Alopecia Treatments: FDA-Approved Medications and Clinical Trials Underway
Alopecia causes distressing hair loss, but treatment can help you regrow hair. Check out all treatments for alopecia areata, plus clinical trials for new drugs.
Leqselvi
Used for Alopecia
Used for Alopecia
Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor. It's approved for adults with severe alopecia areata, an autoimmune condition that can cause patchy or total hair loss. The medication comes as a tablet that's taken by mouth twice a day, with or without food. Common side effects include headache, acne, and cold symptoms. There are also important safety warnings that you should discuss with your prescriber before starting treatment.
What is Leqselvi (deuruxolitinib)?
What is Leqselvi (deuruxolitinib) used for?
- Severe alopecia areata in adults
How Leqselvi (deuruxolitinib) works
Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor. It blocks JAK proteins in your immune system from sending signals. This helps stop your immune system from attacking your own hair follicles. It helps stop more hair loss and allows hair to grow back.
When does Leqselvi (deuruxolitinib) start working?Time passed since treatment started:
Drug facts
| Common Brands | Leqselvi |
|---|---|
| Drug Class | JAK inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Leqselvi (deuruxolitinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (12%)
- Acne (10%)
- Cold symptoms, like sore throat or runny nose (8%)
- Higher creatine phosphokinase (CPK) (5%)
- High cholesterol or triglycerides (4%)
- Fatigue (4%)
Less Common Side Effects
- Weight gain
- Skin and soft tissue infections
- Herpes infection
- Higher platelet count
- Anemia (low red blood cells)
- Low white blood cells
Leqselvi (deuruxolitinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: fever, chills, cough, shortness of breath, painful skin sores, burning when urinating, feeling very unwell
- Stroke: sudden weakness in your body, trouble speaking, confusion, dizziness
- Heart attack: 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
- Tear in the stomach or gut: sudden or severe belly pain, fever, chills, nausea, vomiting
- Cancers (including skin cancers): new or changing skin spots, unusual lumps, night sweats, unexplained weight loss
The following Leqselvi (deuruxolitinib) 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
- Stomach pain that is severe, does not go away, or gets worse
- 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):
- Acne
- Fatigue
- Headache
- Runny or stuffy nose
- Sore throat
- Weight gain
Get your GoodRx coupon
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GoodRx discount
$4387.41
Pros and cons of Leqselvi (deuruxolitinib)
Pros
- Taken by mouth as a tablet
- Can take at home
- Can take with or without food
- Can help some adults with severe alopecia areata regrow their hair
Cons
- Requires safety screening and ongoing blood tests
- Has serious risks like infection and blood clots
- Not recommended with certain immunosuppressants
- Not studied in children and teens
Pharmacist tips for Leqselvi (deuruxolitinib)
- Before starting Leqselvi (deuruxolitinib), you’ll need a genetic test to check your CYP2C9 genotype. This test helps your prescriber see how well your body can break down the medication. If you have genes that make your body break it down too slowly, you might have a higher risk of serious side effects. In that case, your prescriber will choose a different medication for you. Ask about what your results mean for you.
- Take Leqselvi (deuruxolitinib) twice a day, about the same times each day. If you miss a dose, skip it and take your next dose at the regular time. Don’t double up. This keeps your dosing consistent and avoids extra side effects.
- Acne can sometimes be a side effect of Leqselvi (deuruxolitinib). Be sure to wash your face twice a day with a gentle cleanser and warm water, especially after sweating. Also use non-comedogenic skin care products that won't clog pores. Talk to your care team if any acne becomes bothersome or doesn't get better, since treatment might help.
- Watch for signs of infection while taking Leqselvi (deuruxolitinib). This medication can raise your risk of infections. Call your care team if you have a fever, chills, cough, burning when you urinate, or a painful rash that blisters. Getting care early can help keep the infection from becoming serious.
- Get the blood tests your prescriber orders on time during treatment. These tests check your blood counts and cholesterol levels. Leqselvi (deuruxolitinib) can lower blood cell counts and raise cholesterol. Your prescriber can help make sure the medication stays safe for you.
- Before getting any vaccines, tell the healthcare professional you're taking Leqselvi (deuruxolitinib). It's important to be up to date on your vaccines to lower your risk of infection. But you should avoid live vaccines during treatment. This is because it's not clear how the medication affects your body's response to these types of vaccines. The healthcare professional can check the vaccine is safe for you.
- Tell your prescriber and pharmacist about all the medications and supplements you take or plan to take. Certain medications, like fluconazole (Diflucan), can raise the levels of Leqselvi (deuruxolitinib) in your body. This can put you at risk of side effects. Others, such as rifampin and St. John’s wort, can make Leqselvi (deuruxolitinib) work less well. Your care team can check if they need to make changes to your treatment, such as switching medications, to keep you safe.
- Use sun protection while taking Leqselvi (deuruxolitinib). Also remember to schedule skin checks if you’re at higher risk for skin cancer. There's a risk that Leqselvi (deuruxolitinib) might raise the risk of certain cancers, like skin cancers. Talk to your care team if you're worried, and be sure to tell them about any unusual changes in your skin.
- If you're pregnant or thinking of becoming pregnant: Talk with your prescriber about birth control and family planning. Based on animal studies, Leqselvi (deuruxolitinib) might harm an unborn baby. If you become pregnant during treatment, tell your prescriber right away.
- If you plan to breastfeed: Don't breastfeed while taking Leqselvi (deuruxolitinib) and for 1 day after your last dose. It's not known if the medication passes into breast milk. But it has the potential to cause serious side effects in your baby if it does. Talk with your prescriber or a lactation expert about safe feeding options for your baby.
- Keep Leqselvi (deuruxolitinib) in the original bottle at room temperature (68°F to 77°F). This keeps the tablets stable and protects them from moisture.
Risks and warnings for Leqselvi (deuruxolitinib)
Leqselvi (deuruxolitinib) 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 tuberculosis (TB)| Taking medications that weaken your immune system
Leqselvi (deuruxolitinib) lowers parts of your immune response. This can make infections more likely and more serious. Some old infections can also come back. This can include tuberculosis (TB) and shingles.
Before starting Leqselvi (deuruxolitinib), tell your prescriber about your full medical history. This includes any long-term or serious infections. You'll also get tested for TB and for hepatitis. Your prescriber can make sure it's safe for you. You can't take Leqselvi (deuruxolitinib) if you have any sort of active infection. You'll likely need to get it treated before you can start this medication.
During treatment, tell your care team if you have any symptoms of an infection. This can include fever, cough, night sweats, weight loss, or a painful blistering rash. Your prescriber might pause Leqselvi (deuruxolitinib) until the infection is treated.
Possible higher risk of death
- Risk factors: Age 50 years and older | High blood pressure | High cholesterol | High blood sugar
In study of a different JAK inhibitor for rheumatoid arthritis, results showed that it was linked to a higher risk of death in adults 50 years and older with at least one heart-related risk factor. This was compared to those who took a different type of medication called a TNF blocker.
We don't know if this higher risk has happened with Leqselvi (deuruxolitinib) for alopecia areata. To be safe, your prescriber will weigh the risks and benefits for you. This is especially true if you have cardiovascular risks. Talk to your prescriber if you have concerns about Leqselvi (deuruxolitinib).
Possible risk of cancer
- Risk factors: History of cancer | Smoking
Although rare, cancers have occurred in people taking Leqselvi (deuruxolitinib) during studies. This has included non‑melanoma skin cancers as well as some other cancers.
Talk to your prescriber about the risks and benefits of Leqselvi (deuruxolitinib). In particular, tell them if you have a known cancer or if you develop cancer during treatment. Also tell them if you've ever smoked.
Because there have been some cases of skin cancer, your care team might recommend getting a skin cancer screening every year. To lower your risk, wear protective clothing and use sunscreen if you're out in the sun. Also avoid tanning beds and other sources of ultraviolet light. Tell your care team about any new skin lesions or lumps. Also let them know about any night sweats or unexplained weight loss.
Possible risk of heart attack, stroke, and other blood clots
- Risk factors: Age 50 years and older | High blood pressure | High cholesterol | High blood sugar | People who smoke | Past blood clots
Some people taking Leqselvi (deuruxolitinib) had blood clots. These blood clots can happen in various parts of the body. Depending on where it is, it can block blood flow to the legs, lungs, or brain. Studies of other JAK inhibitors have shown that some people had a higher risk of serious problems from blood clots, including heart attack and stroke.
Be sure you know the signs of a blood clot to look out for.
- Blood clot in the leg (deep vein thrombosis, DVT): leg cramp, leg swelling, leg pain, muscle tightness in the leg
- Blood clot in the lung (pulmonary embolism, PE): cough, chest pain, trouble breathing, racing heart
- Blood clot affecting the heart (heart attack): chest pain; pain in the jaw, neck, or back; short of breath; cold sweat; nausea; indigestion; feeling weak or lightheaded
- Blood clot affecting the brain (stroke): sudden severe headache, weakness on one side of your body, droopy face, trouble speaking, trouble walking, confusion
Get medical help right away if you have any symptoms of a blood clot while taking Leqselvi (deuruxolitinib). It's important to get it treated as soon as possible.
Higher risk of serious side effects in CYP2C9 poor metabolizers or with CYP2C9 inhibitors
In certain situations, Leqselvi (deuruxolitinib) can build up in your body. This can raise your risk of serious side effects like blood clots.
It can happen if your body breaks down Leqselvi (deuruxolitinib) slowly. This is based on your genes. Before starting treatment, you'll need a one‑time genetic test called a CYP2C9 test. If you're a CYP2C9 poor metabolizer, your body will likely break down Leqselvi (deuruxolitinib) too slowly. You'll need a different treatment option.
Leqselvi (deuruxolitinib) can also build up in your body if you take certain medications that block it from being broken down. These are called CYP2C9 inhibitors. Examples include amiodarone (Pacerone), fluconazole (Diflucan), and metronidazole (Flagyl). You shouldn’t take Leqselvi (deuruxolitinib) with moderate or strong CYP2C9 inhibitors. Share a list of your medications with your prescriber. They can check for interactions and make sure Leqselvi (deuruxolitinib) is safe for you.
Tear in the stomach or gut
- Risk factors: History of diverticulitis or other conditions that raise tear risk
In studies, some people have developed bowel damage while taking Leqselvi (deuruxolitinib). This damage can be a tear in the stomach or gut.
Tell your prescriber if you've had bowel problems like diverticulitis. They'll weigh the risks and benefits of treatment and make sure to monitor you more closely.
Get urgent care if you have new or severe belly pain, fever, chills, nausea, or vomiting while taking this medication. These can be signs of serious damage to your bowels.
Changes in cholesterol levels and blood cell counts
Leqselvi (deuruxolitinib) can raise your cholesterol and triglyceride levels. It can also lower blood cell counts, including your red and white blood cells.
Before you start Leqselvi (deuruxolitinib), your prescriber will order blood tests for you. This helps them check your cholesterol and blood cell counts. You'll continue to have blood tests during treatment to make sure the medication is safe for you. Your prescriber might pause treatment if your blood counts get too low and will help manage high cholesterol if needed.
Tell your care team if you notice any unusual tiredness, pale skin, frequent infections, or easy bruising. These can be signs of low blood counts.
Avoid live vaccines right before or during treatment
Avoid getting live vaccines right before starting Leqselvi (deuruxolitinib) and while taking it. It's not known how the medication might affect how well vaccines work. Before you start treatment, make sure you're up to date on your recommended vaccines.
Leqselvi (deuruxolitinib) dosage
The average cost for 60 tablets of 8mg of of Leqselvi (deuruxolitinib) is $4,387.41 with a free GoodRx coupon.
Tablet
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 8mg of | 60 tablets | $4,387.41 | $73.12 |
Typical dosage for Leqselvi (deuruxolitinib)
The typical dose is 8 mg by mouth twice daily.
How much does Leqselvi (deuruxolitinib) cost?
To access savings, use a GoodRx coupon and pay just a fraction of the retail price.
Leqselvi (brand)
$4,387.41
Leqselvi (deuruxolitinib) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Leqselvi (deuruxolitinib) will not be safe for you to take.
- Have genetics that make you a CYP2C9 poor metabolizer (i.e., have a higher risk of serious side effects)
- Take medications known as moderate or strong CYP2C9 inhibitors
What are alternatives to Leqselvi (deuruxolitinib)?
There are a number of medications that your doctor can prescribe in place of Leqselvi (deuruxolitinib). Compare a few possible alternatives below.
News about Leqselvi (deuruxolitinib)
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