LITFULO® (ritlecitinib) 5 WARNINGS AND PRECAUTIONS

(ritlecitinib)

Prescribing Information

5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis [see Adverse Reactions (6.1)]. Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO.

Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients:

•: with chronic or recurrent infection
•: who have been exposed to TB
•: with a history of serious infection or an opportunistic infection
•: who have resided or traveled in areas of endemic TB or mycoses, or
•: with underlying conditions that may predispose them to infection

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LITFULO. Interrupt LITFULO if a patient develops a serious or opportunistic infection. A patient who develops a new infection during treatment with LITFULO should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored. LITFULO may be resumed once the infection is controlled.

Tuberculosis

Screen patients for tuberculosis (TB) before starting therapy. LITFULO should not be given to patients with active TB. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk and consider screening patients at high risk for TB during treatment with LITFULO.

Viral Reactivation

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical trials [see Adverse Reactions (6.1)]. If a patient develops herpes zoster, consider interrupting treatment until the episode resolves.

Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with LITFULO. Patients with evidence of HIV infection or hepatitis B or C infection were excluded from clinical trials.

5.2 Mortality

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO.

5.3 Malignancy and Lymphoproliferative Disorders

Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials of LITFULO [see Adverse Reactions (6.1)].

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies.

The risks and benefits of ritlecitinib treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than a successfully treated NMSC or cervical cancer.

Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

5.4 Major Adverse Cardiovascular Events (MACE)

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with LITFULO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue LITFULO in patients that have experienced a myocardial infarction or stroke.

5.5 Thromboembolic Events

An event of pulmonary embolism (PE) was reported in a patient receiving LITFULO [see Adverse Reactions (6.1)]. In a ritlecitinib higher dosing group, 1 patient reported an event of retinal artery occlusion.

In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers.

Avoid LITFULO in patients who may be at increased risk of thrombosis. If symptoms of thrombosis or embolism occur, patients should interrupt LITFULO and be evaluated promptly and treated appropriately.

5.6 Hypersensitivity

Serious reactions including anaphylactic reactions, urticaria and rash have been observed in patients receiving LITFULO in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue LITFULO and institute appropriate therapy [see Adverse Reactions (6.1)].

5.7 Hypoglycemia in Patients with Diabetes

Hypoglycemia, including severe hypoglycemia, has been reported following initiation of JAK inhibitors in patients with diabetes. During treatment with LITFULO, consider increased monitoring of blood glucose in patients with diabetes. Advise diabetic patients to notify their healthcare provider(s) if they develop signs or symptoms of hypoglycemia.

5.8 Laboratory Abnormalities

Treatment with LITFULO was associated with decreases in lymphocytes and platelets [see Adverse Reactions (6.1)].

Prior to LITFULO initiation, perform ALC and platelet counts [see Dosage and Administration (2.1)]. After initiating treatment with LITFULO, treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities [see Dosage and Administration (2.4)].

Liver Enzyme Elevations – Treatment with LITFULO was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times the upper limit of normal (ULN) and increases of AST ≥5 times the ULN were observed in patients in LITFULO clinical trials. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO until this diagnosis is excluded.

Creatine Phosphokinase (CPK) Elevations – Treatment with LITFULO was associated with increased incidence of CPK elevation compared to placebo.

5.9 Vaccinations

No data are available on the response to vaccination in patients receiving LITFULO. Use of live attenuated vaccines should be avoided during or shortly prior to initiating treatment. Prior to initiating LITFULO, it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 6/2026
Medication Guide LITFULO™ (lit-FUL-oh) (ritlecitinib) capsules, for oral use
What is the most important information I should know about LITFULO? LITFULO may cause serious side effects, including: 1. Serious infections LITFULO is a medicine that affects your immune system. LITFULO can lower the ability of your immune system to fight infections. Some people have had serious infections while taking LITFULO or other similar medicines, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body and have been hospitalized. Some people taking similar medicines to LITFULO have died from these infections. • Your healthcare provider should test you for TB before starting treatment with LITFULO. • Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with LITFULO. You should not start taking LITFULO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting LITFULO, tell your healthcare provider if you: • are being treated for an infection. • have an infection that has not gone away or that keeps coming back. • have diabetes, chronic lung disease, HIV, or a weak immune system. • have TB or have been in close contact with someone with TB. • have had shingles (herpes zoster). • have had hepatitis B or hepatitis C. • live or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use LITFULO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. • think you have an infection or have symptoms of an infection such as:
	o fever, sweating, or chills o muscle aches o cough or shortness of breath		o blood in your phlegm o weight loss o warm, red, or painful skin or sores on your body			o diarrhea or stomach pain o burning when you urinate or urinating more often than usual o feeling very tired
After starting LITFULO, call your healthcare provider right away if you have any symptoms of an infection. LITFULO can make you more likely to get infections or make any infections that you have worse. If you get a serious infection, your healthcare provider may stop treatment with LITFULO until your infection is controlled. 2. Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called Janus kinase (JAK) inhibitors. LITFULO is a kinase inhibitor medicine. 3. Cancer and immune system problems LITFULO may increase your risk of certain cancers by changing the way your immune system works. • Lymphoma and other cancers, including skin cancers, can happen in people taking LITFULO. • People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are current or past smoker. • Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment with LITFULO. Tell your healthcare provider if you have ever had any type of cancer. 4. Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Get emergency help right away if you have any symptoms of a heart attack or stroke while using LITFULO, including: • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw • pain or discomfort in your arms, back, neck, jaw, or stomach • shortness of breath with or without chest discomfort • breaking out in a cold sweat • nausea or vomiting • feeling lightheaded • weakness in one part or on one side of your body • slurred speech 5. Blood clots Blood clots in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or eyes can happen in some people taking LITFULO. This may be life-threatening. Blood clots in the veins of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors. • Tell your healthcare provider if you have had blood clots in the past. • Stop taking LITFULO and get medical help right away if you have any signs and symptoms of blood clots during treatment with LITFULO, including: o swelling, pain or tenderness in one or both legs o sudden, unexplained chest or upper back pain o shortness of breath or difficulty breathing o changes in vision, especially in one eye only 6. Allergic reactions Symptoms that may mean you are having an allergic reaction have been seen during treatment with LITFULO. Some of these reactions were serious. Stop taking LITFULO and get emergency medical help right away if you have symptoms of allergic reaction, including:
• hives • rash • trouble breathing				• feeling faint or dizzy • swelling of your lips, tongue, or throat
7. Low blood sugar in people with diabetes If you have diabetes, your healthcare provider may instruct you to check your blood sugar levels more often during treatment with LITFULO. Call your healthcare provider if you have any problems with low blood sugar (hypoglycemia). 8. Changes in certain laboratory test results Your healthcare provider should do blood tests before you start taking LITFULO and during treatment to check for the following: • low lymphocyte count. Lymphocytes are white blood cells that help the body fight off infections. • low platelet count. Platelets help form clots and stop or prevent bleeding. • elevated liver enzymes. Liver enzymes help to tell if your liver is functioning normally. Elevated liver enzymes may indicate that your healthcare provider needs to do additional tests on your liver. • increased creatine phosphokinase (CPK). Increased CPK levels in the blood are common with LITFULO and can also be severe. You should not take LITFULO if your lymphocyte counts or platelet counts are too low or your liver tests are too high. Your healthcare provider may stop your LITFULO treatment for a period of time if needed because of changes in these blood test results. See "What are the possible side effects of LITFULO?" for more information about side effects.
What is LITFULO? LITFULO is a prescription medicine that is a kinase inhibitor. LITFULO is used to treat an immune system problem that causes severe hair loss (alopecia areata) in adults and children 12 years and older. It is not known if LITFULO is safe and effective in children under 12 years of age.
Before taking LITFULO, tell your healthcare provider about all of your medical conditions, including if you: • See "What is the most important information I should know about LITFULO?" • have an infection • are a current or past smoker • have had a heart attack, other heart problems, or stroke • have liver problems • have diabetes • have low platelet counts or white blood cell counts • have recently received or are scheduled to receive an immunization (vaccine). People who take LITFULO should not receive live vaccines during treatment or right before starting treatment with LITFULO. • are pregnant or plan to become pregnant. It is not known if LITFULO will harm your unborn baby. Females who are able to become pregnant: o Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with LITFULO. o There is a pregnancy registry for people who take LITFULO during pregnancy. Report pregnancies to Pfizer Inc. at 1-877-390-2940. • are breastfeeding or plan to breastfeed. It is not known if LITFULO passes into your breast milk. Do not breastfeed during treatment with LITFULO and for 14 hours after your last dose of LITFULO. Talk to your healthcare provider about the best way to feed your baby during treatment with LITFULO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LITFULO and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist whenever you get a new medicine.
How should I take LITFULO? • Take LITFULO exactly as your healthcare provider tells you to take it. • Take LITFULO 1 time each day, with or without food. • Swallow LITFULO capsules whole. Do not crush, split, or chew the capsules. • If you miss a dose of LITFULO, take the missed dose as soon as you remember. If it is less than 8 hours before your next scheduled dose of LITFULO, skip the missed dose and take the next dose at your usual time. If you take too much LITFULO, call the Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What are the possible side effects of LITFULO? LITFULO may cause serious side effects, including: See "What is the most important information I should know about LITFULO?" The most common side effects of LITFULO include:
• headache • diarrhea • acne • rash		• hives • inflamed hair pores (folliculitis) • fever • eczema			• dizziness • shingles • decreased red blood cell counts • mouth sores, redness and swelling of the lining of your mouth
These are not all the possible side effects of LITFULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
How should I store LITFULO? • Store LITFULO at room temperature between 68°F to 77°F (20°C to 25°C). • Keep LITFULO in the original package. • The LITFULO bottle has a child resistant closure and contains a cannister with a drying agent (desiccant). Do not eat the desiccant. Keep LITFULO and all medicines out of the reach of children.
General information about the safe and effective use of LITFULO. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LITFULO for a condition for which it was not prescribed. Do not give LITFULO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LITFULO that is written for health professionals.
What are the ingredients in LITFULO? Active ingredient: ritlecitinib Inactive ingredients: crospovidone, glyceryl dibehenate, lactose monohydrate, microcrystalline cellulose, and hypromellose (HPMC) capsule shells. The yellow/blue, opaque capsule shells contain Brilliant blue FCF – FD&C Blue, hypromellose, titanium dioxide, and yellow iron oxide. LAB-1525-2.0

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