What are the necessary steps and precautions for an adult patient with rheumatoid arthritis, psoriatic arthritis, or atopic dermatitis when taking upadacitinib (Rinvoq)?

Essential Steps and Precautions When Using Upadacitinib

Before starting upadacitinib, you must complete mandatory screening tests and vaccinations, monitor specific laboratory parameters during treatment, and understand critical safety warnings—particularly if you are over 50 years old with cardiovascular risk factors. 1

Pre-Treatment Requirements (Must Complete Before Starting)

Mandatory Screening Tests

• Tuberculosis screening with IGRA or tuberculin skin test; if latent TB is detected, treat for at least 1 month before starting upadacitinib 2, 1
• Complete blood count with differential to ensure absolute lymphocyte count ≥500 cells/mm³, absolute neutrophil count ≥1000 cells/mm³, and hemoglobin ≥8 g/dL 3, 1
• Liver function tests (hepatic enzymes) at baseline 3, 1
• Renal function tests 2
• Lipid profile 3, 2
• Hepatitis B and C testing 3, 2
• Pregnancy test if you are of reproductive potential 3, 1
• HIV testing if you are in a high-risk population 4

Required Vaccinations (Complete Before Starting)

• Herpes zoster vaccine (Shingrix): Complete the 2-dose series separated by 2-6 months, ideally 3-4 weeks before starting upadacitinib if you are ≥18 years old 3, 4, 2, 5
• All other needed live vaccines must be completed before initiating treatment, as live vaccines should be avoided during therapy 3, 1

Ongoing Monitoring Requirements During Treatment

Laboratory Monitoring Schedule

• Complete blood count with differential: Check at 4-8 weeks after starting, then every 3 months 2
• Liver enzymes: Check at 4 weeks after starting or dose escalation, then every 3 months 3, 2
• Lipid profile: Check at 12 weeks after starting, then annually 3, 2
• Renal function: Monitor periodically 2

When to Hold or Stop Treatment

• Hold treatment if absolute neutrophil count drops below 1000/mm³, hemoglobin falls below 8 g/dL, or absolute lymphocyte count is below 500 cells/mm³ 2, 1
• Stop treatment immediately if you develop an active serious infection 4, 2
• Discontinue permanently if you experience a serious hypersensitivity reaction (e.g., anaphylaxis) 1

Critical Safety Warnings You Must Understand

Black Box Warning for High-Risk Patients

If you are ≥50 years old with at least one cardiovascular risk factor, upadacitinib carries increased risks of major adverse cardiovascular events (MACE), venous thromboembolism (VTE), cancer, and death. 3, 4, 2, 5 This warning is based on data from tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients. 3

Specific Risk Factors Requiring Caution

• Age ≥65 years: Use only the 15 mg dose for atopic dermatitis; carefully weigh risks versus benefits 5, 1
• Current or past smoker 3
• History of cardiovascular disease or risk factors (hypertension, diabetes, high cholesterol) 3, 2
• History of blood clots (deep vein thrombosis, pulmonary embolism) 3
• History of cancer 3, 4
• High body mass index 3
• Hormone replacement therapy 3

Infection Risks

• Herpes zoster (shingles) occurs more frequently with upadacitinib than with other treatments—this is why vaccination before starting is critical 3, 4, 6
• Serious and opportunistic infections can occur; avoid starting if you have an active infection 3, 4, 1
• Monitor for signs of infection throughout treatment 4

Other Important Safety Concerns

• Gastrointestinal perforation risk: Seek immediate medical attention if you develop new abdominal pain, especially if you have a history of diverticulitis 1
• Pregnancy: Upadacitinib may cause fetal harm; use effective contraception during treatment and discuss with your doctor 1
• Malignancy risk: Almost all malignancies in clinical trials occurred in patients ≥53 years old 5

Medication-Specific Instructions

What NOT to Combine with Upadacitinib

• Do not use with other JAK inhibitors 1
• Do not use with biologic DMARDs (e.g., TNF inhibitors, IL-17 inhibitors) 1
• Do not use with potent immunosuppressants like azathioprine or cyclosporine 2, 1
• Avoid or reduce dose with strong CYP3A4 inhibitors 2

Dosing Adjustments

• Severe renal impairment: Use only 15 mg once daily 1
• Severe hepatic impairment: Upadacitinib is contraindicated 2, 1
• For atopic dermatitis in adults ≥65 years: Use only 15 mg once daily, not 30 mg 5, 1

How to Take the Medication

• Take once daily at the same time each day 3
• Can be taken with or without food 1
• Swallow extended-release tablets whole; do not crush, split, or chew 1
• If you see medication residue in stool (especially with shortened GI transit times), notify your doctor as this may indicate inadequate absorption 1

Common Pitfalls to Avoid

• Do not skip TB screening—this is mandatory before starting 2
• Do not use the 30 mg dose for rheumatoid arthritis—only 15 mg is approved and the higher dose increases safety risks 2
• Do not initiate in patients ≥65 years with cardiovascular risk factors without extremely careful risk-benefit assessment 2, 5
• Do not forget to complete shingles vaccination before starting, as herpes zoster rates are significantly elevated with JAK inhibitors 4, 2, 5
• Do not continue treatment if lab values fall below safety thresholds (neutrophils <1000, hemoglobin <8, lymphocytes <500) 2, 1