Applies to upadacitinib: oral tablets extended-release.
Warning
-
Serious Infections
- Serious and sometimes fatal infections, including tuberculosis (pulmonary or extrapulmonary disease), bacterial and viral infections, invasive fungal infections (may be disseminated), and other opportunistic infections, reported.1
- Carefully consider risks and benefits prior to initiating upadacitinib therapy in patients with chronic or recurring infections.1
- Evaluate patients for latent tuberculosis infection prior to and periodically during treatment; if indicated, initiate appropriate antimycobacterial regimen prior to initiating upadacitinib therapy.1
- Closely monitor patients for infection, including active tuberculosis in those with a negative test for latent tuberculosis, during and after treatment.1 If serious infection develops, interrupt upadacitinib therapy until infection is controlled.1
-
Mortality
- Higher overall mortality rate, including sudden cardiovascular death, reported with another Janus kinase (JAK) inhibitor compared with tumor necrosis factor (TNF) blocking agents in a postmarketing safety study in rheumatoid arthritis patients ≥50 years of age with ≥1 cardiovascular risk factor.1 27
-
Malignancies
- Lymphoma and other malignancies reported.1
- Risk of lymphomas and lung cancers also increased with another JAK inhibitor compared with TNF blocking agents; patients who are current or past smokers are at additional risk.1
-
Major Adverse Cardiovascular Events
- Higher rate of major adverse cardiovascular events reported with another JAK inhibitor compared with TNF blocking agents in a postmarketing safety study in patients with rheumatoid arthritis ≥50 years of age with ≥1 cardiovascular risk factor.1 Patients who are current or past smokers are at additional risk.1
- Discontinue upadacitinib in patients that experience a MI or stroke.1
-
Thrombosis
- Serious and sometimes fatal thromboembolic events, including DVT, PE, and arterial thrombosis, reported.1
- Consider risks and benefits prior to initiating upadacitinib therapy in patients who may be at increased risk of thrombosis.1
- Promptly evaluate patients with symptoms of thrombosis.1
Side effects include:
Adverse effects occurring in ≥1% of patients with rheumatoid arthritis or psoriatic arthritis: Upper respiratory tract infections, herpes zoster infection, herpes simplex infection, bronchitis, nausea, cough, pyrexia, and acne.
Adverse effects occurring in ≥1% of patients with atopic dermatitis: Upper respiratory tract infections, acne, herpes simplex infection, headache, increased serum creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster infection, influenza, fatigue, neutropenia, myalgia, and influenza-like illness.
For Healthcare Professionals
Applies to upadacitinib: oral tablet extended release.
Hematologic
Frequency not reported: Neutropenia, lymphopenia, anemia[Ref]
Immunologic
Uncommon (0.1% to 1%): Herpes zoster, herpes simplex (includes oral herpes), oral candidiasis
Frequency not reported: Tuberculosis (TB), cellulitis[Ref]
Metabolic
Frequency not reported: Increased lipids[Ref]
Hepatic
Frequency not reported: Liver enzyme elevation[Ref]
Oncologic
Frequency not reported: Non-melanoma skin cancer[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (e.g., acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection) (14%)
Common (1% to 10%): Cough
Frequency not reported: Pneumonia[Ref]
Other
Common (1% to 10%): Pyrexia[Ref]
Cardiovascular
Frequency not reported: Thrombosis (e.g., deep venous thrombosis), pulmonary embolism, arterial thrombosis[Ref]
Gastrointestinal
Frequency not reported: GI perforation[Ref]
