Rinvoq Dosage

2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation

Prior to RINVOQ/RINVOQ LQ treatment initiation, consider performing the following evaluations:

● Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ/RINVOQ LQ use.

● Viral hepatitis screening in accordance with clinical guidelines – RINVOQ/RINVOQ LQ initiation is not recommended in patients with active hepatitis B or hepatitis C.

● A complete blood count – RINVOQ/RINVOQ LQ 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.

● Baseline hepatic function: RINVOQ/RINVOQ LQ initiation is not recommended for patients with severe hepatic impairment (Child-Pugh C).

● Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to starting treatment.

Update immunizations according to current immunization guidelines.

2.2 Important Administration Instructions

​● RINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets.

​● Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.

​● RINVOQ/RINVOQ LQ should be taken orally with or without food.

​● RINVOQ tablets should be swallowed whole. RINVOQ tablets should not be split, crushed, or chewed.

​● RINVOQ LQ should be administered using the provided press-in bottle adapter and oral dosing syringe.

​● RINVOQ LQ is dosed twice daily.

2.3 Recommended Dosage in Rheumatoid Arthritis

The recommended dosage of RINVOQ is 15 mg once daily.

2.4 Recommended Dosage in Psoriatic Arthritis

​Pediatric Patients 2 to Less Than 18 Years of Age

​The recommended dosage is based on body weight (Table 1).

​

​RINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.

​

​Adults 18 Years of Age and Older

​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 RINVOQ 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 of RINVOQ 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 Polyarticular Juvenile Idiopathic Arthritis

​The recommended dosage is based on body weight (Table 2).

​

​RINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.

2.11 Recommended Dosage in Giant Cell Arteritis

​The recommended dosage of RINVOQ is 15 mg once daily in combination with a tapering course of corticosteroids.

​RINVOQ 15 mg once daily can be used as monotherapy following discontinuation of corticosteroids.

2.12 Recommended Dosage in Patients with Renal Impairment or Hepatic Impairment

Renal Impairment

​Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:

● 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 of RINVOQ is 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).

Ulcerative Colitis:

● For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ 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).

Crohn’s Disease:

● For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ 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).

Hepatic Impairment

RINVOQ/RINVOQ LQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).

​Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:

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 of RINVOQ 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 of RINVOQ is:

• Induction: 30 mg once daily for 12 weeks
  
• Maintenance: 15 mg once daily

2.13 Dosage Modifications Due to Drug Interactions

​Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis

No dosage adjustment is needed in patients receiving strong CYP3A4 inhibitors.

Atopic Dermatitis

The recommended dosage of RINVOQ in patients receiving strong CYP3A4 inhibitors is 15 mg once daily.

Ulcerative Colitis

The recommended dosage of RINVOQ in patients with ulcerative colitis receiving strong CYP3A4 inhibitors:

• Induction: 30 mg once daily for 8 weeks
  
• Maintenance: 15 mg once daily

Crohn’s Disease

The recommended dosage of RINVOQ in patients with Crohn’s disease receiving strong CYP3A4 inhibitors:

• Induction: 30 mg once daily for 12 weeks
  
• Maintenance: 15 mg once daily

2.14 Dosage Interruption

Infections

If a patient develops a serious infection, including serious opportunistic infection, interrupt RINVOQ/RINVOQ LQ treatment until the infection is controlled.

Laboratory Abnormalities

Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 3.