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Sealington3
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  1. <!DOCTYPE html>
  2. <html>
  3.  
  4. <head>
  5.     <meta charset="UTF-8">
  6.     <meta name="ad.size" content="width=300,height=250">
  7.     <link rel="icon" href="data:;base64,iVBORw0KGgo=">
  8.     <title>300x250</title>
  9.     <link href="css/default.css" rel="stylesheet" media="all">
  10.     <link href="css/style.css" rel="stylesheet" media="all">
  11. </head>
  12.  
  13. <body>
  14.     <div id="viewport" class="adSize posRel visHid overFlowHid">
  15.  
  16.         <div id="f4-bg" class="bg adSize posAb topLef bgDef"></div>
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  25.         <div id="f1-Pf-logo" class="f1 adSize posAb topLef bgDef"></div>
  26.  
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  48.             <div id="isi-heading-con" class="isi-con">
  49.                 <h2 id="isi-heading" class="heading">IMPORTANT SAFETY INFORMATION AND USE</h2>
  50.             </div>
  51.             <div id="isi-wrapper">
  52.                 <div id="isi-copy-con" class="isi-con">
  53.                     <div id="isi-copy">
  54.                         <h2 class="sub-heading mrgn-btm">LITFULO may cause serious side effects, including:</h2>
  55.                         <p class="mrgn-btm">
  56.                             <strong>Serious infections.</strong> LITFULO can lower the ability of your immune system to
  57.                             fight infections. Do not start LITFULO if you have any kind of infection unless your
  58.                             healthcare provider tells you it is okay. Some people have had serious infections while
  59.                             taking LITFULO or other similar medicines, including tuberculosis (TB), and infections
  60.                             caused by bacteria, fungi, or viruses that can spread throughout the body and have been
  61.                             hospitalized. Some people taking similar medicines to LITFULO have died from these
  62.                             infections. You may be at a higher risk of developing shingles (herpes zoster).
  63.                         </p>
  64.                         <p class="mrgn-btm">
  65.                             Your healthcare provider should test you for TB before starting
  66.                             treatment with LITFULO and should watch you closely for signs and
  67.                             symptoms of TB during treatment with LITFULO.
  68.                         </p>
  69.                         <p>
  70.                             <strong>Before and after starting LITFULO, tell your healthcare provider if you</strong>
  71.                             think you have an infection, are being treated for one, or have symptoms of an infection,
  72.                             including:
  73.                         </p>
  74.                         <ul class="mrgn-btm">
  75.                             <li>fever, sweating, or chills</li>
  76.                             <li>muscle aches</li>
  77.                             <li>cough or shortness of breath</li>
  78.                             <li>blood in your phlegm</li>
  79.                             <li>weight loss</li>
  80.                             <li>warm, red, or painful skin or sores on your body</li>
  81.                             <li>diarrhea or stomach pain</li>
  82.                             <li>burning when you urinate or urinating more often than usual</li>
  83.                             <li>feeling very tired</li>
  84.                         </ul>
  85.                         <p class="mrgn-btm">
  86.                             LITFULO can make you more likely to get infections or worsen infections you have. If you get
  87.                             a serious infection, your healthcare provider may stop treatment with LITFULO until your
  88.                             infection is controlled.
  89.                         </p>
  90.                         <p class="mrgn-btm">
  91.                             <strong>
  92.                                 There is an increased risk of death in people 50 years of age and older who have at
  93.                                 least one heart disease (cardiovascular) risk factor and are taking a Janus kinase (JAK)
  94.                                 inhibitor. LITFULO is a kinase inhibitor medicine.
  95.                             </strong>
  96.                         </p>
  97.                         <p class="mrgn-btm">
  98.                             <strong>Cancer and immune system problems.</strong> LITFULO may
  99.                             increase your risk of certain cancers by changing the way your
  100.                             immune system works. Lymphoma and other cancers, including skin
  101.                             cancers, can happen. People taking JAK inhibitors have a higher risk of certain cancers
  102.                             including lymphoma and lung cancer, especially if you are a current or past smoker. Follow
  103.                             your healthcare provider&#39;s advice about having your skin checked for skin cancer during
  104.                             treatment. Tell your healthcare provider if you have ever had any type of cancer.
  105.                         </p>
  106.                         <p class="mrgn-btm">
  107.                             <strong>
  108.                                 There is an increased risk of major cardiovascular events such as heart attack, stroke,
  109.                                 or death in people 50 years of age and older who have at least one heart disease
  110.                                 (cardiovascular) risk factor and are taking a JAK inhibitor, especially if you are a
  111.                                 current or past smoker.
  112.                             </strong>
  113.                         </p>
  114.                         <p>
  115.                             <strong>Get emergency help right away</strong> if you have any
  116.                             symptoms of a heart attack or stroke while using LITFULO, including:
  117.                         </p>
  118.                         <ul class="mrgn-btm">
  119.                             <li>discomfort in the center of your chest that lasts for more than a few minutes, or that
  120.                                 goes away and comes back</li>
  121.                             <li>severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw</li>
  122.                             <li> pain or discomfort in your arms, back, neck, jaw, or stomach</li>
  123.                             <li>shortness of breath with or without chest discomfort</li>
  124.                             <li>breaking out in a cold sweat</li>
  125.                             <li>nausea or vomiting</li>
  126.                             <li>feeling lightheaded</li>
  127.                             <li>weakness in one part or on one side of your body</li>
  128.                             <li>slurred speech</li>
  129.                         </ul>
  130.                         <p class="mrgn-btm">
  131.                             <strong>Blood clots.</strong> Blood clots in the veins of your legs (deep vein thrombosis,
  132.                             DVT), lungs (pulmonary embolism, PE), or eyes can happen in some people taking LITFULO. This
  133.                             may be life-threatening. Blood clots in the veins of the legs and lungs have happened more
  134.                             often in people 50 years of age and older with at least one heart disease (cardiovascular)
  135.                             risk factor taking a JAK inhibitor. Tell your healthcare provider if you have had blood
  136.                             clots in the past.
  137.                         </p>
  138.                         <p class="mrgn-btm">
  139.                             Stop taking LITFULO and get medical help right away if you have any signs and symptoms of
  140.                             blood clots, including swelling, pain or tenderness in one or both legs; sudden, unexplained
  141.                             chest or upper back pain; shortness of breath or difficulty breathing; or changes in vision,
  142.                             especially in one eye only.
  143.                         </p>
  144.                         <p class="mrgn-btm">
  145.                             <strong>Allergic reactions.</strong> Symptoms that may mean you are having an allergic
  146.                             reaction have been seen during treatment with LITFULO. Some of these reactions were serious.
  147.                             Stop taking LITFULO and get emergency medical help right away if you have symptoms of
  148.                             allergic reaction, including hives; rash; trouble breathing; feeling faint or dizzy; or
  149.                             swelling of your lips, tongue, or throat.
  150.                         </p>
  151.                         <p class="mrgn-btm">
  152.                             <strong>Changes in certain laboratory test results.</strong> Your healthcare provider should
  153.                             do blood tests before you start taking LITFULO and during treatment to check your lymphocyte
  154.                             and platelet counts and liver enzyme and creatine phosphokinase (CPK) levels. You should not
  155.                             take LITFULO if your lymphocyte counts or platelet counts are too low or your liver tests
  156.                             are too high. Increased CPK levels in the blood are common with LITFULO and can also be
  157.                             severe. Your healthcare provider may stop treatment for a period of time if there are
  158.                             changes in these blood test results.
  159.                         </p>
  160.                         <p class="mrgn-btm">
  161.                             <strong>Do not take LITFULO if you are allergic to ritlecitinib or any of the ingredients in
  162.                                 LITFULO.</strong> See the Medication Guide for a complete list of ingredients.
  163.                         </p>
  164.                         <p>
  165.                             <strong>
  166.                                 Before taking LITFULO, tell your healthcare provider if you:
  167.                             </strong>
  168.                         </p>
  169.                         <ul class="mrgn-btm">
  170.                             <li>have an infection, are being treated for one, or have one that won&#39;t go away or keeps
  171.                                 returning</li>
  172.                             <li>have diabetes, chronic lung disease, HIV, or a weak immune system</li>
  173.                             <li>have TB or have been in close contact with someone with TB</li>
  174.                             <li>have had shingles (herpes zoster)</li>
  175.                             <li>have had hepatitis B or hepatitis C</li>
  176.                             <li>live, have lived, or traveled to certain parts of the country (such as the Ohio &amp;
  177.                                 Mississippi River Valleys and the Southwest) where there is an increased chance for
  178.                                 getting certain kinds of fungal infections. These infections may happen or worsen when
  179.                                 taking LITFULO. Ask your healthcare provider if you&#39;re unsure if you have lived in an
  180.                                 area where these infections are common.</li>
  181.                             <li>have had any type of cancer</li>
  182.                             <li>have had blood clots</li>
  183.                             <li>are a current or past smoker</li>
  184.                             <li>have had a heart attack, other heart problems, or stroke</li>
  185.                             <li>have liver problems</li>
  186.                             <li>have low platelet counts or white blood cell counts</li>
  187.                             <li>have recently received or are scheduled to receive any vaccinations. People who take
  188.                                 LITFULO should not receive live vaccines right before or during treatment. </li>
  189.                             <li>are pregnant or plan to become pregnant. It is not known if LITFULO will harm your
  190.                                 unborn baby. Tell your healthcare provider if you are pregnant or plan to become
  191.                                 pregnant during treatment with LITFULO. There is a pregnancy registry for people who
  192.                                 take LITFULO during pregnancy. Report pregnancies to Pfizer Inc. at <span class="nowrap">1-877-390-2940.</span></li>
  193.                             <li>are breastfeeding or plan to breastfeed. It is not known if LITFULO passes into your
  194.                                 breast milk. Do not breastfeed during treatment with LITFULO and for 14 hours after your
  195.                                 last dose of LITFULO. Talk to your healthcare provider about the best way to feed your
  196.                                 baby during treatment with LITFULO. </li>
  197.                         </ul>
  198.                         <p class="mrgn-btm">
  199.                             <strong>Tell your healthcare provider about all the medicines you take,</strong> including
  200.                             prescription and over-the-counter medicines, vitamins, and herbal supplements. LITFULO and
  201.                             other medicines may affect each other causing side effects.
  202.                         </p>
  203.                         <p class="mrgn-btm">
  204.                             <strong>The most common side effects of LITFULO include</strong> headache; diarrhea; acne;
  205.                             rash; hives; inflamed hair pores (folliculitis); fever; eczema; dizziness; shingles;
  206.                             decreased red blood cell counts; and mouth sores, redness and swelling of the lining of your
  207.                             mouth. These are not all of the possible side effects
  208.                             of LITFULO.
  209.                         </p>
  210.                         <p>
  211.                             <strong>What is LITFULO?</strong>
  212.                         </p>
  213.                         <p class="mrgn-btm">
  214.                             LITFULO (ritlecitinib) is a prescription medicine used to treat severe alopecia areata in
  215.                             adults and adolescents 12 years and older.
  216.                         </p>
  217.                         <p class="mrgn-btm">
  218.                             It is not known if LITFULO is safe and effective in children under 12 years of age.
  219.                         </p>
  220.                         <p class="mrgn-btm">
  221.                             Please see full <span id="clickTagPI1" class="underline clickTag">Prescribing Information</span>, including
  222.                             <strong>BOXED WARNING,</strong> and <span id="clickTagMedGuide1" class="underline clickTag">Medication Guide</span>.
  223.                         </p>
  224.                         <p class="mrgn-btm">
  225.                             You are encouraged to report adverse events related to Pfizer products by calling
  226.                             <strong><span class="nowrap">1-800-438-1985</span></strong> (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit  <span id="clickTagFDA" class="underline clickTag">www.fda.gov/MedWatch</span> or call
  227.                             <strong><span class="nowrap">1-800-FDA-1088</span></strong>.
  228.                         </p>
  229.                         <p>© 2025 Pfizer Inc.</p>
  230.                         <p>All rights reserved.</p>
  231.                         <p>March 2025</p>
  232.                         <p><span class="nowrap">PP-LGF-USA-0585</span></p>
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  238.                 <p><span id="clickTagPI2" class="underline clickTag">Prescribing Info</span> <span class="reg">including </span>BOXED WARNING<span class="reg"> and </span><span id="clickTagMedGuide2" class="underline clickTag">Medication Guide</span></p>
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