LITFULO™ (ritlecitinib)

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. 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 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?

LAB-1525-1.0

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Full Patient Information

This Medication Guide has been approved by the U.S. Food and Drug Administration.						Issued: 6/2023
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. 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 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-1525-1.0

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration

Advise patients not to crush, split or chew LITFULO capsules [see Dosage and Administration (2.2)].

Serious Infections

Inform patients that they may develop infections when taking LITFULO which in some cases can be serious. Instruct patients to tell their healthcare provider if they develop any signs or symptoms of an infection [see Warnings and Precautions (5.1)].

Advise patients that the risk of herpes zoster is increased in patients treated with LITFULO [see Warnings and Precautions (5.1)].

Malignancies

Inform patients that LITFULO may increase their risk of certain cancers, including skin cancers. Periodic skin examinations are recommended while using LITFULO [see Warnings and Precautions (5.3)].

Thromboembolic Events

Advise patients that events of PE and retinal artery occlusion have been reported in clinical trials with LITFULO. Instruct patients to seek immediate medical attention if they develop any signs or symptoms of a thrombosis [see Warnings and Precautions (5.5)].

Hypersensitivity Reactions

Advise patients to discontinue LITFULO and seek immediate medical attention if they develop any signs and symptoms of serious allergic reaction [see Warnings and Precautions (5.6)].

Laboratory Abnormalities

Inform patients that LITFULO may affect certain lab tests, and that blood tests are required before and during LITFULO treatment [see Dosage and Administration (2.1) and Warnings and Precautions (5.7)].

Vaccinations

Advise patients that vaccination with live vaccines is not recommended during LITFULO treatment and shortly prior to LITFULO treatment. Instruct patients to inform the healthcare practitioner that they are taking LITFULO prior to a potential vaccination [see Warnings and Precautions (5.8)].

Pregnancy

Advise pregnant females and females of reproductive potential to inform their healthcare providers if they are pregnant or intend to becomes pregnant during treatment with LITFULO. Instruct patients to report their pregnancy to Pfizer Inc. at 1-877-390-2940 [see Use in Specific Populations (8.1)].

Lactation

Advise women not to breastfeed during treatment with LITFULO and for 14 hours after the last dose [see Use in Specific Populations (8.2)].