Leqselvi (Oral)
Deuruxolitinib is used in adults to treat a certain type of hair loss called severe alopecia areata.
Your doctor will perform tests to make sure deuruxolitinib is the right treatment for you.
Deuruxolitinib may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Leqselvi (Oral)?
Tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.
Tell your doctor if you have or have ever had:
- are being treated for an active or chronic infection;
- use any other medications;
- a weak immune system (caused by disease such as HIV or by using certain medicine);
- herpes zoster (also called shingles);
- chronic lung disease;
- a blood clot, stroke, heart attack, or other heart problems;
- high cholesterol;
- diverticulitis or an ulcer in the stomach or intestines;
- diabetes;
- low red or white blood cell counts;
- any type of cancer;
- if you smoke or have smoked in the past; or
- liver (especially hepatitis B or hepatitis C) or kidney disease.
Tell your doctor if you've had or been exposed to tuberculosis or other infections, or if you recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine. Make sure you are current on all vaccines before you start using deuruxolitinib.
Using deuruxolitinib may increase your risk of developing certain cancers such as lymphoma, lung, and skin cancers. Ask your doctor about your individual risk and skin symptoms to watch for.
It is not known if deuruxolitinib will harm an unborn baby. Use birth control and tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of deuruxolitinib on the baby.
Do not breastfeed while using this medicine, and for at least 1 day after your last dose.
Side Effects
What are the side effects of Leqselvi (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some people taking deuruxolitinib have developed heart attacks, strokes, or serious blood clots. Stop taking deuruxolitinib and seek emergency medical attention if you have:
- signs of a heart attack or stroke--chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath; or
- signs of a blood clot--severe headache, sudden chest or back pain, sudden cough or shortness of breath, or pain, swelling, or warmth in one or both legs.
Call your doctor at once if you have:
- signs of infection--fever, chills, sore throat, body aches, easy bruising or bleeding;
- signs of tuberculosis--cough, night sweats, loss of appetite, weight loss, and feeling very tired;
- a hole (perforation) in your digestive tract--severe stomach pain, change in bowel habits; or
- symptoms of herpes zoster (shingles)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.
Your treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- headache, tiredness, weight gain;
- acne, a skin infection, cold sores around your mouth, skin sores or blisters;
- cold symptoms such as stuffy nose, sneezing, sore throat; or
- abnormal blood tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Leqselvi (Oral) if I’m pregnant or breastfeeding?
It is not known if deuruxolitinib will harm an unborn baby. Use birth control and tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of deuruxolitinib on the baby.
Do not breastfeed while using this medicine, and for at least 1 day after your last dose.
Interactions
What drugs and food should I avoid while taking Leqselvi (Oral)?
Avoid receiving a "live" vaccine while you are being treated or right before starting treatment with deuruxolitinib. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Dosage Guidelines & Tips
How to take Leqselvi (Oral)?
Use Leqselvi (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Before you use deuruxolitinib, your doctor will test you for tuberculosis or other infections. Your blood will be tested before and during treatment with deuruxolitinib.
Deuruxolitinib is usually taken twice per day with or without food.
You may get infections more easily, even serious or fatal infections. You will need other medical tests before and during treatment with deuruxolitinib.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using deuruxolitinib.
Store this medicine in the original container at room temperature away from moisture and heat.
Skip the missed dose and take your next dose at the regular time. Do not take two doses at one time.
Overdose Signs
What happens if I overdose on Leqselvi (Oral)?
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