What are the precautions for Leqselvi (Deuruxolitinib)?

In clinical studies of Leqselvi (Deuruxolitinib) in the treatment of severe alopecia areata (AA), warnings and precautions such as serious infections, malignancies and lymphoproliferative diseases, major adverse cardiovascular events (MACE), thrombosis, gastrointestinal perforation, elevated blood lipids, anemia, neutropenia and lymphopenia have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity. Before treatment, attention should also be paid to immunization.

1. Serious infection: Serious infection has been reported in patients with alopecia areata treated withLeqselvi. Leqselvi should be avoided in patients with active serious infections, including localized infections. Before treatment with Leqselvi, consider the risks and benefits in patients who: have chronic or recurring infections; have been exposed to tuberculosis; have a history of serious or opportunistic infections; people who have lived in or traveled to areas with endemic tuberculosis or endemic mycoses; or have underlying conditions that may make them susceptible to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Leqselvi. If a patient develops a serious infection, treatment with Leqselvi should be interrupted until the infection resolves or is adequately treated. If a patient develops a new infection during treatment with Leqselvi, initiate complete diagnostic testing and appropriate antimicrobial therapy as appropriate for immunocompromised patients.

2. Malignant tumors and lymphoproliferative diseases: Malignant tumors were observed in clinical trials of Leqselvi. Consider the benefits and risks for individual patients before and during treatment with Leqselvi, particularly patients with known malignancies (other than successfully treated NMSC), patients who develop malignancies, and patients who are current or past smokers. Non-Melanoma Skin Cancer Non-melanoma skin cancers (NMSCs) have been reported in patients treated with Leqselvi. For patients at increased risk of skin cancer, regular skin examinations are recommended.

3. Major Adverse Cardiovascular Events (MACE): In another large randomized postmarketing safety trial of JAK inhibitors, subjects taking JAK inhibitors had higher rates of major adverse cardiovascular events (MACE) (defined as cardiovascular death, nonfatal myocardial infarction [MI], and nonfatal stroke) compared with subjects taking TNF blockers. Patients who are current or former smokers face an additional increased risk.

In useConsider the benefits and risks for the individual patient before and during treatment with Leqselvi, especially patients who are current or past smokers and those with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and what to do if they occur. Leqselvi should be discontinued in patients who experience symptoms of myocardial infarction or stroke.

4. Thrombosis: Including pulmonary embolism (PE), deep vein thrombosis (DVT) and cerebral venous sinus thrombosis (CVT) have been reported in clinical trials of Leqselvi. There is no clear relationship between elevated platelet counts and thrombotic events. Thrombosis (including deep vein thrombosis, pulmonary embolism, and arterial thrombosis) has been reported in subjects receiving JAK inhibitors for the treatment of inflammatory diseases. Many of these adverse reactions are serious, and some result in death. Leqselvi should be avoided in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue Leqselvi and have the patient evaluated and treated appropriately.

5. Patients with poor metabolism of CYP2C9 or patients who are concurrently taking moderate-dose or high-dose drugs are at increased risk of serious adverse reactions related to Leqselvi: Before treatment with Leqselvi, patients should be tested for CYP2C9 mutations to determine whether they are poor metabolizers. There are currently no FDA-approved or recognized CYP2C9 variant detection methods to guide the use of LEQSELVI. Leqselvi is contraindicated in patients who are poor metabolizers of CYP2C9 or who are concurrently taking moderate or strong CYP2C9 inhibitors.

6. Gastrointestinal perforation: Gastrointestinal perforation was reported in clinical trials of Leqselvi. Monitor patients receiving Leqselvi who may be at higher risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who develop new abdominal symptoms to allow early identification of gastrointestinal perforation.

7. Elevated blood lipids, anemia, neutropenia and lymphopenia: Perform a complete blood count before and regularly during treatment with Leqselvi.

8. Immunizations: Before treatment withLeqselvi, complete all necessary immunizations according to current immunization guidelines, including varicella-zoster or prophylactic shingles vaccine. Avoid using live vaccines during or before treatment with Leqselvi.