Rulicent Tablet

Rulicent Tablet is used for: Myelofibrosis, Polycythemia Vera, Acute Graft versus Host Disease

Oral Post-essential thrombocythaemia myelofibrosis, Post-polycythaemia vera myelofibrosis, Primary myelofibrosis Adult: Initial dose (based on platelet count): >200,000/mm3: 20 mg bid; 100,000-200,000/mm3: 15 mg bid; 50,000-<100,000/mm3: 5 mg bid. Titrate doses based on efficacy and tolerability. Discontinue if platelet count is <50,000/mm3 or absolute neutrophil count (ANC) <500/mm3. Dose may be reduced if platelet is <100,000/mm3. If response is insufficient and blood counts are adequate, doses may be increased by up to 5 mg bid. Max: 25 mg bid. Initial dose may be increased after the 1st 4 weeks of treatment and thereafter no more frequently than every 2 weeks. Discontinue if there is no improvement in symptoms or reduction in spleen size after 6 months. Polycythemia vera Adult: In patients who are resistant or intolerant to hydroxyurea: Initially, 10 mg bid. Titrate doses based on efficacy and tolerability. Dose may be reduced if Hb decreases below 12 g/dL. Interrupt dosing if Hb <8 g/dL. If response is insufficient and blood counts are adequate, doses may be increased by up to 5 mg bid. Max: 25 mg bid. Initial dose may be increased after the 1st 4 weeks of treatment and thereafter no more frequently than every 2 weeks. Steroid-refractory acute graft-versus-host disease Adult: Initially, 5 mg bid, may increase to 10 mg bid after at least 3 days if platelet and neutrophil counts have not decreased by at least 50% from baseline. Gradually reduce dose after 6 months by 1 dose level approx every 8 weeks in responsive patients who have stopped corticosteroid treatment. Retreatment may be needed if signs/symptoms recur during or after dose reduction. Dosage may be modified based on blood parameters result. Hepatic impairment (any severity) Myelofibrosis Platelet count >150 x10^9/L: No dosage adjustment necessary Platelet count 100-150 x10^9/L: Starting dose is 10 mg BID Platelet count 50 to <100 x10^9/L: Starting dose is 5 mg once a Day Hepatic impairment Polycythemia Vera Mild, moderate, or severe (Child-Pugh A, B, C) with any platelet count: Starting dose is 5 mg BID Platelet count <50 x10^9/L: Avoid use

Acute Graft versus Host Disease Indicated for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adults and children (>12 years) <12 years: Safety and efficacy not established >12 years Initial dose: 5 mg PO BID; may increase to 10 mg BID after at least 3 days if ANC and platelet counts have not decreased by ?50% compared to baseline Consider tapering after 6 months of treatment in patients with response who have discontinued therapeutic doses of corticosteroids Tapering dose Taper by 1 dose level ~q8Weeks (eg, 10 mg BID to 5 mg BID to 5 mg qDay) Patients unable to tolerate 5 mg qDay: Interrupt treatment until clinical and/or laboratory parameters recover If acute GVHD signs or symptoms recur during or after taper, consider retreatment

Myelofibrosis Renal impairment Moderate-to-severe (CrCl 15-59 mL/min) Platelet count >150 x10^9/L: No dosage adjustment necessary Platelet count 100-150 x10^9/L: Starting dose is 10 mg BID Platelet count 50 to <100 x10^9/L: Starting dose is 5 mg once a Day Platelet count <50 x10^9/L: Avoid use ESRD (CrCl <15 mL/min) On dialysis and platelet count 100-200 x10^9/L: 15 mg once following dialysis session On dialysis and platelet count >200 x10^9/L: 20 mg once following dialysis session Not on dialysis: Avoid use Polycythemia Vera Renal impairment Moderate-to-severe (CrCl 15-59 mL/min) with any platelet count: Starting dose is 5 mg BID ESRD (CrCl <15 mL/min) on dialysis: 10 mg once after dialysis session ESRD (CrCl <15 mL/min) not on dialysis: Avoid use

May be taken with or without food.

Pregnancy and lactation.

Patient with TB or risk of TB, chronic hepatitis B virus infection. Patients taking strong CYP3A4 inhibitors or dual inhibitors of CY3A4 and CYP2C9 enzymes (e.g. fluconazole). Hepatic and moderate to severe renal impairment. Treatment has been associated with increases in lipid parameters including total cholesterol, low density lipoprotein, and triglycerides; assess lipid parameters approximately 8-12 weeks following initiation of therapy; monitor according to clinical guidelines for management of hyperlipidemia. Nonmelanoma skin cancers reported including basal cell, squamous cell, and Merkel cell carcinoma. Monitor CBC with differential (prior to therapy and every 2-4 weeks until doses are stabilised, then as clinically indicated), lipid parameters, hepatic and renal function, HBV-DNA titer; signs and symptoms of infections. Evaluate patients for presence of active or latent TB prior to treatment.

Pregnancy When pregnant rats and rabbits were administered ruxolitinib during organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity There are no studies with use in pregnant women to inform drug-associated risks Lactation No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast fed child, or the effects on milk production Ruxolitinib and/or its metabolites were present in the milk of lactating rats Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for ruxolitinib in human studies, discontinue breastfeeding during treatment and for 2 weeks after final dose

Increased plasma concentration with strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, indinavir, itraconazole, lopinavir, ritonavir, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole) and mild or moderate CYP3A4 inhibitors (e.g. ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine). Decreased plasma concentration with CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin). May increase plasma concentration of substances transported by P-glycoprotein and breast cancer resistance protein (e.g. dabigatran, ciclosporin, rosuvastatin, digoxin).

Side effects of Ruxolitinib : >10% (MF and PV) Anemia (96.1%) Thrombocytopenia (69.7%) Increased ALT, grade 1 (25.2%) Bruising (23.2%) Neutropenia (18.7%) Dizziness (18.1%) Increased AST, grade 1 (17.1%) Increased cholesterol, grade 1 (16.8%) Headache (14.8%) >10% (GvHD) Anemia (75%) Thrombocytopenia (75%) Thrombocytopenia, Grade 3-4 (61%) Neutropenia (58%) Infections (55%) Edema (51%) Hemorrhage (49%) Anemia, Grade 3-4 (45%) Infections, Grade 3-4 (41%) Neutropenia (40%) Elevated ALT/AST (48%) Fatigue (37%) Bacterial infections (32%) Bacterial infections, Grade 3-4 (28%) Hemorrhage, Grade 3-4 (20%) Fatigue, Grade 3-4 (14%) Edema, Grade 3-4 (13%) Hypertriglyceridemia (11%) 1-10% (MF and PV) Urinary tract infection (9%) Weight gain (7.1%) Flatulence (5.2%) Herpes zoster (1.9%) Increased ALT, grade 2 (1.9%) Increased ALT, grade 3 (1.3%) 1-10% (GvHD) Elevated ALT/AST, Grade 3-4 (6-8%) Hypertriglyceridemia, Grade 3-4 (1%) <1% Increased AST, grade 2 (0.6%) Increased cholesterol, grade 2 (0.6%)

Ruxolitinib is a selective inhibitor of Janus Associated Kinases (JAKs), JAK1 and JAK2 which mediate the signaling of cytokines and growth factors that are important for haematopoiesis and immune function. In myelofibrosis and polycythaemia vera are known to be associated with dysregulation of JAK 1/2. JAK mediated signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, thus leading to modulation of gene expression. JAK-STAT signaling is involved with the regulation of the development, proliferation, and activation of immune cell types important to GVHD pathogenesis.

Rulicent 5mg Tablet generic name is Ruxolitinib. Rulicent 5mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Rulicent is availble in all over Bangladesh. Mes BD drug index information on Rulicent Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.