Tralokinumab-ldrm injection

WHY is this medicine prescribed?

Tralokinumab injection is used to treat eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Tralokinumab 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?

Tralokinumab injection comes as a solution (liquid) in a prefilled syringe and as an autoinjector to be injected subcutaneously (under the skin). It is given as 2 to 4 injections for the first dose and then 1 to 2 injections every 2 weeks thereafter for 16 weeks. After 16 weeks, you may be told to use 1 to 2 injections every 4 weeks. Follow the directions on your prescription label carefully. 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 tralokinumab 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. 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 tralokinumab injection before you inject the medication.

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

You can inject tralokinumab injection anywhere on the front of your thighs 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, that person can also inject the medication into your upper arms. Use different injection sites within the same body area for each dose of tralokinumab injection; give each injection at least 1 inch away from a spot that you have used before. At the next dose, rotate injection site to a different area of the body. Do not inject the medication into damaged, bruised, scarred or tender skin.

If syringe or autoinjector have been stored in the refrigerator, place the syringe or autoinjectoron a flat surface without removing the needle cap and allow it to warm to room temperature for 30 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 that contains tralokinumab.

Always look at tralokinumab injection solution before injecting it. Check that the expiration date has not passed and that the liquid is clear or slightly pearly and colorless or pale yellow. 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 tralokinumab injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• 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 tralokinumab 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?

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

• cough, runny nose, sneezing, sore throat
• watery, red, itchy eyes
• 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:

• breathing problems; swelling of the mouth, face and tongue; rash; hives; itching; fainting; or dizziness
• eye pain or changes in vision

Tralokinumab 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 container it came in, tightly closed, and out of reach of children. Store tralokinumab injection in the refrigerator and protect it from light. Tralokinumab injection prefilled syringes or autoinjector may also be stored at room temperature (up to 77°F [25°C]) for up to 14 days and protected from light. If tralokinumab injection is stored at room temperature for more than 14 days and it is not used, it must be disposed. Do not freeze it. Dispose of any medication that has been frozen.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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 use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.