What is mechanism of action?

mechanism of action is Interleukin-23 Antagonists [MoA] or Interleukin-12 Antagonists [MoA]

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Dosage & administration

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage (

2.1 Recommended Dosage in Plaque Psoriasis

Subcutaneous Adult Dosage Regimen

* For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
* For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects

[see Clinical Studies (14)]

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
more than 100 kg	90 mg

For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Table 2: Injection volumes of STELARA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic ArthritisRefer to 2.2 Psoriatic Arthritis; Subcutaneous Pediatric Dosage Regimen.Weighing Less Than 60 kg
Body Weight (kg) at the time of dosing	Dose (mg)	Volume of injection (mL)
15	11.3	0.12
16	12	0.13
17	12.8	0.14
18	13.5	0.15
19	14.3	0.16
20	15	0.17
21	15.8	0.17
22	16.5	0.18
23	17.3	0.19
24	18	0.20
25	18.8	0.21
26	19.5	0.22
27	20.3	0.22
28	21	0.23
29	21.8	0.24
30	22.5	0.25
31	23.3	0.26
32	24	0.27
33	24.8	0.27
34	25.5	0.28
35	26.3	0.29
36	27	0.3
37	27.8	0.31
38	28.5	0.32
39	29.3	0.32
40	30	0.33
41	30.8	0.34
42	31.5	0.35
43	32.3	0.36
44	33	0.37
45	33.8	0.37
46	34.5	0.38
47	35.3	0.39
48	36	0.4
49	36.8	0.41
50	37.5	0.42
51	38.3	0.42
52	39	0.43
53	39.8	0.44
54	40.5	0.45
55	41.3	0.46
56	42	0.46
57	42.8	0.47
58	43.5	0.48
59	44.3	0.49

)

Weight Range (kilograms)	Dosage
less than or equal to 100 kg	45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks
greater than 100 kg	90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks

Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage (

2.1 Recommended Dosage in Plaque Psoriasis

Subcutaneous Adult Dosage Regimen

In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects

[see Clinical Studies (14)]

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
more than 100 kg	90 mg

For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Table 2: Injection volumes of STELARA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic ArthritisRefer to 2.2 Psoriatic Arthritis; Subcutaneous Pediatric Dosage Regimen.Weighing Less Than 60 kg
Body Weight (kg) at the time of dosing	Dose (mg)	Volume of injection (mL)
15	11.3	0.12
16	12	0.13
17	12.8	0.14
18	13.5	0.15
19	14.3	0.16
20	15	0.17
21	15.8	0.17
22	16.5	0.18
23	17.3	0.19
24	18	0.20
25	18.8	0.21
26	19.5	0.22
27	20.3	0.22
28	21	0.23
29	21.8	0.24
30	22.5	0.25
31	23.3	0.26
32	24	0.27
33	24.8	0.27
34	25.5	0.28
35	26.3	0.29
36	27	0.3
37	27.8	0.31
38	28.5	0.32
39	29.3	0.32
40	30	0.33
41	30.8	0.34
42	31.5	0.35
43	32.3	0.36
44	33	0.37
45	33.8	0.37
46	34.5	0.38
47	35.3	0.39
48	36	0.4
49	36.8	0.41
50	37.5	0.42
51	38.3	0.42
52	39	0.43
53	39.8	0.44
54	40.5	0.45
55	41.3	0.46
56	42	0.46
57	42.8	0.47
58	43.5	0.48
59	44.3	0.49

)

: Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms)	Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
greater than 100 kg	90 mg

Psoriatic Arthritis Adult Subcutaneous Recommended Dosage (

2.2 Recommended Dosage in Psoriatic Arthritis

Subcutaneous Adult Dosage Regimen

* The recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
* For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).

Table 3: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kgFor pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

* The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
* For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

Psoriatic Arthritis Pediatric 6 years of Age and Older Subcutaneous Recommended Dosage (

2.2 Recommended Dosage in Psoriatic Arthritis

Subcutaneous Adult Dosage Regimen

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).

Table 3: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kgFor pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms)	Dose
less than 60 kg	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dose (

2.3 Recommended Dosage in Crohn's Disease and Ulcerative Colitis

Intravenous Induction Adult Dosage Regimen

A single intravenous infusion dose of STELARA using the weight-based dosage regimen specified in Table 4

[see Instructions for dilution of STELARA 130 mg vial for intravenous infusion (2.5)]

Table 4: Initial Intravenous Dosage of STELARA
Body Weight of Patient at the time of dosing	Dose	Number of 130 mg/26 mL (5 mg/mL) STELARA vials
55 kg or less	260 mg	2
more than 55 kg to 85 kg	390 mg	3
more than 85 kg	520 mg	4

Subcutaneous Maintenance Adult Dosage Regimen

The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

)

A single intravenous infusion using weight-based dosing:

Weight Range (kilograms)	Recommended Dose
up to 55 kg	260 mg (2 vials)
greater than 55 kg to 85 kg	390 mg (3 vials)
greater than 85 kg	520 mg (4 vials)

Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage (

2.3 Recommended Dosage in Crohn's Disease and Ulcerative Colitis

Intravenous Induction Adult Dosage Regimen

A single intravenous infusion dose of STELARA using the weight-based dosage regimen specified in Table 4

[see Instructions for dilution of STELARA 130 mg vial for intravenous infusion (2.5)]

Table 4: Initial Intravenous Dosage of STELARA
Body Weight of Patient at the time of dosing	Dose	Number of 130 mg/26 mL (5 mg/mL) STELARA vials
55 kg or less	260 mg	2
more than 55 kg to 85 kg	390 mg	3
more than 85 kg	520 mg	4

Subcutaneous Maintenance Adult Dosage Regimen

The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

)

A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

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Stelara prescribing information

Recent Major Changes

Warnings and Precautions

Serious Hypersensitivity Reactions (

5.5 Serious Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first intravenous dose of STELARA

[seeAdverse Reactions (6.1,6.3)].

If a severe or clinically significant hypersensitivity reaction occurs, discontinue STELARA immediately and initiate appropriate medical treatment

[seeContraindications (4)].

)

11/2025

Indications & Usage

STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of:

Adult patients with:

moderate to severe plaque psoriasis (PsO)
who are candidates for phototherapy or systemic therapy. (

1.1 Plaque Psoriasis (PsO)
STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
)
active psoriatic arthritis (PsA)
. (

1.2 Psoriatic Arthritis (PsA)
STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
)
moderately to severely active Crohn's disease (CD)
. (

1.3 Crohn's Disease (CD)
STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
)
moderately to severely active ulcerative colitis.
(

1.4 Ulcerative Colitis
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
)

Pediatric patients 6 years and older with:

moderate to severe plaque psoriasis (PsO)
, who are candidates for phototherapy or systemic therapy. (

1.1 Plaque Psoriasis (PsO)
STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
)
active psoriatic arthritis (PsA)
. (

1.2 Psoriatic Arthritis (PsA)
STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
)

Dosage & Administration

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage (

2.1 Recommended Dosage in Plaque Psoriasis

Subcutaneous Adult Dosage Regimen

For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects

[seeClinical Studies (14)]

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
more than 100 kg	90 mg

For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Table 2: Injection volumes of STELARA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic ArthritisRefer to 2.2 Psoriatic Arthritis; Subcutaneous Pediatric Dosage Regimen.Weighing Less Than 60 kg
Body Weight (kg) at the time of dosing	Dose (mg)	Volume of injection (mL)
15	11.3	0.12
16	12	0.13
17	12.8	0.14
18	13.5	0.15
19	14.3	0.16
20	15	0.17
21	15.8	0.17
22	16.5	0.18
23	17.3	0.19
24	18	0.20
25	18.8	0.21
26	19.5	0.22
27	20.3	0.22
28	21	0.23
29	21.8	0.24
30	22.5	0.25
31	23.3	0.26
32	24	0.27
33	24.8	0.27
34	25.5	0.28
35	26.3	0.29
36	27	0.3
37	27.8	0.31
38	28.5	0.32
39	29.3	0.32
40	30	0.33
41	30.8	0.34
42	31.5	0.35
43	32.3	0.36
44	33	0.37
45	33.8	0.37
46	34.5	0.38
47	35.3	0.39
48	36	0.4
49	36.8	0.41
50	37.5	0.42
51	38.3	0.42
52	39	0.43
53	39.8	0.44
54	40.5	0.45
55	41.3	0.46
56	42	0.46
57	42.8	0.47
58	43.5	0.48
59	44.3	0.49

)

Weight Range (kilograms)	Dosage
less than or equal to 100 kg	45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks
greater than 100 kg	90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks

Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage (

2.1 Recommended Dosage in Plaque Psoriasis

Subcutaneous Adult Dosage Regimen

For patients weighing 100 kg or less, the recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

In subjects weighing more than 100 kg, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy in these subjects

[seeClinical Studies (14)]

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with plaque psoriasis based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
more than 100 kg	90 mg

For pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.

Table 2: Injection volumes of STELARA 45 mg/0.5 mL Vials for Pediatric Patients 6 Years of Age and Older With Plaque Psoriasis and Pediatric Patients 6 Years of Age and Older With Psoriatic ArthritisRefer to 2.2 Psoriatic Arthritis; Subcutaneous Pediatric Dosage Regimen.Weighing Less Than 60 kg
Body Weight (kg) at the time of dosing	Dose (mg)	Volume of injection (mL)
15	11.3	0.12
16	12	0.13
17	12.8	0.14
18	13.5	0.15
19	14.3	0.16
20	15	0.17
21	15.8	0.17
22	16.5	0.18
23	17.3	0.19
24	18	0.20
25	18.8	0.21
26	19.5	0.22
27	20.3	0.22
28	21	0.23
29	21.8	0.24
30	22.5	0.25
31	23.3	0.26
32	24	0.27
33	24.8	0.27
34	25.5	0.28
35	26.3	0.29
36	27	0.3
37	27.8	0.31
38	28.5	0.32
39	29.3	0.32
40	30	0.33
41	30.8	0.34
42	31.5	0.35
43	32.3	0.36
44	33	0.37
45	33.8	0.37
46	34.5	0.38
47	35.3	0.39
48	36	0.4
49	36.8	0.41
50	37.5	0.42
51	38.3	0.42
52	39	0.43
53	39.8	0.44
54	40.5	0.45
55	41.3	0.46
56	42	0.46
57	42.8	0.47
58	43.5	0.48
59	44.3	0.49

)

: Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms)	Dose
less than 60 kg	0.75 mg/kg
60 kg to 100 kg	45 mg
greater than 100 kg	90 mg

Psoriatic Arthritis Adult Subcutaneous Recommended Dosage (

2.2 Recommended Dosage in Psoriatic Arthritis

Subcutaneous Adult Dosage Regimen

The recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).

Table 3: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kgFor pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

Psoriatic Arthritis Pediatric 6 years of Age and Older Subcutaneous Recommended Dosage (

2.2 Recommended Dosage in Psoriatic Arthritis

Subcutaneous Adult Dosage Regimen

The recommended dosage is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dosage is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Subcutaneous Pediatric Dosage Regimen

Administer STELARA subcutaneously at Weeks 0 and 4, then every 12 weeks thereafter.

The recommended dose of STELARA for pediatric patients 6 years of age and older with psoriatic arthritis, based on body weight, is shown below (Table 3).

Table 3: Recommended Dose of STELARA for Subcutaneous Injection in Pediatric Patients 6 Years of Age and Older With Psoriatic Arthritis
Body Weight of Patient at the Time of Dosing	Recommended Dose
less than 60 kgFor pediatric patients weighing less than 60 kg, the administration volume for the recommended dose (0.75 mg/kg) is shown in Table 2; withdraw the appropriate volume from the vial.	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.

Weight Range (kilograms)	Dose
less than 60 kg	0.75 mg/kg
60 kg or more	45 mg
greater than 100 kg with co-existent moderate-to-severe plaque psoriasis	90 mg

Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dose (

2.3 Recommended Dosage in Crohn's Disease and Ulcerative Colitis

Intravenous Induction Adult Dosage Regimen

A single intravenous infusion dose of STELARA using the weight-based dosage regimen specified in Table 4

[seeInstructions for dilution of STELARA 130 mg vial for intravenous infusion (2.5)]

Table 4: Initial Intravenous Dosage of STELARA
Body Weight of Patient at the time of dosing	Dose	Number of 130 mg/26 mL (5 mg/mL) STELARA vials
55 kg or less	260 mg	2
more than 55 kg to 85 kg	390 mg	3
more than 85 kg	520 mg	4

Subcutaneous Maintenance Adult Dosage Regimen

The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

)

A single intravenous infusion using weight-based dosing:

Weight Range (kilograms)	Recommended Dose
up to 55 kg	260 mg (2 vials)
greater than 55 kg to 85 kg	390 mg (3 vials)
greater than 85 kg	520 mg (4 vials)

Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage (

2.3 Recommended Dosage in Crohn's Disease and Ulcerative Colitis

Intravenous Induction Adult Dosage Regimen

A single intravenous infusion dose of STELARA using the weight-based dosage regimen specified in Table 4

[seeInstructions for dilution of STELARA 130 mg vial for intravenous infusion (2.5)]

Table 4: Initial Intravenous Dosage of STELARA
Body Weight of Patient at the time of dosing	Dose	Number of 130 mg/26 mL (5 mg/mL) STELARA vials
55 kg or less	260 mg	2
more than 55 kg to 85 kg	390 mg	3
more than 85 kg	520 mg	4

Subcutaneous Maintenance Adult Dosage Regimen

The recommended maintenance dosage is a subcutaneous 90 mg dose administered 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

)

A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

Dosage Forms & Strengths

STELARA (ustekinumab) is a colorless to light yellow solution and may contain a few small translucent or white particles.

Pregnancy & Lactation

Risk Summary

Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby STELARA Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not identified a STELARA-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes

(see

Data

Human Data

An observational pregnancy registry conducted by (OTIS)/MotherToBaby in the U.S. and Canada (enrollment between 2013 and 2019) assessed the risk of major birth defects, pattern of major and minor anomalies in live-born infants, miscarriage, and adverse infant outcomes in women with STELARA exposure. In the registry study, there were 101 participants and 107 pregnancies with exposure to STELARA (88 prospective; 19 retrospective). Most participants had a primary indication of CD (65.4%) or psoriasis (30.8%). The pregnancy registry did not identify a STELARA -associated risk of major birth defects, pattern of major or minor anomalies, increased risk of miscarriage or adverse infant outcomes. Methodological limitations of the registry include small sample size, lack of an internal comparison group, a mix of prospective and retrospective reports, and unmeasured confounders. The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance.

Animal Data

Ustekinumab was tested in two embryo-fetal development toxicity studies in cynomolgus monkeys. No teratogenic or other adverse developmental effects were observed in fetuses from pregnant monkeys that were administered ustekinumab subcutaneously twice weekly or intravenously weekly during the period of organogenesis. Serum concentrations of ustekinumab in pregnant monkeys were greater than 100 times the serum concentration in patients treated subcutaneously with 90 mg of ustekinumab weekly for 4 weeks.

In a combined embryo-fetal development and pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of ustekinumab twice weekly at exposures greater than 100 times the MRHD from the beginning of organogenesis to Day 33 after delivery. Neonatal deaths occurred in the offspring of one monkey administered ustekinumab at 22.5 mg/kg and one monkey dosed at 45 mg/kg. No ustekinumab-related-effects on functional, morphological, or immunological development were observed in the neonates from birth through six months of age.

)

. There are risks to the mother and the fetus associated with inflammatory bowel disease (IBD) in pregnancy. In animal reproductive and developmental toxicity studies, no adverse developmental effects were observed in offspring after administration of ustekinumab to pregnant monkeys at exposures greater than 100 times the maximum recommended human dose (MRHD).

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Contraindications

STELARA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients in STELARA

[see

5.5 Serious Hypersensitivity Reactions

[seeAdverse Reactions (6.1,6.3)].

If a severe or clinically significant hypersensitivity reaction occurs, discontinue STELARA immediately and initiate appropriate medical treatment

[seeContraindications (4)].

Warnings & Precautions

Infections
: Serious infections have occurred. Avoid starting STELARA during any clinically important active infection. If a serious infection or clinically significant infection develops, discontinue STELARA until the infection resolves. (
5.1 Infections
STELARA may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving STELARA
[seeAdverse Reactions (6.1,6.3)]
.
Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:
- Plaque Psoriasis
  : diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
- Psoriatic arthritis
  : cholecystitis.
- Crohn's disease
  : anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
- Ulcerative colitis
  : gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
Avoid initiating treatment with STELARA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA in patients with a chronic infection or a history of recurrent infection.
Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA and discontinue STELARA for serious or clinically significant infections until the infection resolves or is adequately treated.
)
Theoretical Risk for Particular Infections
: Serious infections from mycobacteria, salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. (

5.2 Theoretical Risk for Vulnerability to Particular Infections
Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients.
It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA may be susceptible to these types of infections. Consider appropriate diagnostic testing, (e.g., tissue culture, stool culture, as dictated by clinical circumstances).
)
Tuberculosis (TB)
: Evaluate patients for TB prior to initiating treatment with STELARA. Initiate treatment of latent TB before administering STELARA. (

5.3 Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis infection prior to initiating treatment with STELARA.
Avoid administering STELARA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering STELARA. Consider anti-tuberculosis therapy prior to initiation of STELARA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving STELARA for signs and symptoms of active tuberculosis during and after treatment.
)
Malignancies
: STELARA may increase risk of malignancy. The safety of STELARA in patients with a history of or a known malignancy has not been evaluated. (

5.4 Malignancies
STELARA is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA in clinical trials
[seeAdverse Reactions (6.1)]
. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy
[seeNonclinical Toxicology (13)]
.
The safety of STELARA has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving STELARA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment
[seeAdverse Reactions (6.1)]
.
)
Serious Hypersensitivity Reactions
: If a severe or other clinically significant hypersensitivity reaction occurs, discontinue STELARA immediately and initiate appropriate medical treatment. (
5.5 Serious Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first intravenous dose of STELARA
[seeAdverse Reactions (6.1,6.3)].
If a severe or clinically significant hypersensitivity reaction occurs, discontinue STELARA immediately and initiate appropriate medical treatment
[seeContraindications (4)].
)
Posterior Reversible Encephalopathy Syndrome (PRES)
: If PRES is suspected, treat promptly, and discontinue STELARA. (

5.6 Posterior Reversible Encephalopathy Syndrome (PRES)
Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
Monitor all patients treated with STELARA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA.
)
Immunizations:
Avoid use of live vaccines in patients during treatment with STELARA . (

5.7 Immunizations
Prior to initiating therapy with STELARA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STELARA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA because of the potential risk for shedding from the household contact and transmission to patient.
Non-live vaccinations received during a course of STELARA may not elicit an immune response sufficient to prevent disease.
)
Noninfectious Pneumonia
: Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA. If diagnosis is confirmed, discontinue STELARA and institute appropriate treatment. (

5.8 Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA and institute appropriate treatment
[seePostmarketing Experience (6.3)]
.
)

Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the label:

Infections
[see
5.1 Infections
STELARA may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving STELARA
[seeAdverse Reactions (6.1,6.3)]
.
Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following:
Plaque Psoriasis
: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections.
Psoriatic arthritis
: cholecystitis.
Crohn's disease
: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
Ulcerative colitis
: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.
Avoid initiating treatment with STELARA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA in patients with a chronic infection or a history of recurrent infection.
Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA and discontinue STELARA for serious or clinically significant infections until the infection resolves or is adequately treated.
]
Malignancies
[see
5.4 Malignancies
STELARA is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among subjects who received STELARA in clinical trials
[seeAdverse Reactions (6.1)]
. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy
[seeNonclinical Toxicology (13)]
.
The safety of STELARA has not been evaluated in patients who have a history of malignancy or who have a known malignancy.
There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving STELARA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment
[seeAdverse Reactions (6.1)]
.
]
Serious Hypersensitivity Reactions
[see
5.5 Serious Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA in clinical trials and postmarketing. Some serious hypersensitivity reactions have occurred during the first intravenous dose of STELARA
[seeAdverse Reactions (6.1,6.3)].
If a severe or clinically significant hypersensitivity reaction occurs, discontinue STELARA immediately and initiate appropriate medical treatment
[seeContraindications (4)].
]
Posterior Reversible Encephalopathy Syndrome (PRES)
[see
5.6 Posterior Reversible Encephalopathy Syndrome (PRES)
Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis, and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.
Monitor all patients treated with STELARA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA.
]
Noninfectious Pneumonia
[see
5.8 Noninfectious Pneumonia
Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA and institute appropriate treatment
[seePostmarketing Experience (6.3)]
.
]

Drug Interactions

In trials in subjects with plaque psoriasis the safety of STELARA in combination with immunosuppressive agents or phototherapy has not been evaluated . In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In trials in subjects with Crohn's disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of STELARA.

Description

Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.

STELARA
^®(ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7– 6.3.

Pharmacology

Ustekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In

in vitro

models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rβ1. The cytokines IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis. In animal models of colitis, genetic absence or antibody blockade of the p40 subunit of IL-12 and IL-23, the target of ustekinumab, was shown to be protective.

Nonclinical Toxicology

Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of STELARA. Published literature showed that administration of murine IL-12 caused an anti-tumor effect in mice that contained transplanted tumors and IL-12/IL-23p40 knockout mice or mice treated with anti-IL-12/IL-23p40 antibody had decreased host defense to tumors. Mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12 alone developed UV-induced skin cancers earlier and more frequently compared to wild-type mice. The relevance of these experimental findings in mouse models for malignancy risk in humans is unknown.

No effects on fertility were observed in male cynomolgus monkeys that were administered ustekinumab at subcutaneous doses up to 45 mg/kg twice weekly (45 times the MRHD on a mg/kg basis) prior to and during the mating period. However, fertility and pregnancy outcomes were not evaluated in mated females.

No effects on fertility were observed in female mice that were administered an analogous IL-12/IL-23p40 antibody by subcutaneous administration at doses up to 50 mg/kg, twice weekly, prior to and during early pregnancy.

Clinical Studies

Two multicenter, randomized, double-blind, placebo-controlled trials (Ps STUDY 1 and Ps STUDY 2) enrolled a total of 1996 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy. Subjects with guttate, erythrodermic, or pustular psoriasis were excluded from the trials.

Ps STUDY 1 enrolled 766 subjects and Ps STUDY 2 enrolled 1230 subjects. The trials had the same design through Week 28. In both trials, subjects were randomized in equal proportion to placebo, 45 mg or 90 mg of STELARA. Subjects randomized to STELARA received 45 mg or 90 mg doses, regardless of weight, at Weeks 0, 4, and 16. Subjects randomized to receive placebo at Weeks 0 and 4 crossed over to receive STELARA (either 45 mg or 90 mg) at Weeks 12 and 16.

In both trials, subjects in all treatment groups had a median baseline PASI score ranging from approximately 17 to 18. Baseline PGA score was marked or severe in 44% of subjects in Ps STUDY 1 and 40% of subjects in Ps STUDY 2. Approximately two-thirds of all subjects had received prior phototherapy, 69% had received either prior conventional systemic or biologic therapy for the treatment of psoriasis, with 56% receiving prior conventional systemic therapy and 43% receiving prior biologic therapy. A total of 28% of subjects had a history of psoriatic arthritis.

In both trials, the endpoints were the proportion of subjects who achieved at least a 75% reduction in PASI score (PASI 75) from baseline to Week 12 and treatment success (cleared or minimal) on the Physician's Global Assessment (PGA). The PGA is a 6-category scale ranging from 0 (cleared) to 5 (severe) that indicates the physician's overall assessment of psoriasis focusing on plaque thickness/induration, erythema, and scaling.

How Supplied/Storage & Handling

STELARA
^®(ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials.

Instructions for Use

INSTRUCTIONS FOR USE

STELARA (stel ar a)

(ustekinumab)

injection, for subcutaneous use

This Instructions for Use contains information on how to inject STELARA using a vial.

Read this Instructions for Use before you start using STELARA. A healthcare provider should show you how to prepare, measure the dose, and give an injection of STELARA the right way.

If you cannot give the injection:

ask your healthcare provider to help you, or
ask someone who has been trained by a healthcare provider to give the injections.

Do not try to inject STELARA until you have been shown how to inject STELARA by a healthcare provider.

Important information You Need to Know Before Injecting STELARA:

Before you start, check the carton to make sure that it is the right dose. You will have either 45 mg or 90 mg as prescribed by the healthcare provider.
- If the dose is 45 mg or less you will receive one 45 mg vial.
- If the dose is 90 mg, you will receive two 45 mg vials
  
  and you will need to give two injections, one right after the other.
Check the expiration date on the vial and carton. If the expiration date has passed, do not use it. If the expiration date has passed, call the healthcare provider or pharmacist, or call 1-800-526-7736 for help.
Check the vial for any particles or discoloration. The liquid in the vial should look clear and colorless to light yellow with a few small clear or white particles.
Do not use if it is frozen, discolored, cloudy or has large particles. Get a new vial.
Do not shake the vial at any time.
Shaking the vial may damage the STELARA medicine. If the vial has been shaken, do not use it. Get a new vial.
Do not use a STELARA vial more than one time, even if there is medicine left in the vial. After the rubber stopper is punctured, STELARA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused STELARA after you give the injection.
Safely throw away (dispose of) STELARA vials, needles, and syringes after use. See "

Step 6: Disposing of the needles, syringes, and vials.
"
Do not re-use syringes or needles.
To avoid needle-stick injuries,

do not
recap needles.

Storing STELARA vials

Store STELARA vials in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store STELARA vials standing up straight (upright).
Store STELARA vials in the original carton to protect from light until the time of use.
Do not
freeze STELARA vials.

Keep STELARA and all medicines out of the reach of children.

Gather the supplies you will need to prepare STELARA and to give your injection. (See

Figure A)

You will need:

a syringe with the needle attached, you will need a prescription from a healthcare provider to get syringes with the needles attached from a pharmacy.
antiseptic wipes
cotton balls or gauze pads
adhesive bandage
your prescribed dose of STELARA
FDA-cleared sharps disposal container. See "

Step 6: Disposing of the needles, syringes, and vials.
"

Figure A

Referenced Image

Step 1: Preparing the injection.

Choose a well-lit, clean, flat work surface.
Wash your hands well with soap and warm water.

Step 2: Preparing your injection site

Choose an injection site around your stomach area (abdomen), buttocks, and upper legs (thighs).
If a caregiver is giving you the injection, the outer area of the upper arms may also be used.

(See

Figure B)
Use a different injection site for each injection. Do not
give an injection in an area of the skin that is tender, bruised, red or hard.
Clean the skin with an antiseptic wipe where you plan to give the injection.
Do not
touch this area again before giving the injection. Let the skin dry before injecting.
Do not
fan or blow on the clean area.

Figure B

Referenced Image

*Areas in gray are recommended injection sites.

Step 3: Preparing the vial

Remove the cap from the top of the vial. Throw away the cap but do not remove the rubber stopper.

(See

Figure C)

Figure C

Referenced Image

Clean the rubber stopper with an antiseptic wipe.

(See

Figure D)

Figure D

Referenced Image

Do not touch the rubber stopper after you clean it.
Put the vial on a flat surface.

Step 4: Preparing the syringe

Pick up the syringe with the needle attached.
Remove the cap that covers the needle.

(See

Figure E)
Throw the needle cap away. Do not touch the needle or allow the needle to touch anything.

Figure E

Referenced Image

Carefully pull back on the plunger to the line that matches the dose prescribed by the healthcare provider.
Hold the vial between your thumb and index (pointer) finger.
Use your other hand to push the syringe needle through the center of the rubber stopper.

(See

Figure F)

Figure F

Referenced Image

Push down on the plunger until all of the air has gone from the syringe into the vial.
Turn the vial and the syringe upside down.

(See

Figure G)
Hold the STELARA vial with one hand.
It is important that the needle is always in the liquid in order to prevent air bubbles forming in the syringe.
Pull back on the syringe plunger with your other hand.
Fill the syringe until the black tip of the plunger lines up with the mark that matches the prescribed dose.

Figure G

Referenced Image

Do not remove the needle from the vial.
Hold the syringe with the needle pointing up to see if it has any air bubbles inside.
If there are air bubbles, gently tap the side of the syringe until the air bubbles rise to the top.

(See

Figure H)
Slowly press the plunger up until all of the air bubbles are out of the syringe (but none of the liquid is out).
Remove the syringe from the vial. Do not lay the syringe down or allow the needle to touch anything.

Figure H

Referenced Image

Step 5: Injecting STELARA

Hold the barrel of the syringe in one hand, between the thumb and index fingers.
Do not
pull back on the plunger at any time.
Use the other hand to gently pinch the cleaned area of skin. Hold firmly.
Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45-degree angle.

(See

Figure I)

Figure I

Referenced Image

Push the plunger with your thumb as far as it will go to inject all of the liquid. Push it slowly and evenly, keeping the skin gently pinched.
When the syringe is empty, pull the needle out of the skin and then let go of the skin.

(See

Figure J)

Figure J

Referenced Image

When the needle is pulled out of the skin, there may be a little bleeding at the injection site. This is normal. You can press a cotton ball or gauze pad to the injection site if needed. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.

If the dose is 90 mg, you will receive two 45 mg vials and you will need to give a second injection right after the first. Repeat Steps 1 to 5 using a new syringe.

Choose a different site for the second injection.

Step 6: Disposing of the needles, syringes, and vials.

Do not
re-use a syringe or needle.
To avoid needle-stick injuries, do not recap a needle.
Put the needles and syringes in an FDA-cleared sharps disposal container right away after use.

Do not throw away (dispose of) needles and syringes in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant,
- and properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how to throw away syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your sharps disposal container.
Throw away the vial into the container where you put the syringes and needles.
If you have any questions, talk to your healthcare provider or pharmacist.

Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, USA License No. 1864 at Cilag AG, Schaffhausen, Switzerland

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 06/2025

Mechanism of Action

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