LITFULO

Generic Name/API: ritlecitinib

Manufacturer: PIFZER

Dosage Forms & Strength & Pack Size:
Capsules: 50 mg of ritlecitinib

Storage:
Store LITFULO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original package.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
What is LITFULO?

LITFULO (ritlecitinib) is a prescription medicine used to treat severe alopecia areata in adults and adolescents 12 years and older.
It is not known if LITFULO is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION
LITFULO may cause serious side effects, including:

Serious infections.
LITFULO can lower the ability of your immune system to fight infections. Do not start LITFULO if you have any kind of infection unless your healthcare provider tells you it is okay. 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. You may be at a higher risk of developing shingles (herpes zoster).

Your healthcare provider should test you for TB before starting treatment with LITFULO and should watch you closely for signs and symptoms of TB during treatment with LITFULO.

Before and after starting LITFULO, tell your healthcare provider if you think you have an infection, are being treated for one, or have symptoms of an infection, including:

fever, sweating, or chills
muscle aches
cough or shortness of breath
blood in your phlegm
weight loss
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than usual
feeling very tired
LITFULO can make you more likely to get infections or worsen infections you have. If you get a serious infection, your healthcare provider may stop treatment with LITFULO until your infection is controlled.

There is an increased risk of death in people 50 years of age and older who have at least one heart disease (cardiovascular) risk factor and are taking a Janus kinase (JAK) inhibitor. LITFULO is a kinase inhibitor medicine.

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. People taking JAK inhibitors have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your healthcare provider’s advice about having your skin checked for skin cancer during treatment. Tell your healthcare provider if you have ever had any type of cancer.

There is an 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 one heart disease (cardiovascular) risk factor and are taking a JAK inhibitor, 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
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 and lungs have happened more often in people 50 years of age and older with at least one heart disease (cardiovascular) risk factor taking a JAK inhibitor. 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, including swelling, pain or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing; or changes in vision, especially in one eye only.

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; or swelling of your lips, tongue, or throat.

Changes in certain laboratory test results.
Your healthcare provider should do blood tests before you start taking LITFULO and during treatment to check your lymphocyte and platelet counts and liver enzyme and creatine phosphokinase (CPK) levels. You should not take LITFULO if your lymphocyte counts or platelet counts are too low or your liver tests are too high. Increased CPK levels in the blood are common with LITFULO and can also be severe. Your healthcare provider may stop treatment for a period of time if there are changes in these blood test results.

Do not take LITFULO if you are allergic to ritlecitinib or any of the ingredients in LITFULO. See the Medication Guide for a complete list of ingredients.

Before taking LITFULO, tell your healthcare provider if you:

have an infection, are being treated for one, or have one that won’t go away or keeps returning
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, have lived, or traveled to certain parts of the country (such as the Ohio & Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or worsen when taking LITFULO. Ask your healthcare provider if you’re unsure if you have lived in an area where these infections are common.
have had any type of cancer
have had blood clots
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 any vaccinations. People who take LITFULO should not receive live vaccines right before or during treatment.
are pregnant or plan to become pregnant. It is not known if LITFULO will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with LITFULO. 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.

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; and mouth sores, redness and swelling of the lining of your mouth. These are not all of the possible side effects of LITFULO.

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