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RUXOLITINIB TORRENT is a brand name for Ruxolitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Myelofibrosis (MF) Ruxolitinib Phosphate is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Polycythaemia vera…
Verbatim from this product's MHRA label. Tap a section to expand.
Ruxolitinib Phosphate treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with Ruxolitinib Phosphate.
4). Posology Starting dose Myelofibrosis (MF) The recommended starting dose of Ruxolitinib Phosphate in myelofibrosis (MF) is based on platelet counts (see Table 1): Table 1: Starting doses in myelofibrosis Platelet count Starting dose Greater than 200,000/mm3 20 mg orally twice daily 100,000 to 200,000/mm3 15 mg orally twice daily 75,000 to less than 100,000/mm3 10 mg orally twice daily 50,000 to less than 75,000/mm3 5 mg orally twice daily Polycythaemia vera (PV) The recommended starting dose of Ruxolitinib Phosphate in PV is 10 mg given orally twice daily.
Graft versus host disease (GvHD) The recommended starting dose of Ruxolitinib Phosphate in acute and chronic graft versus host disease (GvHD) is based on age (see Table 2): Table 2 Starting doses in acute and chronic graft versus host disease Age group Starting dose 12 years old and above 10 mg orally twice daily 6 years to less than 12 years old 5 mg orally twice daily 2 years to less than 6 years old 4 mg/m2 orally twice daily These starting doses in GvHD can be administered using either the tablet for patients at or above 6 years old who can swallow tablets or the other oral solution available in the market for patients under 12 years old.
Dose modifications Doses may be titrated based on efficacy and safety. Myelofibrosis and polycythaemia vera If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily.
The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals. Treatment should be discontinued for platelet counts less than 50,000/mm3 or absolute neutrophil counts less than 500/mm3.
In PV, treatment should also be interrupted when haemoglobin is below 8 g/dl. After recovery of blood counts above these levels, dosing may be re-started at 5 mg twice daily and gradually increased based on careful monitoring of complete blood cell count, including a white blood cell count differential.
Summary of the safety profile Myelofibrosis The most frequently reported adverse drug reactions were thrombocytopenia and anaemia. 8%). Anaemia, thrombocytopenia and neutropenia are dose-related effects. 9%). 2%). In phase 3 clinical studies in MF, neither CTCAE grade 3 or 4 hypertriglyceridaemia or increased aspartate aminotransferase, nor CTCAE grade 4 increased alanine aminotransferase or hypercholesterolaemia were observed.
0% of patients. Polycythaemia vera The most frequently reported adverse drug reactions were anaemia and increased alanine aminotransferase. 3%). 6% of the patients, respectively. 9%). 7%). No CTCAE grade 4 increased alanine aminotransferase or hypercholesterolaemia, and one CTCAE grade 4 increased aspartate aminotransferase were observed.
4% of patients. Acute GvHD REACH 1 The most frequently reported adverse drug reactions were anaemia, thrombocytopenia, and neutropenia. 2%). 03). 2% of patients, respectively. 5%). 7%). The majority were of grade 1 and 2. 4% of patients REACH 2 The most frequently reported adverse drug reactions (>50%) in REACH2 (adult and adolescent patients) were thrombocytopenia, anaemia neutropenia, increased alanine aminotransferase and increased aspartate aminotransferase.
0%), respectively. 8% of paediatric patients. 4% of patients in the paediatric pool, respectively. 0% of patients in the paediatric pool, respectively. 9%), respectively. 2%), respectively. 3% of patients in the paediatric pool. 6% of patients in the paediatric pool.
Chronic GvHD The most frequently reported adverse drug reactions (>50%) in REACH3 (adult and adolescent patients) were anaemia, hypercholesterolemia and increased aspartate aminotransferase. The most frequently reported adverse drug reactions (>50%) in the pool of paediatric patients (adolescents from REACH3 and paediatric patients from REACH5) were neutropenia, hypercholesterolaemia and increased alanine aminotransferase.
Myelosuppression Treatment with Ruxolitinib Phosphate can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia. A complete blood count, including a white blood cell count differential, must be performed before initiating therapy with Ruxolitinib Phosphate.
2). It has been observed that MF patients with low platelet counts (<200,000/mm3) at the start of therapy are more likely to develop thrombocytopenia during treatment. 8). However, platelet transfusions may be required as clinically indicated.
Patients developing anaemia may require blood transfusions. Dose modifications or interruption for patients developing anaemia may also need to be considered. 1%). 0 g/dl. 8). 8). Infections Serious bacterial, mycobacterial, fungal, viral and other opportunistic infections have occurred in patients treated with Ruxolitinib Phosphate.
Patients should be assessed for the risk of developing serious infections. Physicians should carefully observe patients receiving Ruxolitinib Phosphate for signs and symptoms of infections and initiate appropriate treatment promptly.
Treatment with Ruxolitinib Phosphate should not be started until active serious infections have resolved. Tuberculosis has been reported in patients receiving Ruxolitinib Phosphate. Before starting treatment, patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Hepatitis B viral load (HBV-DNA titre) increases, with and without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Ruxolitinib Phosphate.
1. Pregnancy and lactation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose reductions should be considered if the platelet count decreases during treatment as outlined in Table 3, with the goal of avoiding dose interruptions for thrombocytopenia.
Table 3:
Dosing recommendation for thrombocytopenia Dose at time of platelet decline 25 mg twice daily 20 mg twice daily 15 mg twice daily 10 mg twice daily 5 mg twice daily Platelet count New dose In PV, dose reductions should also be considered if haemoglobin decreases below 12 g/dl and is recommended if it decreases below 10 g/dl.
Graft versus host disease Dose reductions and temporary interruptions of treatment may be needed in GvHD- patients with thrombocytopenia, neutropenia, or elevated total bilirubin after standard supportive therapy including growth-factors, anti-infective therapies and transfusions.
One dose level reduction step is recommended (10 mg twice daily to 5 mg twice daily or 5 mg twice daily to 5 mg once daily). In patients who are unable to tolerate Ruxolitinib Phosphate at a dose of 5 mg once daily, treatment should be interrupted.
Detailed dosing recommendations are provided in Table 4.
Table 4:
Dosing recommendations for GvHD patients with thrombocytopenia, neutropenia, or elevated total bilirubin Laboratory parameter Dosing recommendation Platelet count <20,000/mm3 Reduce Ruxolitinib Phosphate by one dose level. If platelet count≥20,000/mm3 within seven days, dose may be increased to initial dose level, otherwise maintain reduced dose.
Platelet count <15,000/mm3 Hold Ruxolitinib Phosphate until platelet count ≥20,000/mm3, then resume at one lower dose level. Absolute neutrophil count (ANC) ≥500/mm3 to <750/mm3 Reduce Ruxolitinib Phosphate by one dose level. Resume at initial dose level if ANC >1,000/mm3.
Absolute neutrophil count <500/mm3 Hold Ruxolitinib Phosphate until ANC >500/mm3, then resume at one lower dose level. If ANC >1,000/mm3, dosing may resume at initial dose level. 0 x ULN. 0 x ULN. 0 x ULN dosing may resume at current dose.
0 x ULN after 14 days, resume at one lower dose level. 0 x ULN, then resume at one lower dose level. 0 x ULN. g. 5). The concomitant use of ruxolitinib with fluconazole doses greater than 200 mg daily should be avoided. g. twice a week) of haematology parameters and of clinical signs and […]
2%) respectively. Grade 3 anaemia was reported in […]
It is recommended to screen for HBV prior to commencing treatment with Ruxolitinib Phosphate. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. Herpes zoster Physicians should educate patients about early signs and symptoms of herpes zoster, advising that treatment should be sought as early as possible.
Progressive multifocal leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has been reported with Ruxolitinib Phosphate treatment. , cognitive, neurological or psychiatric symptoms or signs). Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML should be considered.
If PML is suspected, further dosing must be suspended until PML has been excluded. Lipid abnormalities/elevations Treatment with Ruxolitinib Phosphate has been associated with increases in lipid parameters including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended. Major adverse cardiac events (MACE) In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years of age and older with at least one additional cardiovascular risk factor, a higher rate of MACE, defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors.
MACE have been reported in patients receiving Ruxolitinib Phosphate. Prior to initiating or continuing therapy with Ruxolitinib Phosphate, the benefits and risks for the individual patient should be considered particularly in patients 65 years of age and older, patients who are current or past long-time smokers, and patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors.
Thrombosis In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years of age and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of venous thromboembolic events (VTE) including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving Ruxolitinib Phosphate. In patients with MF and PV treated with Ruxolitinib Phosphate in clinical studies, the rates of thromboembolic events were similar in Ruxolitinib Phosphate and control-treated patients.
Prior to initiating or continuing therapy with […]