Rinvoq Dosage

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 (2.11) 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)].

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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.

2.4 Recommended Dosage in Psoriatic 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 dose of RINVOQ is 45 mg once daily for 8 weeks.

​Adult Patients: Maintenance

​The recommended dose 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.

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2.7 Recommended Dosage in Ankylosing Spondylitis

​The recommended dosage of RINVOQ is 15 mg once daily.

2.8 Recommended Dosage in Non-radiographic Axial Spondyloarthritis

The recommended dosage of RINVOQ is 15 mg once daily.

2.9 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)].

​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

2.10 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

2.11 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)].