IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with oral Janus kinase (JAK) inhibitors for inflammatory conditions are at risk for serious infections that may lead to hospitalization or death. These include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
- Invasive fungal infections, including cryptococcosis and pneumocystosis.
- Other bacterial or viral infections, including herpes zoster, due to opportunistic pathogens.
Avoid use in patients with an active, serious infection. If a serious infection develops, stop OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to use in patients with chronic or recurrent infection. Closely monitor patients for the development of signs of infection during and after treatment with OPZELURA.
Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.
No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA; however, cases were reported in clinical trials of oral JAK inhibitors to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to treatment. Monitor patients for the development of signs and symptoms of TB.
Viral reactivation, including cases of herpes virus reactivation, were reported in clinical trials with JAK inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.
Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA is not recommended in patients with active hepatitis B or hepatitis C.
POST-MARKETING SAFETY
In a large randomized postmarketing safety study of rheumatoid arthritis (RA) patients 50 years and older with at least one cardiovascular risk factor, the following were higher with an oral JAK inhibitor than with a tumor necrosis factor (TNF) blocker:
all-cause mortality, major adverse cardiovascular events (defined as cardiovascular death, myocardial infarction, and stroke), thrombosis, malignancies (excluding non-melanoma skin cancer [NMSC]).
Consider the benefits and risks prior to initiating or continuing therapy with OPZELURA. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.
MALIGNANCIES
Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Patients who are current or past smokers are at increased risk. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
Consider the benefits and risks prior to initiating therapy with OPZELURA, particularly in patients:
- with a known malignancy (other than successfully treated non-melanoma skin cancers),
- who develop a malignancy when on treatment,
- with cardiovascular risk factors and
- who are current or past smokers.
Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment. Limit exposure to sunlight and UV light with protective clothing and broad-spectrum sunscreen.
THROMBOSIS
Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious, and some resulted in death. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.
CYTOPENIAS
Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for patients who have a known history of these events prior to initiating therapy. Perform CBC monitoring as clinically indicated. Discontinue OPZELURA if symptoms associated with clinically significant decreases in laboratory values occur.
POTENTIAL RISKS RELATED TO JAK INHIBITION
Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, as well as hypoglycemia in patients with diabetes.
ADVERSE REACTIONS
In atopic dermatitis, the most common adverse reactions (≥1%) are nasopharyngitis, bronchitis, ear infection, eosinophil count increased, urticaria, diarrhea, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reaction, pyrexia, and white blood cell decreased.
PREGNANCY REGISTRY
There is a registry that monitors pregnancy outcomes in persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463 or visiting www.opzelura.pregnancy.incyte.com.
LACTATION
Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).
