Precautions for the Use of Filgotinib

Precautions for the Use of Filgotinib

Malignancies, Skin Cancer, and Smoking History

JAK inhibitors may theoretically affect tumor immune surveillance, thus requiring attention to malignancy risk. In clinical trials, a slight increase in the incidence of non-melanoma skin cancers (such as basal cell carcinoma and squamous cell carcinoma) has been observed in filgotinib users. Therefore, it is recommended that you undergo regular full-body skin examinations during treatment, especially if you have a history of sun exposure or prior skin cancer. If you find any new skin lesions (e.g., non-healing ulcers, nodules, or pigment changes) or changes in the shape or color of pre-existing moles, you should inform your doctor immediately. In addition, smokers or those with a long-term smoking history, as well as individuals aged ≥65 years, already have an increased overall cancer risk; a personalized benefit-risk assessment by your physician is required before starting filgotinib. Although there is currently no clear evidence that this drug increases the risk of lymphoma or other solid tumors, clinical vigilance remains. For patients with a history of cancer, it is generally recommended to wait for at least a 5-year disease-free period before considering use. During treatment, any unexplained weight loss, persistent fever, or lymphadenopathy should prompt prompt medical evaluation.

Vaccination and Cardiac Issues

During filgotinib treatment, immune responses may be suppressed; therefore, live vaccines (e.g., measles-mumps-rubella, varicella, yellow fever vaccines) are not recommended, as vaccine-strain infection may occur. If inactivated or recombinant protein vaccines (e.g., influenza vaccine, COVID-19 vaccine) are planned, they can theoretically be administered, but the production of protective antibodies may be reduced. You should consult your doctor to appropriately time vaccinations. It is generally advised to complete all necessary routine immunizations before starting the drug. Regarding cardiac aspects, observational studies suggest that JAK inhibitors may be associated with major adverse cardiovascular events (such as myocardial infarction and stroke), especially in patients with pre-existing atherosclerotic cardiovascular disease, hypertension, or hyperlipidemia. Therefore, if you have a history of coronary artery disease, heart failure, or peripheral vascular disease, your doctor will carefully consider whether to initiate filgotinib. During treatment, blood pressure, lipids, and heart rate should be monitored, and a healthy lifestyle should be maintained. If you experience chest pain, chest tightness, shortness of breath, or lower extremity edema, you must report immediately to rule out acute coronary syndrome or worsening heart failure.

Venous Thromboembolism Risk and Special Considerations for the Elderly

Venous thromboembolism (including deep vein thrombosis and pulmonary embolism) is a potential serious adverse reaction for the JAK inhibitor class. The incidence of thrombotic events in filgotinib clinical trials is low, but patients with high-risk factors still need to be vigilant. These factors include: recent major surgery (especially orthopedic or abdominal surgery), prolonged immobility, use of estrogen-containing contraceptives or hormone replacement therapy, presence of inherited or acquired coagulation disorders (e.g., antiphospholipid antibody syndrome), and a history of prior thrombosis. If you develop unilateral lower limb swelling, pain, increased skin temperature or discoloration, or sudden dyspnea, chest pain, or hemoptysis, seek emergency medical care immediately. Elderly patients (≥65 years) are not only at higher risk for infections and cancers, but their cardiovascular events and thrombotic risks also increase with age; therefore, physicians may preferentially use the lower 100 mg dose and intensify follow-up. For ulcerative colitis patients over 75 years of age, use is not recommended due to lack of evidence. All patients should maintain moderate physical activity, avoid dehydration, and control body weight to reduce thrombotic tendency.