Cibinqo and Opzelura Comparison

Cibinqo®(abrocitinib)	Opzelura®(ruxolitinib)
Prescription Only Cibinqo (abrocitinib) is a medication in the form of an oral tablet. It is used to treat moderate to severe eczema in adults who are unable to use topical medications or whose...	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
Oral. Learn more.	Topical. Learn more.
Dosing
100 mg once daily, 200 mg once daily for those not responding to 100 mg. Moderate renal impairment and CYP2C19 Poor Metabolizers: 50 mg once daily or 100 mg once daily for those not responding to 50 mg once daily. . 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
100mg qd or 200mg qd for those not responding. Renal impairment: 50mg qd or 100mg qd for those not responding. CYP2C19 poor metabolizer: 50mg qd or 100 mg qd for those not responding. . 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
12/31/2023. Learn more.	12/31/2023. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis. Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia. . 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 there a pregnancy exposure registry for CIBINQO? Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770. Is CIBINQO safe to use during pregnancy? Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. However, all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. Pregnant women should consult with their healthcare provider before using CIBINQO. Is it safe to breastfeed while using CIBINQO? No data is available on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose. Can CIBINQO impair female fertility? Based on findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration. Women who are trying to conceive should consult with their healthcare provider before using CIBINQO. Is CIBINQO safe for pediatric patients? The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older weighing 25 kg or more with atopic dermatitis has been established. The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age. In addition, irreversible bone findings have been observed in juvenile animal toxicity studies in rats. Parents or guardians of pediatric patients should consult with their healthcare provider before using CIBINQO. Is CIBINQO safe for geriatric patients? Clinical trials of CIBINQO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. However, a higher proportion of patients 65 years of age and older discontinued from clinical trials compared to younger patients, and they may be at increased risk of certain adverse reactions. Geriatric patients should consult with their healthcare provider before using CIBINQO. What should I know about using CIBINQO if I have renal impairment? In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30–59 mL/min) renal impairment, the combined exposure of abrocitinib and its active metabolites is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as infections. CIBINQO is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy. A dosage reduction is recommended in patients with moderate renal impairment, and no dosage adjustment is required in patients with mild renal impairment. Can I use CIBINQO if I have hepatic impairment? CIBINQO is not recommended for use in patients with severe (Child Pugh C) hepatic impairment. Dosage adjustment is not required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment based on similar combined exposure of abrocitinib and its active metabolites compared to patients with normal hepatic function. In clinical trials, CIBINQO was not evaluated in patients with severe hepatic impairment. What should I know about using CIBINQO if I am a CYP2C19 poor metabolizer? In patients who are CYP2C19 poor metabolizers, the exposure of abrocitinib is increased due to reduced metabolic clearance. Dosage reduction of CIBINQO is recommended in patients who are known or suspected to be CYP2C19 poor metabolizers based on genotype or previous history/experience with other CYP2C19 substrates.	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.

Cibinqo®(abrocitinib)

Opzelura®(ruxolitinib)

Prescription Only

Cibinqo (abrocitinib) is a medication in the form of an oral tablet. It is used to treat moderate to severe eczema in adults who are unable to use topical medications or whose...

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

Oral. Learn more.

Topical. Learn more.

Dosing

100 mg once daily, 200 mg once daily for those not responding to 100 mg. Moderate renal impairment and CYP2C19 Poor Metabolizers: 50 mg once daily or 100 mg once daily for those not responding to 50 mg once daily. . 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

100mg qd or 200mg qd for those not responding. Renal impairment: 50mg qd or 100mg qd for those not responding. CYP2C19 poor metabolizer: 50mg qd or 100 mg qd for those not responding. . 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

12/31/2023. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis. Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia. . 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 there a pregnancy exposure registry for CIBINQO?

Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770.

Is CIBINQO safe to use during pregnancy?

Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. However, all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. Pregnant women should consult with their healthcare provider before using CIBINQO.

Is it safe to breastfeed while using CIBINQO?

No data is available on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose.

Can CIBINQO impair female fertility?

Based on findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration. Women who are trying to conceive should consult with their healthcare provider before using CIBINQO.

Is CIBINQO safe for pediatric patients?

The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older weighing 25 kg or more with atopic dermatitis has been established. The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age. In addition, irreversible bone findings have been observed in juvenile animal toxicity studies in rats. Parents or guardians of pediatric patients should consult with their healthcare provider before using CIBINQO.

Is CIBINQO safe for geriatric patients?

Clinical trials of CIBINQO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. However, a higher proportion of patients 65 years of age and older discontinued from clinical trials compared to younger patients, and they may be at increased risk of certain adverse reactions. Geriatric patients should consult with their healthcare provider before using CIBINQO.

What should I know about using CIBINQO if I have renal impairment?

In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30–59 mL/min) renal impairment, the combined exposure of abrocitinib and its active metabolites is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as infections. CIBINQO is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy. A dosage reduction is recommended in patients with moderate renal impairment, and no dosage adjustment is required in patients with mild renal impairment.

Can I use CIBINQO if I have hepatic impairment?

CIBINQO is not recommended for use in patients with severe (Child Pugh C) hepatic impairment. Dosage adjustment is not required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment based on similar combined exposure of abrocitinib and its active metabolites compared to patients with normal hepatic function. In clinical trials, CIBINQO was not evaluated in patients with severe hepatic impairment.

What should I know about using CIBINQO if I am a CYP2C19 poor metabolizer?

In patients who are CYP2C19 poor metabolizers, the exposure of abrocitinib is increased due to reduced metabolic clearance. Dosage reduction of CIBINQO is recommended in patients who are known or suspected to be CYP2C19 poor metabolizers based on genotype or previous history/experience with other CYP2C19 substrates.

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.

Cibinqo® Alternatives