STELARA

STELARA- ustekinumab injection, solution
STELARA- ustekinumab solution
Janssen Biotech, Inc.

1 INDICATIONS AND USAGE

1.1 Psoriasis (Ps)

STELARA® is indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

1.2 Psoriatic Arthritis (PsA)

STELARA® is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).

1.3 Crohn’s Disease (CD)

STELARA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.

1.4 Ulcerative Colitis

STELARA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

2 DOSAGE AND ADMINISTRATION

2.1 Psoriasis

Subcutaneous Adult Dosage Regimen

  • For patients weighing 100 kg or less, the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.
  • For patients weighing more than 100 kg, the recommended dose 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 (6–17 years old) based on body weight is shown below (Table 1).

Table 1: Recommended Dose of STELARA® for Subcutaneous Injection in Pediatric Patients (6–17 years old) with 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 single-dose vial.

Table 2: Injection volumes of STELARA® 45 mg/0.5 mL single-dose vials for pediatric patients (6–17 years old) with psoriasis 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 0.13
17 12.8 0.14
18 13.5 0.15
19 14.3 0.16
20 15.0 0.17
21 15.8 0.17
22 16.5 0.18
23 17.3 0.19
24 18.0 0.20
25 18.8 0.21
26 19.5 0.22
27 20.3 0.22
28 21.0 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

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