[U] Ruxolitinib

is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as.

4. CONTRAINDICATIONS None. None.

6. ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions ] Risk of Infection [see Warnings and Precautions ] Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi [see Warnings and Precautions ] Non-Melanoma Skin Cancer [see Warnings and Precautions ] Lipid Elevations [ see Warnings and Precautions ] Major Adverse Cardiovascular Events (MACE) [ see Warnings and Precautions ] Thrombosis [ see Warnings and.

2. DOSAGE AND ADMINISTRATION Doses should be individualized based on safety and efficacy. Starting doses per indication are noted below. Myelofibrosis The starting dose of Jakafi is based on patient’s baseline platelet count: • Greater than 200 x 10 9 /L: 20 mg given orally twice daily • 100 x 10 9 /L to 200 x 10 9 /L: 15 mg given orally twice daily • 50 x 10 9 /L to less than 100 x 10 9 /L: 5 mg given orally twice daily Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Modify or interrupt dosing for thrombocytopenia. Polycythemia.

12.1 Mechanism of Action Ruxolitinib, a kinase inhibitor, inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. MF and PV are myeloproliferative neoplasms (MPN) known to be associated with dysregulated JAK1 and JAK2 signaling. In a mouse model.

8.1 Pregnancy Pregnancy Exposure Registry 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 or visiting www.opzelura.pregnancy.incyte.com. Risk Summary 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.

12.3 Pharmacokinetics Mean ruxolitinib maximal plasma concentration (C max ) and AUC increased proportionally over a single dose range of 5 mg to 200 mg (4 times the approved highest recommended total daily dosage of 25 mg twice daily). Mean ruxolitinib C max ranged from 205 nM to 7100 nM and AUC ranged from 862 nM*hr to 30700 nM*hr over a single dose range of 5 mg to 200 mg. Absorption Ruxolitinib achieves C max within 1 hour to 2 hours post-dose. Oral absorption of ruxolitinib is estimated to be at least 95%. Effect of Food No clinically relevant changes in the pharmacokinetics of.