RELENZA (Page 7 of 7)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Bronchospasm
Inform patients of the risk of bronchospasm, especially in the setting of underlying airways disease, and advise patients to stop RELENZA and contact their healthcare provider if they experience increased respiratory symptoms during treatment such as worsening wheezing, shortness of breath, or other signs or symptoms of bronchospasm [see Warnings and Precautions (5.1)]. If a decision is made to prescribe RELENZA for a patient with asthma or chronic obstructive pulmonary disease, the patient should be made aware of the risks and should have a fast-acting bronchodilator available.
Concomitant Bronchodilator Use
Patients scheduled to take inhaled bronchodilators at the same time as RELENZA should be advised to use their bronchodilators before taking RELENZA.
Neuropsychiatric Events
Inform patients with influenza (the flu), particularly children and adolescents, they 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 behavior [see Warnings and Precautions (5.3)].
Risk of Influenza Transmission to Others
Inform patients that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.
Missed Dose
Instruct patients that if they miss a dose of RELENZA, to take it as soon as they remember. If it is 2 hours or less before their next dose, instruct patients not to take the missed dose and to take the next dose of RELENZA at the next scheduled time. Advise patients not to double their next dose or take more than the prescribed dose.
Instructions for Use
Instruct patients in use of the delivery system. Instructions should include a demonstration whenever possible. For the proper use of RELENZA, the patient should read and follow carefully the accompanying Instructions for Use.
If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see Dosage and Administration (2.1)].
Trademarks are owned by or licensed to the GSK group of companies.
GlaxoSmithKline
Durham, NC 27701
©2023 GSK group of companies or its licensor.
RLZ:14PI
PATIENT INFORMATION | ||
RELENZA (ruh-LENS-uh) (zanamivir inhalation powder) for oral inhalation use | ||
What is RELENZA? RELENZA is a prescription medicine used to:
RELENZA is not recommended for the treatment or prevention of the flu in people with breathing problems, such as asthma and chronic obstructive pulmonary disease (COPD). RELENZA does not treat or prevent illness that is caused by infections other than the influenza virus (A and B). Using RELENZA for the treatment of the flu has not been shown to reduce the risk of spreading the flu to others. It is not known if RELENZA is:
RELENZA does not take the place of receiving a flu vaccination. Talk to your healthcare provider about when you should receive an annual flu vaccination. | ||
Do not take RELENZA if you are allergic to zanamivir or any other ingredient of RELENZA, including milk proteins. See the end of this Patient Information leaflet for a complete list of ingredients in RELENZA. | ||
Before taking RELENZA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | ||
How should I take RELENZA? Read the Instructions for Use at the end of this Patient Information for detailed information on how to take RELENZA.
For the treatment of flu in people aged 7 years and older, take RELENZA as follows:
To help prevent the flu in people aged 5 years and older, take RELENZA as follows:
If you miss a dose of RELENZA, take it as soon as you remember. If it is 2 hours or less before your next dose, do not take the missed dose. Take your next dose of RELENZA at your scheduled time. Do not take 2 doses at the same time. | ||
What are the possible side effects of RELENZA? RELENZA can cause serious side effects, including:
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The most common side effects of RELENZA include: | ||
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Other kinds of infections can appear like flu or happen along with flu, and may need different kinds of treatment. Call your healthcare provider if you feel worse or develop new symptoms during or after treatment with RELENZA, or if your flu symptoms do not start to get better. These are not all of the possible side effects of RELENZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. | ||
How should I store RELENZA?
Keep RELENZA and all medicines out of the reach of children. | ||
General information about the safe and effective use of RELENZA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use RELENZA for a condition for which it was not prescribed. Do not give RELENZA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about RELENZA that is written for health professionals. | ||
What are the ingredients in RELENZA? Active ingredient: zanamivir Inactive ingredients: lactose (which contains milk proteins) | ||
GlaxoSmithKline Durham, NC 27701 Trademarks are owned by or licensed to the GSK group of companies. ©2023 GSK group of companies or its licensor. RLZ:9PIL For more information call -1-888-825-5249. | ||
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 10/2023 |
- This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 10/2023
PRINCIPAL DISPLAY PANEL
NDC 0173-0681-01
RELENZA
(ZANAMIVIR) INHALATION POWDER
20 mg per Rotadisk
(5 mg per blister)
Each blister contains 5 mg zanamivir with lactose.
Use RELENZA with DISKHALER inhalation device only.
See enclosed “Patient Information” and “Patient Instructions for Use.”
Store at 25o C (77o F); excursions permitted to 15o to 30o C (59o to 86o F) (see USP Controlled Room Temperature).
Contains 5 RELENZA ROTADISKS® each containing four 5-mg blisters and one DISKHALER inhalation device.
Rx only
See prescribing information for dosage information.
20 blisters
FOR ORAL INHALATION ONLY
Made in UK
©2020 the GSK group of companies
Rev. 2/20
62000000045728
RELENZA zanamivir powder | |||||||||||||||||||||||||
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Labeler — GlaxoSmithKline LLC (167380711) |
Revised: 10/2023 GlaxoSmithKline LLC
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