Relenza Diskhaler

What is Relenza Diskhaler?

Relenza Diskhaler is a prescription medicine that is used to treat or prevent the flu.

Description

The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)- 4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of C₁₂H₂₀N₄O₇ and a molecular weight of 332.3. It has the following structural formula:

Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg per mL in water at 20°C.

RELENZA is for administration to the respiratory tract by oral inhalation only. Each RELENZA ROTADISK contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose (which contains milk proteins). The contents of each blister are inhaled using a specially designed breath-activated plastic device for inhaling powder called the DISKHALER. After a RELENZA ROTADISK is loaded into the DISKHALER, a blister that contains medication is pierced and the zanamivir is dispersed into the air stream created when the patient inhales through the mouthpiece. The amount of drug delivered to the respiratory tract will depend on patient factors such as inspiratory flow. Under standardized in vitro testing, RELENZA ROTADISK delivers 4 mg of zanamivir from the DISKHALER device when tested at a pressure drop of 3 kPa (corresponding to a flow rate of about 62 to 65 L per min) for 3 seconds.

Before taking Relenza Diskhaler, tell your doctor:

• If you are allergic to milk, talk with the doctor.
• If you are allergic to Relenza Diskhaler; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Asthma or other breathing problems like COPD (chronic obstructive pulmonary disease) or sleep apnea (breathing problems during sleep).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Relenza Diskhaler with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Relenza Diskhaler?

• Tell all of your health care providers that you take Relenza Diskhaler. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is not to be taken in place of a flu shot. If your doctor told you to get the flu shot, you need to get it.
• This medicine does not treat the common cold.
• This medicine does not stop the spread of the flu to others.
• Talk with your doctor before getting a flu vaccine after taking Relenza Diskhaler. Talk with your doctor before you take Relenza Diskhaler if you have just gotten a flu vaccine.
• Some people have had very bad breathing problems with Relenza Diskhaler. Most of the people who had this problem had asthma or other breathing problems like COPD, but some did not. Sometimes, this has been deadly. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Relenza Diskhaler while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Relenza Diskhaler best taken?

Use Relenza Diskhaler as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep using Relenza Diskhaler as you have been told by your doctor or other health care provider, even if you feel well.
• For breathing in only.
• Use Relenza Diskhaler after other breathed in drugs.
• Do not puncture a blister until you are ready to take a dose.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is less than 2 hours until your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Relenza Diskhaler that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Shortness of breath.
• Trouble breathing that is new or worse.
• Chest pain.
• Signs of ear, nose, or throat infection like fever, chills, redness or white patches in mouth or throat, very bad sore throat, ear or sinus pain, or discharge coming out of the ear.
• People with the flu can have nervous system problems and behavior problems that can lead to death. The chance may be higher in children. Call your doctor right away if you have change in thinking clearly and with logic, change in the way you act, speech problems, shakiness, seizures, or hallucinations.

What are some other side effects of Relenza Diskhaler?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Diarrhea.
• Upset stomach or throwing up.
• Nose and throat irritation.
• Sore throat.
• Dizziness.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Relenza Diskhaler?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

SRC: NLM .