Litfulo

Pronunciation: lit-FUL-oh
Generic name: ritlecitinib
Dosage form: oral capsule
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 17, 2024.

What is Litfulo?

Litfulo (ritlecitinib) is a once-daily, oral, prescription medication that may be used to improve hair loss in adults and adolescents aged 12 and older with severe alopecia areata.

Litfulo targets and selectively blocks specific proteins involved in hair loss called Janus kinase 3 (JAK3) and TEC kinases, which play an important role in inflammation. This reduces the number of inflammatory cells attacking the hair follicle, which allows hair to regrow. Within 6 months, nearly a quarter of people using Litfulo experienced at least 80% hair regrowth, compared to only 1.6% of those using a placebo.

Litfulo was approved on June 23, 2023.

Does Litfulo work?

Litfulo 50 mg/day is significantly more effective than placebo (an inactive treatment) for scalp hair regrowth in people with alopecia, with 23% of people achieving a SALT score (see below) of 20 or less by 24 weeks. By 48 weeks, 43.2% had achieved a SALT score of 20 or less. Significant eyelash and eyebrow regrowth also occurred.

Evidence for the effectiveness of Litfulo for alopecia comes from the ALLEGRO 2b/3 trial, which initially followed 718 adolescents and adults with either alopecia totalis or alopecia universalis for 24 weeks, with extensions to 48 weeks and beyond.

• Hair loss was based on the Severity of Alopecia Tool (SALT) which assesses the proportion of the scalp surface affected by hair loss where a SALT score of 0 represents no hair loss and a SALT score of 100 represents 100% hair loss.
• All participants had SALT scores greater than 50 representing severe alopecia. 46% had a SALT score of 100.
• After 24 weeks, 23% of people taking Litfulo 50 mg reported a SALT score of 20 or less which was significantly more effective than those receiving placebo (an inactive pill).
• By 48 weeks, 43.2% of trial participants taking Litfulo 50 mg reported a SALT score of 20.
• This response rate continued to improve for up to 2 years.
• In addition, more people had eyebrow and eyelash hair regrowth with Litfulo compared to placebo.
• Side effects, such as headache, diarrhea, and acne were reported in 82% of people taking Litfulo 50 mg for up to 48 weeks.

Litfulo side effects

The most common side effects of Litfulo are:

• headache
• diarrhea
• acne
• rash
• urticaria
• folliculitis
• fever
• atopic dermatitis
• dizziness
• increases in laboratory values of creatine phosphokinase and decreases in red blood cell counts
• mouth ulcers.

Serious side effects and warnings

Litfulo carries a Boxed Warning for an increased risk of serious infections; a higher rate of all-cause death, heart attack, and stroke; a higher rate of cancer; and an increased risk for blood clots.

Litfulo affects your immune system and can lower its ability to fight infections. Some people have had serious infections while taking Litfulo or similar medicines, such as tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body and have been hospitalized. Some have died. Your healthcare provider should test you for TB before starting treatment and monitor you for TB during treatment. You should not start Litfulo if you have an infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Tell your healthcare provider right away if you think you have an infection or have symptoms of an infection such as:

• 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.

JAK inhibitors, such as Litfulo, are associated with 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 1 heart disease (cardiovascular) risk factor, 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, which may be life-threatening, have also occurred in patients treated with Litfulo. These could happen in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or eyes. The risk is higher in people who are 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor. 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, such as:

• swelling, pain, or tenderness in one or both legs
• sudden, unexplained chest or upper back pain
• shortness of breath or difficulty breathing
• changes in vision, especially in one eye only.

Litfulo may increase your risk of certain cancers by changing the way your immune system works. People taking JAK inhibitors such as Litfulo have a higher risk of certain cancers including skin cancer, 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 with Litfulo.

Litfulo may cause allergic reactions, some of which may be severe, such as anaphylaxis. Stop taking Litfulo and get emergency medical help right away if you have symptoms of an allergic reaction, including:

• hives
• rash
• trouble breathing
• feeling faint or dizzy
• swelling of your lips, tongue, or throat.

Not recommended in people with severe liver disease.

Before taking this medicine

You should not use Litfulo if you are allergic to ritlecitinib, Litfulo, or any of the inactive ingredients in the capsule.

Before starting Litfulo, tell your healthcare provider about all your medical conditions, including if you:

• are being treated for an infection
• have an infection that has not gone away or that keeps coming back. Symptoms of an infection include fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination
• 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 or liver disease
• have any type of cancer
• have heart problems or have had a heart attack, stroke, or blood clot
• have ever smoked
• are scheduled to receive a vaccine
• 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 of getting certain kinds of fungal infections. These infections may happen or become more severe if you use Litfulo.

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 treatment for a period if needed because of changes in these blood test results.

Children

The safety of Litfulo in children under 12 years of age has not been established.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm an unborn baby. If you inadvertently become pregnant ask your healthcare providers to ring 1-877-390-2940.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Litfulo and for approximately 14 hours after the last dose.

How do I take Litfulo?

Take Litfulo exactly as your healthcare provider tells you to take it. Do not take more or less than prescribed.

Litfulo may be taken with or without food.

• Swallow the capsules whole. Do not crush, split, or chew.

Litfulo dosage

The usual dosage of Litfulo for alopecia areata is 50 mg (one capsule) once daily.

Related/similar drugs

triamcinolone, minoxidil topical, Kenalog-40, Olumiant, Rogaine, baricitinib

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is less than 8 hours before the next dose. Do not use extra medicine to make up for the missed dose.

Temporary treatment interruptions for less than 6 weeks are not expected to result in significant loss of regrown scalp hair.

What happens if I overdose?

Litfulo is not expected to be toxic in overdose. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Litfulo?

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect Litfulo?

Tell your doctor about all your other medicines, especially:

• CYP3A substrates (such as acetaminophen, codeine, ciclosporin, diazepam, and erythromycin)
• CYP3A inducers (such as rifampicin)
• CYP1A2 substrates, such as caffeine, clozapine, tacrine, propranolol, and mexiletine.

Should not be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

This list is not complete. Other drugs may affect Litfulo, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Litfulo ingredients

Active: ritlecitinib 50 mg (equivalent to 80.13 mg ritlecitinib tosylate)

Inactive: 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.

Each bottle of Litfulo contains 28 capsules..

Storage

Store Litfulo capsules at 20°C to 25°C (68°F to 77°F) in their original package.

The Litfulo bottle has a child-resistant closure and contains a canister with a drying agent (desiccant). Do not eat the desiccant.

Keep out of the reach of children.

Who makes Litfulo?

Pfizer Inc. makes Litfulo.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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