Litfulo
Litfulo (ritlecitinib) is both a Janus kinase (JAK) inhibitor and a tyrosine kinase inhibitor. It's used to treat alopecia areata, an autoimmune condition that results in hair loss, in adults and children ages 12 years and older. Litfulo (ritlecitinib) comes as a capsule that's taken by mouth once per day. The most common side effects of this medication are headache and diarrhea.
What is Litfulo (ritlecitinib)?
What is Litfulo (ritlecitinib) used for?
Severe hair loss (alopecia areata) in people ages 12 years and older
How Litfulo (ritlecitinib) works
People who have alopecia areata have a condition where their immune system attacks hair follicles by mistake, which results in hair loss.
Litfulo (ritlecitinib) is a kinase inhibitor. It works by blocking immune proteins called Janus kinase (JAK) and tyrosine kinase. In doing so, Litfulo (ritlecitinib) blocks your immune system from attacking hair follicles and causing hair loss.
Drug Facts
What are the side effects of Litfulo (ritlecitinib)?
Common Side Effects
- Headache (11%)
- Diarrhea (10%)
- Acne (6%)
- Rash (5%)
- Hives (5%)
Other Side Effects
- Fever
- Dizziness
- Small red bumps on skin (folliculitis)
- Dry, itchy skin (eczema)
- Herpes zoster infection
- Mouth ulcers or pain
Serious Side Effects
- Stroke: sudden weakness in your body, trouble speaking, confusion, dizziness
- Arterial thrombosis (blood clot in the heart): chest pain; short of breath; pain in the jaw, neck, or back; feeling weak or light-headed
- Pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
- Deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, muscle tightness
- Serious bleeds: bleed or bruise easily, bleeding that's hard to stop, coughing blood, stomach pain, blood in urine or stool
- Serious infections: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills, burning when you urinate, urinating more often
- Allergic reaction: hives, rash, feeling faint, trouble breathing, swelling of your lips or tongue
Source: DailyMed
More on Litfulo (ritlecitinib) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Litfulo (ritlecitinib)
Pros
Taken by mouth once per day
Can be taken by males and females ages 12 years and older
Can be taken with or without food
Cons
Raises your risk for serious side effects, such as blood clots and infections
Not a good choice for people who have trouble swallowing because capsules can't be opened or crushed, and no liquid form is available
Can't be used in people with severe liver problems
Pharmacist tips for Litfulo (ritlecitinib)
Make sure to mark your appointments on your calendar to see your prescriber and get any tests done so you can be properly monitored while taking Litfulo (ritlecitinib). This is because this medication can cause serious side effects (e.g., higher liver enzyme levels, lower platelet count) that might not cause noticeable symptoms, but can be seen on lab tests.
Litfulo (ritlecitinib) can raise your risk of getting a serious or life-threatening infection. If you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while taking Litfulo (ritlecitinib), get medical help right away. You might have to stop taking Litfulo (ritlecitinib) so your body can fight the infection.
Tell your prescriber about all the medications you're taking before and during treatment with Litfulo (ritlecitinib), especially if you're taking other medications that weaken your immune system. Certain medications can interact with Litfulo (ritlecitinib) and raise your risk of serious infections or side effects.
You can take Litfulo (ritlecitinib) with or without food. If it's hurting your stomach, taking it with food might help.
Swallow Litfulo (ritlecitinib) capsules whole. Do not crush, split, or chew the capsules. If you're having trouble swallowing the capsules, contact your prescriber because you might need to stop taking Litfulo (ritlecitinib) and switch to a different medication.
There haven't been enough studies looking at how safe Litfulo (ritlecitinib) is during pregnancy. If you're pregnant or thinking of getting pregnant, talk to your obstetrician about the potential risks of taking Litfulo (ritlecitinib) during pregnancy.
Because of the potential harm to babies, it's not recommended to breastfeed while taking Litfulo (ritlecitinib) and for 14 hours after your last dose. Talk to your healthcare team about safe ways to feed your baby while taking this medication.
If you forget to take your dose of Litfulo (ritlecitinib), take it as soon as you remember. However, if it's less than 8 hours until your next dose is due, just skip the missed dose and take your next dose at the usual time.
Frequently asked questions about Litfulo (ritlecitinib)
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What are the risks and warnings for Litfulo (ritlecitinib)?
Litfulo (ritlecitinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections
Risk factors: Current infection | Past infections that keep coming back | Other conditions that raise your risk of infection | Living in or traveling to places with high rates of TB infections | Taking medications that weaken your immune system
Litfulo (ritlecitinib) can affect your body's ability to fight off infections. This can raise your risk of serious bacterial (e.g., tuberculosis (TB)), viral (e.g., COVID-19, hepatitis), or fungal infections. Your prescriber will routinely monitor you for infections before and during treatment with Litfulo (ritlecitinib). If you notice any signs of infection during treatment like fever, chills, body aches, or cough, let your care team know right away.
Possible higher risk of death
Risk factors: Age 50 years and older | High blood pressure | High cholesterol (fat) | High blood sugar
In study of a different JAK inhibitor for rheumatoid arthritis, results showed that it was linked to higher risk of death for some people, such as older adults with at least one heart-related risk factor. Talk to your prescriber about the risks and benefits of using Litfulo (ritlecitinib) before you start treatment.
Possible risk of cancer
Risk factors: History of cancer | People who smoke
In study of a different JAK inhibitor for rheumatoid arthritis, people who took the medication were at higher risk for cancer during treatment. These cancers included lymphoma and skin cancer. Some cancers have been reported by people taking Litfulo (ritlecitinib) during clinical studies. Because of this, your prescriber will monitor you for your risk of cancer during treatment. Additionally, make sure you schedule yearly screenings for skin cancer and let your healthcare team know if you notice changes to your skin. Wear protective clothing and use sunscreen if you're out in the sun, and avoid UV light (e.g., tanning beds) to lower your risk of skin cancer.
Possible risk of heart attack, stroke, and other blood clots
Risk factors: Age 50 years and older | High blood pressure | High cholesterol (fat) | High blood sugar | People who smoke | Past blood clots
People who took JAK inhibitors reported blood clots in various parts of the body, including the heart and brain. While these conditions haven't been linked to Litfulo (ritlecitinib), these risks are still possible. Get medical help right away if you experience symptoms of blood clots, such as:
- Legs (deep vein thrombosis): leg cramp, swelling, pain, muscle tightness;
- Lungs (pulmonary embolism): cough, chest pain, trouble breathing, racing heart
- Heart (arterial thrombosis): chest pain, short of breath, pain in the jaw, neck, or back, feeling weak or light-headed
- Brain (stroke): sudden weakness in your body, trouble speaking, confusion, dizziness
- Eyes: vision changes, pain.
Severe allergic reaction
Although rare, Litfulo (ritlecitinib) can cause serious allergic reactions, including anaphylaxis (e.g., closing of the throat). If you experience hives, swelling in your lips, tongue, or throat, or trouble breathing, get medical help right away.
Changes in lab tests
Some people who took Litfulo (ritlecitinib) saw changes in their lab tests, such as lower levels of white blood cells and platelets and higher liver enzyme levels. Because of this, your prescriber will order lab tests before and after you start Litfulo (ritlecitinib) treatment.
Vaccines
It's not known how Litfulo (ritlecitinib) might affect your body's response to vaccines. Before you start Litfulo (ritlecitinib) treatment, make sure you're up to date on all your vaccines. You'll need to avoid receiving live vaccines right before starting and during Litfulo (ritlecitinib) treatment.
Litfulo (ritlecitinib) dosage forms
Typical dosing for Litfulo (ritlecitinib)
Adults and children ages 12 years and older: The typical dose is 50 mg by mouth once daily.
What are alternatives to Litfulo (ritlecitinib)?
Severe hair loss (alopecia areata) in people ages 12 years and older
Male-pattern or female-pattern hair loss
Moderate-to-severe rheumatoid arthritis (RA) in adults
COVID-19 in hospitalized adults who need oxygen or support from machines to help breathe
Severe hair loss (alopecia areata) in adults
What is the latest news about Litfulo (ritlecitinib)?
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References
Best studies we foundAmerican Cancer Society. (n.d.). Lymphoma.
American Society of Hematology. (n.d.). Blood clots.
Blair, H. A. (2023). Ritlecitinib: First Approval. Drugs.
Centers for Disease Control and Prevention. (2023). Fungal infections: Protect your health.
Centers for Disease Control and Prevention. (2023). Know your risk for heart disease.
Martin, D. A., et al. (2023). Target Occupancy and Functional Inhibition of JAK3 and TEC Family Kinases by Ritlecitinib in Healthy Adults: An Open-Label, Phase 1 Study. The Journal of Clinical Pharmacology.
Pfizer Laboratories Div Pfizer Inc. (2023). Litfulo- ritlecitinib capsule [package insert]. DailyMed.
Samarasinghe, V., et al. (2012). Nonmelanoma skin cancer. Journal of Cutaneous and Aesthetic Surgery.
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