STELARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90 MG/1 ML [SIN13996P]

Product Info

STELARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 90 MG/1 ML

[SIN13996P]

Indications
Plaque Psoriasis:
STELARA® is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate or PUVA.

Pediatric Plaque Psoriasis:
STELARA® is indicated for the treatment of pediatric patients (children and adolescents) (6 years and older) with moderate to severe plaque psoriasis who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Psoriatic Arthritis (PsA):
STELARA®, alone or in combination with methotrexate (MTX), is indicated for:

• the treatment of adult patients (18 years or older) with active psoriatic arthritis when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate

• inhibiting the progression of structural damage

Crohn’s Disease:
STELARA® is indicated for the treatment of adults with moderately to severe active Crohn’s disease who have:

• failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or

• failed or were intolerant to treatment with one or more TNF blockers

Ulcerative Colitis:
STELARA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Dosage and Administration
Dosage – Adults
Plaque Psoriasis
For the treatment of plaque psoriasis, STELARA® is administered by subcutaneous injection. STELARA® is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.

1. For patients weighing ≤ 100 kg, the recommended dose is 45 mg initially and 4 weeks later, followed by dosing every 12 weeks.

2. For patients weighing > 100 kg, alternatively a dose of 90 mg initially and 4 weeks later, followed by dosing every 12 weeks may be used.

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

Re-treatment
Re-treatment with a dosing regimen of Weeks 0 and 4, followed by 12 weeks dosing after interruption of therapy has been shown to be safe and effective.

Psoriatic Arthritis
For the treatment of psoriatic arthritis, STELARA® is administered by subcutaneous injection. The recommended dose of STELARA® is 45 mg administered at Weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg.

Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.

Crohn’s Disease and Ulcerative Colitis
In patients with Crohn’s disease and ulcerative colitis, the recommended treatment regimen is a single intravenous (IV) tiered dose of STELARA® based on body weight (Table 1), followed by 90 mg subcutaneous dosing 8 weeks later, then every 8 weeks thereafter (see Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For some patients, a single IV dose based on body weight (Table 1) followed by 90 mg subcutaneous dosing 8 weeks later, then every 12 weeks thereafter may be acceptable according to clinical judgment. Patients who inadequately respond to 90 mg subcutaneous dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Immunomodulators and/or corticosteroids may be continued during treatment with STELARA®. In patients who have responded to treatment with STELARA® corticosteroids may be reduced or discontinued in accordance with standard of care.

If therapy in Crohn’s disease or Ulcerative Colitis is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.

Dosage – Pediatric Population (6 years and older)
Plaque Psoriasis
For the treatment of plaque psoriasis, STELARA® should be administered by subcutaneous injection. The recommended dose of STELARA® based on body weight is shown below (Table 2). STELARA® should be administered at week 0 and 4, then every 12 weeks thereafter.
The pre-filled pen is not recommended for use in pediatric patients.

General Consideration for Administration
Subcutaneous administration
STELARA® is intended for use under the guidance and supervision of a physician. Patients or their caregivers may inject STELARA® if a physician determines that it is appropriate and with medical follow-up as necessary, after proper training in subcutaneous injection technique and disposal (see Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In pediatric patients, it is recommended that STELARA® be administered by a healthcare provider. The pre-filled pen has not been studied in the pediatric population and is not recommended for use in pediatric patients.

Comprehensive instructions for the subcutaneous administration of STELARA® are given in the “Patient Information Leaflet”. Patients should be instructed to inject the prescribed amount of STELARA® subcutaneously according to the directions provided in the patient information leaflet. The needle cover on the pre-filled syringe and the needle cover inside the bottom cap of the pre-filled pen contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex. Each pre-filled syringe and pre-filled pen is for single dose only. Patients may encounter resistance while injecting. It is important to instruct patients to inject the full amount to receive either 45 mg or 90 mg of STELARA®.

Do not inject STELARA® into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis [see the Patient Information Leaflet].

Before injection, remove STELARA® pre-filled pen from the refrigerator and allow STELARA® to reach room temperature (30 minutes) without removing the needle cap.

Inspect STELARA® visually for particulate matter and discoloration prior to administration. STELARA® is a colorless to light yellow solution and may contain a few small translucent or white particles. Do not use STELARA® if it is discolored or cloudy, or if other particulate matter is present. STELARA® does not contain preservatives; therefore, discard any unused product remaining in the vial, pre-filled syringe or pre-filled pen.

Intravenous infusion (Crohn’s Disease and Ulcerative Colitis)
STELARA® 130 mg vial is for IV infusion only. Intravenous infusion of STELARA® should be administered by qualified health-care professionals (for preparation, see Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations
Pediatrics
Studies of STELARA® in pediatric patients below 6 years of age have not been conducted. No studies have been conducted in pediatric patients with psoriatic arthritis, Crohn’s disease or ulcerative colitis.

Elderly
Of the 6710 patients exposed to STELARA®, a total of 353 were 65 years or older (183 patients with psoriasis, 69 patients with psoriatic arthritis, 58 with Crohn’s disease, and 43 patients with ulcerative colitis). No major age-related differences in clearance or volume of distribution were observed in clinical studies. Although no overall differences in safety or efficacy were observed between older and younger patients in clinical studies in approved indications, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

Renal impairment
Specific studies have not been conducted in patients with renal insufficiency.

Hepatic impairment
Specific studies have not been conducted in patients with hepatic insufficiency.

Contraindications
Severe hypersensitivity to ustekinumab or to any of the excipients (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).