tralokinumab

tralokinumab

tralokinumab

What is tralokinumab?

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

Side effects of tralokinumab

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Tralokinumab can cause serious side effects. Call your doctor immediately if you have:

• Worsening of eye problems, eye pain or changes in your vision.

Common side effects of tralokinumab may include:

• pain, bruising, swelling, or irritation at the injection site of the drug;

• redness, swelling and itching of the eyes and eyelids; or

• high numbers of a certain type of white blood cell (eosinophilia).

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

Warnings

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

Before you take this medicine

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 have a vaccination.

Tell your doctor if you are pregnant or breastfeeding.

How should I use tralokinumab?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Tralokinumab is injected under the skin. A doctor can teach you how to properly use the medication yourself.

Carefully read and follow all instructions for use that come with your medicine. Ask your doctor or pharmacist if you do not know how to use an injection.

Do not prepare an injection until you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed color, or contains particles.

Do not reuse a needle or syringe. Place them in a puncture-resistant sharps container and dispose of in accordance with state or local laws. Keep out of the reach of children and pets.

Store tralokinumab in the original packaging in the refrigerator. Protect from light and do not freeze.

Tralokinumab dosage information

Usual adult dose for atopic dermatitis:

Initial dose: 600 mg once subcutaneously
Maintenance dose (after initial dose): 300 mg subcutaneously every two weeks
-After 16 weeks of therapy: In patients less than 100 kg who have achieved clear or almost clear skin, subcutaneous administration of 300 mg every 4 weeks may be considered

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

Uses: For the treatment of moderate to severe atopic dermatitis when the disease cannot be adequately controlled with topical prescription agents or when such agents are inadvisable

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid when using tralokinumab?

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).

What other drugs affect tralokinumab?

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

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More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.