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The US Food and Drug Administration (FDA) has approved Adbry TM (tralokinumab-ldrm) for the treatment of moderate to severe atopic dermatitis in adults 18 years of age and older. Adbry can be given with or without topical corticosteroids. To better understand what Adbry is, what Adbry does, let's learn more in the article below.
1. What is Adbry?
Adbry is a prescription medication used to treat adults with moderate to severe atopic dermatitis (eczema) that is not well controlled by prescription therapies used on the skin (topical) ) or who cannot use topical therapies.
2. What does Adbry do?
IL-13 is a natural cytokine of the type 2 immune response. Tralokinumab will bind to inhibit the biological activity of IL-13 by blocking the interaction of IL-13 with the IL-13Rα1 receptor complex. /IL-4Rα. Tralokinumab inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines, and IgE.
Treatment for this condition includes: Moisturizing, avoiding allergens and irritants, topical corticosteroids or immunosuppressants, etc. Atopic dermatitis in children usually goes away or significantly decreased in adulthood.
3. Side effects of the drug Adbry
Adbry can lead to serious side effects, including:
Allergic reactions (hypersensitivity), including a serious reaction called anaphylaxis. Stop using Adbry and tell your healthcare provider or get emergency help right away if you experience any of the following symptoms: Respiratory problems Swelling of the face, mouth and tongue Honeycomb Itching Fainting, dizziness and feeling lightheaded (low blood pressure) Skin rash Eye problems. Tell your healthcare provider if you have any worsening eye problems, including eye pain or vision changes.
The most common side effects include:
Inflammation of the eyes and eyelids, including redness, swelling and itching Injection site reactions High numbers of certain white blood cells (eosinophils)
4. Before Using Adbry
Before you start treatment tell your healthcare provider about all of your medical conditions, including if you:
Have eye problems. You have a parasitic infection (such as a worm). You are scheduled to receive any vaccine. You should not receive a “live vaccine” if you are being treated with Adbry. Are pregnant or planning to become pregnant. It is not known whether Adbry will harm your unborn baby. Breastfeeding. It is not known whether Adbry passes into your breast milk and if it could harm your baby.
5. How to use Adbry effectively
Prepare for use
Before injecting, remove the ADBRY prefilled syringe from the refrigerator and let it come to room temperature (30 min for a 150 mg/mL prefilled syringe) without removing the needle cap.
Once removed from the refrigerator, the prefilled syringe can be kept at room temperature up to 25°C (77°F) and must be used within 14 days or thrown away.
Visually inspect ADBRY for particulate matter and discoloration before use. ADBRY Injection is a clear to opalescent, colorless to pale yellow solution. Do not use if the liquid contains visible, discolored or cloudy granular substances (except transparent to opalescent, colorless to pale yellow).
ADBRY does not contain preservatives; Therefore, discard any unused product.
Important Administration Guide
ADBRY is intended for use in accordance with the instructions of a healthcare provider. Patients can self-inject ADBRY after training in subcutaneous injection techniques. Provide appropriate training to patients and/or caregivers regarding preparation and use in accordance with the “Instructions for Use”.
For the initial 600 mg dose, administer each of the four 150 mg ADBRY injections at different injection sites in the same body area.
For subsequent 300mg doses, administer two 150mg ADBRY injections at different injection sites in the same body area.
Inject subcutaneously into the thigh or abdomen and except for 2 inches (5cm) around the navel. The upper arm may also be used if the caregiver gives the injection.
Rotate the body area with each subsequent injection. DO NOT inject ADBRY into tender, damaged, bruised, or scarred skin.
Use Adbry exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how much Adbry to inject and when.
If your healthcare provider decides that you or your caregiver can give the injection, you or your caregiver should be trained in how to properly prepare and inject Adbry. Do not attempt to inject Adbry until you have been properly prescribed by your healthcare provider.
If you miss a dose, inject the missed dose as soon as possible, then continue with the next dose at your usual scheduled time.
Your healthcare provider may prescribe other medicines for use with Adbry. Use other prescribed medications exactly as your healthcare provider tells you to.
6. Dosage information of adbry
Usual Adult Dose for Atopic Dermatitis
Initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) given every other week. A dose of 300 mg every 4 weeks may be considered for patients under 100 kg who achieve clear or nearly clear skin after 16 weeks of treatment. Use: treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled by prescription topical therapies or when such therapies would not be recommended.
7. Clinical efficacy of adbry
Adbry was approved by the FDA based on data coming from the ECZTRA 1, ECZTRA 2, and ECZTRA 3 trials, which included nearly 2,000 adult patients with moderate to severe atopic dermatitis. In trials, Adbry 300mg was used every 2 weeks as monotherapy or in combination with topical corticosteroids as needed. Adbry that met the primary assessment criteria at week 16 will be based on the IGA (Investigator Global Assessment) scale of clear or nearly clear skin (0/1) and/or improved at least an EASI-75 score (Eczema Area and Severity Index -75%). The secondary endpoint was a reduction in daily (Worst Daily Pruritus) and weekly mean pruritus scores of 4 or more.
8. Storage and handling of adbry
ADBRY contains no preservatives. Discard any unused product remaining in the prefilled syringe.
Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
If needed, prefilled syringes can be kept at room temperature up to 25°C (77°F) for up to 14 days in the original carton. Do not store above 25°C (77°F). If the carton needs to be permanently removed from the refrigerator, the date of removal may be indicated on the outer carton in the space provided. Once removed from the refrigerator, Adbry must be used within 14 days or thrown away.
Do not expose the prefilled syringe to heat or direct sunlight.
Do not freeze. Don't shake.
9. Measures to prevent side effects of adbry
Hypersensitivity
Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of Adbry.
If a serious hypersensitivity reaction occurs, discontinue Adbry immediately and initiate appropriate therapy.
Conjunctivitis and keratitis
Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects receiving Adbry. Conjunctivitis is the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis resolved or were recovering during treatment
Advise patients to report new onset or worsening eye symptoms to healthcare provider their health.
Parasitic (helminthic) infections
Patients with known helminth infections were excluded from participation in clinical studies. It is not clear if Adbry affects the immune response against helminth infections by inhibiting IL-13 signaling.
Treat patients with pre-existing helminthic infections before starting treatment with Adbry. If the patient develops an infection while taking Adbry and does not respond to anthelmintic treatment, discontinue Adbry treatment until the infection clears.
Administration Guide
Patient or caregiver instruction:
Administer the first injection yourself under the supervision and guidance of a qualified medical professional to be trained in proper subcutaneous injection technique. Inject full dose of Adbry Follow sharps removal recommendations
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