• Short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
• Nonsegmental vitiligo.

Contraindicated in:

• Active, serious infection
• Risk factor for thrombosis
• Lactation: Lactation.

Use Cautiously in:

• Chronic or recurrent infection
• History of a serious infection or opportunistic infection
• Exposure to tuberculosis
• Resided or traveled in areas of endemic tuberculosis or endemic mycoses
• Immunocompromised
• OB: Other agents preferred for the topical treatment of atopic dermatitis and vitiligo in pregnancy
• Pedi: Children <12 yr (safety and effectiveness not established).

CV: ARTERIAL THROMBOSIS, DEEP VEIN THROMBOSIS.

Derm: acne, erythema, folliculitis, NON-MELANOMA SKIN CANCER, pruritus, urticaria.

EENT: nasopharyngitis, rhinorrhea, tonsillitis.

GI: diarrhea.

Hemat: anemia, eosinophilia, neutropenia, thrombocytopenia.

Metab: hyperlipidemia.

Neuro: headache.

Resp: PULMONARY EMBOLISM.
Misc: fever, (INCLUDING REACTIVATION TUBERCULOSIS AND OTHER OPPORTUNISTIC INFECTIONS DUE TO BACTERIAL, FUNGAL, VIRAL, AND MYCOBACTERIAL PATHOGENS)INFECTION .

Drug-Drug:

• Strong CYP3A4 inhibitors, including ketoconazole, may ↑ levels and risk of toxicity; avoid concurrent use.

• Cream: 1.5%;

Atopic Dermatitis

• Topical (Adults and Children 12 yr): Apply a thin layer twice daily to affected area(s) of up to 20% body surface area. Discontinue once signs/symptoms resolve. Reassess therapy if signs/symptoms have not resolved within 8 wk. Do not use more than one 60-g tube per wk or one 100-g tube per 2 wk.

Nonsegmental Vitiligo

• Topical (Adults and Children 12 yr): Apply a thin layer twice daily to affected area(s) of up to 10% body surface area. Reassess need for continued therapy if no meaningful improvement with repigmentation by 24 wk. Do not use more than one 60-g tube per wk or one 100-g tube per 2 wk.

Opzelura

• Inhibits Janus kinase 1 and 2 which are normally involved in the signaling of hematopoiesis and immune processes.

• Decreased severity of atopic dermatitis.
• Reduction in depigmented areas in nonsegmental vitiligo.

Therapeutic Classification: n/a

Pharmacologic Classification: kinase inhibitors

Absorption: Systemic absorption occurs following topical administration and is dependent on dose and surface area of application.

Distribution: Unknown.

Protein Binding: 97%.

Metabolism/Excretion: Primarily metabolized in the liver via the CYP3A4 isoenzyme, with minor contribution from CYP2C9. Primarily excreted in the urine (74%), with 22% excreted in the feces. Less than 1% excreted as unchanged drug.

Half-life: 116 hr.

(plasma concentrations)

• Instruct patient to apply cream as directed. Wash hands after applying, unless hands are being treated. Ruxolitinib is only for use on the skin only; do not use in eyes, mouth, or vagina. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional promptly if signs and symptoms of infection (fever, sweating, chills, muscle aches, cough or shortness of breath, blood in phlegm, weight loss, warm, red, or painful skin or sores on body, diarrhea or stomach pain, burning during urination or urinating more often than usual, feeling very tired), heart attack or stroke (discomfort in center of chest that lasts > a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw, pain or discomfort in arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of body, slurred speech), blood clots (swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing) or low blood counts (unusual bleeding, shortness of breath, bruising, fever, tiredness) occur.
• Advise patient to wear protective clothing and sunscreen and to exposure to sunlight and UV light to decrease risk of developing skin cancer.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications during therapy.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during and for 4 wk after last dose. There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to ruxolitinib during pregnancy. Pregnant persons exposed to ruxolitinib and health care providers should report ruxolitinib exposure by calling 1-855-463-3463.

RUX-oh-LI-ti-nib