IMPORTANT SAFETY INFORMATION
What is LEQSELVI (deuruxolitinib)?
LEQSELVI is used to treat adults with severe hair loss (alopecia areata).
It is not known if LEQSELVI is safe and effective in children.
Who should not take LEQSELVI?
Do not take LEQSELVI if you are a poor metabolizer of CYP2C9 medicines or are taking moderate or strong CYP2C9 inhibitors. Before starting treatment, your healthcare provider should test you for CYP2C9 variants. Tell your healthcare provider if you take moderate or strong CYP2C9 inhibitor medicines. Ask your healthcare provider or pharmacist if you are not sure.
What is the most important safety information I should know about LEQSELVI?
You should not start taking LEQSELVI if you have any kind of infection unless your healthcare provider tells you it is okay. LEQSELVI affects your immune system and may cause serious side effects, including serious infections, which may be life-threatening. Your healthcare provider should test you for TB before starting treatment with LEQSELVI and should watch you closely for signs and symptoms of TB during treatment.
LEQSELVI may increase your risk of certain cancers by changing the way your immune system works.
There may be an increased risk of major cardiovascular events in people 50 years of age and older who have at least one heart disease risk factor and are taking a medicine in the class of medicines called JAK inhibitors, especially if they are a current or past smoker.
Blood clots in the veins of your legs, lungs or brain (cerebral venous sinus thrombosis, CVT) can happen in some people during treatment with LEQSELVI. These may be life-threatening.
Some people taking LEQSELVI can get tears in their stomach or intestines.
What should I tell my healthcare provider before starting LEQSELVI?
Tell your healthcare provider if you have an infection; are a current or past smoker; have had a heart attack, or other heart problems or stroke; have had blood clots in your legs, lungs or brain; have kidney problems; have liver problems; have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestine; have low red or white blood cell counts; or have recently received or are scheduled to receive a vaccine.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with LEQSELVI. Talk to your healthcare provider if you are planning to become pregnant. You should not breastfeed during treatment with LEQSELVI and for one day after the last dose.
What else should I be aware of when taking LEQSELVI?
Your healthcare provider should do blood tests before you start taking LEQSELVI and during treatment to check for increased fat (lipid) levels in your blood (triglycerides and cholesterol), low red blood cell counts, or low lymphocyte or neutrophil counts.
How should I take LEQSELVI?
Take LEQSELVI 2 times a day with or without food.
What are the possible side effects of LEQSELVI?
The most common side effects of LEQSELVI include:
- headache
- acne
- pain or swelling of your nose or throat (nasopharyngitis)
- increased blood creatine phosphokinase
- increased blood cholesterol
- tiredness
- weight gain
- increased platelets in your blood (thrombocytosis)
- low red blood cell count (anemia)
- skin and soft tissue infections
- low white blood cell count (neutropenia)
- herpes simplex including cold sores
These are not all of the possible side effects of LEQSELVI. Call your healthcare provider for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.