Tremfya

Tremfya

guselkumab

Manufacturer:

Johnson & Johnson

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Guselkumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. As monotherapy or in combination w/ MTX for active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Dosage/Direction for Use
SC 100 mg at wk 0 & 4, followed by maintenance dose every 8 wk. Consider 100 mg every 4 wk for patients w/ psoriatic arthritis at high risk for joint damage according to clinical judgement.
Contraindications
Serious hypersensitivity. Clinically important active infections (eg, active TB).
Special Precautions
Immediately discontinue administration in case of serious hypersensitivity reactions. Avoid psoriatic skin as inj sites. Increased risk of infection. Do not initiate treatment in patients w/ any clinically important active infection until it resolves or is adequately treated. Evaluate for TB infection prior to treatment initiation. Monitor for signs & symptoms of active TB during & after treatment. Evaluate liver enzymes at baseline & thereafter when prescribing Tremfya every 4 wk in psoriatic arthritis. Temporarily interrupt treatment if increases in ALT or AST are observed & drug-induced liver injury is suspected. Live vaccines should not be used concurrently. Before live viral or bacterial vaccination, treatment should be w/held for at least 12 wk after the last dose & can be resumed at least 2 wk after vaccination. Has not been studied in patients w/ renal or hepatic impairment. Women of childbearing potential should use effective methods of contraception during treatment & for at least 12 wk after treatment. Preferable to avoid use during pregnancy. Discontinue breast-feeding, or abstain from Tremfya therapy during lactation. Safety & efficacy in childn & adolescents <18 yr have not been established. Limited information in elderly ≥65 yr & very limited information in elderly ≥75 yr.
Adverse Reactions
Resp tract infections. Headache; diarrhoea; arthralgia; inj site reactions; increased transaminases.
Drug Interactions
Safety & efficacy in combination w/ immunosuppressants (eg, biologics) or phototherapy have not been evaluated.
MIMS Class
Immunosuppressants / Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
L04AC16 - guselkumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Tremfya soln for inj 100 mg/mL
Packing/Price
1's
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