Ruxolitinib spc. Ruxolitinib Uses, Side Effects & Warnings 2022-10-24
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Ruxolitinib is a prescription medication that belongs to a class of drugs known as Janus kinase (JAK) inhibitors. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain types of blood disorders and certain types of cancer.
In the treatment of blood disorders, ruxolitinib is used to treat myelofibrosis, a rare type of bone marrow cancer that results in scarring of the bone marrow and abnormal production of blood cells. It is also used to treat polycythemia vera, a blood disorder characterized by the production of too many red blood cells. Ruxolitinib works by inhibiting the activity of JAK enzymes, which play a role in the development and progression of these blood disorders.
In the treatment of cancer, ruxolitinib is used to treat mantle cell lymphoma, a type of non-Hodgkin's lymphoma. It is also being studied in the treatment of other types of cancer, including breast cancer, pancreatic cancer, and prostate cancer.
Ruxolitinib is taken orally in the form of a tablet. The recommended dosage and duration of treatment depends on the patient's medical condition and response to the medication. Common side effects of ruxolitinib include anemia, diarrhea, fatigue, and low platelet counts. It is important to discuss all potential risks and benefits with a healthcare provider before starting treatment with ruxolitinib.
In summary, ruxolitinib is a prescription medication used to treat certain types of blood disorders and certain types of cancer. It works by inhibiting the activity of JAK enzymes and is taken orally in the form of a tablet. As with any medication, it is important to discuss all potential risks and benefits with a healthcare provider before starting treatment.
JAKAVI® (ruxolitinib)
Mesa RA, Kantarjian H, Tefferi A, et al. COMFORT-I bola dvojito zaslepená, randomizovaná, placebom kontrolovanáštúdia s 309 pacientmi, ktorí nereagovali na dostupnú liečbu alebo táto pre nich nebola vhodná. In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms. The dose was adjusted for lack of efficacy or excess toxicity as specified in the protocol see the The primary end point was the proportion of patients with a reduction of 35% or more in spleen volume from baseline to week 24, measured by means of magnetic resonance imaging or computed tomography. Adverse Events Observed in 10% or More of Patients Who Received Ruxolitinib. Thirty-six patients in the placebo group 23. There were no transformations in the placebo group.
Po jednorazovej dávke ruxolitinibu 25 mg bola jeho expozícia podobná u jedincov s rôznymi stupňami poruchy funkcie obličiek s tými, ktorí mali normálnu funkciu obličiek. The most frequent non-hematological laboratory abnormalities identified as adverse drug reactions were increased ALT 50. In the analyses of change from baseline to week 24, patients who discontinued the study drug or crossed over before week 24 were counted as not having a response for response measures of a reduction in spleen volume and symptom improvement. Haematological adverse reactions any CTCAE grade included anaemia 61. Patients who discontinued the study drug or for whom data were missing were considered not to have had a response. Frekvencia výskytu závažnej trombocytopénie t.
Discontinuation due to adverse events, regardless of causality, was observed in 30. Effects of ruxolitinib on other medicinal products Substances transported by P-glycoprotein or other transporters Ruxolitinib may inhibit P-glycoprotein and breast cancer resistance protein BCRP in the intestine. International Working Group IWG consensus criteria for treatment response in myelofibrosis with myeloid metaplasia, for the IWG for Myelofibrosis Research and Treatment IWG-MRT. Erickson-Viitanen, being an employee of Incyte and receiving stock or stock options as part of her compensation; Dr. The study included 3. Food and Drug Administration.
BAT was selected by the investigator on a patient-by-patient basis and included extracorporeal photopheresis ECP , low dose methotrexate MTX , mycophenolate mofetil MMF , mTOR inhibitors everolimus or sirolimus , infliximab, rituximab, pentostatin, imatinib, or ibrutinib. In juvenile rat studies, administration of ruxolitinib resulted in effects on growth and bone measures. The starting dose of ruxolitinib depended on the baseline platelet count: 15 mg twice daily for a platelet count of 100×10 9 to 200×10 9 per liter and 20 mg twice daily for a count that exceeded 200×10 9 per liter. Verstovsek reports receiving grant support through his institution from Incyte, Exelixis, Celgene, NS Pharma, Infinity Pharmaceuticals, SBIO, Lilly Oncology, AstraZeneca, Geron, Bristol-Myers Squibb, YM BioSciences, Gilead, and Roche; Dr. However, the exposure margins compared to the highest clinical dose were low and the results are therefore of limited relevance for humans. Sun, being an employee of Incyte and receiving stock options as part of his compensation; Dr. In the best available therapy arm, 47% of patients received hydroxyurea and 16% of patients received glucocorticoids.
U pacientov so zvýšenými hladinami lipázy neboli hlásené súčasné prejavy a príznaky pankreatitídy. The mean C max was moderately decreased 24% while the mean AUC was nearly unchanged 4% increase on dosing with a high-fat meal. The upper edge of each I bar corresponds to the 75th percentile, and the lower edge to the 25th percentile. The frequency of severe i. Funding and Disclosures Dr.
Paediatric population The safety and effectiveness of Jakavi in paediatric patients with MF and PV have not been established The safety, efficacy and pharmacokinetic profile observed in adolescent patients with acute or chronic GvHD was comparable to the overall patient population see section 5. V RESPONSE 2 boli frekvencie porovnateľné medzi ruxolitinibom, a kontrolným ramenom 10,8 % oproti 8 %. Reductions in spleen volume were durable; 67. No effects were noted on fertility. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
The primary endpoint defined as the proportion of patients achieving HCT control absence of phlebotomy eligibility at week 28 was met 62. 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. Excipient with known effect Each tablet contains 214. Baseline Characteristics of the Patients. The recommended starting dose for PV and GvHD patients with severe renal impairment is 5 mg twice daily.
Ruxolitinib Side Effects: Common, Severe, Long Term
Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. The proportion of patients with a reduction of 35% or more in spleen volume at week 24 primary end point was 41. Počas predĺženého sledovania 3. Patients should be carefully monitored with regard to safety and efficacy during ruxolitinib treatment. Infekcie V pivotných štúdiách 3. SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU Jakavi 5 mg tablety Jakavi 10 mg tablety Jakavi 15 mg tablety Jakavi 20 mg tablety Jakavi 5 mg tablety Každá tableta obsahuje 5 mg ruxolitinibu ako fosfátu.
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. Od zdravotníckych pracovníkov sa vyžaduje, aby hlásili akékoľvek podozrenia na nežiaduce reakcie na národné centrum hlásenia uvedené v Nie je známe antidotum pri predávkovaní s Jakavi. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. During the randomised period, dose holding or reductions due to neutropenia were reported in 1. Secondary end points included the durability of response, changes in symptom burden assessed by the total symptom score , and overall survival.
