Rutinib Cream ( Ruxolitinib )

Rutinib (Ruxolitinib) is a Janus kinase (JAK) inhibitor approved for:

• Short-term and intermittent long-term topical treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and adolescents (12 years and older) who have not responded adequately to topical prescription therapies or for whom those therapies are unsuitable.

• Topical treatment of nonsegmental vitiligo in adults and adolescents 12 years of age and older.

Limitations of Use:
The use of Ruxolitinib in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants (e.g., azathioprine or cyclosporine) is not recommended.

Ruxolitinib Cream Dosage

      • Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks.

      • For topical use only.

      • Not for ophthalmic, oral, or intravaginal use.

      • Atopic Dermatitis o Apply a thin layer twice daily to affected areas of up to 20% body surface area.

      • Nonsegmental Vitiligo o Apply a thin layer twice daily to affected areas of up to 10% body surface area.

Serious infections, including bacterial, mycobacterial, fungal, and viral, have been reported. Monitor patients regularly for signs of infection and initiate appropriate management promptly.

Non-Melanoma Skin Cancers:
Cases of basal cell carcinoma and squamous cell carcinoma have occurred. Conduct periodic skin examinations during and, if appropriate, after treatment.

Thrombosis:
Thromboembolic events have been observed.

Hematologic Abnormalities – Thrombocytopenia, Anemia, and Neutropenia:
Instances of thrombocytopenia, anemia, and neutropenia have been reported. Monitor complete blood counts (CBC) as clinically indicated.

Ruxolitinib cream ADVERSE REACTIONS

 • 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

RUXOLITINIB may cause serious side effects, including:

1. Serious Infections
RUXOLITINIB contains ruxolitinib, a Janus kinase (JAK) inhibitor that affects the immune system. JAK inhibitors can reduce your body’s ability to fight infections. Serious infections—including tuberculosis (TB), and bacterial, fungal, or viral infections that can spread throughout the body—have occurred in people taking oral JAK inhibitors. Some of these infections have led to hospitalization or death. Lung infections have also been reported in patients using RUXOLITINIB.

Do not use RUXOLITINIB if you have an active, serious infection, including localized infections. Do not start treatment unless your healthcare provider confirms it is safe. RUXOLITINIB may also increase your risk of shingles (herpes zoster).

Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment.

2. Increased Risk of Death (All Causes)
People aged 50 and older with at least one cardiovascular risk factor who take oral JAK inhibitors have shown an increased risk of death from any cause.

3. Cancer and Immune System Effects
RUXOLITINIB may increase your risk of certain cancers by altering immune function. Cases of lymphoma and other cancers, including lung cancer and skin cancer, have occurred in people taking oral JAK inhibitors—especially in current or former smokers.

Your healthcare provider will check your skin regularly during treatment. Limit sun exposure, wear protective clothing, and use broad-spectrum sunscreen.

4. Cardiovascular Events
An increased risk of major cardiovascular events—such as heart attack, stroke, or death—has been observed in people aged 50 and older with cardiovascular risk factors using oral JAK inhibitors, particularly those who smoke or have smoked.

5. Blood Clots
Blood clots in the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have occurred with RUXOLITINIB and may be life-threatening. These events have been more common in patients aged 50+ with cardiovascular risk factors using oral JAK inhibitors.

6. Low Blood Cell Counts
RUXOLITINIB may cause low platelet counts (thrombocytopenia), red blood cell counts (anemia), and white blood cell counts (neutropenia). Your healthcare provider will monitor your blood counts and may pause treatment if abnormalities occur.

7. Cholesterol Increases
Elevations in cholesterol and triglyceride levels have been reported with oral ruxolitinib. Inform your provider if you have a history of high cholesterol.

 Ruxolitinib Cream PI

 For more Prescribing information，please check the → “FDA Prescribing Information”.