Adbry
(tralokinumab-ldrm)Dosage & Administration
Dosage in Adults
| 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 |
Dosage in Pediatric Patients 12 Years of Age and Older
| Initial Loading Dose | Subsequent Dosage | |
|---|---|---|
| Prefilled syringe | 300 mg (two 150 mg injections) | 150 mg (one 150 mg injection) every other week |
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Adbry Prescribing Information
ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.
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)].
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].
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 |
Concomitant Topical Therapies
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.
Missed Doses
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Preparation for Use
- Before injection, remove ADBRY prefilled syringes or autoinjectors from the refrigerator and allow to reach room temperature (at least 30 minutes for the prefilled syringes and at least 45 minutes for the autoinjectors) without removing the needle cover or cap, respectively.
- After removal from the refrigerator, ADBRY may be kept at room temperature up to 30°C (86°F) 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.
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
Pregnancy
Pregnancy Exposure Registry
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/.
Risk Summary
There are limited data from the use of ADBRY in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus.
In an enhanced pre-and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after intravenous administration of tralokinumab-ldrm during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (MRHD).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal Data
In a pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys once every week from gestation day 20 to parturition. No maternal or developmental toxicity was observed at doses up to 100 mg/kg/week (10 times the MRHD on a mg/kg basis of 10 mg/kg/week).
In an enhanced pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm (10 times the MRHD on a mg/kg basis of 10 mg/kg/week) were administered to pregnant cynomolgus monkeys once every week from the beginning of organogenesis to parturition. No treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age.
Lactation
Risk Summary
There are no data on the presence of tralokinumab-ldrm in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is present in breast milk. The effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for ADBRY and any potential adverse effects on the breastfed child from ADBRY or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of ADBRY have been established for the treatment of moderate-to-severe atopic dermatitis in pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Use of ADBRY in this age group is supported by a multicenter, randomized, double-blind, placebo-controlled trial (ECZTRA 6) in 289 subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis. Of the 289 subjects, 195 were treated with ADBRY and 94 were treated with matching placebo The safety and effectiveness were consistent between subjects 12 to 17 years of age and adult subjects [see Adverse Reactions (6.1) and Clinical Studies (14)].
Safety and effectiveness of ADBRY have not been established in pediatric patients younger than 12 years of age.
Geriatric Use
Of the 1605 subjects exposed to ADBRY in 5 atopic dermatitis trials in the initial treatment period of up to 16 weeks, 77 subjects were 65 years or older. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see Clinical Pharmacology (12.3)].
ADBRY is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in ADBRY [see Warnings and Precautions (5.1)].
Hypersensitivity
Hypersensitivity reactions including anaphylaxis and angioedema, have been reported with 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 who received ADBRY. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period [see Adverse Reactions (6.1)].
Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Parasitic (Helminth) Infections
Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if ADBRY will influence the immune response against helminth infections by inhibiting IL-13 signaling.
Treat patients with pre-existing helminth infections before initiating treatment with ADBRY. If patients become infected while receiving ADBRY and do not respond to antihelminth treatment, discontinue treatment with ADBRY until the infection resolves.
Risk of Infection with Live Vaccines
ADBRY may alter a patient's immunity and increase the risk of infection following administration of live vaccines. Prior to initiating therapy with ADBRY, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines during treatment with ADBRY. Limited data are available regarding coadministration of ADBRY with non-live vaccines [see Clinical Pharmacology (12.2)].