ONE PILL,
ONCE DAILY¹

RINVOQ Dosing

A Once-Daily Pill That Comes in 3 Dosage Strengths¹

1 Strength for Induction and 2 Strengths for Maintenance

1 Strength for Induction and 2 Strengths for Maintenance

Induction Dose

RINVOQ® (upadacitinib) 45 mg yellow pill and bottle.

Images not reflective of actual pill size.

RECOMMENDED INDUCTION DOSE

CD: 45 mg once daily for 12 weeks

UC: 45 mg once daily for 8 weeks

Maintenance Dose

RINVOQ® (upadacitinib) 15 mg purple pill and bottle and RINVOQ® (upadacitinib) 30 mg red pill and bottle.

Images not reflective of actual pill size.

RECOMMENDED MAINTENANCE DOSE

15 mg once daily for CD and UC

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 dose
Use the lowest effective dosage needed to maintain response

CD=Crohn’s disease; NDC=National Drug Code; UC=ulcerative colitis.

Download Dosing Guide

ADMINISTRATION

Instruct patients to take 1 pill, once daily¹
Ensure pill is taken whole. Do not split, crush, or chew¹
RINVOQ can be taken with or without food. Advise patients to avoid food or drink containing grapefruit during treatment with RINVOQ¹

MEDICATION RESIDUE IN STOOL

Instruct patients to notify their healthcare provider if they repeatedly notice intact RINVOQ tablet or fragments in stool or ostomy output¹

Limitations of Use for CD and UC: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD or UC, or with potent immunosuppressants such as azathioprine and cyclosporine.¹

Please see Important Safety Information, including BOXED WARNING on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis, below.

Learn more about these and the full Important Safety Information below

Lab Monitoring & Dosing Considerations

Lab Monitoring

Lab Abnormalities

Perform lab testing for¹:

	Laboratory Parameter	Check Lab Values	Treatment should NOT be INITIATED or CONTINUED if:
CBC Differential	Neutrophils	At baseline and periodically thereafter according to routine patient management	<1000 cells/mm^3*
	Lymphocytes		<500 cells/mm^3*
	Hemoglobin		<8 g/dL*
Liver enzymes			Elevated liver enzymes and suspected drug-induced injury
Lipids^a		At 12 weeks and thereafter according to clinical guidelines

INTERRUPT IF PATIENT DEVELOPS A SERIOUS OR OPPORTUNISTIC INFECTION.

*Treatment can be initiated or restarted after levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.¹

^aLipids include total cholesterol, LDL cholesterol, and HDL cholesterol.

CBC=complete blood count; HDL=high-density lipoprotein; LDL=low-density lipoprotein

Lab abnormalities across doses from the placebo-controlled induction and maintenance studies^1-3

<<Swipe table to see more

		CD INDUCTION (WEEK 12)		CD MAINTENANCE (WEEK 52)			UC INDUCTION (WEEK 8)		UC MAINTENANCE (WEEK 52)
	LAB ABNORMALITY	Placebo (N=347)	RINVOQ 45 mg (N=674)	Placebo (N=223)	RINVOQ 15 mg (N=221)	RINVOQ 30 mg (N=229)	Placebo (N=378)	RINVOQ 45 mg (N=719)	Placebo (N=245)	RINVOQ 15 mg (N=250)	RINVOQ 30 mg (N=251)
Liver Transaminases	ALT ≥3 x ULN	2.9%	2.1%	1.8%	0.9%	2.6%	0%	1.5%	0.8%	2%	4%
	ALT ≥5 x ULN	0%	0.4%	0.5%	0%	0%	0%	0.4%	0.4%	0.4%	0.8%
	AST ≥3 x ULN	0.9%	1.5%	1.4%	0.9%	0.9%	0.3%	1.5%	0.4%	1.6%	2%
Creatine Phosphokinase Elevations	>5 x ULN	0.6%	2.4%	0.9%	1.4%	4.8%	0.3%	2.2%	1.2%	4.0%	6.4%
Absolute Neutrophil Count	<1000 cells/mm³	0%	0.9%	0%	0.9%	2.2%	0%	2.8%	0.8%	0.8%	2.4%
Absolute Lymphocyte Count	<500 cells/mm³	2.0%	2.2%	1.8%	3.7%	3.9%	0.8%	2%	0.8%	1.6%	0.8%
Hemoglobin	<8 g/dL	1.4%	2.7%	2.3%	1.4%	3.5%	2.1%	0.3%	1.2%	0.4%	0.4%

Lipid elevations: RINVOQ treatment was associated with increases in lipid parameters including total cholesterol, LDL cholesterol, and HDL cholesterol in placebo-controlled induction and maintenance studies.¹

Interested in the safety data of RINVOQ?

Review Safety Profile

	U-ACHIEVE Induction		U-ACCOMPLISH Induction
Baseline Characteristics²	Placebo (N=154)	RINVOQ 45 mg (upadacitinib) 45 mg(N=319)	Placebo (N=174)	RINVOQ 45 mg(N=341)
Female, %	37	38	39	37
Race (White), %	65	65	71	69
Median age, years	45	43	42	40
Median disease duration, years	6.0	6.6	4.9	5.6
Median weight, kg	70	69	72	71
Disease extent
Left-sided, %	48	50	51	48
Extensive/pancolitis, %	52	50	49	52
Median fecal calprotectin, mg/kg	1902	1780	1552	1655
Median hs-CRP, mg/L	4.7	4.1	4.7	3.8
Baseline immunosuppressant use, %	2	1	2	<1
Baseline aminosalicylates use, %	67	69	69	68
Baseline corticosteroid use,^a %	40	39	41	35
Baseline biologic experience^a
Bio-naïve,^b %	49	47	49	50
Bio-failure, %	51	53	51	50
Baseline Adapted Mayo Score^a
≤7,%	61	61	59	60
>7,%	39	39	41	40

Baseline Characteristics²	Placebo (N=149)	RINVOQ (upadacitinib) 15 mg QD(N=148)	RINVOQ 30 mg QD(N=154)
	U-ACHIEVE Maintenance
Female, %	43	36	44
Race (White), %	62	66	66
Median age, years	40	40	41
Median disease duration, years	6.2	6.4	6.0
Median weight, kg	70	72	69
Disease extent
Left-sided, %	53	45	44
Extensive/pancolitis, %	47	55	56
Median fecal calprotectin, mg/kg	1991	1718	1465
Median hs-CRP, mg/L	4	4	4
Baseline immunosuppressant use, %	0	<1	<1
Baseline aminosalicylates use, %	66	67	69
Baseline corticosteroid use^a, %	40	37	37
Baseline biologic experience^a
Bio-naïve,^b%	46	52	53
Bio-failure, %	54	48	47

	U-EXCEL MIXED POPULATION^a		U-EXCEED BIOLOGIC-FAILURE POPULATION^b
Baseline Characteristics²	Placebo (N=143)	RINVOQ 45 mg (upadacitinib)(N=295)	Placebo (N=146)	RINVOQ 45 mg (upadacitinib)(N=273)
Female, %	48	44	45	47
Race (White), %	74	75	76	70
Median age, years	40.0	37.0	34.5	36.0
Median disease duration, years	5.7	6.5	9.9	9.4
Median weight, kg	68.9	67.0	64.0	64.5
Median body mass index, kg/m²	24.4	22.9	22.6	22.8
Mean very soft/liquid stool frequency	5.4	5.4	6.4	6.0
Median CDAI	313.0	297.1	322.9	314.8
Mean AP score	2.0	2.0	1.9	2.0
Median SES-CD^c	12.0	12.0	12.5	13.0
Median fecal calprotectin, μg/g	1003.0	910.5	1161.5	1107.0
Median hs-CRP, mg/L	8.1	8.7	11.4	11.8
Baseline immunosuppressant use, %	2	4	9	7
Baseline aminosalicylates use, %	28	23	16	14
Baseline corticosteroid use,^c %	38	37	36	35
BASELINE BIOLOGIC EXPERIENCE^c
Bio-naive,^d %	57	54	N/A	N/A
Bio-failure,^b %	43	46	100	100
1 bio-failure, %	27	34	36	39
2 bio-failures, %	34	34	34	29
≥3 bio-failures, %	39	32	30	32

Baseline Characteristics²(At baseline of induction)	Placebo (N=111)	RINVOQ 15 mg (upadacitinib)(N=113)	RINVOQ 30 mg (upadacitinib)(N=119)
	U-ENDURE MIXED POPULATION^a
Female, %	47	43	41
Race (White), %	74	73	66
Median age, years	34.0	33.0	32.0
Median disease duration, years	7.8	8.4	6.5
Median weight, kg	63.0	65.0	63.0
Median body mass index, kg/m²	22.7	22.2	22.1
Mean very soft/liquid stool frequency	5.9	5.7	5.6
Median CDAI	330.0	326.6	319.8
Mean AP score	2.1	2.1	2.1
Median SES-CD	15.0	16.0	14.0
Median fecal calprotectin, mg/kg	1274.0	1778.0	1739.0
Median hs-CRP, mg/L	12.9	15.2	13.2
Baseline immunosuppressant use, %	7	4	4
Baseline aminosalicylates use, %	18	20	16
Baseline corticosteroid use, %^c	41	39	38
BASELINE BIOLOGIC EXPERIENCE
Bio-naive^b, %	22	25	24
Bio-failure^c, %	78	75	76
1 bio-failure, %	37	44	36
2 bio-failures, %	26	26	31
>3 bio-failures, %	37	31	33

PATIENT POPULATION	RECOMMENDED DOSAGE
Severe Renal Impairment (eGFR 15 to <30 mL/min/1.73 m²)	Induction for CD: 30 mg once daily for 12 weeks Induction for UC: 30 mg once daily for 8 weeks Maintenance for CD and UC: 15 mg once daily
Mild to Moderate Hepatic Impairment (Child-Pugh A or B)
Patients Receiving Strong CYP3A4 Inhibitors
End-Stage Renal Disease (eGFR <15 mL/min/1.73 m²)	RINVOQ is not recommended for use
Severe Hepatic Impairment (Child-Pugh C)	RINVOQ is not recommended for use

ONE PILL,
ONCE DAILY¹

RINVOQ Dosing

A Once-Daily Pill That Comes in 3 Dosage Strengths¹

Induction Dose

Maintenance Dose

Lab Monitoring & Dosing Considerations

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

ONE PILL, ONCE DAILY1

RINVOQ Dosing

A Once-Daily Pill That Comes in 3 Dosage Strengths1

Induction Dose

Maintenance Dose

Lab Monitoring & Dosing Considerations

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION & INDICATIONS1

INDICATIONS1

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

SERIOUS INFECTIONS

MORTALITY

MALIGNANCIES

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

THROMBOSIS

HYPERSENSITIVITY

GASTROINTESTINAL PERFORATIONS

LABORATORY ABNORMALITIES

EMBRYO-FETAL TOXICITY

VACCINATION

MEDICATION RESIDUE IN STOOL

LACTATION

HEPATIC IMPAIRMENT

ADVERSE REACTIONS

ONE PILL,
ONCE DAILY¹

A Once-Daily Pill That Comes in 3 Dosage Strengths¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION & INDICATIONS¹

INDICATIONS¹