Precautions you must know before using ruxolitinib/ruxolitinib cream

Ruxolitinib is a topical Janus kinase (JAK) 1/2 inhibitor, mainly used to treat inflammatory skin diseases, such as atopic dermatitis (AD) and vitiligo. It improves skin symptoms by inhibiting the JAK-STAT signaling pathway and blocking the release of inflammatory factors. However, because its active ingredient ruxolitinib is closely related to the immune system, it has been found in clinical studies that some patients may experience serious adverse events, so the following warnings and precautions should be paid close attention to when using it.

1.Serious infection is an important risk. JAK inhibitors reduce the immune system's ability to fight bacteria, viruses, and fungi, increasing the chance of infection. In clinical reports, some patients have developed serious complications such as tuberculosis (TB), systemic bacterial infection, fungal infection, and even sepsis. Some cases require hospitalization and even lead to death. If a patient develops serious or opportunistic infection during treatment, ruxolitinib cream should be discontinued immediately and avoid starting treatment in a state of active infection (including local infection).

2. The risks of malignant tumors and lymphoproliferative diseases need to be taken seriously. Non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma, have been reported in patients treated with ruxolitinib cream. Therefore, it is recommended to conduct regular skin examinations during treatment and follow-up visits, and to reduce UV exposure and skin cancer risk by wearing protective clothing and using broad-spectrum sunscreen.

3. Major adverse cardiovascular events (MACE) include cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke. The patient's cardiovascular risk needs to be assessed before use, especially for smokers and people with risk factors such as hypertension and hyperlipidemia. Patients should be informed to recognize symptoms of cardiovascular and cerebrovascular events such as chest pain, shortness of breath, facial or limb numbness, and to discontinue medication and seek medical attention immediately if they occur.

4. Thrombosis is also a complication that requires vigilance. Deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombotic events, some of which are fatal, have been reported in some patients receiving JAK inhibitors. For patients with a high risk of thrombosis, ruxolitinib cream should be used with caution; once symptoms related to thrombosis occur, the drug should be discontinued immediately and evaluation and intervention should be carried out.

5. Hematological abnormalities such as thrombocytopenia, anemia and neutropenia may also occur. Use with caution in patients with relevant medical history and monitor complete blood count as clinically appropriate during treatment. Once there is an obvious drop in blood indicators and related clinical symptoms, the drug should be discontinued and corresponding treatments should be taken.

6. The phenomenon of elevated blood lipids, including total cholesterol, low-density lipoprotein (LDL) and triglyceride levels are elevated. Although the systemic absorption of topical preparations is low, long-term attention should still be paid to changes in blood lipids, and blood lipids should be monitored and intervened if necessary.

7. The risk of hepatitis B and C reactivation requires special attention. Although patients with active hepatitis B or C were excluded from clinical trials of topical ruxolitinib cream, increased hepatitis B viral load (HBV-DNA), with or without elevated liver enzymes, has been reported in users of the oral formulation. Therefore, it is not recommended to use this drug in the presence of active hepatitis B or hepatitis C infection. For patients with a history of chronic viral hepatitis, it is recommended to conduct virological evaluation and close follow-up before taking the drug.

Reference: https://www.opzelura.com/