How does this medication work? What will it do for me?

Tralokinumab belongs to the class of medications called immunomodulators, more specifically, interleukin inhibitors. It is used to treat adults with moderate to severe atopic dermatitis (eczema) when topical prescriptions, such as corticosteroids, haven't been effective or cannot be used. It may be used alone or with topical medications.

Tralokinumab works by blocking the action of a protein called interleukin-13 (IL-13) which is higher for people with atopic dermatitis. This results in less skin inflammation, itching, redness, and scaling.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each single-use pre-filled syringe contains 150 mg of tralokinumab in 1 mL of solution. Nonmedicinal ingredients: acetic acid, polysorbate 80, sodium acetate trihydrate, sodium chloride, and water for injection.

How should I use this medication?

For the treatment of atopic dermatitis, the starting dose of tralokinumab for adults is 600 mg injected subcutaneously (under the skin). This dose is injected as four 150 mg injections. After the first dose, 300 mg is injected subcutaneously every 2 weeks, as two 150 mg injections. Depending on how you respond to the medication, your doctor may consider treating you with a maintenance dose every 4 weeks.

If you are injecting this medication yourself, your doctor will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor any questions you might have. If a caregiver will be giving you the injections, your doctor should instruct them on how to give the injection.

Use a different injection site for each dose. Tralokinumab may be injected into the thigh or abdomen, avoiding a 5 cm (2 inch) area around the navel. If someone is injecting the medication for you, the upper arm may also be used as an injection site. You should avoid injecting this medication into an area of skin that is sore, red, infected, bruised, or otherwise damaged. If you are having difficulty giving yourself injections, talk to your health care provider.

Tralokinumab should be clear to opalescent and colourless to pale yellow in colour. Do not use the contents of a syringe if the medication is cloudy, discoloured, or has particles in it. Do not shake this medication.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in the refrigerator. Keep the syringe in the outer carton to protect it from light. Remove the pre-filled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes before injecting. Once the syringes have reached room temperature, do not return them to the refrigerator. If it is not used immediately, this medication may be kept at room temperature for up to 14 days. Keep this medication out of the reach and sight of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to tralokinumab or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cold or flu symptoms (e.g., sore throat, stuffy or runny nose, muscle aches, fatigue)
  • itching, pain, redness, or irritation at the injection site
  • redness, swelling, or itchiness of the eyes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • eye pain
  • increased frequency of infections
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.

Eye problems: Inflammation of the white part of the eye has been reported by people using tralokinumab. If you experience symptoms such as red eyes, moderate-to-severe eye pain, a feeling of grittiness in the eye, or increased sensitivity to light, contact your doctor as soon as possible.

Parasite infections: This medication may weaken your resistance to parasite infections, such as pinworms or tapeworms. If you already have a parasite infection it should be treated before starting this medication. If you are living in or travelling to a region where parasite infections are frequent, discuss with your doctor any special precautions that may be needed.

Vaccines: Live vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella) should not be given when you are using tralokinumab. Before starting treatment with this medication, check with your doctor to ensure your immunizations are up to date.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if tralokinumab passes into breast milk. If you are breast-feeding  and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between tralokinumab and any of the following:

  • live vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over the counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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