Healthcare Professional Pandemic Planners

Frequently asked questions about RELENZA

What is RELENZA?

Who should not take RELENZA?

Who should consider taking RELENZA?

Can I take other medications with RELENZA?

How and when should I take RELENZA?

What if I miss a dose?

What are important or common possible side effects of taking RELENZA?

Should I get a flu shot?

What if I am pregnant or nursing?

How and where should I store RELENZA?

 

What is RELENZA?

RELENZA (ruh-LENS-uh) is a medicine for the treatment of influenza (or flu, the infection caused by the influenza virus) and for reducing the chances of catching 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

Some patients 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 (COPD).

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 a chronic respiratory disease such as asthma or 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.

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

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 may be at increased risk of seizures, confusion, or abnormal behavior early in their illness. Therefore, patients should be observed for signs of unusual behavior. A healthcare professional should be contacted if needed.

This list of side effects is not complete. You and your healthcare provider or pharmacist can discuss a more complete list of possible side effects with RELENZA. Talk to your healthcare provider promptly about any side effects you have.

Who should not take RELENZA?

RELENZA is not recommended for people who have chronic lung diseases 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 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 or food products, or if you are pregnant.

RELENZA was not effective in reducing the chance of catching the flu in 2 studies in nursing home patients.

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 should consider taking RELENZA. Typical symptoms of influenza include sudden onset of fever, cough, headache, fatigue, muscular weakness, and sore throat.

RELENZA can also help reduce the chances of catching the flu in adults and children at least 5 years of age who have a higher chance of catching the flu because they are more likely to be in proximity to others who are infected. RELENZA can also reduce the chances 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.

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 5mg of active drug and 20mg 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 RELENZA. For more information on how to use the RELENZA DISKHALER watch this short video.

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 after the first appearance of your flu symptoms. Take 2 doses on the first day of treatment whenever possible and ensure that there are at least 2 hours between doses.

To reduce the chances of catching 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 as you. If you feel worse, 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, unless it is within two hours of your previous or next scheduled dose. 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 may 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 reaction, some of which were severe.

This list of side effects is not complete. You and your healthcare provider or pharmacist can discuss a more complete list of possible side effects with RELENZA. Talk to your healthcare provider promptly about any side effects you have.

Please refer to the section entitled Important Safety Information About RELENZA for additional information.

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 does not come in a childproof container. Keep RELENZA out of the reach of children. Discard the DISKHALER after finishing your treatment.

Important Safety Information about RELENZA

Some people have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these people had previous asthma or other pulmonary disease. RELENZA has not been shown to shorten the time of flu 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 best for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease (COPD).

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

If you have diseases like asthma and 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 flu symptoms do not start to get better.

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 may be at increased risk of seizures, confusion, or abnormal behavior early in their illness. Therefore, patients should be observed for signs of unusual behavior, and a healthcare professional contacted if needed.

This list of side effects is not complete. Your doctor or pharmacist can discuss with you a more complete list of possible side effects with RELENZA. Talk to your doctor promptly about any side effects you have.

Important Safety Information

Some people have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Many but not all of these people had previous asthma or pulmonary disease.

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