TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML

CILAG AG (SWITZERLAND)🇸🇬 Health Sciences Authority

Approval Date: Jan 17, 2020
Approval ID: c98d29f10a821f7f
Company: CILAG AG (SWITZERLAND)
Type: Therapeutic

Approval Details

Approval Id: c98d29f10a821f7f
Drug Name: TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
Product Name: TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
Approval Number: SIN15876P
Approval Date: 2020-01-17
Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence Holder: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: Dosage and Administration Dosage – Adults (18 years of age and older) TREMFYA® is administered by intravenous infusion or subcutaneous injection. Plaque psoriasis The recommended dosage of TREMFYA® is 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Psoriatic arthritis The recommended dose of TREMFYA® is 100 mg to be given as subcutaneous injection at weeks 0 and 4 and every 8 weeks thereafter. For patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered (see Clinical studies, Radiographic response – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). TREMFYA® may be administered alone or in combination with a conventional synthetic disease-modifying antirheumatic drug (csDMARD) (e.g., methotrexate). Ulcerative colitis Induction: The recommended induction dosage of TREMFYA® is 200 mg administered by intravenous infusion over a period of at least one hour at Week 0, Week 4 and Week 8. Maintenance: After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w). Alternatively, according to clinical judgment, a maintenance dose regimen of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered (see Clinical Efficacy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment. Crohn’s Disease Induction: The recommended induction dosage of TREMFYA® is: <ul> <li>200 mg administered by intravenous infusion over a period of at least one hour at Week 0, Week 4 and Week 8. or</li> <li>400 mg administered by subcutaneous injection at Week 0, Week 4 and Week 8</li> </ul> Maintenance: After completion of the induction dose regimen, the recommended maintenance dose starting at Week 16 is 100 mg administered by subcutaneous injection every 8 weeks (q8w). Alternatively, according to clinical judgment, a maintenance dose regimen of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w) thereafter, may be considered (see Clinical Efficacy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment. Immunomodulators and/or corticosteroids may be continued during treatment with TREMFYA®. In patients who have responded to treatment with TREMFYA®, corticosteroids may be reduced or discontinued in accordance with standard of care. Palmoplantar pustulosis The recommended dosage of TREMFYA® is 100 mg administered by subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter. General considerations for administration Subcutaneous administration TREMFYA® is intended for use under the guidance and supervision of a physician. TREMFYA® may be administered by a health care professional, or a patient may self-inject after proper training in subcutaneous injection technique. Comprehensive instructions for the administration of TREMFYA® are given in “Instructions for use, handling, and disposal” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information and in the package leaflet, “Instructions for preparation and giving an injection of TREMFYA®.” Full amount of TREMFYA® should be injected according to the directions provided in the patient information leaflet. If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. Intravenous infusion (Ulcerative Colitis and Crohn’s Disease) TREMFYA® 200 mg vial is for IV infusion only. Intravenous infusion of TREMFYA® should be administered by qualified healthcare 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 (below 18 years of age) The safety and efficacy of TREMFYA® in pediatric patients have not been evaluated; therefore, no recommendations on dosing can be made (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Elderly (65 years of age and older) Of the 5926-plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease patients exposed to TREMFYA® in Phase 2 and Phase 3 clinical trials, a total of 339 patients were 65 years or older, and 34 patients were 75 years of age or older. No overall differences in safety or effectiveness were observed between older and younger patients who received TREMFYA® in clinical studies. However, the number of patients 65 years of age and older was not sufficient to determine whether elderly patients respond differently from younger patients (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment Specific studies of TREMFYA® have not been conducted in patients with renal insufficiency. Hepatic impairment Specific studies of TREMFYA® have not been conducted in patients with hepatic insufficiency.
Route Of Administration: SUBCUTANEOUS
Indication Info: Indications Plaque psoriasis Adults TREMFYA® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriatic arthritis TREMFYA® is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. Ulcerative colitis TREMFYA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Crohn’s disease TREMFYA® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. Palmoplantar pustulosis TREMFYA® is indicated for the treatment of moderate to severe palmoplantar pustulosis (PPP) in adult patients who do not adequately respond to conventional therapy.
Contraindications: Contraindications None.
Atc Code: L04AC16
Atc Item Name: guselkumab
Pharma Manufacturer Name: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/johnson-and-johnson-international-singapore-pte-ltd

Active Ingredients

Guselkumab

100mg/ml

GUSELKUMAB

100 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jan 17, 2020

Approval ID

c98d29f10a821f7f

Type

Therapeutic

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