Pronunciation:

za-NA-mi-veer

Brand Names:

• Relenza

Dosage Forms:

• Disk

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Neuraminidase Inhibitor, Influenza A&B Virus

Uses of This Medicine:

Zanamivir is used in the treatment of the infection caused by the flu virus (influenza A and influenza B). Zanamivir may reduce flu symptoms (weakness, headache, fever, cough, and sore throat) by 1 to 1.5 days. Zanamivir may also be used to prevent influenza infection .

This medicine must be started within 2 days of having flu symptoms (weakness, headache, fever, cough, and sore throat). Zanamivir will not keep you from spreading the flu virus to other people. Zanamivir may not work for everybody. Zanamivir may not be for you if you are severely sick or have a breathing problem (like asthma or chronic obstructive pulmonary disease). If you receive the flu vaccine every year, continue to do so.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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.

Children—

Appropriate studies for the treatment of influenza infection in children up to 7 years of age have not been performed. Appropriate studies for the prevention of influenza infection in children up to 5 years of age have also not been performed. Safety and efficacy of zanamivir for the treatment and prevention of influenza infection have not been established in these age groups .

Note: This medicine is available in Canada. It is not recommended in children younger than 12 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of zanamivir in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, which may require caution in patients receiving zanamivir .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart Disease—Zanamivir may not work in patients with heart disease.

• Lung Disease—Patients with lung disease (chronic obstructive pulmonary disease or asthma) may experience trouble breathing with the use of zanamivir. Zanamivir may not work in patients with chronic lung disease.

Proper Use of This Medicine:

Talk to your doctor about the possibility of getting a flu shot if you have not had one yet. This medicine works best if taken as soon as possible after exposure to people who have the flu. If you already have the flu, continue taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return. This medicine should be taken for 5 days.

Inhaled zanamivir is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do.

To load the inhaler:

• Pull off the blue cover. Make sure the mouthpiece is clean and free of foreign objects.
• Pull the white mouthpiece until the tray is extended.
• Hold the corners of the white tray and pull out gently until you can see all the raised ridges on the sides of the tray.
• Put your finger and thumb on the ridges, squeeze inward, and gently pull the tray out of the body of the inhaler.
• Place a disk on the wheel and then slide the tray back into the inhaler
• To replace the empty disk with a full disk, follow the same steps you used to load the inhaler.

To use the inhaler:

• Hold the inhaler flat in your hand.
• A plastic needle will break the blister containing one inhalation of medicine. When the flap is raised as far as it will go, the blister will be pierced. Do not lift the flap if the cartridge is not in the inhaler. Doing this will break the needle and you will need a new inhaler.
• After the blister is broken open, close the lid. Keeping the inhaler flat and well away from your mouth, breathe out to the end of a normal breath.
• Raise the inhaler to your mouth, and place the mouthpiece in your mouth.
• Close your lips around the mouthpiece and tilt your head slightly back. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue. Do not cover the air holes on the side of the mouthpiece.
• Breathe in through your mouth as steadily and as deeply as you can until you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
• Hold the inhaler well away from your mouth and breathe out to the end of a normal breath.
• Prepare the cartridge for your next inhalation. Pull the mouthpiece to extend the tray then push it in until it clicks. The disk will turn to the next dose. Do not pierce the blister until just before the inhalation.
• Take the second puff following exactly the same steps you used for the first puff.
• When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.

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 inhalation dosage form (powder):
  • For prevention of flu (Influenza A and Influenza B) in a household:
    • Adults and children 5 years of age and older—Two puffs twice daily for 10 days. Doses should be taken at the same time each day. Zanamivir must be started within 36 hours after the onset of signs and symptoms of the flu in a household.
    • Children below 5 years of age—Use and dose must be determined by your doctor .
  • For prevention of flu (Influenza A and Influenza B) during community outbreaks:
    • Adults and children 5 years of age and older—Two puffs twice daily for 28 days. Doses should be taken at the same time each day. Zanamivir must be started within 5 days after the outbreak was identified in the community.
    • Children below 5 years of age—Use and dose must be determined by your doctor .
  • For treatment of flu (Influenza A and Influenza B):
    • Adults and children 7 years of age and older—Two puffs twice daily (approximately 12 hours apart in the morning and evening) for 5 days. Two doses should be taken on the first day of treatment whenever possible provided there are at least 2 hours between doses. Zanamivir must be started within 48 hours after the onset of signs and symptoms of the flu.
    • Children below 7 years of age—Use and dose must be determined by your doctor .
  • Canada: For treatment of flu (Influenza A and Influenza B):
    • Adults and children 12 years of age and older—Two puffs twice daily (approximately 12 hours apart in the morning and evening) for 5 days. Two doses should be taken on the first day of treatment whenever possible provided there are at least 2 hours between doses. Zanamivir must be started within 48 hours after the onset of signs and symptoms of the flu.
    • Children below 12 years of age—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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 While Using This Medicine:

Zanamivir may cause people with lung disease (chronic obstructive lung disease or asthma) to experience trouble breathing. If this should happen contact your doctor immediately. Zanamivir may not work in patients with lung disease, heart disease, or serious medical conditions.

Bronchospasm (wheezing) is a risk for patients with asthma or chronic respiratory disease. Always have a fast-acting inhaled bronchodilator available for your use.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine .

This medicine contains lactose. Tell your doctor if you are allergic to lactose before you start using this medicine .

Before using this medicine, tell your doctor if you have received a live, attenuated intranasal influenza vaccine (FluMist®) in the past two weeks .

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

Rare

Convulsions

dizziness and fainting

heartbeat, fast, slow, or irregular

increased sensitivity to sunlight

itching, pain, redness, swelling or watering of eye or eyelid

flushing or reddening of skin

joint pain

severe skin rash or hives

shortness of breath or troubled breathing

swelling or puffiness of face

swollen glands or tightness in throat

tightness in chest or wheezing

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:

Less common

Change in hearing

cough

cough producing mucus

diarrhea

dizziness

ear drainage

ear, nose and throat infections

earache

fever or chills

headache

nasal signs and symptoms

nausea

pain and pressure over cheeks

pain in ear

shortness of breath

tightness in chest

vomiting

wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.