Ruxolitinib CAS 941678-49-5

Ruxolitinib is used to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Myelofibrosis is a life-threatening bone marrow problem which is manifested by the following symptoms: enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness. It is also used to treat polycythemia vera in patients who have been previously treated with hydroxyurea that did not work well.
Ruxolitinib is also used to treat acute graft-versus-host disease (aGVHD) in patients who have been treated with other medicines (eg, steroids) that did not work well. It is also used to treat chronic graft-versus-host disease (cGVHD) in patients who have been treated with 1 or 2 previous treatments that did not work well.

Ruxolitinib is a type of targeted cancer drug called a cancer growth blocker. A cancer growth blocker blocks the growth factors Open a glossary item that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene Open a glossary item that is important in the making of blood cells Open a glossary item. This gene is called Janus Associated Kinases 1 or 2 (JAK 1 or JAK2).
You have a blood test to check for the JAK gene change before you start treatment.

Ruxolitinib comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take ruxolitinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ruxolitinib exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.
If you are being treated for myelofibrosis or PV your doctor may start you on a low dose of ruxolitinib for the first four weeks of treatment, and gradually increase your dose after that time, not more than once every 2 weeks. If you are being treated for acute GVHD your doctor may start you on a low dose of ruxolitinib and may increase your dose after at least 3 days of therapy. If you are being treated for acute or chronic GVHD your doctor may gradually lower your dose of ruxolitinib after at least 6 months of therapy.
If you can not have food by mouth and have a nasogastric (NG) tube, your doctor may tell you to take ruxolitinib through the nasogastric (NG) tube. Your doctor or pharmacist will explain how to prepare ruxolitinib to give through an NG tube.
Your doctor will order blood tests before and during your treatment to see how you are affected by this medication. Your doctor may increase or decrease your dose of ruxolitinib during your treatment, or may tell you to stop taking ruxolitinib for awhile. This depends on how well the medication works for you, your lab test results, and if you experience side effects. Talk to your doctor about how you are feeling during your treatment. Continue to take ruxolitinib even if you feel well. Do not stop taking ruxolitinib without talking to your doctor. If your doctor decides to stop your treatment with ruxolitinib, your doctor may decrease your dose gradually.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Ruxolitinib was also generally safe and well tolerated and provided meaningful reductions in splenomegaly and symptoms in patients who restarted ruxolitinib after treatment interruption. Consistent with ruxolitinib's mechanism of action, hematologic adverse events were the primary cause of treatment interruptions. In the 207 patients who restarted treatment after therapy interruption, ruxolitinib provided reductions in palpable spleen length and symptoms prior to and after treatment interruption. After restarting treatment, patients were able to stay on ruxolitinib at a median dose of ≈10 mg bid, and most patients did not require another interruption. Rates of adverse events did not increase after restarting treatment. Additionally, the discontinuation rate after restarting treatment was comparable to that observed in the overall study population. Of note, there was no evidence of a withdrawal effect after discontinuation of ruxolitinib treatment in this cohort of patients.
The adverse event profile of ruxolitinib in intermediate-risk patients was consistent with that previously reported in higher-risk patients. Rates of non-hematologic adverse events were similar in both groups of patients, although those with higher-risk MF reported higher rates of fatigue (12.9% versus 5.5%). Herpes zoster reactivation was observed in both groups, with intermediate–risk patients reporting higher rates of reactivation (8.0% versus 3.6%).
Patients with intermediate-1-risk MF achieved clinically meaningful reductions in spleen size and symptom improvement consistent with those seen in intermediate-2- and high-risk patients enrolled in this study. At week 24, slightly more patients with intermediate--risk MF had achieved a ≥50% reduction from baseline in palpable spleen length than had patients in the overall population (63.8% versus 56.9%, respectively); the rates were similar at week 48 (60.5% versus 62.3%). Additionally, a similar proportion of patients in each cohort achieved a ≥50% reduction from baseline in palpable spleen length at any time (overall population, 69%; intermediate-1-risk patients, 77.6%). The median time to a spleen response was also similar (4.7 versus 5.1 weeks). Likewise, the proportion of patients who achieved clinically meaningful improvements in symptoms (≈30% to 40%) was within the expected range and consistent with that seen in the overall JUMP population (≈45% to 50%).