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Overview: Litfulo is used for a certain type of hair loss, alopecia areata. It calms your immune system by blocking a protein called Janus kinase, which is involved in inflammation in the hair follicle. The hair follicle is where hair growth begins. Common side effects include infections of the nose and throat, headache, acne, and diarrhea. Get emergency help if you have chest pain, trouble breathing, or sudden weakness on one side of your body, severe headache, slurred speech, or trouble understanding speech.

Uses

What is Litfulo used for?

Litfulo (ritlecitinib) is commonly used to treat severe alopecia areata. Alopecia areata is a type of hair loss that occurs when your immune system mistakenly attacks your hair follicles. The hair follicle is where hair growth begins.

Litfulo may also be used for other conditions as determined by your healthcare provider.

How does Litfulo work (mechanism of action)?

Litfulo works by binding to a protein called Janus kinase (JAK) to block the immune system attack on your hair follicles, reducing inflammation and allowing hair to grow.

How is Litfulo supplied (dosage forms)?

Brand and other names

  • Litfulo

Dosage forms and strengths

  • 50 mg oral capsules

How should I store Litfulo?

Litfulo should be stored in the original container at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Litfulo?

The most common side effects of Litfulo are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Headache
  • Diarrhea
  • Acne, rash, itching, red or swollen areas where your hair comes out of your skin
  • Atopic dermatitis (the most common type of eczema)
  • Fever 
  • Dizziness
  • Shingles
  • Low red blood cell levels (anemia)
  • Increased creatine phosphokinase (CPK)
  • Mouth sores

There may be other side effects of Litfulo that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Litfulo?

While less common, the most serious side effects of Litfulo are described below, along with what to do if they happen.

Severe Allergic Reactions. Litfulo may cause allergic reactions, which can be serious. Stop taking Litfulo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infections. Litfulo can increase your risk of infections, including shingles and serious infections, such as appendicitis, pneumonia, and sepsis. Your healthcare provider may do some tests to see if you have or have had certain infections in the past. Call your healthcare provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Skin rash or itchy, painful sores

Cancer. Litfulo can cause a new cancer to develop or cause a previously treated cancer to recur. Your risk may be higher if you smoke or used to smoke. Tell your healthcare provider about any cancers that you or your family members have had in the past. Keep any appointments to get your skin checked. Tell your healthcare provider about any new symptoms that you may get. 

Heart Attack and Stroke. Litfulo can increase your risk of a heart attack or stroke that can lead to death. This risk of heart attack, stroke, or death is higher in people who are 50 years old or older, have a high risk of heart disease, and either smoke now or did in the past. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, stomach, or arm
  • Sweating, upset stomach, vomiting, dizziness, or lightheadedness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech

Blood Clots. Litfulo may cause blood clots in your veins or arteries and could cause venous thromboembolism (VTE), or a blood clot in the lungs (pulmonary embolism) or the back of your eye (retinal artery occlusion). This risk is higher in people who are 50 years old or older or have a high risk of heart disease. Stop taking Litfulo and get emergency help if you have any of the following signs of blood clots. 

  • Back pain, chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain, swelling, or tenderness in your arm or leg
  • Vision changes, especially if just in one eye

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Litfulo. Litfulo should not be used if your liver is not working as well as it should be. Keep all appointments including lab appointments, before and while you are taking Litfulo, to make sure your liver is working well enough for you to take this medicine.

Blood Disorders. Litfulo can cause blood disorders, such as low platelet levels (thrombocytopenia) and low white blood cell levels (lymphopenia). Litfulo should not be used if your platelet or white blood cell levels are too low. Keep all appointments including lab appointments, before and while you are taking Litfulo, to make sure your white blood cell levels are high enough for you to take this medicine.

Warnings & Precautions

Who should not use Litfulo?

Allergies to Ingredients. People who are allergic to any of the following should not take Litfulo.

  • Ritlecitinib
  • Litfulo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Litfulo.

What should I know about Litfulo before using it?

Do not take Litfulo unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Litfulo with other people, even if they have the same condition as you. It may harm them.

Keep Litfulo out of the reach of children.

Do not break, split, crush, or chew Litfulo tablets. They should be swallowed whole. 

Litfulo can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Litfulo affects you.

What should I tell my healthcare provider before using Litfulo?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Litfulo is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before or while taking Litfulo. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Liver Problems. Litfulo should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Have or think you have an infection, sores that are warm, red, or hurt, even if you are being treated
  • Infections that will not go away or keep coming back
  • Trouble breathing or lung problems, such as asthma or chronic obstructive pulmonary disease (COPD)
  • A weak immune system, HIV, or diabetes
  • Tuberculosis (TB) or in close contact with someone who has it
  • Stroke or heart problems, such as a heart attack
  • Shingles, hepatitis B, or hepatitis C
  • Live, lived, or traveled to parts of the country like the Ohio or Mississippi River Valley or the southwestern United States
  • Fever, sweating, or chills
  • Muscle aches or feel tired
  • Cough or coughing up blood
  • Heart attack, heart problems, or a stroke
  • Low platelet or white blood cell levels
  • Pain when you go pee or peeing more often than you normally do
  • Smoke tobacco now or used to
  • History or family history of cancer
  • Blood clots

Other Medicines and Supplements. Litfulo may interact with other medicines and supplements. Before taking Litfulo, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Litfulo could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking Litfulo, you can sign up for the Litfulo pregnancy registry by calling 877-390-2940. This registry collects safety information about the use of Litfulo during pregnancy.

Breastfeeding. It is not known if Litfulo passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Litfulo.

How can I get more information about Litfulo?

For more information about Litfulo, you can visit the manufacturer’s website at www.litfulo.com or call them at 800-879-3477.

Interactions

Does Litfulo interact with foods or drinks?

There are no known interactions between Litfulo and foods or drinks.

It is unknown if drinking alcohol will affect Litfulo. The risk of dizziness and liver damage may be increased if you drink alcohol while taking Litfulo.

Does Litfulo interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Litfulo.

  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Baricitinib (Olumiant), which is a medicine used to treat rheumatoid arthritis, coronavirus infection (COVID-19), or a type of hair loss called alopecia areata 
  • Ruxolitinib (Jakafi), which is a medicine used to treat myelofibrosis, polycythemia vera, or graft versus host disease
  • Tofacitinib (Xeljanz), which is a medicine used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular course juvenile idiopathic arthritis, or ulcerative colitis
  • Abrocitinib (Cibinqo), which is a medicine used to treat atopic dermatitis
  • Ritlecitinib (Litfulo), which is a medicine used to treat a type of hair loss called alopecia areata 
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), azathioprine (Azasan, Imuran), tacrolimus (Prograf, Envarsus XR, Astagraf XL), or mycophenolate (Cellcept, Myfortic, and others), which is a medicine to suppress your immune system
  • A medicine used to treat autoimmune conditions, such as tocilizumab (Actemra), etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), golimumab (Simponi), ustekinumab (Stelara), secukinumab (Cosentyx), vedolizumab (Entyvio), or ixekizumab (Taltz)

Many other medicines may alter the blood levels of Litfulo, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Litfulo. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Litfulo?

If you or someone else has used too much Litfulo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Litfulo?

If you miss a dose, take it as soon as you remember unless you have less than eight hours before your next dose. If it is less than eight hours before your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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