ICHALIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45MG/0.5ML [SIN17553P]

Product Info

ICHALIG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45MG/0.5ML

[SIN17553P]

Indication

Indications

Plaque Psoriasis:

Ichalig 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:

Ichalig 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):

Ichalig, 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:

Ichalig 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

Dosing

Dosage and Administration

Dosage – Adults

Plaque Psoriasis

For the treatment of plaque psoriasis, Ustekinumab is administered by subcutaneous injection. Ustekinumab 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, ustekinumab is administered by subcutaneous injection. The recommended dose of ustekinumab 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

In patients with Crohn’s disease, the recommended treatment regimen is a single intravenous (IV) tiered dose of ustekinumab based on body weight (Table 1), followed by 90 mg subcutaneous dosing 8 weeks later, then every 8 weeks thereafter.

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 ustekinumab. In patients who have responded to treatment with ustekinumab corticosteroids may be reduced or discontinued in accordance with standard of care.

If therapy in Crohn’s disease 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, ustekinumab should be administered by subcutaneous injection. The recommended dose of ustekinumab based on body weight is shown below (Table 2). Ustekinumab should be administered at week 0 and 4, then every 12 weeks thereafter.

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

General Consideration for Administration
Subcutaneous administration
Ustekinumab is intended for use under the guidance and supervision of a physician. In pediatric patients, it is recommended that ustekinumab be administered by a healthcare provider. Patients or their caregivers may inject ustekinumab 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).

Comprehensive instructions for the subcutaneous administration of ustekinumab are given in the “Patient Information Leaflet”. Patients should be instructed to inject the prescribed amount of ustekinumab subcutaneously according to the directions provided in the patient information leaflet. The needle cover on the pre-filled syringe contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex. Each pre-filled syringe 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 ustekinumab.

Do not inject ustekinumab into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

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

Special populations
Pediatrics

Studies of ustekinumab 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.

Elderly

Of the 6667 patients exposed to ustekinumab, a total of 310 were 65 years or older (183 patients with psoriasis, 69 patients with psoriatic arthritis, 58 with Crohn’s disease). 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

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).