Fraizeron Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Secukinumab

Indications/Uses

Moderate to severe plaque psoriasis in patients ≥6 yr who are candidates for systemic therapy or phototherapy. Alone or in combination w/ MTX for active psoriatic arthritis in adult patients who have responded inadequately to previous DMARD therapy. Active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Active non-radiographic axial spondyloarthritis w/ objective signs of inflammation who have responded inadequately to conventional therapy. Active enthesitis-related arthritis & juvenile psoriatic arthritis in patients ≥6 yr.

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Dosage/Direction for Use

SC Plaque psoriasis Adult & patient who are anti-TNF-α inadequate responders 300 mg w/ initial dose at wk 0, 1, 2, 3 & 4 followed by mthly maintenance dose given as 1 SC inj of 300 mg or 2 SC inj of 150 mg. Patient ≥90 kg may derive additional benefit from 300 mg every 2 wk. Ped ≥50 kg 150 mg, may be increased to 300 mg in some patients, 25 to <50 kg 75 mg, may be increased to 150 mg in some patients, <25 kg 75 mg. Each 75 & 150 mg dose is given as single dose. Each 300 mg dose is given as 1 SC inj of 300 mg or 2 SC inj of 150 mg. Psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis 150 mg w/ initial dose at wk 0, 1, 2, 3 & 4 followed by mthly maintenance dose, may be increased to 300 mg given as 1 SC inj of 300 mg or 2 SC inj of 150 mg. Patient w/ concomitant moderate to severe plaque psoriasis Follow adult plaque psoriasis dosage & administration. Non-radiographic axial spondyloarthritis 150 mg w/ initial dose at wk 0, 1, 2, 3 & 4 followed by mthly maintenance dose. Enthesitis-related arthritis & juvenile psoriatic arthritis Patients ≥50 kg 150 mg at wk 0, 1, 2, 3 & 4 followed by mthly maintenance dose given as single dose, <50 kg 75 mg at wk 0, 1, 2, 3 & 4 followed by mthly maintenance dose given as single dose.

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Overdosage

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Contraindications

Severe hypersensitivity.

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Special Precautions

Discontinue use if anaphylactic or other serious allergic reaction occurs. Not to be given concurrently w/ live vaccines. Patients w/ chronic or history of recurrent infection. Should not be administered until the infection resolves. Should not be given to patients w/ active TB. Consider anti-TB therapy in patients w/ latent TB. Patients w/ active inflammatory bowel disease. Renal or hepatic impairment. Pregnancy & breast-feeding. Ped patients w/ plaque psoriasis & in the juvenile idiopathic arthritis categories of enthesitis-related arthritis & juvenile psoriatic arthritis <6 yr. Ped patients <18 yr in other indications. Pre-filled pen: Avoid inj in areas of the skin that show psoriasis. Latex-sensitive individuals.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaphylactic reactions. URTI (eg, nasopharyngitis, rhinitis, pharyngitis, sinusitis, tonsillitis). Oral herpes, diarrhoea, urticaria, rhinorrhoea.

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Drug Interactions

Not to be given concurrently w/ live vaccines. Clinically relevant effect on CYP450 substrates w/ narrow therapeutic index.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Fraizeron detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants / Psoriasis, Seborrhea & Ichthyosis Preparations

ATC Classification

L04AC10 - secukinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

Regulatory Classification

Presentation/Packing

Form

Fraizeron powd for inj 150 mg

Packing/Price

(vial) 1's

Form

Fraizeron soln for inj 150 mg/mL

Packing/Price

1's

Form

Fraizeron soln for inj 300 mg/2 mL

Packing/Price

1's

Fraizeron

secukinumab

Manufacturer:

Novartis Indonesia