Adbry and Opzelura Comparison

Adbry®(tralokinumab-ldrm)	Opzelura®(ruxolitinib)
Prescription Only Adbry is a prescription medication used to treat adults who have moderate-to-severe eczema that is not controlled well by topical prescription therapies or for those who cannot...	Prescription Only Opzelura is for mild to moderate eczema and nonsegmental vitiligo. It is intended for short-term and non-continuous use in people aged 12 and above who are not immunocompromised...
Administration
Subcutaneous Injection. Learn more.	Topical. Learn more.
Dosing
Initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. A dosage of 300 mg every 4 weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks.. Learn more.	Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Not for ophthalmic, oral, or intravaginal use. Atopic Dermatitis: Apply a thin layer twice daily to affected areas of up to 20% body surface area. . Learn more.
Latin Shorthand
600 mg q0 (4 x 150 mg), 300 mg q2w (2 x 150 mg). 300 mg q4w (consider for patients <100 kg with clear/almost clear skin after 16 wks of tx). Learn more.	Apply a thin layer BID to affected areas up to 20% body surface area.. Learn more.
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$15,000. Learn more.	$1,755 per tube, $10,000 per calendar year. Learn more.
Assistance Expiration
Learn more.	12/31/2023. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.. Learn more.	In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.. Learn more.
Mechanism of Actions (MoA)
Agents for dermatitis excluding corticosteroids. Learn more.	Protein kinase inhibitors. Learn more.
Special Populations
Is ADBRY safe to use during pregnancy? There is limited data on the use of ADBRY in pregnant women to determine if there is a drug-associated risk of adverse developmental outcomes. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in a pregnancy exposure registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. Human IgG antibodies, such as those in ADBRY, are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown, and all pregnancies have a background risk of adverse outcomes. Has ADBRY been tested in animals for pregnancy and developmental effects? In animal studies, intravenous doses of up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys without observing any maternal or developmental toxicity at doses up to 100 mg/kg/week. 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 in another enhanced pre- and post-natal development study. Is it safe to use ADBRY while breastfeeding? There is no data on the presence of tralokinumab-ldrm in human milk or its effects on breastfed infants or milk production. Maternal IgG is present in breast milk, and the effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown. Healthcare providers should consider the development and health benefits of breastfeeding 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. Is ADBRY safe for use in pediatric patients? The safety and effectiveness of ADBRY have not been established in pediatric patients. Is ADBRY safe for use in geriatric patients? Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Healthcare providers should exercise caution in dose selection for elderly patients, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.	Is there a pregnancy exposure registry for OPZELURA? Yes, there is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463. What is the risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with OPZELURA? Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity. The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. What is the recommended duration of not breastfeeding during treatment with OPZELURA? Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives). What is the safety and effectiveness of OPZELURA in pediatric patients? The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established. The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established. Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. Is there a difference in safety and effectiveness of OPZELURA between geriatric and younger patients? No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

Adbry®(tralokinumab-ldrm)

Opzelura®(ruxolitinib)

Prescription Only

Adbry is a prescription medication used to treat adults who have moderate-to-severe eczema that is not controlled well by topical prescription therapies or for those who cannot...

Prescription Only

Opzelura is for mild to moderate eczema and nonsegmental vitiligo. It is intended for short-term and non-continuous use in people aged 12 and above who are not immunocompromised...

Dosage & Administration

Administration

Subcutaneous Injection. Learn more.

Topical. Learn more.

Dosing

Initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. A dosage of 300 mg every 4 weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks.. Learn more.

Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Not for ophthalmic, oral, or intravaginal use. Atopic Dermatitis: Apply a thin layer twice daily to affected areas of up to 20% body surface area. . Learn more.

Latin Shorthand

600 mg q0 (4 x 150 mg), 300 mg q2w (2 x 150 mg). 300 mg q4w (consider for patients <100 kg with clear/almost clear skin after 16 wks of tx). Learn more.

Apply a thin layer BID to affected areas up to 20% body surface area.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$0. Learn more.

Annual Cap

$15,000. Learn more.

$1,755 per tube, $10,000 per calendar year. Learn more.

Assistance Expiration

Learn more.

12/31/2023. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.. Learn more.

In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.. Learn more.

Mechanism of Actions (MoA)

Agents for dermatitis excluding corticosteroids. Learn more.

Protein kinase inhibitors. Learn more.

Special Populations

Is ADBRY safe to use during pregnancy?

There is limited data on the use of ADBRY in pregnant women to determine if there is a drug-associated risk of adverse developmental outcomes. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in a pregnancy exposure registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. Human IgG antibodies, such as those in ADBRY, are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown, and all pregnancies have a background risk of adverse outcomes.

Has ADBRY been tested in animals for pregnancy and developmental effects?

In animal studies, intravenous doses of up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys without observing any maternal or developmental toxicity at doses up to 100 mg/kg/week. 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 in another enhanced pre- and post-natal development study.

Is it safe to use ADBRY while breastfeeding?

There is no data on the presence of tralokinumab-ldrm in human milk or its effects on breastfed infants or milk production. Maternal IgG is present in breast milk, and the effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown. Healthcare providers should consider the development and health benefits of breastfeeding 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.

Is ADBRY safe for use in pediatric patients?

The safety and effectiveness of ADBRY have not been established in pediatric patients.

Is ADBRY safe for use in geriatric patients?

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Healthcare providers should exercise caution in dose selection for elderly patients, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Is there a pregnancy exposure registry for OPZELURA?

Yes, there is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

What is the risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with OPZELURA?

Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity. The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes.

What is the recommended duration of not breastfeeding during treatment with OPZELURA?

Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

What is the safety and effectiveness of OPZELURA in pediatric patients?

The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established. The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established. Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures.

Is there a difference in safety and effectiveness of OPZELURA between geriatric and younger patients?

No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

Adbry® Alternatives