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Drug overview for OPZELURA (opzelura):
Generic name: OPZELURA (RUX-oh-LI-ti-nib)
Drug class: Janus Kinase (JAK) Inhibitors
Therapeutic class: Dermatological
Ruxolitinib phosphate is a selective inhibitor of Janus kinase (JAK) 1 and 2.
No enhanced Uses information available for this drug.
Generic name: OPZELURA (RUX-oh-LI-ti-nib)
Drug class: Janus Kinase (JAK) Inhibitors
Therapeutic class: Dermatological
Ruxolitinib phosphate is a selective inhibitor of Janus kinase (JAK) 1 and 2.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for OPZELURA (opzelura) have been approved by the FDA:
Indications:
Atopic dermatitis
Vitiligo
Professional Synonyms:
Acquired leukoderma
Acquired leukopathia
Atopic eczema
Disseminated neurodermatitis
Leukasmus
Indications:
Atopic dermatitis
Vitiligo
Professional Synonyms:
Acquired leukoderma
Acquired leukopathia
Atopic eczema
Disseminated neurodermatitis
Leukasmus
The following dosing information is available for OPZELURA (opzelura):
No enhanced Dosing information available for this drug.
Ruxolitinib is applied topically to the skin as a 1.5% cream. The cream should not be applied to the eye and should not be administered orally or intravaginally. A patient should not use more than a single 60 g tube per week or a single 100 g tube per 2 weeks.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| OPZELURA 1.5% CREAM | Maintenance | Adults apply a thin layer to the affected area(s) by topical route 2 times per day (do not exceed 60 grams per week) |
No generic dosing information available.
The following drug interaction information is available for OPZELURA (opzelura):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for OPZELURA (opzelura):
Drug contraindication overview.
*None.
*None.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Thromboembolic disorder |
There are 12 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Active tuberculosis |
| Anemia |
| Atherosclerotic cardiovascular disease |
| Cerebrovascular accident |
| Herpes zoster |
| Malignancy |
| Malignant lymphoma |
| Neutropenic disorder |
| Opportunistic fungal infection |
| Opportunistic viral infection |
| Severe infection |
| Thrombocytopenic disorder |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Basal cell carcinoma of skin |
| Squamous cell carcinoma |
The following adverse reaction information is available for OPZELURA (opzelura):
Adverse reaction overview.
Adverse effects occurring in >=1% of patients receiving topical ruxolitinib for atopic dermatitisinclude nasopharyngitis, bronchitis, ear infection, increased eosinophil counts, urticaria, diarrhea, folliculitis, tonsillitis, and rhinorrhea. Adverse effects occurring in>=1% of patients receiving topical ruxolitinib for nonsegmental vitiligo include application site acne, pruritus and erythema, nasopharyngitis, headache, urinary tract infection, and pyrexia.
Adverse effects occurring in >=1% of patients receiving topical ruxolitinib for atopic dermatitisinclude nasopharyngitis, bronchitis, ear infection, increased eosinophil counts, urticaria, diarrhea, folliculitis, tonsillitis, and rhinorrhea. Adverse effects occurring in>=1% of patients receiving topical ruxolitinib for nonsegmental vitiligo include application site acne, pruritus and erythema, nasopharyngitis, headache, urinary tract infection, and pyrexia.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Infection |
| Rare/Very Rare |
|---|
|
Anemia Herpes zoster Neutropenic disorder Thrombocytopenic disorder Thromboembolic disorder |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bronchitis Diarrhea Eosinophilia Folliculitis Infection of ear Pharyngitis Rhinorrhea Tonsillitis Urticaria |
None. |
| Rare/Very Rare |
|---|
|
Acneiform eruption Allergic conjunctivitis Basal cell carcinoma of skin Bruising Contact dermatitis Dyschromia Flu-like symptoms Gastritis Gastroenteritis Hordeolum Insomnia Nasal congestion Squamous cell carcinoma of skin Vomiting |
The following precautions are available for OPZELURA (opzelura):
Safety and efficacy of topical ruxolitinib for treatment of mild to moderate atopic dermatitis and nonsegmental vitiligohave been established in pediatric patients >=12 years of age. No overall differences in safety or efficacy relative to adults were observed. Safety and efficacy of topical ruxolitinib have not been established in pediatric patients <12 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data are inadequate to assess whether use of topical ruxolitinib during pregnancy is associated with major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, adverse developmental effects were observed following administration of oral ruxolitinib to pregnant rats and rabbits during the period of organogenesis at maternally toxic dosages producing exposures greater than those achieved with the maximum recommended human dose. A registry is available that monitor outcomes in pregnant women exposed to ruxolitinib. Patients and clinicians may report ruxolitinib exposure during pregnancy by calling 1-855-463-3463.
It is not known whether ruxolitinib is distributed into human milk; the drug is distributed into milk in rats. The effects of ruxolitinib on breastfed infants or on milk production also are unknown. Because of the serious adverse effects (e.g.,infections, thrombocytopenia, neutropenia, anemia) observed in ruxolitinib-treated adults, breastfeeding is not recommended during topical ruxolitinib therapy and for approximately 4 weeks after the last dose.
In controlled clinical trials of topical ruxolitinib in patients with atopic dermatitis, 9% of patients were >=65 years of age. No overall differences in safety or efficacy relative to younger adults were observed. In clinical trials of topical ruxolitinib in patients with nonsegmental vitiligo, 8% were>=65 years of age. Trials did not include a sufficient number of geriatric patients to determine whether they respond differently from younger adults.
The following prioritized warning is available for OPZELURA (opzelura):
WARNING: This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. People taking ruxolitinib by mouth have had very serious (possibly fatal) infections (such as fungal infections, tuberculosis, herpes zoster).
Tell your doctor right away if you have any signs of infection (such as a sore throat that doesn't go away, cough that doesn't go away, fever, chills, unusual sweating, painful skin rash/blisters). Cancers (such as skin cancer) and blood clots have been reported in people using ruxolitinib cream. Also, another medication similar to ruxolitinib has, when taken by mouth, caused serious (possibly fatal) side effects, including heart problems, blood clots, and cancer (such as lymphoma).
Before using ruxolitinib, tell your doctor or pharmacist if you have a history of heart disease, stroke, cancer, or any risk factors for heart disease (such as high blood pressure, diabetes, previous blood clots, high cholesterol, smoking or history of smoking). Patients who are 50 years of age or older may be at increased risk for heart problems or blood clots. Discuss the risks and benefits of treatment with your doctor. Get medical help right away if you have symptoms such as shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, confusion, sudden vision changes, or weakness on one side of the body.
WARNING: This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. People taking ruxolitinib by mouth have had very serious (possibly fatal) infections (such as fungal infections, tuberculosis, herpes zoster).
Tell your doctor right away if you have any signs of infection (such as a sore throat that doesn't go away, cough that doesn't go away, fever, chills, unusual sweating, painful skin rash/blisters). Cancers (such as skin cancer) and blood clots have been reported in people using ruxolitinib cream. Also, another medication similar to ruxolitinib has, when taken by mouth, caused serious (possibly fatal) side effects, including heart problems, blood clots, and cancer (such as lymphoma).
Before using ruxolitinib, tell your doctor or pharmacist if you have a history of heart disease, stroke, cancer, or any risk factors for heart disease (such as high blood pressure, diabetes, previous blood clots, high cholesterol, smoking or history of smoking). Patients who are 50 years of age or older may be at increased risk for heart problems or blood clots. Discuss the risks and benefits of treatment with your doctor. Get medical help right away if you have symptoms such as shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, confusion, sudden vision changes, or weakness on one side of the body.
The following icd codes are available for OPZELURA (opzelura)'s list of indications:
| Atopic dermatitis | |
| L20 | Atopic dermatitis |
| L20.0 | Besnier's prurigo |
| L20.8 | Other atopic dermatitis |
| L20.81 | Atopic neurodermatitis |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
| Vitiligo | |
| H02.73 | Vitiligo of eyelid and periocular area |
| H02.731 | Vitiligo of right upper eyelid and periocular area |
| H02.732 | Vitiligo of right lower eyelid and periocular area |
| H02.733 | Vitiligo of right eye, unspecified eyelid and periocular area |
| H02.734 | Vitiligo of left upper eyelid and periocular area |
| H02.735 | Vitiligo of left lower eyelid and periocular area |
| H02.736 | Vitiligo of left eye, unspecified eyelid and periocular area |
| H02.739 | Vitiligo of unspecified eye, unspecified eyelid and periocular area |
| L80 | Vitiligo |
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