Description
Tralokinumab-ldrm injection is used alone or in combination with other medicines (eg, topical corticosteroids) to treat moderate to severe atopic dermatitis in patients who have been treated with topical medicines that did not work well or who cannot use topical treatment.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tralokinumab-ldrm injection in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tralokinumab-ldrm injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Conjunctivitis (pink eye) or
- Keratitis (inflammation of the cornea of the eye)—Use with caution. May make these conditions worse.
- Parasitic infection—Use with caution. It is not known if this medicine may affect patients with this condition. Treat the infection first before using this medicine.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thigh, stomach area, or upper arm. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you use Adbry® at home, 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. This will help prevent skin problems. 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 (eg, microwave, hot water, sunlight).
To use the 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.
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.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For moderate to severe atopic dermatitis:
- For injection dosage form (autoinjector):
- Adults—At first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every other week.
- Children 12 to 17 years of age—Use of prefilled syringe is recommended.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For injection dosage form (prefilled syringe):
- Adults—At first, 600 milligrams (mg) (four 150 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg (two 150 mg injections) every other week.
- Children 12 to 17 years of age—At first, 300 mg (two 150 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 150 mg every other week.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For injection dosage form (autoinjector):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. 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.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after using this medicine.
Check with your doctor right away if you have redness, irritation, or itching the of eye, eyelid, or inner lining of the eyelid. These could be symptoms of eye problems, including conjunctivitis or keratitis.
Do not have any live vaccines (immunizations) while you are being treated with tralokinumab-ldrm. Check with your doctor before having any vaccines.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Body aches or pain
- burning, dry, or itching eyes
- chills
- cough
- discharge, excessive tearing
- ear congestion
- fever
- headache
- loss of voice
- redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Less common
- Black, tarry stools
- chest pain
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- swollen glands
- unusual bleeding or bruising
Incidence not known
- Chest tightness
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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