Tralokinumab is used in adults to treat moderate-to-severe eczema (atopic dermatitis) that is not well controlled with topical medicines (applied to the skin), or in people who cannot use topical medicines. tralokinumab can be used with or without topical steroids.

Tralokinumab may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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

Tralokinumab is injected under the skin. A healthcare provider may teach you 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 don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not reuse a needle or syringe. 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 tralokinumab in the original carton in the refrigerator. Protect from light and do not freeze.

Usual Adult Dose for Atopic Dermatitis:

Initial dose: 600 mg subcutaneously once
Maintenance dose (after initial dose): 300 mg subcutaneously every other week
-After 16 weeks of therapy: 300 mg subcutaneously every 4 weeks may be considered for patients below 100 kg who achieved clear or almost clear skin

Comments:
-Treatment should be initiated by health care providers experienced in the diagnosis and treatment of atopic dermatitis.
-Before starting this drug, all age-appropriate vaccinations (as recommended by current immunization guidelines) should be completed.
-This drug can be used with or without topical corticosteroids.
-Topical calcineurin inhibitors may be used, but should be reserved for problem areas (face, neck, intertriginous, and genital).

Use: For the treatment of moderate to severe atopic dermatitis when the disease is not adequately controlled with topical prescription agents or when such agents are not advisable

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

Tell your doctor if you have:

• eye problems;

• a parasitic infection; or

• if you are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or breastfeeding.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

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

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using tralokinumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

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

Tralokinumab may cause serious side effects. Call your doctor at once if you have:

• worsening eye problems, eye pain, or changes in your vision.

Common side effects of tralokinumab may include:

• pain, bruising, swelling, or irritation where the medicine was injected;

• eye and eyelid redness, swelling, and itching; or

• high count of a certain type of white blood cells (eosinophilia).

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.

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