Adbry Autoinjector (Subcutaneous)
Tralokinumab is used alone or with topical steroids (for the skin) in adults and children at least 12 years old to treat moderate-to-severe eczema (atopic dermatitis) that is not well controlled with topical medicines or in people who cannot use topical medicines.
The autoinjector is for use only in adults. The prefilled syringe is for use in adults and children at least 12 years old.
Tralokinumab may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Adbry Autoinjector (Subcutaneous)?
You should not use tralokinumab if you are allergic to it or any of its ingredients.
Tell your doctor if you have or have ever had:
- eye problems;
- infection caused by helminthic parasites; or
- if you are scheduled to receive a vaccine.
While you are using tralokinumab, you may have an increased risk of becoming infected with parasites (helminths). Talk with your doctor about what to look out for and how to treat this condition.
Make sure you are current on all vaccines before you start using tralokinumab.
It is not known if tralokinumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tralokinumab on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
Do not allow a child to use this medicine without help from an adult.
Side Effects
What are the side effects of Adbry Autoinjector (Subcutaneous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- new or worsening eye problems--eye pain, or changes in your vision.
Common side effects may include:
- pain, bruising, swelling, or irritation where the medicine was injected;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- eye and eyelid redness, swelling, 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.
Pregnancy & Breastfeeding
Can I take Adbry Autoinjector (Subcutaneous) if I’m pregnant or breastfeeding?
It is not known if tralokinumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tralokinumab on the baby.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Adbry Autoinjector (Subcutaneous)?
Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Dosage Guidelines & Tips
How to take Adbry Autoinjector (Subcutaneous)?
Use Adbry Autoinjector (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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 in the stomach, thigh, or upper arm, usually once every 2 to 4 weeks. Your first dose may be given in 2 injections to receive the total dose.
A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine. Read and carefully follow the 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 inject within 2 inches of your navel (belly button), or areas where the skin is damaged, tender, bruised, or has scars. Do not inject into the same place two times in a row.
If you also use a topical steroid medication for this condition, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
Throw away a prefilled syringe or autoinjector after one use, even if there is still medicine left inside. 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 this medicine in the original container in the refrigerator. Protect from light and do not freeze or shake.
Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Do not warm the medicine with hot water, sunlight, or a microwave.
You may store this medicine at room temperature for up to 14 days. Throw the medicine away if not used within 14 days. Do not put it back into the refrigerator.
Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.