Litfulo is a brand-name oral capsule that’s prescribed for alopecia. Litfulo contains the active drug ritlecitinib and belongs to the kinase inhibitor drug class.

The Food and Drug Administration (FDA) has approved Litfulo to treat severe alopecia areata in adults and children ages 12 years and older.

Drug details

You’ll find key information about Litfulo below.

  • Drug class: kinase inhibitor
  • Drug form: oral capsule
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2023

Litfulo is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Litfulo comes as an oral capsule. It’s available in one strength: 50 milligrams (mg).

Dosage for alopecia areata

The recommended Litfulo dosage for adults is 50 mg once per day.

Children’s dosage

The Food and Drug Administration (FDA) has approved Litfulo to treat severe alopecia areata in children ages 12 years and older. The recommended dosage is 50 mg once per day.

About taking Litfulo

Below, you will find information about key dosage issues.

  • When to take: Take Litfulo around the same time each day. This helps keep a steady level of the drug in your body, which helps Litfulo work effectively.
  • If you miss a dose: If you miss a dose, take it as soon as possible. But if it’s less than 8 hours until your next dose is due, skip the missed dose and take your next dose as scheduled. Do not take two doses together to make up for missing a dose. This can raise your risk of side effects.
  • Taking Litfulo with food: You can take Litfulo with or without food.
  • Crushing, splitting, or chewing Litfulo: Do not crush, split, or chew Litfulo. Swallow the capsule whole. If you have trouble swallowing Litfulo, talk with your doctor.
  • Length of use: Litfulo is meant to be used as a long-term treatment. If you and your doctor determine that Litfulo is safe and effective for you, you’ll likely take it long term.

Overdose

Do not use more Litfulo than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Litfulo

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.

Litfulo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Litfulo. These lists do not include all possible side effects.

For more information about the possible side effects of Litfulo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Litfulo, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Litfulo. To learn about other mild side effects, talk with your doctor or pharmacist or view Litfulo’s prescribing information.

Mild side effects of Litfulo can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or do not go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Litfulo, see “Allergic reaction” below.

Serious side effects

Serious side effects from Litfulo are not common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Decreased white blood cell count. Symptoms can include:
    • fever
  • Decreased platelet count. Symptoms can include:
    • bruising easily
    • bleeding, such as nosebleeds or bleeding gums
    • taking longer than usual to stop bleeding if you injure yourself
  • Shingles. Symptoms can include:
    • blistering skin rash
    • burning or stabbing pain
    • fever or chills
    • headache
  • Increased levels of liver enzymes, which may be a sign of liver damage.
  • Increased levels of creatinine phosphokinase, which may be a sign of muscle damage.
  • Risk of serious infections.*
  • Increased risk of death.*
  • Risk of cancer.*
  • Risk of blood clots.*
  • Risk of cardiovascular problems.*
  • Severe allergic reaction.†

* Litfulo has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Litfulo precautions” section below.
† For details about allergic reaction and Litfulo, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Litfulo. This was a rare side effect in clinical trials of this drug.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Litfulo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Litfulo to treat certain conditions. Litfulo may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Litfulo for alopecia areata

Litfulo is FDA-approved to treat severe alopecia areata in adults and children ages 12 years and older.

Alopecia areata is an autoimmune condition that causes hair loss. It occurs when your immune system (your body’s defense system) mistakenly attacks your hair follicles.

With alopecia areata, you may have a few small patches of hair loss. But if the condition is severe, you may have widespread patches of hair loss or lose all the hair on your scalp and body.

Litfulo is an immunosuppressant drug. It dampens down activity in your immune system, which helps stop it from attacking your hair follicles.

Litfulo has a limitation of use. It’s not recommended for use with other immunosuppressant drugs. These include Janus kinase (JAK) inhibitors, biologic immunosuppressants, and cyclosporine (Neoral, Sandimmune, and others).

Litfulo and children

Litfulo is FDA-approved to treat severe alopecia areata in children ages 12 years and older. It’s unknown if the medication is safe or effective in younger children.

Litfulo can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before taking Litfulo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Litfulo. This list does not contain all drugs that may interact with Litfulo. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Litfulo• carbamazepine (Tegretol, Carbatrol, others)
• midazolam (Seizalam)
• phenytoin (Dilantin)
• rifampin (Rifadin, Rimactane)
Foods that can interact with Litfulocaffeine, such as coffee, cola, tea, or energy drinks
Vitamins or supplements that can interact with LitfuloSt. John’s wort
Lab tests or vaccines that can interact with Litfulo• live vaccines, such as chickenpox vaccine (Varivax) or measles, mumps, and rubella (MMR)

Alcohol interaction

Alcohol is not known to interact with Litfulo. However, alcohol and Litfulo can cause some similar side effects, such as headache, diarrhea, and dizziness. So you may have an increased risk of these side effects if you drink alcohol with Litfulo.

If you have questions about how much alcohol is safe to drink while taking Litfulo, talk with your doctor or pharmacist.

As with all medications, the cost of Litfulo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons. You can visit Optum Perks for price estimates of Litfulo. These estimates are based on the use of Optum Perks coupons. Note: You cannot use Optum Perks coupons with any insurance copays or benefits.

Financial and insurance assistance. If you need financial support to pay for Litfulo, or if you need help understanding your insurance coverage, help is available.

A program called Pfizer Dermatology Patient Access is available for Litfulo. For more information and to find out if you’re eligible for support, visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version. Litfulo is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

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Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Litfulo, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are alternatives to Litfulo:

Note: Doctors may prescribe some of these drugs off-label for alopecia areata. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Litfulo and pregnancy

It’s unknown whether you should take Litfulo during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

If you become pregnant while taking Litfulo, talk with your doctor right away.

If you become pregnant while taking Litfulo, you can also take part in the drug’s pregnancy registry. A pregnancy registry helps gather information on how certain drugs can affect pregnancy. To learn more, call 877-390-2940 or talk with your doctor.

Litfulo and birth control

It’s unknown if Litfulo is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Litfulo.

Litfulo and breastfeeding

You should not take Litfulo while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your infant during Litfulo treatment. You should not breastfeed while taking Litfulo and for at least 14 hours after your last dose.

Here are answers to some frequently asked questions about Litfulo.

How does Litfulo work?

Doctors prescribe Litfulo to treat alopecia areata, which is an autoimmune condition that causes hair loss. With this condition, your immune system (your body’s defense system) mistakenly attacks your hair follicles. This causes inflammation that damages the hair follicle and leads to the hair falling out.

Litfulo is a type of drug called a kinase inhibitor. It works by dampening down activity in your immune system. Specifically, Litfulo blocks the action of certain proteins called Janus kinase 3 (JAK3) and TEC kinases. These proteins pass signals that cause immune cells to produce cytokines (proteins that cause inflammation).

By blocking JAK3 and TEC kinases, Litfulo stops your immune cells from producing cytokines. This reduces the inflammation that damages your hair follicles and allows your hair to grow back.

If you have questions about how Litfulo works, talk with your doctor or pharmacist.

Is Litfulo an effective treatment option for alopecia areata?

Litfulo has been found to be effective in treating severe alopecia areata.

The American Academy of Dermatology recommends ritlecitinib, the active drug in Litfulo, as a treatment option for this condition. For information on how the drug performed in clinical trials, see Litfulo’s prescribing information.

If you have questions about the effectiveness of Litfulo, talk with your doctor.

Can Litfulo cause long-term side effects?

Yes, Litfulo can cause some long-term side effects. For example, Litfulo can raise your risk of infections and certain cancers while you continue taking the medication. Litfulo has boxed warnings about these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the Litfulo precautions” section below.

Some side effects, such as cancer or a serious infection, such as tuberculosis, can last a long time after stopping Litfulo, even with treatment.

If you have questions or concerns about long-term side effects with Litfulo, talk with your doctor.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Serious infections. Litfulo weakens your immune system. It can raise your risk of serious infections that may need treatment in the hospital and could even lead to death. Examples of these infections include tuberculosis (TB), pneumonia, shingles, and infections that spread throughout your body.

Before starting Litfulo, tell your doctor if you have any active infections or infections that keep coming back. Also tell them about past infections such as hepatitis B, hepatitis C, chickenpox, or shingles. Your doctor will likely test you for TB before prescribing Litfulo.

Your doctor may prescribe medication to treat infections before you start taking Litfulo. They may also recommend getting certain immunizations before starting Litfulo.

While taking Litfulo, talk with your doctor right away if you have any symptoms of infection. These can include:

  • fever or chills
  • cough
  • sore throat
  • shortness of breath
  • pain when urinating
  • diarrhea or vomiting
  • warm, red, discolored, or painful areas of skin

If you have an infection, your doctor will likely prescribe medication to treat it. They may also recommend stopping Litfulo until the infection is managed.

Increased risk of death. Medications that are similar to Litfulo (JAK inhibitors) can increase the risk of death in certain people who take them for rheumatoid arthritis (RA). The increased risk of death was reported in people ages 50 years and older with at least one risk factor for heart disease.

Your doctor will consider your age and health history when determining if Litfulo is right for you.

Cancer. Litfulo can raise your risk of developing certain cancers, such as lymphoma, lung cancer, and non-melanoma skin cancer. If you’ve ever had cancer or you’re a current or past smoker, you may have an increased risk.

Talk with your doctor about whether Litfulo is right for you.

Blood clots. Litfulo can increase your risk of dangerous blood clots, for example, in your legs, lungs, or eyes. If you have had a blood clot or have other risk factors for blood clots, you may have a higher risk.

While taking Litfulo, see your doctor right away if you have any symptoms of a blood clot. These can include:

  • pain, warmth, swelling, redness, or discoloration in one or both legs
  • sudden chest or upper back pain
  • shortness of breath
  • sudden vision change, especially in one eye

If you have a blood clot, your doctor will likely prescribe medication to treat it. They’ll also likely recommend pausing your Litfulo treatment.

Talk with your doctor about whether Litfulo is right for you.

Cardiovascular problems. Drugs that are similar to Litfulo (JAK inhibitors) can increase the risk of cardiovascular (heart and blood vessel) problems in certain people who take them for RA. These problems include heart attack, stroke, and death. This increased risk is seen in people ages 50 years and older with at least one risk factor for heart disease, such as smoking, high blood pressure, or diabetes.

Your doctor will consider your age and health history when determining if Litfulo is right for you.

Get emergency medical help if you have any symptoms of a heart attack or stroke while taking Litfulo. These can include:

  • pain, pressure, or tightness in your chest, back, arm, throat, neck, or jaw
  • shortness of breath
  • dizziness
  • sudden weakness or numbness in one side of your body or face
  • trouble speaking or walking

Other precautions

Before taking Litfulo, discuss your health history with your doctor. Litfulo may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • low platelet or white blood cell counts
  • liver problems
  • previous allergic reaction to this or a similar drug
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Litfulo, see the “Litfulo side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.