure to tell your doctor what medications you are using.

PROPER USE OF THIS MEDICATION

Usual dose:

For the Treatment of Influenza: You need to inhale two blisters in the morning and two blisters in the evening. You will use 1 ROTADISK disk each day for 5 days. RELENZA works best when you start taking it as soon as you begin to feel symptoms and no later than 2 days after flu symptoms start. Take the entire dosage (all 5 ROTADISK disks) of RELENZA even if you start to feel better before you’ve finished all your medicine.

For the Prevention of Influenza: To reduce the chance of getting the flu, the usual dose is two blisters once daily for 10 or 28 days as prescribed by your doctor.

If you are scheduled to use an inhaled bronchodilator at the same time as RELENZA, you should use your bronchodilator first, before using RELENZA.

See also section entitled “How to take RELENZA” for instructions on how to use the DISKHALER inhalation device.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, don’t worry. Take a 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 doctor or pharmacist and follow the advice given to you.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

In studies, the most common side effects during treatment with RELENZA have been headaches, diarrhea, nausea, vomiting, appetite problems, nasal irritation, bronchitis, cough, sinusitis, ear, nose and throat infections, fever, chills, body pain, fatigue and dizziness. Other side effects that have been reported, but are not as common include allergic reactions and rashes.

If you are feeling unwell when you take RELENZA you may faint or become lightheaded after inhaling RELENZA. You must sit down in a relaxed position before inhaling the dose of RELENZA, and you must only hold your breath for as long as is comfortable after inhaling the dose. If you are feeling unwell, you are advised to have someone with you while you are inhaling the dose of RELENZA.

People with influenza (the flu), particularly children and adolescents, may be at an increased risk of seizures, confusion, delirium, hallucinations, or abnormal behaviour 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 behaviour and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behaviour.

Serious Warnings and Precautions are described above, and Serious Side Effects are in the table below.

If you notice any of the symptoms listed in the table above stop taking RELENZA and contact a doctor urgently.

This is not a complete list of side effects. For any unexpected effects while taking RELENZA, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15 to 30°C) in a dry place. Use the ROTADISK disk before the expiration date. Do not puncture any RELENZA ROTADISK disk blister until you are ready to inhale a dose of RELENZA.

Keep RELENZA and the DISKHALER inhalation device in a safe place away from children.

HOW TO TAKE RELENZA

The medicine in the ROTADISK disk must only be inhaled using the DISKHALER inhalation device. Follow the instructions as shown below. Children (7 years and older) who use RELENZA should always be supervised by an adult who understands how to use RELENZA. It is important that you inhale, not swallow, each dose as instructed by your doctor or pharmacist. If you have any problems taking this medicine, or do not understand the instructions below, tell your doctor or pharmacist.

The parts of your DISKHALER inhalation device are:

• Half-Circle Flap - Lifts up and down to operate the

  plastic needle.

• Needle - Punctures the blister to release medicine.
• Brown Wheel - Rotates to the next blister.
• White Tray - Pulls in and out.

• Raised Ridges - Help you pull out the tray for

  loading.

• Air Holes.
• White Mouthpiece - Where medicine is inhaled.

• Cover - Keeps the DISKHALER inhalation device

  clean when not in use.

• ROTADISK Medicine Disk - Contains 4 blisters of

  medicine; the disk fits onto the brown wheel inside the DISKHALER inhalation device.

• Blister of Medicine - Contains dry loose powder

  medicine.

  PATIENT INSTRUCTIONS

  Each disk contains 4 blisters of medicine.

  • ROTADISK disk
  • Blister of dry loose powder medicine

Don’t puncture any blisters until you’ve read all of the instructions and you’re ready to inhale your medicine. Important Instructions! Read instructions before using.

Step 1● Step 2● Step 3● Step 4● TO INHALE RELENZA

Step 1 To Load Medicine

Pull off the blue cover

Remove cover

Check that the mouthpiece is clean, inside and outside.

Pull and Extend

Hold the white sliding tray by the edges as shown and pull it out until it stops.

Pull to extend

Find 4 Ridges

Find the 4 raised ridges (finger grips) on each side of the white tray.

4 raised ridges

Squeeze and Remove

Press in these ridges, both sides at the same time, and pull the whole tray out of the DISKHALER inhalation device. The white tray should come out easily.

Squeeze 4 ridges to remove tray

Drop in ROTADISK disk

Place one ROTADISK disk onto the brown wheel, flat side up. Make sure the printed side is up, with the blisters facing downwards. The 4 blisters will drop neatly into the 4 holes in the wheel.

Drop in disk

Close

Push in the white tray, until it clicks firmly back into place. If you’re not ready to inhale a dose straight away, replace the blue cover.

Push to close (Click!)

Step 2 To Puncture Blister

Find Flap

Find the half-circle flap of the DISKHALER device.

Find flap

From this point on-- KEEP THE DISKHALER inhalation device LEVEL.

(The medicine in the blister is loose powder, so you don’t want it to spill out!)

Lift and Puncture

Lift this flap straight up--all the way— so the needle pierces the blister at both top and bottom.

Lift flap straight up

REMEMBER--Keep the DISKHALER inhalation device level! Do not turn it over or drop it as there is loose powder in the blister and it may spill out. Should you accidently spill out the powder in the blister proceed to Step 4.

Close Flap

Click the flap back down into place.

Close flap

Step 3 To get your dose ready

Don’t do this until just before you inhale a dose. Sit down in a comfortable position. Before putting the white mouthpiece into your mouth, breathe all the way out as far as is comfortable (exhale). Keep the DISKHALER away from your mouth.

Now put the white mouthpiece into your mouth and keep the DISKHALER inhalation device level!

Keep it level!

Close your lips firmly around the mouthpiece. Do not block the airholes on the side of the mouthpiece. Don’t blow into the DISKHALER (if you do, you’ll blow the powder out).

Take one quick deep breath in.

Hold your breath for 3 seconds or as long as is comfortable to help RELENZA stay in your respiratory tract where it can work. (Your breath will pull the medicine into your respiratory tract.)

Breathe in

You will feel some powder in your throat. This is normal. The powder may have a sweet taste. It’s O.K. to take a drink of water.

Go to Step 4 to inhale your next blister now.

Step 4 Next Blister

To automatically advance to the next blister, just pull the white tray by the edges until it stops. (Don’t remove it.)

Pull to extend

Then push it back until it clicks. Repeat if necessary until a full blister is positioned under the piercing needle.

Push to close (Click!)

This pull-push motion rotates the ROTADISK disk to the next blister.

Now you need to puncture this blister by lifting then closing the flap - See STEP 2.

Then you need to inhale with a quick deep breath- See STEP

3.

Once you have inhaled 2 blisters, wipe the mouthpiece with a tissue and put the blue cover back on the DISKHALER inhalation device to keep it clean until your next dose.

When all 4 blisters have been used, replace the disk with a fresh one - See STEP 1.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

The current version of this document plus the full product monograph, prepared for health professionals can be found at: http://www.gsk.ca or by contacting the sponsor,

GlaxoSmithKline Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

1-800-387-7374

Last revised: July 20, 2018

^©2018 GSK Group of companies or its Licensor.

Trademarks are owned by or licensed to the GSK group of companies.