Only the immediaterelease version of xeljanz is fdaapproved for the treatment of uc. It may be used as monotherapy or in combination with. The fda doesnt necessarily have to follow the advice of its advisory committee but, hopefully, it will, given the severity of. Highlights of prescribing information recommended dosage in. This draft guidance, once finalized, will represent the. Evaluation of pharmacokinetics compared with immediaterelease. Australian public assessment report for tofacitinib citrate proprietary product name. Food and drug administration fda voted 101 to recommend the approval of the proposed dose of tofacitinib for. Tofacitinib uses, dmf, dossier, manufacturer, supplier. If you have an allergy to tofacitinib or any other part of this medicine tofacitinib tablets. Tofacitinib for the treatment of ulcerative colitis.
Tofacitinib has been released from the fdas risk evaluation and mitigation strategy requirement. Fda approval history for xeljanz tofacitinib used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis. For more information, please call 844 9897284 or visit eligible patients can register for valuable savings offers for nearly 40 brand name medications. Australian public assessment report for tofacitinib as. Xeljanz is a medicine that affects your immune system. When fda first approved tofacitinib, we required a clinical trial among patients with ra to evaluate the risk of heartrelated events, cancer, and opportunistic infections with the.
Each tablet of xeljanz contains 5 mg tofacitinib equivalent to 8. The aqueous ph solubility of tofacitinib the citrate salt was determined to be 0. The us food and drug administration fda has approved tofacitinib citrate extendedrelease xeljanz xr, pfizer inc 11mg tablets for oncedaily treatment of moderate to severe rheumatoid. Xeljanz can lower the ability of your immune system to fight infections. Information on submitting spl files using elist may be found in the guidance for industry spl standard for. Tofacitinib can be considered a bcs class 3 drug because of high aqueous solubility and moderate permeability. This information should not take the place of medical care and advice from your healthcare provider. Pfizer announces fda approval of xeljanz xr tofacitinib citrate, the first and only oncedaily oral jak inhibitor treatment for rheumatoid arthritis. Effects of tofacitinib and other dmards on lipid profiles in rheumatoid arthritis.
This sheet talks about exposure to tofacitinib in pregnancy and while breastfeeding. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab. If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Highlights of prescribing information psoriatic arthritis.
Although not all of these side effects may occur, if they do occur they may need medical attention. Tofacitinib has been used for the treatment of adults with moderatetosevere rheumatoid arthritis ra since its initial food and drug administration fda approval in 2012, and in 2018 the fda expanded this approval to include treatment of adults with moderate to severe uc. According to the 2018 american college of rheumatology and national psoriasis foundation guidelines, tnf inhibitors or oral small molecules e. Xeljanz tofacitinibtablets,fororaluse xeljanz xr tofacitinibextendedrelease tablets, fororal use initial u. The fifth joint task force of the european society of cardiology and other societies on cardiovascular. Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular cv risk factor treated with xeljanz 10 mg twice a day had a higher rate of allcause mortality, including sudden cv death, compared to those treated with xeljanz 5 mg given twice daily or tnf blockers in a large, ongoing, postmarketing safety study see warnings and precautions 5. Pdf extendedrelease oncedaily formulation of tofacitinib. An efficacy and safety study evaluating tofacitinib with. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Xeljanz tofacitinib this product information is intended only for residents of the united states. Patients treated with tofacitinib 5 mg filmcoated tablets twice daily may be switched to tofacitinib 11 mg prolongedrelease tablets once daily on the day following the.
Xeljanz and xeljanz xr are inhibitors of janus kinases jaks indicated for the treatment of. Tofacitinib xeljanz, xeljanz xr is a janus kinase jak inhibitor. Besides rheumatoid arthritis, tofacitinib has also been. Tofacitinib in the treatment of ulcerative colitis. A link to download a pdf version of the drug profile will be included in your email receipt. Fda food and drug administration us gfr glomerular filtration rate. Dosage and administration drug name indication dosing regimen maximum dose. Xeljanzxeljanz xr is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Patient safety is of the utmost importance to pfizer and the. European guidelines on cardiovascular disease prevention in clinical practice version 2012. It is approved by the fda for treatment of moderate to severe rheumatoid arthritis that responds inadequately to methotrexate or in those who are intolerant to methotrexate.
Serious infections, mortality, malignancy and thrombosis see full prescribing information for complete boxed warning. Tofacitinib is a prescription medication used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. What is the most important information i should know about tofacitinib xeljanz, xeljanz xr. To compare effects on all health outcomes measures in the study. An efficacy and safety study evaluating tofacitinib with and without methotrexate compared to adalimumab with methotrexate oral strategy. Xeljanz xr is provided as 11 mg tofacitinib equivalent to 17.
Medication guide xeljanz zel jans tofacitinib what. Tofacitinib is an orally active small molecule, immunosuppressant and janus activated kinase 1, 2 and 3 inhibitor developed by pfizer. Tofacitinib immediaterelease xeljanz psa, ra 5 mg po bid 10 mgday. Xeljanz tofacitinib blocks the activity of certain enzymes in the body that affect immune system function. Endpoints included regrowth of scalp hair, as assessed by the severity of alopecia tool salt, duration of hair growth after completion of therapy, and disease transcriptome. Dec 17, 2019 xeljanz is supplied for oral administration as a 5 mg white round, immediaterelease filmcoated tablet. Listing a study does not mean it has been evaluated by the u. Fda approves tofacitinib for rheumatoid arthritis medscape.
Prescribing information pdf, search, whats new, other resources, therapeutic area. The resulting normbased scores for both the sf36 version 2 v2 and sf36 health domain scales and component summary. Tofacitinib cp 690,550 a3921091 final protocol, 21 december 2012. Tofacitinib is an inhibitor of janus kinases, a group of intracellular enzymes involved in signalling pathways that affect hematopoiesis and immune cell function. Adult patients with moderately to severely active ulcerative colitis uc. Switching between tofacitinib 5 mg filmcoated tablets and tofacitinib 11 mg prolongedrelease tablets. Peak concentrations and auc are equivalent following oral. Jul 10, 2014 to compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. Aug 12, 2019 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Xeljanz tofacitinib xeljanz xr tofacitinib extended. And chs0214, a proposed etanercept biosimilar, has met its primary endpoint at week 24 in an ongoing 52week study. Aug 30, 20 tofacitinib xeljanz special investigation for rheumatoid arthritis the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Xeljanz is provided as 5 mg tofacitinib equivalent to 8 mg tofacitinib citrate tablets.
Tofacitinib for induction and maintenance therapy of crohn. Tofacitinib has recently been approved for the treatment of moderatesevere uc by the fda 29 and the european medicines agency. Tofacitinib 5 mg was given twice daily for 3 months. Pdf tofacitinib is an oral janus kinase inhibitor for the treatment of rheumatoid arthritis. Tofacitinib citrate reference guide for safe and effective use from the. What are the possible side effects of tofacitinib xeljanz, xeljanz xr. Ibm micromedex along with its needed effects, a medicine may cause some unwanted effects. Clinical trials for tofacitinib the european union clinical trials register allows you to search for protocol and results information on. Here, we report the results of pk evaluations from 2 key phase 1 studies of the tofacitinib xr 11. The fda approved only the 5 mg twicedaily dose on the grounds that a higher dose was not considered to have an adequate risktobenefit ratio.
Discontinue 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved. Tofacitinib tofacitinib xeljanz national drug monograph april 2014. Fda approved indications xeljanz is indicated for the treatment of. Food and drug administration fda has approved xeljanz xr tofacitinib extendedrelease 11 mg and 22 mg tablets for the oncedaily treatment of adult patients with moderately to severely active ulcerative colitis uc, after an inadequate response or intolerance to tnf blockers. The us food and drug administration fda has approved tofacitinib citrate extendedrelease xeljanz xr, pfizer inc 11mg tablets for oncedaily treatment of. Limit use of 10 mg twice daily beyond induction to those with loss of response. Ra is a chronic autoimmune disease characterized by inflammation and destruction of joints. Objective tofacitinib is an oral, smallmolecule janus kinase inhibitor that is being investigated for ibd. Australian public assessment report for tofacitinib citrate. Xeljanztofacitinib, an rx option for moderate to severe rheumatoid arthritis, moderate to severe ulcerative colitis, or active psoriatic. Tofacitinib is an oral janus kinase inhibitor for the treatment of rheumatoid arthritis.
The indications below including fdaapproved indications and compendial uses are considered a covered. Australian public assessment report for tofacitinib as citrate. Va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Mar 02, 2016 tofacitinib has been released from the fdas risk evaluation and mitigation strategy requirement. Fda approves boxed warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib xeljanz, xeljanz xr other resources tofacitinib pregnancy exposure registry.
Tofacitinib xeljanz special investigation for rheumatoid. Xeljanz xeljanz xr tofacitinib is a prescription medicine called a janus kinase jak inhibitor used to treat. Highlights of prescribing information recommended dosage. White, round, immediaterelease filmcoated tablets, debossed with. Food and drug administration fda has extended the action date by three months for the supplemental new drug application snda for xeljanz tofacitinib, an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis uc. Design we conducted two randomised, doubleblind, placebocontrolled, multicentre phase iib studies. Xeljanz xeljanz xr tofacitinib boxed warning pfizer. To evaluate the safety and tolerability of tofacitinib and adalimumab. Pink, oval, extended release filmcoated tablets with a drilled.
Food and drug administration fda voted 101 to recommend the approval of the proposed dose of tofacitinib for treating adults with active psoriatic arthritis psa. Xeljanz xr tofacitinib extendedrelease tablets, for oral use. Xeljanz official website xeljanz tofacitinib safety info. Aug 22, 2017 fda committee approves tofacitinib for psa on aug. Jan 01, 20 a new oral agent, tofacitinib xeljanzpfizer, has been approved by fda to treat adults with moderately to severely active rheumatoid arthritis ra who have had an inadequate response or intolerance to methotrexate.
Fda approves boxed warning about increased risk of blood clots and death with. Auspar xeljanz tofacitinib citrate pfizer australia pty ltd pm20120078833. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Xeljanz xeljanz xr tofacitinib other pfizer medical. An efficacy and safety study evaluating tofacitinib with and. If needed, continue 10 mg twice daily for a maximum of 16 weeks. Xeljanzxeljanz xr is indicated for the treatment of adult patients with. Xeljanz xeljanz xr tofacitinib indications and usage pfizer. Fdas announcement and drug safety communication are attached for your reference. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderatetosevere crohns disease cd. Pfizer announces fda approval of xeljanz tofacitinib and xeljanz xr for the treatment of active psoriatic arthritis. The fda said today that tofacitinib was approved ahead of the products prescription drug user fee goal date of november 21, 2012, the date the agency was. This draft guidance, once finalized, will represent the food.
Xeljanz is used to treat moderate to severe rheumatoid arthritis or active psoriatic arthritis in adults who have tried methotrexate or other medications without successful treatment of symptoms. Xeljanztofacitinib, an rx option for moderate to severe rheumatoid arthritis, moderate to severe ulcerative colitis, or active psoriatic arthritis. Xeljanz and xeljanz xr are indicated for the treatment of. Xeljanz xr tofacitinib extended release tablets notice. Xeljanz, xeljanz xr tofacitinib dosing, indications. The recommended dose of xeljanz is 5 mg twice daily. Safety trial finds risk of blood clots in the lungs and. Each tablet of xeljanz contains 5 mg tofacitinib equivalent to 8 mg tofacitinib. Contains nonbinding recommendations draft guidance on tofacitinib citrate recommended dec 2014 this draft guidance, once finalized, will represent the food and drug administration s fdas. Xeljanz tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Important reminder at the end of this policy for important regulatory and legal information. Oct 06, 2016 evaluations using a preliminary version of the 11. If you would like to request an accessible version of this document, please contact customer service at 8005249242. Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated.
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