Tralokinumab-ldrm injection

Tralokinumab injection is used to treat moderate to severe eczema (atopic dermatitis; 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 whose eczema has not responded to topical medications. 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.

Tralokinumab injection comes as a solution (liquid) to be injected subcutaneously (under the skin). It is usually given as four injections for the first dose, followed by two injections every 2 weeks after the first dose for 16 weeks, and then may be continued as two injections 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 tralokinumab 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 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. If you will be injecting tralokinumab 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 tralokinumab injection before you inject the medication.

Tralokinumab injection comes in prefilled syringes. Use each syringe only once and inject all the solution in the syringe. 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 you are using pre-filled syringes that have been refrigerated, place the syringe on 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.

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

Before using tralokinumab injection,

• tell your doctor and pharmacist if you are allergic to tralokinumab, any other medications, or any of the ingredients in tralokinumab 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 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.

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

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

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

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.

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