Adbry (Tralokinumab-Ldrm)

• Prior to ADBRY initiation, complete all age appropriate vaccinations as recommended by current immunization guidelines (
  2.1 Vaccination Prior to Treatment

  Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with ADBRY

  [see Warnings and Precautions (5.4)]

  .
  )
• Administer ADBRY by subcutaneous injection. (
  2.2 Important Administration Instructions

  • ADBRY is administered by subcutaneous injection.
  • ADBRY is intended for use under the guidance of a healthcare provider. Provide proper training to patients and/or caregivers on the preparation and administration of ADBRY prior to use according to the "Instructions for Use"
    [see Instructions for Use]
    .

  Use of the Autoinjector

  • The ADBRY autoinjector is for use in adults only.
  • A caregiver or adult patient may inject ADBRY using the autoinjector.

  Use of the Prefilled Syringe

  • The ADBRY prefilled syringe is for use in adults and pediatric patients 12 years of age and older.
  • A caregiver or patient 12 years of age and older may inject ADBRY using the prefilled syringe. In pediatric patients 12 years of age and older, administer ADBRY under the supervision of an adult.

  Administration Instructions

  • 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.
  • DO NOT inject ADBRY into skin that is tender, damaged, bruised, or scarred.
  • For adults taking the initial loading dose of 600 mg, administer each of the injections (four ADBRY 150 mg injections using prefilled syringes or two ADBRY 300 mg injections using autoinjectors) at different injection sites within the same body area.
    • For the subsequent 300 mg doses using
      the prefilled syringe
      , administer the two ADBRY 150 mg injections at different injection sites within the same body area, rotating the body area with each subsequent set of injections.
    • For the subsequent 300 mg doses using
      the autoinjector
      , administer one ADBRY 300 mg injection, rotating the body area with each subsequent injection
  • For pediatric patients 12 years of age and older taking the initial loading dose of 300 mg,

    use prefilled syringes

    to administer the two ADBRY 150 mg injections at different injection sites within the same body area.
    • For the subsequent 150 mg doses,
      use a prefilled syringe
      to administer one ADBRY 150 mg injection, rotating the body area with each subsequent injection.
  • The ADBRY "Instructions for Use" contains more detailed instructions on the preparation and administration of ADBRY
    [see Instructions for Use]
    .
  )
• In pediatric patients 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult. (
  2.2 Important Administration Instructions

  • ADBRY is administered by subcutaneous injection.
  • ADBRY is intended for use under the guidance of a healthcare provider. Provide proper training to patients and/or caregivers on the preparation and administration of ADBRY prior to use according to the "Instructions for Use"
    [see Instructions for Use]
    .

  Use of the Autoinjector

  • The ADBRY autoinjector is for use in adults only.
  • A caregiver or adult patient may inject ADBRY using the autoinjector.

  Use of the Prefilled Syringe

  • The ADBRY prefilled syringe is for use in adults and pediatric patients 12 years of age and older.
  • A caregiver or patient 12 years of age and older may inject ADBRY using the prefilled syringe. In pediatric patients 12 years of age and older, administer ADBRY under the supervision of an adult.

  Administration Instructions

  • 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.
  • DO NOT inject ADBRY into skin that is tender, damaged, bruised, or scarred.
  • For adults taking the initial loading dose of 600 mg, administer each of the injections (four ADBRY 150 mg injections using prefilled syringes or two ADBRY 300 mg injections using autoinjectors) at different injection sites within the same body area.
    • For the subsequent 300 mg doses using
      the prefilled syringe
      , administer the two ADBRY 150 mg injections at different injection sites within the same body area, rotating the body area with each subsequent set of injections.
    • For the subsequent 300 mg doses using
      the autoinjector
      , administer one ADBRY 300 mg injection, rotating the body area with each subsequent injection
  • For pediatric patients 12 years of age and older taking the initial loading dose of 300 mg,

    use prefilled syringes

    to administer the two ADBRY 150 mg injections at different injection sites within the same body area.
    • For the subsequent 150 mg doses,
      use a prefilled syringe
      to administer one ADBRY 150 mg injection, rotating the body area with each subsequent injection.
  • The ADBRY "Instructions for Use" contains more detailed instructions on the preparation and administration of ADBRY
    [see Instructions for Use]
    .
  )
• The recommended dosage of ADBRY (
  2.3 Recommended Dosage

  Dosage in Adults

  The recommended dosage for adults is:

  	Initial Loading Dose	Subsequent Dosage
  Prefilled syringe	600 mg (four 150 mg injections)	300 mg (two 150 mg injections) every other week
  Autoinjector	600 mg (two 300 mg injections)	300 mg (one 300 mg injection) every other week

  After 16 weeks of treatment, for adult patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered.

  Dosage in Pediatric Patients 12 Years of Age and Older

  The recommended dosage for pediatric patients 12 years of age and older is:

  	Initial Loading Dose	Subsequent Dosage
  Prefilled syringe	300 mg (two 150 mg injections)	150 mg (one 150 mg injection) every other week
  )

• A dosage of 300 mg every 4 weeks may be considered for adult patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment. (
  2.3 Recommended Dosage

  Dosage in Adults

  The recommended dosage for adults is:

  	Initial Loading Dose	Subsequent Dosage
  Prefilled syringe	600 mg (four 150 mg injections)	300 mg (two 150 mg injections) every other week
  Autoinjector	600 mg (two 300 mg injections)	300 mg (one 300 mg injection) every other week

  After 16 weeks of treatment, for adult patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered.

  Dosage in Pediatric Patients 12 Years of Age and Older

  The recommended dosage for pediatric patients 12 years of age and older is:

  	Initial Loading Dose	Subsequent Dosage
  Prefilled syringe	300 mg (two 150 mg injections)	150 mg (one 150 mg injection) every other week
  )

ADBRY is a clear to opalescent, colorless to pale yellow solution available as:

• Injection: 150 mg/mL solution in a single-dose prefilled syringe with needle guard
• Injection: 300 mg/2 mL solution in a single-dose autoinjector

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.