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Uses

What is Leqselvi used for?

Leqselvi (deuruxolitinib) 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, which is where hair growth begins.

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

How does Leqselvi work (mechanism of action)?

Leqselvi works by binding to Janus kinase (JAK) enzymes to block the immune system attack on your hair follicles, reducing inflammation and allowing for regrowth of hair.

How is Leqselvi supplied (dosage forms)?

Leqselvi is available as an 8 mg oral tablet that is taken by mouth.

How should I store Leqselvi?

Leqselvi should be stored in the original bottle (to protect from moisture) 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 Leqselvi?

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

  • Headache
  • Acne
  • Common cold symptoms
  • Increased blood levels of creatine phosphokinase (CPK)
  • Increased cholesterol blood levels
  • Fatigue
  • Weight gain
  • Herpes
  • Blood disorders (see below)
  • Infections of the skin or surrounding tissue

There may be other side effects of Leqselvi 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 Leqselvi?

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

Severe Allergic Reactions. Leqselvi may cause allergic reactions, which can be serious. Stop taking Leqselvi 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

Serious Infection. Leqselvi may increase your risk of developing a serious infection, such as tuberculosis (TB) or shingles, or other infections from bacteria, fungi, or viruses. Some infections may require treatment in the hospital or lead to death. Call your healthcare provider right away if you notice any of the following signs and symptoms of a serious infection.

  • Cough or difficulty breathing
  • Fever
  • Low blood pressure or fast heartbeat
  • Extreme weakness or tiredness
  • Skin rash associated with severe pain

Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Cerebral Venous Sinus Thrombosis (CVST). Leqselvi may increase your chance of developing a clot in your blood vessels (often in your legs), lungs, or part of your brain. Stop Leqselvi and tell your healthcare provider right away if you notice any of the following.

  • Swelling, pain or tenderness in one or both legs
  • Sudden, unexplained chest or upper back pain
  • Shortness of breath or difficulty breathing
  • Severe headaches

Heart Attack, Stroke, and Death. Leqselvi can increase your risk of a heart attack, stroke, or can lead to death. This risk may be increased in people with existing heart disease if you are 50 years or older and have risk factors for heart disease, such as high blood pressure, high blood cholesterol levels, or diabetes. Do not take Leqselvi if you have a heart attack or stroke. Stop Leqselvi and get emergency help if you have any of the following symptoms of a heart attack or stroke.

  • Nausea or vomiting
  • Fast or abnormal heartbeat
  • Severe tightness, pain, pressure, or heaviness in your arms, back, chest, neck, jaw, throat, or arm
  • Breaking out in a cold sweat, dizziness, or lightheadedness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • Shortness of breath with or without chest discomfort

Blood Disorders. Leqselvi can cause blood disorders, such as anemia and low white blood cell levels (lymphocytopenia and neutropenia). Keep all appointments to have your blood checked. Call your healthcare provider if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat
  • Unusual weakness or tiredness
  • Cold hands and feet
  • Shortness of breath

Cancer. Leqselvi may increase your risk of developing certain types of cancer, such as lung cancer (especially if you ever smoked), lymphomas, or skin cancers. Follow your healthcare provider’s advice on how to minimize your risk for cancers. Discuss the risks and benefits with your healthcare provider.

Severe Stomach Problems. Leqselvi can cause tears in the stomach or intestines. Tell your healthcare provider right away if you have any of the following symptoms of severe stomach problems.

  • Severe stomach pain
  • ‌Nausea or vomiting
  • ‌Fever and/or chills

Warnings & Precautions

Who should not use Leqselvi?

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

  • Leqselvi
  • Deuruxolitinib
  • Any of the ingredients in the specific product dispensed

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

Drug Interactions. Leqselvi should not be taken while you are using certain other medicines. Before taking Leqselvi, 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.

Genetics. Leqselvi should not be taken if your CYP2C9 protein enzyme (a naturally occurring enzyme that helps your body process medications and other substances) is not working as well as it should be. Your healthcare provider may do a genetic test to determine the functionality of your CYP2C9 enzyme. 

What should I know about Leqselvi before using it?

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

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

Keep Leqselvi out of the reach of children.

Take Leqselvi twice a day. It can be taken with or without food.

If you are able to become pregnant, you should use effective birth control while taking Leqselvi.

Keep all appointments, including lab appointments for blood work, while taking Leqselvi.

What should I tell my healthcare provider before using Leqselvi?

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 Leqselvi is right for you.

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

Vaccines. You should not receive any live vaccines right before or while using Leqselvi. Tell your healthcare provider if you have recently received a live vaccine or have any scheduled.

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

  • Being treated for an infection or have symptoms of an infection, such as fever, chills, cough, etc.
  • Have an infection that will not go away or keeps coming back
  • Cancer
  • Diabetes
  • Chronic lung disease, such as asthma or chronic obstructive lung disease (COPD)
  • Shingles
  • Tuberculosis or have been in close contact with someone who has tuberculosis
  • Human immunodeficiency virus (HIV)
  • Live in an area with an increased risk of fungal infections, such as the Ohio or Mississippi River valley or in the Southwestern United States
  • Weakened immune system
  • Hepatitis B or C
  • Smoke or previous smoker
  • Heart attack, or other heart problems or stroke
  • Blood clots in your legs, lungs, or brain
  • Kidney or liver problems
  • Stomach pain or diverticulitis or ulcers in your stomach or intestine
  • Anemia

Pregnancy. It is not known if or how Leqselvi could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Leqselvi while you are pregnant or trying to get pregnant. If you become pregnant while taking Leqselvi, you are encouraged to report your pregnancy to the manufacturer by calling 800-818-4555.

Breastfeeding. Do not breastfeed while you take Leqselvi and for 1 day after your last dose. It is not known if Leqselvi passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Leqselvi?

For more information about Leqselvi, you can visit the manufacturer’s website at https://www.leqselvi.com/ or call them at 800-818-4555.

Interactions

Does Leqselvi interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Leqselvi.

Does Leqselvi 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 medications that affect your immune system before taking Leqselvi. The following are examples of some medicines that can affect your immune system.

  • Janus kinase inhibitors (Xeljanz, Cibinqo, Rinvog, others), which are medicines used to treat inflammatory conditions such as rheumatoid arthritis and psoriatic arthritis
  • Biologic immunomodulators (Humira, Cimzia, Enbrel, others), which are medicines used to treat autoimmune, inflammatory, and allergic conditions
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine to suppress your immune system
  • Potent immunosuppressants (Cytoxan, MMF, others), which are medicines used to treat autoimmune and inflammatory conditions, or prevent transplant rejection

Many other medicines may alter the blood levels of Leqselvi. 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 Leqselvi. 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 Leqselvi?

If you or someone else has taken too much Leqselvi, 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 Leqselvi?

If you miss a dose, skip the missed dose, and only take the next dose. Do not take double or extra doses.