LITFULO® (ritlecitinib) 8 USE IN SPECIFIC POPULATIONS

(ritlecitinib)

Prescribing Information

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940.

Risk Summary

Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison, respectively (see Animal Data).

The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The estimated background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively.

Data

Animal Data

In an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the MRHD based on AUC comparison). Maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the MRHD based on AUC comparison). There was no developmental toxicity at 75 mg/kg/day (16 times the MRHD based on AUC comparison).

In an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the MRHD based on AUC comparison). There was no developmental toxicity at doses up to 25 mg/kg/day (12 times the MRHD based on AUC comparison).

In a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the MRHD based on AUC comparison). At 175 mg/kg/day (41 times the MRHD based on AUC comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. Bred females in the F1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day.

8.2 Lactation

Risk Summary

There are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Ritlecitinib is present in the milk of lactating rats (see Data). When a drug is present in animal milk, it is likely that it will be present in human milk. Because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with LITFULO and for approximately 14 hours after the last dose (approximately 6 elimination half-lives).

Data

After a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. The mean milk to plasma AUC ratio was 2.2.

8.4 Pediatric Use

The safety and effectiveness of LITFULO for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. A total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (Trial AA-I). Efficacy was consistent between the pediatric patients and adults [see Clinical Studies (14)]. The adverse reaction profile in the pediatric patients was similar to adults.

The safety and efficacy of LITFULO have not been established in pediatric patients under 12 years of age.

8.5 Geriatric Use

No dose adjustment is required for patients ≥65 years of age.

A total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. Clinical trials of LITFULO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly.

8.6 Hepatic Impairment

No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.

LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

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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