Drug Detail:Rinvoq (Upadacitinib [ ue-pad-a-sye-ti-nib ])
Generic Name: upadacitinib 15mg
Dosage Form: tablet, extended release
Drug Class: Antirheumatics
2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation
Prior to RINVOQ treatment initiation, consider performing the following evaluations:
● Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ use [see Warnings and Precautions (5.1)].
● Viral hepatitis screening in accordance with clinical guidelines - RINVOQ initiation is not recommended in patients with active hepatitis B or hepatitis C [see Warnings and Precautions (5.1)].
● A complete blood count - RINVOQ initiation is not recommended in patients with an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL [see Dosage and Administration (2.12) and Warnings and Precautions (5.8)].
● Baseline hepatic function: RINVOQ initiation is not recommended for patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
● Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to starting treatment [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1, 8.3)].
Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.10)].
2.2 Important Administration Instructions
● RINVOQ tablets should be taken orally with or without food [see Clinical Pharmacology (12.3)].
● RINVOQ tablets should be swallowed whole. RINVOQ should not be split, crushed, or chewed.
2.3 Recommended Dosage in Rheumatoid Arthritis
The recommended dosage of RINVOQ is 15 mg once daily.
2.5 Recommended Dosage in Atopic Dermatitis
Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults Less Than 65 Years of Age
Initiate treatment with 15 mg once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg once daily. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dose needed to maintain response.
Adults 65 Years of Age and Older
The recommended dosage is 15 mg once daily.
2.6 Recommended Dosage in Ulcerative Colitis
Adult Patients: Induction
The recommended induction dosage of RINVOQ is 45 mg once daily for 8 weeks.
Adult Patients: Maintenance
The recommended dosage of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
2.7 Recommended Dosage in Crohn’s Disease
Adult Patients: Induction
The recommended induction dosage of RINVOQ is 45 mg once daily for 12 weeks.
Adult Patients: Maintenance
The recommended dosage of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
2.8 Recommended Dosage in Ankylosing Spondylitis
The recommended dosage of RINVOQ is 15 mg once daily.
2.9 Recommended Dosage in Non-radiographic Axial Spondyloarthritis
The recommended dosage of RINVOQ is 15 mg once daily.
2.10 Recommended Dosage in Patients with Renal Impairment or Hepatic Impairment
Renal Impairment
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis:
● No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.
Atopic Dermatitis:
● For patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 15 to < 30 mL/min/1.73m2] the recommended dosage is 15 mg once daily [see Use in Specific Populations (8.6)].
● No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
● RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2) [see Use in Specific Populations (8.6)].
Ulcerative Colitis:
● For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage is:
• Induction: 30 mg once daily for 8 weeks
• Maintenance: 15 mg once daily
● No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
● RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2) [see Use in Specific Populations (8.6)].
Crohn’s Disease:
● For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage is:
• Induction: 30 mg once daily for 12 weeks
• Maintenance: 15 mg once daily
● No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
● RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2) [see Use in Specific Populations (8.6)].
Hepatic Impairment
RINVOQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.7)].
Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis:
No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B).
Ulcerative Colitis:
For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage is:
- Induction: 30 mg once daily for 8 weeks
- Maintenance: 15 mg once daily
Crohn’s Disease:
For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage is:
● Induction: 30 mg once daily for 12 weeks
● Maintenance: 15 mg once daily
2.11 Dosage Modifications Due to Drug Interactions
Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis
The recommended dosage in patients receiving strong CYP3A4 inhibitors is 15 mg once daily [see Drug Interactions (7.1)].
Ulcerative Colitis
The recommended dosage in patients with ulcerative colitis receiving strong CYP3A4 inhibitors [see Drug Interactions (7.1)]:
• Induction: 30 mg once daily for 8 weeks
• Maintenance: 15 mg once daily
Crohn’s Disease
The recommended dosage in patients with Crohn’s disease receiving strong CYP3A4 inhibitors [see Drug Interactions (7.1)]:
• Induction: 30 mg once daily for 12 weeks
• Maintenance: 15 mg once daily
2.12 Dosage Interruption
Infections
If a patient develops a serious infection, including serious opportunistic infection, interrupt RINVOQ treatment until the infection is controlled [see Warnings and Precautions (5.1)].
Laboratory Abnormalities
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1 [see Warnings and Precautions (5.8)].
| Laboratory Measure | Action |
| Absolute Neutrophil Count (ANC) | Interrupt treatment if ANC is less than 1000 cells/mm3; treatment may be restarted once ANC returns above this value |
| Absolute Lymphocyte Count (ALC) | Interrupt treatment if ALC is less than 500 cells/mm3; treatment may be restarted once ALC returns above this value |
| Hemoglobin (Hb) | Interrupt treatment if Hb is less than 8 g/dL; treatment may be restarted once Hb returns above this value |
| Hepatic transaminases | Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. |
