Leqselvi
Pronunciation: lek-sel-vee
Generic name: deuruxolitinib
Dosage form: tablet (8 mg)
What is Leqselvi?
Leqselvi (deuruxolitinib) is a JAK (Janus kinase) inhibitor used to treat severe hair loss (alopecia areata) in adults. Leqselvi is a tablet taken twice daily to help hair growth in affected areas.
Leqselvi FDA approval was received on July 25, 2024, for the company Sun Pharma after positive results from the clinical trials THRIVE-AA1 and THRIVE-AA2. Patients started with an average of 13% of their scalp having hair coverage, and after 6 months of taking Leqselvi, more than 30% of patients had 80% hair coverage, and up to 25% had 90% or more hair coverage of the scalp.
Leqselvi is not recommended in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
What is alopecia areata?
Alopecia areata is an autoimmune condition caused by the immune system wrongly attacking hair follicles, causing hair loss. Hair is usually lost in small round patches on the head and face. Hair loss patches can become larger and spread to other areas of the body, or hair may regrow and improve over a few months.
How does Leqselvi work?
JAK enzymes are proteins that send signals to cause inflammation and an immune response, which may lead to alopecia areata and other autoimmune conditions. Leqselvi works by binding to JAK enzymes, which block the overactive immune response and reduce inflammation of the hair follicle. This results in healthier hair follicles, which in turn improves hair growth. Leqselvi’s mechanism of action is as a Janus kinase (JAK) inhibitor that targets the JAK1 and JAK2 pathways.
Leqselvi side effects
Common Leqselvi side effects are headache, acne, cold symptoms, tiredness, weight gain, skin infections, soft tissue infections, herpes, change in blood tests including low white cells levels (lymphopenia), increase in blood platelet levels (thrombocytosis), low iron levels (anemia), increase in blood creatine phosphokinase, and low white blood cell levels (neutropenia). These side effects occured in 1% or more of patients.
Serious Leqselvi side effects
Leqselvi may cause serious side effects, as it may lower the immune system's ability to fight infections. Some people have had serious bacteria, fungi, or viral infections during treatment with Leqselvi that can spread throughout the body. Some people may be hospitalized or even die from these infections.
Treatment with Leqselvi should be interrupted if a serious infection occurs until the infection is controlled.
You should be tested for latent tuberculosis (TB) before and during therapy, and latent TB should be treated before Leqselvi treatment. Monitor all patients for active TB during treatment, even patients with initial negative latent TB 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 the FDA at 1-800-FDA-1088.
Also, see the Warning section.
Warnings
Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death.
Mortality (death). There is a higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) compared to using TNF blockers in rheumatoid arthritis (RA) patients. Leqselvi is not approved for use in RA patients.
Malignancy. Malignancies have occurred in patients treated with Leqselvi. There are higher rates of lymphomas and lung cancers with another JAK inhibitor compared to TNF blockers in RA patients.
Major Adverse Cardiovascular Events. There is a higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) compared to TNF blockers in rheumatoid arthritis (RA) patients.
Thrombosis Blockage of blood vessels with a blood clot (thrombosis), including a blood clot in an artery of the lung (pulmonary embolism (PE)), in deep veins such as the leg (deep vein thrombosis, DVT) or brain (cerebral venous thrombosis (CVT)), has occurred in patients treated with Leqselvi. There is an Increased incidence of pulmonary embolism and venous and arterial thrombosis with another JAK inhibitor compared to TNF blockers.
Gastrointestinal Perforations. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate patients promptly if they present with new-onset abdominal symptoms.
Changes in blood tests This medicine may cause lipid elevations, anemia, neutropenia, and lymphopenia. The patient should be monitored for changes in lipids, hemoglobin, neutrophils, and lymphocytes.
Immunizations: Avoid the use of live vaccines during or immediately prior to Leqselvi treatment.
Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors: Leqselvi should not be used in patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor.
Before taking this medicine
Before taking Leqselvi, tell your healthcare provider about all of your medical conditions, including if you:
- have an infection.
- are you a current or past smoker.
- have had a heart attack, or other heart problems or stroke.
- have you 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.
- have recently received or are scheduled to receive a vaccine. You should not receive live vaccines if you take this medicine.
Pregnancy
Tell your healthcare provider if you are pregnant or plan to become pregnant, as it is not known if Leqselvi will harm an unborn baby.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with Leqselvi. Talk to your healthcare provider about birth control methods that may be right for you during treatment with this medicine.
If you become pregnant during treatment with this medicine, call Sun Pharmaceuticals Industries, Inc. at 1-800-818-4555 to report your pregnancy.
Breastfeeding
Tell your healthcare provider you are breastfeeding or plan to breastfeed. It is not known if Leqselvi passes into your breastmilk. You should not breastfeed during treatment with Leqselvi and for 1 day after the last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.
How should I take Leqselvi?
Leqselvi tablets are taken twice a day with or without food.
Leqselvi dosing information
Usual Leqselvi dose is 8 mg twice daily.
Leqselvi is available in 8mg tablets.
What happens if I miss a dose?
If a dose is missed, skip the missed dose and resume dosing at the next scheduled dose.
What happens if I overdose?
In case of overdose, consider contacting the Poison Center at 1-800-222-1222 for the latest recommendations.
Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Leqselvi and other medicines may affect each other causing side effects.
Especially tell your healthcare provider if you take medicines that affect your immune system such as biologic medicines, other JAK inhibitors, and strong immunosuppressants (such as cyclosporine) as these medicines may increase your risk of infection.
Ask your healthcare provider or pharmacist if you are not sure if you are taking one of these medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist whenever you get a new medicine.
Leqselvi is contraindicated in patients taking a moderate or strong CYP2C9 inhibitor.
Not all possible interactions are listed here.
Storage
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Store tablets in the original container to protect from moisture.
- Bottle comes with a child-resistant cap.
- Keep LEQSELVI and all medicines out of the reach of children.
Ingredients
Active ingredient: deuruxolitinib
Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone. The tablet film coat contains: carmine, FD&C blue #2 aluminum lake, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.
Company
Manufactured for Sun Pharmaceutical Industries, Inc. by Halo Pharmaceutical Inc., Whippany, NJ, 07981, USA.
References
More about Leqselvi (deuruxolitinib)
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
