Each filmcoated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib. Xeljanz belongs to a group of drugs called jak inhibitors which work by suppressing the immune system against the damaging inflammation of rheumatoid. Prescribing information pdf open prescribing information. Tofacitinib 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. The information contained in the truven health micromedex products as delivered by goodrx is intended as an educational aid only. Dec 20, 2019 recommended dosage in rheumatoid arthritis and psoriatic arthritis. Medication guide xeljanz zel jans tofacitinib what. Adults with moderately to severely active rheumatoid arthritis in whom methotrexate did not work well or cannot be tolerated. Please see full prescribing information, including boxed warning and medication guide. Xeljanz is the brand name of the prescription medicine tofacitinib, which is used to treat rheumatoid arthritis, a condition in which the body attacks its own joints and internal organs the drug. Jaks are enzymes proteins that regulate chemical signaling pathways that control biologic processes such as blood formation and the immune response that causes the pain, tenderness and swelling of inflammation jaks are found in.
If a serious infection develops, interrupt xeljanz xeljanz xr until the infection is controlled. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. These highlights do not include all the information needed and administration instructions. Please consult a qualified health professional for. It belongs to a class of drugs called janus kinase jak inhibitors. Moreover, the fda has never approved the twicedaily 10 mg dose of tofacitinib to treat ra, as this regimen is only indicated for use in patients with ulcerative collitis. Xeljanz prescribing information this medicinal product is subject to additional monitoring. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is. Xeljanz tofacitinib citrate juvenile arthritis news. These highlights do not include all the information needed to use xeljanzxeljanz xr safely and effectively. It is not intended as medical advice for individual conditions or treatment. Table 1 displays the recommended adult daily dosage of xeljanz and xeljanz xr and dosage adjustments for patients receiving cyp2c19 andor cyp3a4 inhibitors, in patients with moderate or severe renal impairment including but not limited to those with severe insufficiency who are undergoing hemodialysis or moderate hepatic. This medicinal product is subject to additional monitoring.
I was happy to finally know the source of the weight gain, but sad to say goodbye to the. The rate difference between xeljanz doses and the corresponding 95% confidence interval was 0 0. This booklet contains information on how xeljanz works and how to take it, as well as things to look out for before and during your treatment. This document contains side effect information about tofacitinib. Pfizer research advances body of evidence for tofacitinib. Highlights of prescribing information these highlights do not include all the information needed to use xeljanzxeljanz xr safely and effectively. Your healthcare provider may choose to give you a lower xeljanz dosage if you take it with a cyp 2c19 inhibitor, especially for medications that inhibit cyp 3a4 and cyp 2c19 at the same time such as fluconazole. Xeljanz is supplied for oral administration as a 5 mg white round, immediaterelease filmcoated tablet. Tofacitinib citrate patient fact sheet xeljanz and xeljanz xr. Criteria based consultation prescribing program criteria. Benefits investigation only x date patient information patient authorization to enroll in xelsource and use of protected health information prescriber information clinical information. Xeljanz official website xeljanz tofacitinib safety. See what is the most important information i should know about xeljanzxeljanz xr.
Media zombie ipsum reversus ab viral inferno, nam rick grimes malum cerebro. Xeljanz side effects, uses, dosage, overdose, pregnancy. For full services including prescription fulfillment please sign prescription below. These highlights do not include all the information needed to use xeljanz safely and effectively. Xeljanz tofacitinib tablets, for oral use initial u. Prescriber is a rheumatologist and patient has a diagnosis of rheumatoid arthritis and. Xeljanz tofacitinib side effects, dosage, interactions. Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively. Individuals should consult a qualified health care provider for professional medical advice, diagnosis and treatment of a medical or health condition. If you are a carrier of the hepatitis b or c virus viruses that affect the liver, the virus may become active. A further description of risks and uncertainties can be found in pfizers annual report on form 10k for the fiscal year ended december 31, 2016 and in. Xeljanz tofacitinib is an oral prescription medication indicated to treat moderate to severe rheumatoid arthritis in adults. On friday july 26, 2019, the us fda updated the xeljanz full prescribing information and posted a statement. Financial support xeljanz tofacitinib for uc safety info.
Xeljanz tofacitinib tablets, for oral use xeljanz xr tofacitinib extendedrelease tablets, for oral use initial u. Highlights of prescribing information these highlights. Mar 11, 2019 rheumatoid arthritis patients who take a twicedaily 10 mg dose of xeljanz may face an increased risk for blood clots in their lungs, as well as death. You should not use xeljanz if you have a serious infection. If youve ever had hepatitis b or c, using tofacitinib can cause this virus to.
If you have any doubts or questions, please consult your doctor or pharmacist. A further description of risks and uncertainties can be found in pfizers annual report on form 10k for the fiscal year ended december 31, 2015 and in its subsequent reports on form 10q. See full prescribing information for complete boxed warning. It may be used as monotherapy or in combination with methotrexate or other. Xeljanz warnings and precautions arthritis home page. Interactions between xeljanz oral and tofacitinibstrong. If you are in a clinical trial or compassionateuse programme and need more information about your treatment, contact the doctor who is giving it to you. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Adults with active psoriatic arthritis in which methotrexate or other similar medicines called. Highlights of prescribing information psoriatic arthritis. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr. Rheumatoid arthritis ra is a chronic, systemic autoimmune disease that affects more than 1. Please see indication and important safety information on page 2. Call your doctor if you have a fever, chills, aches, tiredness, cough, trouble breathing, skin sores, diarrhea, weight loss, or burning when you urinate. You may get infections more easily, even serious or fatal infections. Also find the package insert, announcements, resources, and ways to connect with pfizer medical through a variety of channels. The product information provided in this site is intended only for residents of the united states. This medication comes in tablet form and is taken once or twice daily, with or without food. Xeljanz official website xeljanz tofacitinib safety info. Jun 17, 2015 xeljanz belongs to a group of drugs called jak inhibitors which work by suppressing the immune system against the damaging inflammation of rheumatoid arthritis. Nice backs pfizers xeljanz for ra but uks costeffectiveness watchdog removes two drugs from cdf pfizer is celebrating a positive recommendation from the national institute for health and care excellence nice for xeljanz tofacitinib citrate, a new treatment option for patients with a severe, active form of rheumatoid arthritis ra. Hepatitis b or c activation infection in people who carry the virus in their blood.
Jan 31, 2020 tofacitinib affects your immune system. Tofacitinib is sometimes given in combination with methotrexate or. December 02, 2019 healthcare professional communication download pdf, 798kb canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. Fda approves boxed warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib xeljanz. See 17 for patient counseling information and medication. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred.
Food and drug administration and the european commission have both approved xeljanz to treat adults with ra. Pfizer research advances body of evidence for tofacitinib citrate xeljanz providing clinicians with additional information for the treatment of moderate to severe ra. This medication guide summarizes the most important information about xeljanz. Skyrizi risankizumabrzaa full prescribing information. Highlights of prescribing information these highlights do not include all the information needed to use xeljanz xeljanz xr safely and effectively. Serious infections leading to hospitalization cor death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have. Each tablet of xeljanz contains 5 mg tofacitinib equivalent to 8. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals.
See full prescribing information for complete preparation. Xeljanztofacitinib tablets for oral administration initial u. Dailymed xeljanz tofacitinib tablet, film coated xeljanz. See full prescribing information for xeljanzxeljanz xr. Serious infections and malignancy see full prescribing information for complete boxed warning. Xeljanz tofacitinib tablets, for oral use xeljanz xr tofacitinib extended release tablets, for oral use initial u. This will allow quick identification of new safety information. See 17 for patient counseling information and fda approved patient labeling. The median xeljanz exposure prior to diagnosis of an opportunistic infection was 8 months range from 41 to 698 days see warnings and.
See 17 for patient counseling information and medication guide. Tofacitinib is an oral drug used for treating rheumatoid arthritis. Check the boxed warning with the drug for more information. Patients should always ask their doctors for medical advice about adverse events.
Our xeljanz side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Healthcare professionals are asked to report any suspected adverse reactions. Your healthcare provider or pharmacist has a list of the inactive ingredients. Dec 17, 2019 xeljanzxeljanz xr may cause serious side effects, including. Xeljanz tofacitinib tablets for oral administration. You are encouraged to report adverse events related to pfizer products by calling 18004381985 u. 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. Mar 01, 2020 xeljanz is also used to treat adults with moderate to severe ulcerative colitis in adults who cannot use certain other medications, or after other treatments have failed. I have received the necessary authorization to release medical andor other patient information relating to xeljanz xr xeljanz therapy to pfizer inc and its affiliates, agents, representatives, and service providers to use and disclose as necessary. This information is provided for general education only. You should not take xeljanz if you are allergic to it, tofacitinib, or any of the inactive components used to make the medication.
The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of. Xeljanz medication page for healthcare professionals to search for scientific information on pfizer medications. For assistance or additional information, call 18554xeljanz 18554935526, mondayfriday, 8 am8 pm et. Because of the long term side effects of xeljanz, the fda has announced that it is scheduling a study in the future to look at the effects between different dosages and compare results to patients receiving other kinds of treatment.
Before you start treatment, your doctor may perform tests to make sure you do not have an. Food and drug administration fda has extended the action date by three months for the suppleme. The products discussed herein may have different product labeling in different countries. Please keep in mind that the information in this booklet is not a replacement for the advice given to you by your doctor. See the full prescribing information for dosage adjustments by indication for patients receiving cyp2c19 andor cyp3a4 inhibitors. Find medical information documents that include xeljanz xeljanz xr and. Pfizer announces positive topline results from pivotal phase. Webmd provides information about interactions between xeljanz oral and tofacitinibstrongcyp3a4inducers.
Highlights of prescribing information these highlights do not include all the information needed to use xeljanz safely and effectively. Financial support xeljanz tofacitinib citrate safety info. There are a number of situations in which this medication. Food and drug administration extends action date for. Dec 17, 2019 it is unknown if xeljanz passes into breast milk or if it could harm a nursing baby. Pfizer also issued a media statement announcing that the u. Tofacitinib is sometimes given in combination with methotrexate or other arthritis medicines. Xeljanz warnings and precautions who should not take xeljanz. Common side effects of xeljanz include runny or stuffy nose, headaches, and diarrhea. Enbrel etanerceptinjection, for subcutaneous use enbrel etanercept for injection, for subcutaneous use initial u. Food and drug administration approves pfizers xeljanz tofacitinib citrate for adults with moderately to severely active rheumatoid arthritis ra who have had an inadequate response or intolerance to methotrexate. Tofacitinib is also used to treat moderate to severe ulcerative colitis. After a few months of testing, my rheumatologist and i came to the conclusion late last year that it was, in fact, the source of my rapid weight gain, so i had to stop taking it.
Xeljanz tofacitinib tablets for oral administration initial u. Treatment interruptions and dosage modifications based on anc1. Breastfeeding while using xeljanz is not recommended. Patient fact sheet tofacitinib citrate xeljanz and xeljanz xr. Octave sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily. The prescribing information for xeljanz specifically suggests a lower dose for any person taking a medication that is both a potent cyp 2c19 inhibitor and a moderate. People who have diverticulitis or an infection may not be able to use xeljanz safely. Xeljanz is a prescription medication used to treat rheumatoid arthritis in adult patients who have been treated with methotrexate without success rheumatoid arthritis is a disease of the immune system. Xeljanz tofacitinib citrate is an oral small molecule distributed by pfizer and used to treat moderate to severe active rheumatoid arthritis ra patients who have not responded adequately to methotrexate or cannot tolerate it the u.
Pfe announced today topline results from oral clinical trials for tofacitinib in ulcerative colitis octave sustain, the third phase 3 study of xeljanz tofacitinib citrate being investigated in patients with moderately to severely active ulcerative colitis uc. Prescription information and xelsource enrollment form please. Xeljanz 5 mg filmcoated tablets summary of product. Vumerity diroximel fumarate delayedrelease capsules, for oral use. The diagnosis of ra is made on the basis of the symptoms. The plan may request additional information or clarification, if needed, to evaluate requests. Tofacitinib citrate patient fact sheet xeljanz and. Click here for full prescribing information, including boxed warning and medication guide. Interrupt tofacitinib until anc mm 3, then resume tofacitinib 5 mg twice daily as conventional tablets or 11 mg once daily as extendedrelease tablets. Xeljanz xeljanz xr tofacitinib is a prescription medicine called a janus kinase jak inhibitor used to treat. If a serious infection develops, interrupt xeljanzxeljanz xr until the infection is controlled. Xeljanz is the brand name of the prescription medicine tofacitinib, which is used to treat rheumatoid arthritis, a condition in which the body attacks its. 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. Jan 07, 2020 see full prescribing information for complete boxed warning.
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