Lebrikizumab-lbkz Injection

WHY is this medicine prescribed?

Lebrikizumab-lbkz injection is used to treat moderate to severe atopic dermatitis (a type of eczema; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children age 12 years and older who cannot use topical medications for their condition or who have not responded to topical medications. Lebrikizumab-lbkz is in a class of medications called interleukin-13 receptor inhibitors. It works by blocking the activity of interleukin-13, a substance in the body that causes inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lebrikizumab-lbkz injection comes as a solution (liquid) to be injected subcutaneously (under the skin). It is usually given as two injections every 2 weeks for the first two doses, followed by once injection every 2 weeks after the first two doses for 16 weeks, and then may be continued as one injection every 4 weeks after that. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lebrikizumab-lbkz injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You may receive your first dose of lebrikizumab-lbkz injection in your doctor's office. After that, you may be able to inject the medication yourself at home or have a friend or relative perform the injections. If you will be injecting lebrikizumab-lbkz injection subcutaneously by yourself at home or having a friend or relative inject the medication for you, your doctor will show you or the person who will be injecting the medication how to inject it. Read the written instructions for use that come with lebrikizumab-lbkz injection before you inject the medication.

Lebrikizumab-lbkz injection comes in prefilled syringes and prefilled pens. Use each syringe and pen only once and inject all the solution in the syringe or pen. Do not reuse lebrikizumab-lbkz pre-filled syringes and do not recap the syringes after use. Dispose of used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

You can inject lebrikizumab-lbkz injection on the front of your thighs (upper leg), at least 2 inches above your knee and 2 inches below your groin, or abdomen (stomach) except your navel (belly button) and the area 2 inches (5 centimeters) around it. If someone else is giving you the injection, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different injection site for each injection. Do not inject the medication into damaged, bruised, scarred or tender skin.

If you are using a prefilled syringe or prefilled pen that has been refrigerated, place the syringe or pen on a flat surface without removing the needle cap and allow it warm to room temperature for 45 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.

Do not shake a syringe or pen that contains lebrikizumab-lbkz injection.

Always look at lebrikizumab-lbkz injection solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless or pale yellow or brown. Do not use a syringe if it is expired or if the liquid is cloudy, discolored or contains large or colored particles.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using lebrikizumab-lbkz injection,

• tell your doctor and pharmacist if you are allergic to lebrikizumab-lbkz, any other medications, or any of the ingredients in lebrikizumab-lbkz injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had a parasitic infection or any eye problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using lebrikizumab-lbkz injection, call your doctor.

• check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a dose, administer the next dose as soon as you remember and then resume the usual dosing schedule.

What SIDE EFFECTS can this medicine cause?

Lebrikizumab-lbkz may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, swelling, redness at the site of injection

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• new or worsening eye problems, including eye pain, blurred vision, pink or red eye(s), red or swollen eyelids, or changes in vision
• hives; rash; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; dizziness; fainting; or stomach cramps
• painful rash on one side of face or body, with blisters, itching, or tingling in rash area

Lebrikizumab-lbkz injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the original container it came in, tightly closed, and out of reach of children. Store lebrikizumab-lbkz injection in the refrigerator or at room temperature for up to 7 days. Do not freeze. Keep the syringes and pens in their original cartons to protect them from light.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.