Tralokinumab-ldrm (tral-oh-KIN-ue-mab - ldrm)

Treats atopic dermatitis.

Brand Name(s):

Adbry

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the thigh, upper arm, or stomach area.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, damaged, bruised, or scarred.
• This medicine comes in 2 forms: an autoinjector and prefilled syringe.
• Allow the autoinjector to warm to room temperature for 45 minutes and prefilled syringe to warm to room temperature for 30 minutes before using it. Do not warm using heat sources (including microwave, hot water, sunlight).
• Check the liquid in the prefilled syringe. It should be clear and colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake.
• Autoinjector:
  • Wash your hands with soap and water before and after using this medicine.
  • Do not shake the autoinjector. Do not remove the cap until you are ready to use it.
  • Do not use the autoinjector if it looks damaged or has been dropped.
  • Check the liquid in the autoinjector. It should be clear to slightly pearly and colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it.
  • Hold the autoinjector with one hand and pull the cap straight off with your other hand. Do not recap. Do not touch or push the needle guard with your finger.
  • Place the needle guard flat against your skin at a 90-degree angle. Do not change the position of the autoinjector after injection has started.
  • Press the autoinjector down firmly and hold it in place. You will hear a "click" to let you know that the injection has started and the yellow plunger will start to move. It will take up to 15 seconds to inject the full dose. You will hear a second "click" when the yellow plunger fills the viewing window. Continue to press for another 5 seconds to make sure you get the full dose.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from light. Keep your medicine and supplies in the original packages until you are ready to use them. Do not use it if it has been frozen. You may store the autoinjector or prefilled syringe at room temperature for up to 14 days. Do not put the medicine back in the refrigerator. Throw the medicine away if it has been left out of the refrigerator for more than 14 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have eye or vision problems or a parasite infection.
• This medicine may increase risk for eye infections, including conjunctivitis or keratitis
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools, chest pain, trouble breathing
• Burning, dry, or itching eyes, discharge, excessive tearing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Redness, pain, or swelling of the eye, eyelid, or inner lining of eyelid
• Sores or white patches on your lips, mouth, or throat
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088