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Fraizeron

Fraizeron

secukinumab

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Secukinumab
Indications/Uses
Moderate to severe plaque psoriasis in patients ≥6 yr who are candidates for systemic- or phototherapy. Active moderate to severe hidradenitis suppurativa (HS) in adults w/ inadequate response to conventional systemic HS therapy. Alone or in combination w/ MTX for active psoriatic arthritis in adults w/ inadequate response to previous DMARDs therapy. Active ankylosing spondylitis (AS) in adults who inadequately respond to conventional therapy. Active non-radiographic axial spondyloarthritis (nr-axSpA) w/ objective signs of inflammation as indicated by elevated C-reactive protein &/or MRI evidence in adults who inadequately respond to NSAIDs. Active juvenile idiopathic arthritis (JIA) category of enthesitis-related arthritis (ERA) & juvenile psoriatic arthritis (JPsA) in patients ≥6 yr whose disease has responded inadequately to or intolerant to conventional therapy.
Dosage/Direction for Use
Plaque psoriasis & psoriatic arthritis patient who are anti-TNFα inadequate responders or patient w/ concomitant moderate to severe plaque psoriasis 300 mg SC inj given as 1 or 2 doses w/ initial dosing at wk 0, 1, 2, 3 & 4, followed by mthly maintenance dosing. Some patient ≥90 kg may derive additional benefit from 300 mg every 2 wk. For some patient, 150 mg may be acceptable. HS 300 mg SC inj w/ initial dosing at wk 0, 1, 2, 3 & 4, followed by mthly maintenance dosing. Maintenance dose may be increased to 300 mg every 2 wk based on clinical response. Psoriatic arthritis, AS & nr-axSpA 150 mg SC inj w/ initial dosing at wk 0, 1, 2, 3 & 4, followed by mthly maintenance dosing. May be increased to 300 mg based on clinical response for psoriatic arthritis & AS. Ped patient ≥6 yr w/ plaque psoriasis or JIA categories of ERA & JPsA SC inj w/ initial dosing at wk 0, 1, 2, 3 & 4, followed by mthly maintenance dosing. Ped <50 kg 75 mg, ≥50 kg 150 mg, may be increased to 300 mg for ped plaque psoriasis.
Contraindications
Severe hypersensitivity reactions. Active infection eg, TB.
Special Precautions
Discontinue use if anaphylactic or other serious allergic reaction occurs. Not to be given in active TB patients. Patients w/ chronic or history of recurrent infection; inflammatory bowel disease eg, Crohn's disease, ulcerative colitis; severe eczematous eruptions eg, dermatitis-like eruptions, dyshidrotic eczema & erythroderma (exfoliative dermatitis). Latex-sensitive individuals. Not to be given concurrently w/ live vaccines. Hepatic & renal impairment. Pregnancy & lactation. Ped <18 yr; ped w/ plaque psoriasis & JIA categories of ERA & JPsA <6 yr.
Adverse Reactions
URTI eg, nasopharyngitis, rhinitis, pharyngitis. Oral herpes; rhinorrhoea; diarrhoea; urticaria, dermatitis eg, eczema.
Drug Interactions
Not to be given concurrently w/ live vaccines.
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.
Presentation/Packing
Form
Fraizeron soln for inj (pre-filled pen) 150 mg/mL
Packing/Price
2 × 1's
Form
Fraizeron soln for inj (pre-filled pen) 300 mg/2 mL
Packing/Price
1's
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