Pronunciation:

tez-e-PEL-ue-mab - ekko

Brand Names:

• Tezspire

Dosage Forms:

• Solution

Classifications:

Pharmacologic—

Tezepelumab

Uses of This Medicine:

Tezepelumab-ekko injection is used together with other medicines to treat severe asthma. Tezepelumab-ekko helps prevent severe asthma attacks (exacerbations) and can improve your breathing. This medicine will not relieve an asthma attack that has already started.

This medicine is to be given only by or under the direct supervision of your doctor.

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 have not been performed on the relationship of age to the effects of tezepelumab-ekko injection to treat asthma in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tezepelumab-ekko injection in the elderly.

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:

• Bronchospasm (breathing problem), acute or
• Status asthmaticus (severe asthma attack)—Should not be used in patients with these conditions.

• Parasitic infection—Use with caution. It is not known if this medicine may affect patients with this condition. Treat the infection first before using this medicine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thigh, stomach area, or upper arm once every 4 weeks. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are bruised, hardened, red, or tender.

This medicine comes in 3 forms: a vial, prefilled pen, or prefilled syringe. The vial and prefilled syringe are given by a nurse or other trained health professional.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions about:

• How to prepare the injection.
• The proper use of disposable syringes.
• How to give the injection.
• How long the injection can be stored at home.

Allow the medicine to warm to room temperature for 60 minutes before using it. Do not warm it by using a heat source or in any other way. Do not shake.

Check the liquid in the prefilled pen. It should be clear, colorless to light yellow. Do not use this medicine if it is cloudy, discolored, or if it has particles in it. Do not use the prefilled syringe or pre-filled pen if it has been frozen, damaged, or dropped.

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 injectable dosage form (prefilled pen):
  • For severe asthma:
    • Adults and children 12 years of age and older—210 milligrams (mg) injected under the skin once every 4 weeks.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

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.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton until you are ready to use it. Protect it from light. You may keep it at room temperature for 30 days. Do not put back in the refrigerator once it has reached room temperature. Throw away if it has been stored at room temperature for more than 30 days.

Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis or allergic conjunctivitis, which can be serious and can occur within hours or days after receiving the injection. Tell your doctor right away if you have hives, itching, skin rash, lightheadedness, dizziness, fainting, swelling of the face, mouth, or tongue, trouble breathing, burning, dry, or itching eyes, discharge, excessive tearing, or redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid after using this medicine.

If you are using a steroid medicine for your asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.

Do not receive any live vaccines (immunizations) while you are being treated with tezepelumab-ekko. Check with your doctor before receiving any vaccines.

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:

Incidence not known

Burning, dry, or itching eyes

chest tightness

discharge, excessive tearing

fast heartbeat

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

lightheadedness, dizziness, or fainting

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

redness of the skin

swelling of the eyelids, face, lips, mouth, tongue, hands, or feet

trouble breathing

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

Back pain

body aches or pain

cough

difficulty in moving

dryness or soreness of the throat

fever

muscle pain or stiffness

redness, pain, or itching at the injection site

stuffy or runny nose

tender, swollen glands in the neck

trouble swallowing

voice changes

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.