Ruxonib 1.5% Cream 10g

✔️ Dosage & Administration

• Administration Instructions: Ruxolitinib cream should not be used more than 60 grams per week or 100 grams per 2 weeks. It is for topical use only. It is not for intraocular, oral, or intravaginal use.
• Recommended Dosage for Atopic Dermatitis: Patients should apply a thin layer of Ruxolitinib twice daily to affected areas of up to 20% body surface area. When signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve, it should be stopped. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by a registered doctor.
• Recommended Dosage for Nonsegmental Vitiligo: Patients should apply a thin layer of Ruxolitinib twice daily to affected areas of up to 10% body surface area. Satisfactory patient response may require treatment with Ruxolitinib for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by a registered doctor.
• USE IN CHILDREN: The safety and effectiveness of Ruxolitinib in pediatric patients younger than 12 years of age with atopic dermatitis and nonsegmental vitiligo have not been established.

✔️ Interaction

Ruxonib is known to be a substrate for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 may increase Ruxonib systemic concentrations, whereas inducers of CYP3A4 may decrease Ruxonib systemic concentrations.

Strong Inhibitors of CYP3A4: Co-administration of Ruxonib should be avoided with strong inhibitors of CYP3A4, as there is a potential to increase the systemic exposure of Ruxonib and could increase the risk of Ruxonib adverse reactions.

✔️ Pregnancy & Lactation

Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, women should not breastfeed during treatment with Ruxolitinib and for approximately four weeks after the last dose.

✔️ Side Effects

In atopic dermatitis, the most common side effects are nasopharyngitis, diarrhea, bronchitis, ear infection, increased eosinophil count, urticaria, folliculitis, tonsillitis, and rhinorrhea.

In nonsegmental vitiligo, the most common side effects are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.

✔️ Contraindications

It is contraindicated in patients with known hypersensitivity to the drug or any of its components.

✔️ Precautions & Warnings

• Serious Infections: Use of Ruxonib should be avoided in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt Ruxonib until the infection is controlled. The risks and benefits of treatment with Ruxonib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Ruxonib.
• Mortality: In rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.
• Non-melanoma Skin Cancers: Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, can occur in patients treated with Ruxonib. Periodic skin examinations should be performed during Ruxonib treatment. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.
• Major Adverse Cardiovascular Events (MACE): Patients who are current or past smokers are at additional increased risk of Major Adverse Cardiovascular Events. Patients who have experienced a myocar- dial infarction or stroke, Ruxonib should be discontinued.
• Thrombosis: Thromboembolic events were observed in trials with Ruxonib. If symptoms of thrombosis occur, Ruxonib should be discontinued and treat appropriately.
• Thrombocytopenia, Anemia, and Neutropenia: Thrombocytopenia, anemia, and neutropenia can occur. Perform CBC monitoring as clinically indicated.

✔️ Storage:

Store below 30°C in a dry place, away from sunlight & keep out of reach of children.