Adbry
Pronunciation: ad-bree
Generic name: tralokinumab-ldrm
Other brand names of tralokinumab-ldrm include: Adbry, Adbry Autoinjector
Dosage form: prefilled syringe for subcutaneous injection (150 mg/1 mL), single-dose autoinjector (300 mg/2 mL)
Drug class: Interleukin inhibitors
What is Adbry? Biologic for Moderate-to-Severe Atopic Dermatitis
Adbry is used to treat moderate-to-severe atopic dermatitis (eczema) in patients aged 12 years and older when prescription topical treatments fail to provide adequate control or for those who cannot use topical treatments. It is an FDA-approved biologic that is administered by subcutaneous injection every other week.
Key Benefits of Adbry Eczema Treatment:
- Targets the IL-13 protein, which is the key driver of eczema inflammation
- Self-administered subcutaneous injection every other week
- Can be used alone or combined with topical corticosteroids
- FDA-approved for adolescents (ages 12-17) and adults 18+
- Long-term efficacy proven in clinical trials
- Generic name: tralokinumab-ldrm
Adbry (tralokinumab-ldrm) gained FDA approval on December 27, 2021. There is no generic or biosimilar.
How Adbry Works: IL-13 Inhibitor Technology
Adbry belongs to the interleukin-13 (IL-13) inhibitor drug class and works by:
- Binding specifically to IL-13, a key inflammatory protein
- Preventing IL-13 from activating receptors in skin cells
- Blocking the release of inflammatory substances (cytokines, chemokines, IgE)
- Reducing chronic inflammation that causes eczema symptoms.
This targeted approach addresses the underlying immune dysfunction underlying moderate-to-severe atopic dermatitis, providing relief when conventional treatments are not effective enough or are not tolerated.
Adbry Side Effects: What to Expect
Common Side Effects (Most Frequent):
- Cold-like symptoms: stuffy nose, sneezing, sore throat
- Eye and eyelid inflammation: redness, swelling, itching
- Injection site reactions: pain, redness, swelling at the injection site
- Elevated eosinophils: increased white blood cell counts in lab tests
Serious side effects and warnings
Allergic reactions (Seek Immediate Medical Attention)
Allergic reactions, including anaphylaxis and angioedema, have occurred after administration of Adbry. Do not use Adbry if you are allergic to tralokinumab or any of the ingredients. Stop taking Adbry and call your doctor immediately if you develop symptoms of an allergic reaction, such as:
- Breathing difficulties or shortness of breath
- Swelling of the face, mouth, tongue, or throat
- Hives or widespread skin rash
- Severe itching
- Fainting, dizziness, or lightheadedness
- Low blood pressure symptoms.
Eye problems
Adbry may cause eye problems, such as conjunctivitis (an inflammation of the membrane that lines the eyelid and eyeball) or keratitis (corneal inflammation or ulcers). Report any eye symptoms, such as eye pain or vision changes to a healthcare provider immediately.
Infection Concerns
Parasitic worm infections must be treated before starting Adbry. During treatment, if you think you have a worm infection, tell your healthcare provider immediately. If anti-worm treatment does not work, your healthcare provider may temporarily stop treatment until the infection resolves.
Vaccination Concerns
Avoid live vaccines while taking Adbry. Discuss your vaccination schedule with your doctor. Inactivated vaccines are generally safe.
These are not all the possible side effects of Adbry. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Who Should Not Take Adbry?
Absolute Contraindications:
- Allergy to tralokinumab, Adbry, or any of the inactive ingredients in the injection.
Ideal Candidates:
- Age 12 and older with moderate-to-severe atopic dermatitis
- Inadequate response to prescription topical treatments
- Cannot tolerate topical therapies due to side effects
- Seeking systemic treatment for widespread eczema
- Want a self-administered option for convenience.
Before Starting Treatment, Tell Your Doctor About:
- Eye problems or a history of eye conditions
- Parasitic infections or recent travel to endemic areas
- Planned vaccinations or recent immunizations
- Pregnancy or breastfeeding plans
- All medications, including supplements and OTC drugs.
Pregnancy & Breastfeeding Information:
The safety of Adbry during pregnancy has not been fully established, and it is unknown if Adbry causes harm to an unborn baby.
- A pregnancy registry is available. Call 1-877-311-8972 or visit mothertobaby.org/ongoing-study/adbry-tralokinumab/
- Unknown if Adbry passes into breast milk.
- Discuss the risks and benefits with your healthcare provider.
How do I administer Adbry?
See the detailed Instructions for Use that come with your prescription for information on how to prepare and inject Adbry and how to properly store and throw away (dispose of) used prefilled syringes or autoinjectors. Use Adbry exactly as prescribed by your healthcare provider.
- Adbry is usually given every other week (every second week).
- Your healthcare provider will tell you how much Adbry to inject and when to inject it.
- Adbry is available in a single-dose (150 mg) prefilled syringe with a needle guard and a single-dose (300 mg/2 mL) autoinjector.
- Adbry is given as an injection under the skin (subcutaneous injection).
- Most people can be taught how to self-administer it.
If your healthcare provider decides that you or a caregiver can give the injections, you or your caregiver should receive training on the right way to prepare and inject Adbry.
- Do not try to inject Adbry if your healthcare provider has not shown you how.
- Inject the full dose of Adbry.
- Dispose of the used prefilled syringe or autoinjector in an FDA-approved sharps disposal container.
The autoinjector is for use only in adults. The prefilled syringe is for use in adults and children at least 12 years old.
Adbry Dosing information
For Adults (18+ Years)
Initial loading dose: 600 mg.
- Administered by a healthcare provider.
- 4 x 150 mg prefilled syringes OR 2 x 300 mg autoinjectors
- Multiple injection sites on the same day.
Maintenance dose: 300 mg every other week.
- Self-administered at home.
- 2 x 150 mg prefilled syringes OR 1 x 300 mg autoinjector.
- Use a different injection site.
- The frequency in patients under 100 kg with clear skin may be reduced to every 4 weeks after 16 weeks.
For Adolescents (12-17 Years)
Initial loading dose: 300 mg.
- Healthcare provider administered.
- 2 x 150 mg prefilled syringes.
- Different injection sites on the same day.
Maintenance dose: 150 mg every other week.
- Supervised self-administration or caregiver-administered.
- Single prefilled syringe only (autoinjector approved for adults only).
Administration Tips:
- Rotate injection sites (thigh, abdomen, upper arm)
- Allow medication to reach room temperature before injection
- Follow proper injection technique training from a healthcare provider.
Latest Clinical Trial Updates (2024)
Recent clinical data continue to support Adbry's effectiveness:
Results from the long-term ECZTEND trial (NCT03587805) identified no new safety concerns, reinforcing tralokinumab-ldrm's favorable risk-benefit profile for long-term use in patients with moderate-to-severe atopic dermatitis.
What happens if I miss a dose?
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
What happens if I overdose?
If you inject more Adbry than prescribed, call Poison Control at 1-800-222-1222.
Adbry Cost, Insurance Coverage & Patient Assistance Programs
Insurance Coverage Options:
Adbry may be covered under Medicare Part B if it is given in a doctor's office, and most commercial insurance plans provide coverage for this FDA-approved biologic treatment.
Money-Saving Programs Available:
Adbry Advocate™ Program:
- For help coordinating your Adbry shipment, call 844-MY-ADBRY (844-692-3279)
Rapid Access Program:
- If you have commercial health insurance, you may be able to receive your first dose of Adbry® (tralokinumab-ldrm) for free within 48 hours
Patient Assistance Options:
- If you have financial need or limited or no prescription coverage, you may be able to obtain Adbry at no cost under a Patient Assistance Program
Additional Resources:
LEO Pharma, the company that makes Adbry, has programs that may help with your copay costs if needed
Contact Information: Call 1-844-MYADBRY (1-844-692-3279) to learn about available savings programs and eligibility requirements.
What other drugs will affect this medicine?
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
See the product information for a full list of interactions.
Storage Instructions & Proper Handling
Refrigerated Storage (Preferred):
- Store at 36°F to 46°F (2°C to 8°C)
- Keep in the original carton to protect from light
- Do not freeze or shake
Room Temperature Storage (If Needed):
- Maximum 14 days at up to 86°F (30°C)
- Write the removal date on the carton
- Do not return to refrigerator after reaching room temperature
- Discard if not used within 14 days.
Important Storage Don'ts:
- Never expose Adbry to heat or direct sunlight
- Never store above 86°F (30°C)
- Never freeze or shake the medication
- Always discard unused portions after your injection.
Ingredients
Adbry prefilled syringes
Active: tralokinumab-ldrm 150 mg
Inactive: acetic acid (0.3 mg), polysorbate 80 (0.1 mg), sodium acetate trihydrate (6 mg), sodium chloride (5 mg), and Water for Injection, at an approximate pH of 5.5.
Contains no preservatives.
Available as a single-dose (150 mg/1 mL) prefilled syringe with a needle guard.
Adbry autoinjectors
Active: tralokinumab-ldrm 300 mg
Inactive: acetic acid (0.6 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (12 mg), sodium chloride (10 mg), and Water for Injection, at an approximate pH of 5.5.
Contains no preservatives.
Available as a single-dose (300 mg/2 mL) autoinjector.
Manufacturer
Adbry is made by Leo Pharma Inc., with headquarters in Ballerup, Denmark.
Frequently Asked Questions About Adbry
How quickly does Adbry work for eczema?
Most patients begin seeing improvement within 2-4 weeks, with continued improvement over 12-16 weeks of treatment.
Can I use Adbry with my current eczema medications?
Yes, Adbry can be used alone or combined with topical corticosteroids. Discuss all current treatments with your healthcare provider.
What happens if I miss an Adbry injection?
Take the missed dose as soon as possible, then continue with your regular schedule. Don't double-dose.
Is Adbry covered by insurance?
Most insurance plans cover Adbry for approved indications. Patient assistance programs are available for those with coverage gaps.
How do I get started with Adbry treatment?
Consult with a dermatologist or healthcare provider specializing in eczema treatment. They can assess your eligibility and provide proper training.
Adbry Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Adbry.
Adbry (tralokinumab-ldrm) - LEO Pharma A/S
Formulation type | Strength |
---|---|
Autoinjector | 300 mg/2 mL |
Pre-Filled Syringe | 150 mg/mL |
Frequently asked questions
References
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.