Lebrikizumab

Lebrikizumab is used by itself or with skin medications to treat moderate-to-severe eczema (atopic dermatitis) in adults and children who are at least 12 years old and weigh at least 88 pounds (40 kg). Lebrikizumab is used when other skin treatments did not work or have stopped working.

Lebrikizumab may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Lebrikizumab is injected under the skin in the stomach, thigh, or upper arm, usually once every 2 to 4 weeks. Your first dose may be given in 2 injections to receive the total dose.

A healthcare provider may teach you or your caregiver how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. Leave the needle cap on until you are ready to inject your dose. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not inject within 2 inches of your navel (belly button), or areas where the skin is red, hard, tender, bruised, or with lesions. Do not inject into the same place two times in a row.

Throw away a prefilled syringe or pen after one use, even if there is still medicine left inside. Do not reuse a needle, syringe, or pen. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Store this medicine in the original container in the refrigerator. Protect from light and do not freeze or shake it.

Take the medicine out of the refrigerator and let it reach room temperature for 45 minutes before injecting your dose. Do not heat a syringe or pen with hot water, sunlight, or a microwave.

You may store this medicine in the original container at room temperature for up to 7 days. Throw the medicine away if not used within 7 days. Do not put it back into the refrigerator.

Use only as directed. Inform your doctor if you are taking other medicines or if you have other medical conditions or allergies.

You should not use lebrikizumab if you are allergic to it.

Tell your doctor if you have or have ever had:

• eye problems;
• an infection caused by helminthic parasites; or
• if you recently received or are scheduled for a vaccine.

Make sure you are current on all vaccines before you start using lebrikizumab.

Do not allow a child to use lebrikizumab without help from an adult.

While you are using lebrikizumab, you may also have an increased risk of becoming infected with parasites (helminths). Talk with your doctor about what to look out for and how to treat this condition.

It is not known if lebrikizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, you may be asked to share information to track the effects of lebrikizumab on you and the baby.

Ask a doctor if it is safe to breastfeed while using lebrikizumab.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Lebrikizumab may cause serious side effects. Call your doctor right away if you have:

• eye pain, or changes in your vision such as blurred vision;
• skin rash; or
• stomach cramps.

Common side effects of lebrikizumab may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• redness, swelling, itching or inflammation of your eyes or eyelids; or
• skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Atopic Dermatitis:

-Initial dose: 500 mg subcutaneously at week 0 and week 2, followed by 250 mg subcutaneously every 2 weeks until week 16-Maintenance dose: 250 mg subcutaneously every 4 weeksComments:-This drug may be used with or without topical corticosteroids.-See manufacturer product information for complete administration instructions.Use: For the treatment of adults who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Usual Pediatric Dose for Atopic Dermatitis:

12 years and older who weigh at least 40 kg:-Initial dose: 500 mg subcutaneously at week 0 and week 2, followed by 250 mg subcutaneously every 2 weeks until week 16-Maintenance dose: 250 mg subcutaneously every 4 weeksComments:-This drug may be used with or without topical corticosteroids.-See manufacturer product information for complete administration instructions.Use: For the treatment of pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Use the medicine as soon as you remember, and then return to your regular schedule. Do not use two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine during treatment or right before starting treatment with lebrikizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, and varicella (chickenpox).

Do not use topical medications unless your doctor instructs you to.

Other drugs may affect lebrikizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.