This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication GuideLITFULO™ (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.
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:
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.
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:
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.
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:
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:
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:
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?
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?
See "What is the most important information I should know about LITFULO?"
The most common side effects of LITFULO include:
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?
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: ritlecitinibInactive 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.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients not to crush, split or chew LITFULO capsules [see Dosage and Administration (2.2)].
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)].
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)].
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)].
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)].
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)].
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)].
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)].
Advise women not to breastfeed during treatment with LITFULO and for 14 hours after the last dose [see Use in Specific Populations (8.2)].
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