Upadacitinibdosage

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 healthcare provider. Prior to treatment update immunizations and consider evaluating for active and latent tuberculosis, viral hepatitis, hepatic function, and pregnancy status Avoid initiation or interrupt RINVOQ/RINVOQ LQ if absolute lymphocyte count is less than 500 cells/mm 3, absolute neutrophil count is less than 1000 cells/mm 3, or hemoglobin level is less than 8 g/dL. Rheumatoid Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis Adults: The recommended dosage of RINVOQ is 15 mg once daily. Psoriatic Arthritis Pediatric Patients 2 to less than 18 Years of Age Weighing at Least 10 kg: The recommended dosage is based on body weight Adults: The recommended dosage of RINVOQ is 15 mg once daily. 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 orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily. Adults 65 Years of Age and Older: Recommended dosage of RINVOQ is 15 mg once daily.

Severe Renal Impairment: Recommended dosage of RINVOQ is 15 mg once daily.

Ulcerative Colitis Adults: The recommended induction dosage of RINVOQ is 45 mg once daily for 8 weeks. The recommended maintenance dosage of RINVOQ is 15 mg once daily. A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response. See the Full Prescribing Information for the recommended dosage in patients with renal or hepatic impairment and for dosage modification due to drug interactions. Crohn’s D isease Adults: The recommended induction dosage of RINVOQ is 45 mg once daily for 12 weeks. The recommended maintenance dosage of RINVOQ is 15 mg once daily. A maintenance 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. See the Full Prescribing Information for the recommended dosage in patients with renal or hepatic impairment and for dosage modification due to drug interactions. Polyarticular Juvenile Idiopathic Arthritis The recommended dosage is based on body weight 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

2.1 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/mm 3, absolute neutrophil count less than 1000 cells/mm 3, 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 ).

Table 1: RINVOQ/RINVOQ LQ Dosage for Pediatric Patients 2 Years to Less Than 18 Years of Age with Psoriatic Arthritis Patient Weight RINVOQ LQ RINVOQ 10 kg to less than 20 kg 3 mg (3 mL oral solution) twice daily Not recommended 20 kg to less than 30 kg 4 mg (4 mL oral solution) twice daily Not recommended 30 kg and greater 6 mg (6 mL oral solution) twice daily 15 mg (one 15 mg tablet) once daily 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 Recommend ed 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).

Table 2: RINVOQ/RINVOQ LQ Dosage for Patients 2 years and older with pJIA Patient Weight RINVOQ LQ RINVOQ 10 kg to less than 20 kg 3 mg (3 mL oral solution) twice daily Not recommended 20 kg to less than 30 kg 4 mg (4 mL oral solution) twice daily Not recommended 30 kg and greater 6 mg (6 mL oral solution) twice daily 15 mg (one 15 mg tablet) once daily 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. 2.1 2 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/1.73m 2 ] 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/1.73m 2 ). RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m 2 ). Ulcerative Colitis: For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m 2 ), 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/1.73m 2 ). RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m 2 ). Crohn’s Disease: For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m 2 ), 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/1.73m 2 ). RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m 2 ). 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. 1 3 Dosage Modifications Due to Drug Interactions Rheumatoid Arthritis, Psoriatic Arthritis, Ankylos ing 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. 1 4 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. Table 3: Recommended Dosage Interruptions for Laboratory Abnormalities Laboratory Measure Action Absolute Neutrophil Count (ANC) Interrupt treatment if ANC is less than 1000 cells/mm 3; treatment may be restarted once ANC returns above this value Absolute Lymphocyte Count (ALC) Interrupt treatment if ALC is less than 500 cells/mm 3; 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.