Dosing and Administration | SKYRIZI® (risankizumab-rzaa)

The IL-23 inhibitor from AbbVie indicated for the treatment of moderately to severely active Crohn's disease (CD) in adults.¹

RELIABLE DOSING SCHEDULE
AND THE OPTION TO
SELF-ADMINISTER AFTER TRAINING

RELIABLE DOSING SCHEDULE

SC Injection every 8 Weeks at Home or in the Office After 3 IV Infusions¹

INDUCTION

3 IV Infusions

(600 mg per dose)

Administer each dose of SKYRIZI
over at least 1 hour

SKYRIZI 600 mg/10 mL: NDC Code 0‍0‍7‍4‍-‍5‍0‍1‍5‍-‍0‍1 (Carton of 1)

IV=intravenous

MAINTENANCE

Only 6 SC Doses
Per Year

(180 mg/1.2 mL or 360 mg/2.4 mL)

On-Body Injector (OBI) with SKYRIZI
prefilled cartridge for SC injection

Use the lowest effective dosage to maintain therapeutic response

SKYRIZI 180 mg/1.2 mL: NDC Code 0‍0‍7‍4‍-‍1‍0‍6‍5‍-‍0‍1 (Kit)

SKYRIZI 360 mg/2.4 mL: NDC Code 0‍0‍7‍4‍-‍1‍0‍7‍0‍-‍0‍1 (Kit)

SC=subcutaneous

Download the Dosing Card

ADMINISTRATION CONSIDERATIONS: SKYRIZI is intended for use under the guidance and supervision of a healthcare professional (HCP). SKYRIZI vial for intravenous administration is intended for administration by an HCP. Prior to starting therapy, please refer to the Dosage and Administration section of the Prescribing Information for complete information on how to initiate, prepare, and administer SKYRIZI. Patients may self-inject SKYRIZI using the on‑body injector with prefilled cartridge after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI according to the Instructions for Use.¹

LAB MONITORING

Lab Monitoring

Treatment Considerations in Crohn's Disease¹

Perform lab testing for these laboratory parameters: liver enzymes and bilirubin. Check lab value: Evaluate at baseline and during induction (for at least 12 weeks) Monitor thereafter according to routine management. Treatment should not be initiated or continued if drug-induced liver injury is suspected, until this diagnosis is excluded. Consider other treatment options in patients with evidence of liver cirrhosis. A prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.

Infections: SKYRIZI may increase the risk of infections. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, monitor the patient closely and do not administer SKYRIZI until the infection resolves.

Tuberculosis (TB): Evaluate for TB infection prior to initiating treatment with SKYRIZI.

Vaccinations: Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating treatment with SKYRIZI.

ON-BODY INJECTOR (OBI)

INTRODUCING THE ON-BODY INJECTOR (OBI) FOR CD PATIENTS

Single-use SC Injector with SKYRIZI Prefilled Cartridge

Transcript

DESIGNED WITH YOUR PATIENTS IN MIND

COMPACT SIZE

Small enough to fit in the palm of the hand

HANDS-FREE

While adhered to the abdomen or thigh and after activation, patients can do moderate physical activities such as walking, reaching and bending

HIDDEN NEEDLE

Discreet injection so patients don't see the needle

DOSE DELIVERED IN 5 MINUTES

Following preparation steps

AUDIO & VISUAL CUES

Notifies when full dose has been delivered

Have you seen this video on
how to inject SKYRIZI using the ON-BODY INJECTOR (OBI)?

Watch Now

The SKYRIZI "Instructions for Use" includes the full set of detailed instructions on the preparation and administration of SKYRIZI. Instruct the patient to read before administration.

5 P's TO HELP YOUR PATIENTS REMEMBER

1 PREPARE

Gather alcohol wipes, gauze pads or cotton balls, and sharps disposal container.

2 PICK

Pick a place on the thigh or abdomen to inject.

3 PEEL

Peel the 2 green pull tabs to reveal the adhesive without touching the needle.

4 PLACE

Place the OBI onto the skin. Ensure that the status light is visible.

5 PRESS

Press and release the gray start button to begin. A flashing green light will appear. When the injection is complete, the green light goes solid.

Click here to view the instructions for use

ADMINISTRATION CONSIDERATIONS: SKYRIZI is intended for use under the guidance and supervision of a healthcare professional (HCP). Patients may self-inject SKYRIZI using the on-body injector with prefilled cartridge after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI according to the Instructions for Use.¹

46 patients participated in a questionnaire on their experience using the OBI (interim analysis)²:

93%

(42/45) of patients reported the OBI was “easy to use” or “very easy to use” after the first use.²

DESCRIPTION: In an ongoing open label, two-arm multicenter study evaluating the SKYRIZI On-Body Injector (N=46), interim analysis for patient experience was reported through questions within 6 domains of a validated Self-Injection Assessment Questionnaire (SIAQ). Data includes percent of patients reporting easy/very easy from a single item in the ease-of-use domain after the initial injection at Week 0 of the open-label study. All data reported are as observed. The SKYRIZI OBI was not evaluated in the primary analyses of the Phase 3 Clinical Trials in CD.²

HAVE YOU EXPLORED SKYRIZI'S
SAFETY PROFILE?

EXPLORE SAFETY

ARE YOU LOOKING FOR
MORE SKYRIZI RESOURCES?

DOWNLOAD RESOURCES

	ADVANCE N=850
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active CD: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Bio-naïve^d or biologic failure^e

	MOTIVATE N=569
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 12
DURATION	12-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, corticosteroids, and Crohn's-related antibiotics
DOSING	IV infusion of SKYRIZI 600 mg, risankizumab-rzaa 1200 mg^c or placebo, at Weeks 0, 4, and 8
INCLUSION CRITERIA	Moderately to severely active CD: CDAI 220-450 Average daily SF ≥4 or APS ≥2 SES-CD ≥6 (≥4 for isolated ileitis), exluding the narrowing component 16-80 years old Biologic failure^e

	FORTIFY N=382
CO-PRIMARY ENDPOINTS	Endoscopic Response^a (>50% decrease in SES-CD) and Clinical Remission^b (CDAI <150) at Week 52
DURATION	52-week, randomized, double-blind, placebo-controlled, multi-center study
CONCOMITANT THERAPIES	All patients may have received concomitant conventional therapies that included 5-aminosalicylates, immunomodulators, and Crohn's-related antibiotics Patients taking corticosteroids at the start of FORTIFY had their therapy tapered
DOSING	Subcutaneous injection of SKYRIZI 180 mg, SKYRIZI 360 mg or placebo starting at Week 12 and every 8 weeks after
INCLUSION CRITERIA	Moderately to severely active CD: Entry and completion of ADVANCE or MOTIVATE. Completion includes the final endoscopy of ADVANCE or MOTIVATE Achieved Clinical Response^f in ADVANCE or MOTIVATE studies

FORTIFY		Placebo (Induction Responder) N=130	SKYRIZI 180 mg SC N=135	SKYRIZI 360 mg SC N=117
BASELINE OF INDUCTION (ADVANCE, MOTIVATE)
	Male, n (%)	72 (55.4)	62 (45.9)	67 (57.3)
	Age (years), mean (SD)	38.0 (12.8)	39.2 (14.7)	36.2 (12.6)
	Disease duration (years), mean (SD)	9.6 (8.2)	10.6 (10.2)	8.6 (7.1)
	Baseline immunomodulatorimmuno- modulator use, n (%)	33 (25.4)	37 (27.4)	34 (29.1)
	Baseline steroid use, n (%)	40 (30.8)	47 (34.8)	36 (30.8)
	Biologics failure history
	0, n (%)	31 (23.8)	40 (29.6)	34 (29.1)
	1, n (%)	49 (37.7)	34 (25.2)	42 (35.9)
	>1, n (%)	50 (38.5)	61 (45.2)	41 (35.0)
	Baseline CDAI, mean (SD)	314.2 (64.2)	327.6 (68.2)	316.2 (59.6)
	Baseline SES-CD, mean (SD)	14.1 (7.1)	14.9 (7.2)	14.3 (7.0)
	Baseline SF, mean (SD)	5.8 (2.7)	6.2 (3.1)	5.9 (2.7)
	Baseline APS, mean (SD)	1.9 (0.5)	2.0 (0.4)	1.9 (0.5)
	Baseline FCP (mg/kg), median (min,max)	904.0 (30, 11378)	1666.0 (30, 28800)	1622.0 (30, 14649)
	Baseline hs-CRP (mg/L), median (min,max)	7.9 (0.3, 181)	8.7 (0.4, 151)	10.6 (0.3, 129)

Week 0 of Maintenance
	CDAI at Week 0, mean (SD)	111.6 (69.5)	117.6 (66.8)	125.4 (62.7)
	SES-CD at Week 0, mean (SD)	7.9 (6.4)	7.8 (6.4)	8.3 (7.3)
	SF at Week 0, mean (SD)	1.4 (1.7)	2.1 (1.9)	1.9 (1.7)
	APS at Week 0, mean (SD)	0.6 (0.5)	0.6 (0.5)	0.6 (0.5)
	FCP (mg/kg) at Week 0, median (min,max)	300.0 (30, 22912)	361 (30, 28800)	485.5 (30, 14804)
	hs-CRP (mg/L) at Week 0, median (min,max)	3.6 (0, 42)	3.7 (0, 48)	4.0 (0, 258)

RELIABLE DOSING SCHEDULE
AND THE OPTION TO
SELF-ADMINISTER AFTER TRAINING

RELIABLE DOSING SCHEDULE

3 IV Infusions

Only 6 SC Doses
Per Year

Lab Monitoring

INTRODUCING THE ON-BODY INJECTOR (OBI) FOR CD PATIENTS

5 P's TO HELP YOUR PATIENTS REMEMBER

46 patients participated in a questionnaire on their experience using the OBI (interim analysis)²:

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

largest phase 3 clinical program in crohn's disease TO DATE*

largest phase 3 clinical program in crohn's disease TO DATE*
1,419 PATIENTS ENROLLED ACROSS TRIALS

Phase 3 Clinical program: Study Design Details^1-5

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

Phase 3 clinical program: baseline characteristics^1,2

ADVANCE

Placebo
N=175

SKYRIZI 600 mg IV
N=336

MOTIVATE

Placebo
N=187

SKYRIZI 600 mg IV
N=191

FORTIFY

Placebo
(Induction Responder)
N=130

SKYRIZI
180 mg SC
N=135

SKYRIZI
360 mg SC
N=117

FORTIFY

Placebo (Induction Responder)
N=164

SKYRIZI 360mg SC
N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

RELIABLE DOSING SCHEDULE AND THE OPTION TO SELF-ADMINISTER AFTER TRAINING

RELIABLE DOSING SCHEDULE

3 IV Infusions

Only 6 SC Doses Per Year

Lab Monitoring

INTRODUCING THE ON-BODY INJECTOR (OBI) FOR CD PATIENTS

5 P's TO HELP YOUR PATIENTS REMEMBER

46 patients participated in a questionnaire on their experience using the OBI (interim analysis)2:

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

ADVANCE N=850

MOTIVATE N=569

FORTIFY N=382

ADVANCE

Placebo N=175

SKYRIZI 600 mg IV N=336

MOTIVATE

Placebo N=187

SKYRIZI 600 mg IV N=191

FORTIFY

Placebo (Induction Responder) N=130

SKYRIZI 180 mg SC N=135

SKYRIZI 360 mg SC N=117

FORTIFY

Placebo (Induction Responder) N=164

SKYRIZI 360mg SC N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)1

RELIABLE DOSING SCHEDULE
AND THE OPTION TO
SELF-ADMINISTER AFTER TRAINING

Only 6 SC Doses
Per Year

46 patients participated in a questionnaire on their experience using the OBI (interim analysis)²:

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

ADVANCE
N=850

MOTIVATE
N=569

FORTIFY
N=382

Placebo
N=175

SKYRIZI 600 mg IV
N=336

Placebo
N=187

SKYRIZI 600 mg IV
N=191

Placebo
(Induction Responder)
N=130

SKYRIZI
180 mg SC
N=135

SKYRIZI
360 mg SC
N=117

Placebo (Induction Responder)
N=164

SKYRIZI 360mg SC
N=141

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR SKYRIZI® (risankizumab-rzaa)¹