Adbry

About Abrocitinib

• Tlokinumab-ldrm, available as Adbry in the EU/UK and Adbry in the US, is a human monoclonal antibody designed for treating atopic dermatitis by targeting the cytokine interleukin 13.
• Tralokinumab acts as an interleukin-13 antagonist and is approved for use in the European Union, the United Kingdom, and the United States. 
• Specifically, Adbry is indicated for moderate-to-severe atopic dermatitis in individuals aged 12 years and older when topical prescription therapies are inadequate or not recommended. 
• It can be administered alone or in combination with topical corticosteroids. Notably, the U.S.
•  Food and Drug Administration (FDA) recognizes Adbry as a first-in-class medication. 
• Adbry, or tralokinumab-ldrm, is a human IgG4 monoclonal antibody that selectively binds to human interleukin 13 (IL-13), inhibiting its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL13Rα2) in the Type 2 immune response.

Strength: 

Adbry injection is available as a 150 mg/mL solution in a single-dose prefilled syringe with a needle guard.

Recommended Dosage:

This Instructions for Use outlines key steps for administering Adbry through a prefilled syringe, emphasizing consultation with a healthcare provider for proper injection techniques. Storage guidelines include refrigeration and temporary room temperature allowance. The injection process involves site rotation, hand hygiene, and careful disposal in an FDA-cleared sharps container. It is crucial to adhere to recommended doses and consult community guidelines for sharps disposal.

Before administering Adbry, let the prefilled syringes reach room temperature for 30 minutes without removing the needle cap. Once out of the refrigerator, they can be stored at room temperature (up to 30°C or 86°F) for 14 days before disposal. Ensure the solution is clear to opalescent and colorless to pale yellow, inspecting for any particulate matter or discoloration. Do not use it if the liquid is discolored, cloudy, or contains visible particulate matter. Since Adbry lacks preservatives, any unused product should be discarded to maintain safety.

The recommended dosage for Adbry is as follows:

Initial Loading Dose:

• Adults (18 years and older): 600 mg (administered as four 150 mg injections)
• Pediatric (12 to 17 years old): 300 mg (administered as two 150 mg injections)

Subsequent Dosage:

• Adults (18 years and older): 300 mg (administered as two 150 mg injections) every other week
• Pediatric (12 to 17 years old): 150 mg (administered as one 150 mg injection) Additionally, for adult patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment, a dosage adjustment to 300 mg every 4 weeks may be considered.
• Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection.

Important:

Before initiating treatment, it is imperative to disclose any existing or pre-existing medical conditions to your healthcare provider. Additionally, promptly report any observed side effects during treatment to your healthcare provider. Your doctor may consider adjusting the dosage if necessary. This proactive communication ensures a comprehensive and personalized approach to your healthcare.

Warnings & Precautions

• Adbry should not be used in patients with a known hypersensitivity to Tralokinumab-ldrm or any components present in Adbry. 
• Hypersensitivity reactions, including anaphylaxis and angioedema, have been observed post-administration of Adbry. 
• In the event of a hypersensitivity reaction, Adbry should be discontinued promptly. 
• Patients are advised to report any new or worsening eye symptoms to their healthcare provider due to potential conjunctivitis and keratitis risks associated with Adbry. 
• Treatment with Adbry should be preceded by addressing pre-existing Parasitic (helminth) infections, and if a new infection arises during Adbry treatment without responding to anti-helminth therapy, discontinuation of Adbry is recommended until the infection resolves. 
• Additionally, the administration of live vaccines should be avoided. 

Common Adbry Side Effects:

• Upper respiratory infections (Colds, sinus infections, bronchitis)
• Conjunctivitis (pink eye)
• Injection-site reactions (Redness, pain, swelling, and itching at the injection site)
• Eosinophilia (Higher than normal eosinophil (white blood cell) levels)
• Body aches or pain
• Burning, dry, or itching eyes
• Cough
• Discharge, excessive tearing
• Ear congestion
• Headache
• Loss of voice
• Redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• Stuffy or runny nose
• Trouble breathing

Use in Specific Population

• Limited data are available regarding the use of Adbry in pregnant women, making it challenging to determine the drug-associated risk of adverse developmental outcomes. 
• Currently, there is no information on the presence of tralokinumab-ldrm in human milk, its impact on breastfed infants, or its effects on milk production. 
• The safety and effectiveness of Adbry have not been established in pediatric patients below 12 years of age. 
• Prior to initiating treatment, it is imperative to inform your healthcare provider if you are pregnant, planning pregnancy, breastfeeding, or if you have any other health conditions, including issues related to kidney or liver functions. 
• This proactive communication with your healthcare provider is crucial for ensuring the safe and appropriate use of the medication.

Storage and Handling

• Store Adbry in the original carton, refrigerated at temperatures between 2°C to 8°C (36°F to 46°F), ensuring protection from light exposure. 
• If necessary, the prefilled syringes may be temporarily stored at room temperature, up to 30°C (86°F), for a maximum of 14 days within the original carton. 
• Once the prefilled syringes have reached room temperature, refrain from returning them to the refrigerator. 
• If removal from the refrigerator is permanent, consider noting the date in the provided space on the outer carton. 
• After removal from the refrigerator, Adbry must be utilized within 14 days or be discarded. 
• It’s essential to avoid exposing the prefilled syringe to heat, direct sunlight, freezing, or shaking.