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DOSAGE & ADMINISTRATION

Adbry dosing schedule1

THE RECOMMENDED DOSAGE OF ADBRY IS BY SUBCUTANEOUS INJECTION FOR ADULT PATIENTS

Adbry should be administered as an initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week

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Dosage
  • After 16 weeks of treatment, for patients with body weight below 100 kg (220 lb) who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered
  • Adbry can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used but should be reserved for problem areas only, such as the face, neck, intertriginous, and genital areas
  • Prior to Adbry initiation, complete all age-appropriate vaccinations as recommended by current immunization guidelines
  • If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regularly scheduled time
Dosage Forms and Strengths
  • Injection: 150 mg/mL clear to opalescent, colorless to pale yellow solution in a single-dose prefilled syringe with needle guard

PREPARATION FOR USE

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  • Before injection, remove Adbry prefilled syringes from the refrigerator and allow Adbry to reach room temperature (30 minutes for the 150 mg/mL prefilled syringes) without removing the needle cap
  • After removal from the refrigerator, prefilled syringes may be kept at room temperature up to 77°F (25°C) and must be used within 14 days or discarded
  • Inspect Adbry visually for particulate matter and discoloration prior to administration. Adbry injection is a clear to opalescent, colorless to pale yellow solution. Do not use if the liquid contains visible particulate matter, is discolored or cloudy (other than clear to opalescent, colorless to pale yellow)
  • Adbry does not contain preservatives; therefore, discard any unused product
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Important Administration Instructions
  • Adbry is intended for use under the guidance of a healthcare provider. A patient may self-inject Adbry after training in subcutaneous injection technique using the prefilled syringe. Provide proper training to patients and/or caregivers on the preparation and administration of Adbry prior to use according to the “Instructions for Use”
  • For the initial 600 mg dose, administer each of the four Adbry 150 mg injections at different injection sites within the same body area
  • For the subsequent 300 mg doses, administer the two Adbry 150 mg injections at different injection sites within the same body area
  • 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
  • Rotate the body area with each subsequent set of injections. DO NOT inject Adbry into skin that is tender, damaged, bruised, or scarred

HOW SUPPLIED

Single-dose prefilled syringe

  • Adbry (tralokinumab-ldrm) injection is a sterile, clear to opalescent, colorless to pale yellow solution, supplied in single-dose prefilled syringe with a 27-gauge, 1/2-inch needle and a needle guard
  • Each prefilled syringe delivers 150 mg/mL of Adbry

Adbry is available in pack sizes containing 2 or 4 prefilled syringes with needle guard

  • Two cartons (multipack) containing four prefilled syringes [NDC 50222-346-04]
  • One carton containing two prefilled syringes [NDC 50222-346-02]
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Storage and Handling

Adbry does not contain preservatives. Discard any unused product remaining in the prefilled syringe.

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton in order to protect from light.

  • If necessary, prefilled syringes may be kept at room temperature up to 77ºF (25ºC) for a maximum of 14 days in the original carton. Do not store above 77ºF (25ºC). If the carton needs to be removed permanently from refrigerator, the date of removal may be recorded on the outer carton in the space provided. After removal from the refrigerator, Adbry must be used within 14 days or discarded
  • Do not expose the prefilled syringe to heat or direct sunlight
  • Do not freeze. Do not shake

 

 

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Reference: 1. Prescribing Information for Adbry, LEO Pharma.