Tralokinumab-ldrm (Subcutaneous)

Tralokinumab-ldrm injection is used by itself or with other medicines (for example, topical corticosteroids) to treat moderate to severe atopic dermatitis in patients who have tried topical medicines that did not work well or who cannot use topical treatment.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your 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 experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on your face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around your eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after using this medicine.

Check with your doctor right away if you notice redness, irritation, or itching of the eye, eyelid, or inner lining of the eyelid. These could be signs of eye problems, including conjunctivitis or keratitis.

Do not receive any live vaccines (immunizations) while you are being treated with tralokinumab-ldrm. Check with your doctor before getting any vaccines.

In deciding to use a medicine, it is important to look at the risks and benefits. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of tralokinumab-ldrm injection in children. Safety and effectiveness have not been established.

Geriatric

Research so far has not shown any specific problems in older people that would limit the usefulness of tralokinumab-ldrm injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been selected for their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may change the dose or frequency of use for one or both medicines.

• Adenovirus Vaccine, 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, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine in relation to food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, especially:

• Conjunctivitis (pink eye) or
• Keratitis (inflammation of the cornea of the eye)—Use with caution. This medicine may worsen these conditions.

• 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.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also 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.

In the U.S.

• Adbry

Available Dosage Forms:

• Solution

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Tralokinumab

Find detailed information on biosimilars for this medication.

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.

Allow the medicine to warm to room temperature for 30 minutes before using it.

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 injection dosage form (prefilled syringe):For moderate to severe atopic dermatitis: 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 every other week. Children—Use and dose must be determined by your doctor.

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. You may also store the prefilled syringe at room temperature for up to 14 days. Use the medicine within 14 days after removing it from the refrigerator.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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